Practice Implementation - Eye Health Home - Quidel Eye Health€¦ · Dry eye may range in severity...

PracticeImplementation

Quality Control

Facility: _____________________________ InflammaDry® Quality Control Log Year: ___________

InflammaDry Kit

External Control

Internal Control

Positive

Negative

Corrective Action

Employee Initials

Date Rec’d

# Boxes Received

Date QC’d

Lot #

Exp. Date

Lot #

Exp. Date

Present

Result Acceptable

Result Acceptable

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

Y / N Y / N Y / N Y / N

QC1024001EN00 (08/17)

Provided as a courtesy by Quidel Corporation.

InflammaDry External Controls Page 1 of 4

For in vitro diagnostic use

INTENDED USE InflammaDry external controls are only to be used with the InflammaDry Test. They are intended to verify that the test reagents are working and that the test is correctly performed. InflammaDry is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.

REAGENTS AND MATERIALS

Positive Control (1) Negative Control (1) Diluent (1) Package Insert (1)

CONTENTS Positive Control Buffered solution containing detergent and recombinant MMP-9 protein, as well as additional proteins to simulate biological matrix. Negative Control Buffered solution containing detergent and proteins to simulate biological matrix. Contains 0.05%

Proclin 300 as a preservative. Diluent Deionized water

MATERIALS NOT PROVIDED InflammaDry Test Gloves Timer


EXTERNAL CONTROLS STORAGE AND STABILITY The unopened controls are to be stored at room temperature, not to exceed 86°F/30°C, until the expiration date noted on the outer packaging. The controls are designed for one (1) use. Opened vials should be used once within the day of reconstitution, and then discarded.

WARNINGS AND PRECAUTIONS For in vitro diagnostic use. Directions in the InflammaDry Package Insert must be followed for optimal results. Once dissolved, the controls should be clear and colorless. Controls should not be used if there is

flocculation or discoloration. The unopened controls are to be stored at room temperature, not to exceed 86°F/30°C. Unopened controls may be used until the expiration date noted on the outer packaging. Do not use

the controls past their expiration date. Controls are designed for one (1) use. Opened vials should be used within the same day of

reconstitution and then discarded. Follow Universal Precautions when handling these controls. Testing should be performed in an area with adequate ventilation. Dispose of containers and unused contents in accordance with Federal, State and Local regulatory

requirements. Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of

this kit. Wash hands thoroughly after handling. For additional information on hazard symbols, safety, handling and disposal of the components

within this kit, please refer to the Safety Data Sheet (SDS) located at quidel.com.

PROCEDURE 1. Choose either the Positive or Negative Control. The InflammaDry Sample Collector, Test Cassette

and Buffer can only be used once. 2. Remove the cap and rubber stopper from the selected control vial and add five (5) drops of Diluent

from the diluent bottle, one (1) drop at a time. 3. Recap the control vial and gently shake the vial to dissolve the lyophilized powder. Let the vial with

the liquid sit for at least two (2) minutes prior to use. 4. Open the control vial and pour the entire liquid contents of the vial into the inside of the black cap. 5. Open the Sample Collector pouch from an unused InflammaDry Test. 6. Dip the sampling fleece into the control liquid in the black cap. 7. Run and read the InflammaDry results per the instructions provided in the test’s Package Insert. A

Positive Control should show a positive result. A Negative Control should show a negative result. 8. When the correct control results are not obtained, repeat the test control, or contact Quidel

Technical Support before testing patients.

DAILY QUALITY CONTROL InflammaDry has built-in procedural controls (see Procedural Controls section of the InflammaDry Package Insert). For daily quality control, Quidel recommends documenting that these internal procedural controls were checked for the first sample tested each day.


PROCEDURAL CONTROLS The unused test has two (2) faint orange lines in the control zone. If the test flows correctly and the reagents work, a blue line will always appear in the control zone. If the control line does not appear, the test must be interpreted as invalid and should be repeated using a new InflammaDry Test. A purple fluid wave is observed moving across the result window while the test is running. Once the background color within the result window is white and 10 minutes have elapsed, the test may be accurately read. If there is a streaky fluid wave in the background, or if the test is negative after 10 minutes, allow an additional 5-10 minutes of running time, prior to interpretation. The test should be read within 6 hours of test completion.

EXTERNAL POSITIVE AND NEGATIVE CONTROLS In addition to your facility’s standard quality control procedures, it is recommended that both a positive and negative control be tested with each new lot, shipment, and every 30 days. Additional controls may be tested according to the requirements of Federal, State, and Local regulations or accrediting organizations.

TEST LIMITATIONS As with all diagnostic tests, InflammaDry results should be interpreted along with clinical findings and results from other diagnostic methods.

ASSISTANCE If you have any questions regarding the use of this product, please call Quidel’s Technical Support Number 800.874.1517 (n the U.S.) or 858.552.1100 (outside the U.S.), Monday through Friday, from 7:00 a.m. to 5:00 p.m., Pacific Time. If outside the United States contact your local distributor or [email protected].

RPS-DESTD – InflammaDry External Controls

Quidel Corporation 10165 McKellar Court San Diego, CA 92121 quidel.com 1337601EN00 (03/18)

InflammaDry® external controls

▪ Controls are designed for 1-time use only. Opened vials should be used within the day of reconstitution and then discarded.

▪ Components▪ ID Diluent – 1 vial

▪ Positive Control – 1 vial

▪ Negative Control – 1 vial

Prepare the controls

▪ The controls are packaged in a lyophilized (powdered) state and must be rehydrated prior to use.

To rehydrate:

▪ Remove the black cap and gray stopper from each control.

▪ Add 5 drops of the diluent to each control vial. Note: Hold the diluent at a 90 degree angle to ensure a full drop is delivered. Start with the negative control and move to the positive control to prevent cross contamination.

▪ Swirl each vial and allow to sit for 2 minutes.

▪ Document the appropriate lot number and expiration date on the quality control log while the controls are rehydrating.

Run the controls

▪ Only one control may be run on each InflammaDry test.

▪ Open the selected Positive or Negative control vial and place liquid in the black cap.

▪ Obtain an unused InflammaDry Test Cassette and open the Sample Collector pouch.

▪ Dip the Sample Collector’s sampling fleece 6-8 times into the selected control vial cap to moisten the fleece.

Run the controls

▪ Assemble the test

▪ Locate the Test Cassette (B) with the Test Cassette body (D) and the protective cap (F). The opened Test Cassette should be used within 1 hour.1. Assemble the test by gently placing the sampling fleece (C) of the Sample

Collector (A) into the sample transfer window (G) of the Test Cassette body (D).

2. Press firmly where indicated until the test feels secure. A double-click means the test is properly assembled.

3. Place the test wick in the Buffer Vial until the fluid enters the result window. Replace the cap and read at 10 minutes or up to 1 hour.

External control results

▪ A positive control should show a positive result and is noted as Result Acceptable on the QC log.

▪ A negative control should show a negative result and is noted as Result Acceptable on the QC log.

Procedure Manual

InflammaDry Page 1 of 15

This Procedural Bulletin is intended to provide a ready outline reference for performance of the assay. These abbreviated directions for use are not intended to replace the complete package insert. It is the obligation of every manufacturer of medical devices labeled FOR IN VITRO DIAGNOSTIC USE to provide a complete package insert in accordance with FDA labeling regulation (21 CFR 809.10). Quidel Corporation provides CLSI procedures for your use. The procedures are required to include the same information as listed in the package insert. Any modifications to this document are the sole responsibility of the Laboratory. ________________________________________________________________________________________

InflammaDry

CLIA Complexity: Waived

For in vitro diagnostic use, Rx only. A CLIA Certificate of Waiver is required to perform the test in a waived setting. To obtain a Certificate of Waiver, please contact your state health department. Additional CLIA waiver information is available at the Centers for Medicare and Medicaid website at www.cms.hhs.gov/CLIA or from your state health department. Read the Package Insert and quality control procedures completely before using the product. Carefully follow the instructions when performing the test. Failure to follow the instructions or modification to the test system instructions will result in the test no longer meeting the requirements for waived classification. NOTE: Do not discard this Package Insert. There is only one (1) Package Insert per dispenser box. Additional copies of the Package Insert can be found at quidel.com/InflammaDry. INTENDED USE InflammaDry is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites. Store between 39˚F to 77˚F (4˚C to 25˚C). Not to be taken internally. Keep out of reach of children. SUMMARY AND EXPLANATION Dry eye, or dysfunctional tear syndrome, as defined by the Dry Eye Work Shop (DEWS DEWS II), is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.1 Dry eye is an extremely common condition that is often under diagnosed. Dry eye may range in severity from episodic symptoms of ocular discomfort, to a chronic condition requiring therapeutic intervention. Inflammatory mechanisms are believed to be one possible underlying cause of chronic dry eye.1,4 Currently, the diagnosis of dry eye is based upon a clinical exam and supported by some ancillary testing. The clinical diagnosis of dry eye includes utilizing a combination of symptoms and signs.1 Typically, physicians ask patients to report on the presence of burning, stinging, discomfort, tearing, foreign body sensation, and fluctuating vision. The Ocular Surface Disease Index (OSDI) was developed to target and quantify the most common symptoms associated with dry eye. This is a standard instrument used in screening patients with dry eyes for therapeutic dry eye studies.1-2


The clinical signs of dry eye include corneal staining and reduced tear break up time (TBUT). In many cases, a Schirmer tear test is performed to confirm the presence of reduced tear production.1 Other dry eye tests that measure tear osmolarity or lactoferrin are also available. Dry eye involves the relationship between the amount of tears produced, rate of tear evaporation, and the presence or absence of inflammation. Matrix metalloproteinases (MMP) are proteolytic enzymes that are produced by stressed epithelial cells on the ocular surface. MMP-9, in particular, is a nonspecific inflammatory marker that has consistently been shown to be elevated in the tears of patients with dry eyes.3-19 Studies have demonstrated that greater levels of MMP-9 are present in patients with more severe dry eyes, and that the levels correlate with clinical exam findings and contrast sensitivity.4

MMP-9 IN TEARS MMP-9 is a nonspecific inflammatory marker that has consistently been shown to be elevated in the tears of patients with dry eyes. The normal levels of MMP-9 (ng/ml) in human tears range from 3 ng/mL to 40 ng/mL.3-8

Elevated MMP-9 levels in patients with moderate to severe dry eye disease correlate with clinical exam findings.4 Altered corneal epithelial barrier function is the cause for ocular irritation and visual morbidity in dry eye disease. MMP-9 appears to play a physiological role in regulating corneal epithelial desquamation. The increased MMP-9 activity in dry eyes may contribute to deranged corneal epithelial barrier function, increased corneal epithelial desquamation, and corneal surface irregularity.16 InflammaDry detects elevated levels of MMP-9 ≥ 40 ng/mL in tears to aid in the clinical diagnosis of dry eye in patients with suspected dry eye disease in conjunction with other methods of clinical evaluation.

Normal Levels of MMP-9 in Tears

Study Normal Control

Average MMP-9 Levels (ng/mL)

Standard Deviation (ng/mL)

Upper Range (ng/mL)

Acera et al.3 18 23.6 17.4 41.0

Chotikavanich et al4 16 8.4 4.7 13.0

Solomon et al5 17 7.2 2.1 9.0

Leonardi et al6 10 10.5 0.2 11.0

Lema et al7 20 6.9 1.4 8.0

Honda et al8 28 22.7 14.0 37.0

Markouilie et al9 38 11.6 15.2 N/A

Total/Avg/Range 147 12.9 – 41.0 PRINCIPLE OF THE PROCEDURE InflammaDry utilizes Direct Sampling Micro-Filtration technology, based on the principle of lateral flow immunoassay. MMP-9, if present in the tear sample, is captured between MMP-9 specific mouse monoclonal and goat polyclonal antibodies at concentrations ≥ 40 ng/mL. This antigen-antibody complex is captured by NeutrAvidin immobilized as the test line. REAGENTS AND MATERIALS SUPPLIED 20-Test Kit: Individually Packaged Sample Collector (20) Individually Packaged Test Cassettes (20) Buffer Vial (20): buffered salt solution containing 0.1% Sodium Azide, as a preservative Package Insert (1) The Sample Collector (A) is a separately packaged sterile component that can easily be assembled onto the Test Cassette (B). Additionally, the Test Cassette (B) guarantees correct sample transfer onto the lateral flow assay strip.


The buffer vial contains a buffered salt solution containing: 200 mM Tris 10% Fish 81 (sea block) 0.8% Tergitol 100 mM NaCl 0.1% Sodium Azide 0.0126% Gentamycin pH 9.5 ± 0.05

MATERIALS NOT SUPPLIED IN KIT Timer Gloves Quality control materials (see section on external controls) WARNINGS AND PRECAUTIONS For in vitro diagnostic use only. For prescription use. Keep the Test Cassette and Sample Collector in their foil pouches until just before use. The Dacron® material used in the sampling fleece may cause allergic reactions for some people. Do not use InflammaDry past the expiration date. Follow Universal Precautions when handling patient samples. Both InflammaDry and the Buffer Vial are single-use items. Do not reuse with multiple specimens. InflammaDry requires a visual readout. Do not interpret the test result if you have color-impaired vision. Result interpretation requires a brightly lit environment. Do not use the same InflammaDry test on more than one patient. Slit-lamp biomicroscopy is required to eliminate patients with active intraocular inflammation. InflammaDry should be performed prior to instilling ocular anesthetic, topical dyes, or performing

Schirmer testing. Dispose of containers and unused contents in accordance with Federal, State and Local regulatory

requirements. Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this

kit. Wash hands thoroughly after handling. For additional information on hazard symbols, safety, handling and disposal of the components within

this kit, please refer to the Safety Data Sheet (SDS) located at quidel.com.

KIT STORAGE AND STABILITY Store InflammaDry between 39˚F to 77˚F (4˚C to 25˚C). Both InflammaDry and the buffer are stable until the expiration dates marked on their outer packaging and containers.

Sample Collector

(A)

Test Cassette

(B)

Buffer Vial


QUALITY CONTROL InflammaDry has built-in procedural controls (see below). For daily quality control, Quidel recommends documenting that these internal procedural controls were checked for the first sample tested each day. Procedural Controls An unused InflammaDry device has a purple flow indicator on the test strip in the sample transfer window (G). The unused device also has two (2) faint orange lines in the result window (H). If the test is valid, a BLUE line will appear in the control zone. The appearance of the control line indicates the correct application of adequate sample volume. The control line must appear for all tests to be considered as valid tests. If the control line does not appear, the test must be interpreted as invalid and has to be repeated by resampling the eye using a new InflammaDry test. DO NOT report invalid test results. Repeat the test after waiting 60 minutes. A purple fluid wave is observed moving across the result window (H) while the test is running. Once the background within the result window (H) is white and 10 minutes have elapsed, the test may be accurately read. If there is a streaky fluid wave in the background, or if the test is negative after 10 minutes, allow an additional 5-10 minutes of running time prior to interpretation. External Controls InflammaDry external controls are available directly through Quidel. InflammaDry external controls consist of two (2) vials (a positive control containing recombinant MMP-9 protein and a negative control) and diluent. InflammaDry external control testing should be performed with each new lot, each new shipment, and every 30 days. Please refer to the external controls Package Insert for instructions on how to run the external controls. External controls will have an individual expiration date printed on each package. DO NOT use past the expiration date.

When the correct control results are not obtained, repeat the test control or contact Quidel Technical Support at 800.874.1517 (in the U.S.) or 858.552.1100 (outside the U.S.).

Additional External Controls may be obtained separately by contacting Quidel’s Customer Support Services at 800.874.1517 (in the U.S.) or 858.552.1100 (outside the U.S.).


TEST PROCEDURE Expiration date: Check expiration on all packaging. Make sure there is no damage to the foil pouches. Do not use if foil pouches are damaged. Do not use any test past the expiration date on the label.

Preparing the Test Tear open each foil pouch at the indicated perforation and remove the contents. Do not touch the sterile sampling fleece (C) prior to collecting the patient sample.

Sample Collector

Test Cassette Taking a Sample 1. Locate the sampling fleece (C) on the underside of the sample collector (A). 2. If ocular anesthetic or any other topical medication has been applied to the eye, wait at least 2 hours

before collecting a sample. Gently lower the patient’s eyelid to expose the inside of the lower lid (palpebral conjunctiva).

3. Gently dab the sampling fleece (C) in multiple locations along the palpebral conjunctiva, releasing the lid after every 2-3 dabs to allow the patient to blink, until the sampling fleece is saturated. Adequate saturation usually occurs when the sampling fleece is dabbed at least 6-8 times and then allowed to rest against the conjunctiva for an additional 5 seconds. In more severe dry eye states, additional dabbing may be necessary to moisten the sampling fleece. Do not use a dragging motion when collecting the sample.

Upon saturation with tear fluid, the fleece will glisten. Based on tear volume and composition, the fleece may appear white or patchy pink in color.

Assembling the Test 1. Locate the Test Cassette (B) with the Test Cassette body (D) and the protective cap (F). Remove the

protective cap (F) from the test. The opened Test Cassette should be used within 1 hour. 2. Assemble the test by gently placing the sampling fleece (C) of the sample collector (A) into the sample

transfer window (G) of the Test Cassette body (D).

Sampling Fleece (C)

Sample Transfer

Window (G)

Test Cassette Body (D)

Absorbent Tip (E) With Protective

Cap (F) Result

Window (H)


3. Press firmly where indicated until the test feels secure. A double-click means the test is properly assembled.

Running the Test 1. Remove the protective cap (F) from the Test Cassette. Open the Buffer Vial. 2. Immerse the absorbent tip (E) into the Buffer Vial for a minimum of 20 seconds, ensuring that the

absorbent tip is not bent in any manner.

3. Remove the absorbent tip (E) from the Buffer Vial, replace the protective cap (F), and lay the test flat on

a horizontal surface for 10 minutes.

INTERPRETATION OF RESULTS NOTE: Do not interpret the test results before completing at least 10 minutes of development time. A purple fluid wave may be observed moving across the result window (H) while the test is running. Once the background within the result window (H) is white and 10 minutes have elapsed, the test may be accurately read. If there is a streaky fluid wave in the background, or if the test is negative after 10 minutes, allow an additional 5-10 minutes of running time prior to interpretation. The test should be read within 6 hours of test completion. After this period of time, it is possible that the results may change. Accurate visual interpretation requires examination under brightly lit conditions. The results of the test are indicated through two (2) lines, which appear in the result window (H): the control line and the result line. The control line appears as a BLUE line in the control zone. The control line indicates the correct application and performance of the test and must appear for the test to be valid. Positive Result The presence of both a BLUE line in the control zone and a RED line in the result zone indicates a positive result. An uneven or incomplete RED line is due to an uneven distribution of tear fluid on the sampling fleece (C). Even if the RED line is faint in color, incomplete over the width of the test strip, or uneven in color, it must be interpreted as positive. A positive result indicates the presence of MMP-9 ≥ 40 ng/ml. The results should be evaluated with all clinical and laboratory data available. If the results do not agree with the clinical evaluation, additional tests should be performed.


Negative Result The presence of only a BLUE line in the control zone indicates a negative result. A negative result is indicative of an MMP-9 level < 40 ng/ml. The results should be evaluated with all clinical and laboratory data available. If the results do not agree with the clinical evaluation, additional tests should be performed. Invalid Result If a BLUE line does not appear, the test is invalid. Re-immerse the absorbent tip (E) into the Buffer Vial for an additional 10 seconds. If a BLUE line still does not appear, the test must be discarded and the subject retested by resampling the eye using a new InflammaDry test. DO NOT report invalid test results. Although the test requires only 10 μL of fluid, if a second sample is needed, repeat dabbing may result in reducing the available tear fluid required for collecting an adequate sample. Each additional sample collection may reduce or alter the MMP-9 antigen load transferred to the test. If a second sample is needed, the sampling may be repeated 60 minutes later.

LIMITATIONS MMP-9 is a nonspecific indicator for the presence of inflammation. A positive test result should not be

used as the sole basis for treatment or other management decision. Patients with severe aqueous deficient dry eye, who produce a sample volume of less than 6 uL, may

yield a false negative result. InflammaDry should not be used within 20 minutes of performing a Schirmer tear test, as this may

stimulate degranulation of MMP-9 and cause a false positive result. A recent history of ocular surgery or infection, allergic conjunctivitis, or other ocular surface diseases

may lead to elevated levels of MMP-9 and cause a false positive result. Patients with a history of contact lens use or recent ocular surgery were not studied; no data supports

any claims for safety and efficacy in these populations. Certain medications such as systemic immunomodulators, topical or oral steroids, cyclosporine,

tetracycline, and topical azithromycin, are known to inhibit metalloproteinase activity. Use of these medications may lead to false negative results.

Running the test in an environment with a temperature of 45˚C or above, and humidity of 60% or above, may increase sensitivity and cause a false positive result.

InflammaDry should not be performed in conditions which could lead to conjunctival injury, such as Stevens’ Johnson Syndrome or other cicatricial conditions.

Slit-lamp biomicroscopy is required to eliminate patients with active intraocular inflammation. InflammaDry should be performed prior to instilling ocular anesthetic, topical dyes, or performing

Schirmer testing. EXPECTED VALUES Normal levels of MMP-9 (ng/ml) in human tears range from 3 ng/ml to 40 ng/ml.3-8 The prevalence of dry eye ranges from 5% to 30% in people aged > 50 years and dry eye is estimated to affect 21 million people in the United States.1,20-21 A national survey of 2,003 individuals found that nearly 40% of Americans experience dry eye symptoms, which may include dryness, burning, irritation, blurred vision, foreign body sensation and tearing.1,22 The prevalence of dry eye increases with age and is far more common in women. Other risk factors include the use of certain medications, autoimmune inflammatory diseases, contact lens wear, LASIK and refractive surgery, and menopause.1


FDA MEDWATCH Report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of the Quidel InflammaDry Test to Quidel Technical Support at 800.874.1517 (in the U.S.) or 858.552.1100 (outside the U.S.) and/or to FDA MedWatch (tel: 800.FDA.1088, fax: 800.FDA.0178 or www.fda.gov/medwatch). CLIA WAIVER UNTRAINED USER STUDY A clinical study was conducted at four (4) intended use sites and the participants were given only the test instructions. Those patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study. The study enrolled 237 patients, consisting of 164 females and 73 males, between the ages of 18 and 94 years, with an average age of 53 years. Patients presented from both private practices and academic centers, from various regions across the country. The protocol deviation involved patients receiving topical ocular anesthetic prior to the evaluation of the tear break up time (TBUT) and corneal staining, potentially accelerating the TBUT and inducing corneal staining. Inclusion Criteria 18 years of age or older Patient voluntarily reported at least one (1) episode of any of the following ocular symptoms during the

last month: Burning or stinging Sandy or gritty feeling Foreign body sensation Tearing Light sensitivity Intermittent or fluctuating vision Tired eyes

Exclusion Criteria Allergy to cornstarch or Dacron® Allergy to topical anesthetic or fluorescein dye Prior eye injury, trauma, or ocular surgery, within the last three (3) months Known blockage of the lacrimal drainage system Contact lens wear in the last month Previous corneal refractive surgery including RK, LASIK, or PRK surgery Have an active ocular infection or history of a recent ocular infection in the last month Have active intraocular inflammation or history of intraocular inflammation, e.g. uveitis Use of oral doxycycline, corticosteroids, or immunomodulators in the last month Have received topical ocular corticosteroids, topical nonsteroidal (NSAIDs) therapy, or topical ocular

cyclosporine in the last month Pregnant or lactating Use of any topical ophthalmic medications, including artificial tears, 2 hours prior to enrollment Study testing was done on the subject’s more symptomatic eye. If there was no existing symptomic difference between the two eyes, the right eye was tested. Each subject underwent the following sequence of testing: InflammaDry, tear break up time (TBUT), Schirmer tear testing, and corneal staining. The InflammaDry test was compared to the clinical assessment in the following table. Derived from the DEWS criteria, the clinical assessment was developed to represent a combination of symptoms and signs. The pivotal clinical trial used the same metrics for TBUT, Schirmer tear testing, and corneal staining, as described in the DEWS criteria. However, conjunctival injection, conjunctival staining, and the presence of meibomian disease were not tested or used to characterize the severity of dry eye disease. In general, the

http://www.fda.gov/medwatch


worst severity for any sign tested determined the overall severity. Symptoms are known to be poorly correlated with signs, with even the most severe dry eye patients often reporting little to no symptoms. Patients were categorized to the highest severity level at which all required criteria are satisfied. Patients who did not meet all the required clinical criteria for a given severity grade were considered to be the next lower grade.

InflammaDry Compared to Clinical Assessment

Clinical Testing Negative Control

Mild Grade 1

Moderate Grade 2

Moderately Severe

Grade 3

Severe Grade 4

OSDI Score ≤ 13 ≥ 13 ≥ 13 ≥ 13 ≥ 13

TBUT (sec)8 > 10 < 10 ≤ 10 ≤ 5

0 (immediate)

Schirmer (mm/5 min)8

> 10 < 10 ≤ 10 ≤ 5 ≤ 2

Staining (0-5)9 None None 1 – 2 3 ≥ 4

CLINICAL RESULTS FROM FOUR (4) SITES Grade is assessed based on OSDI, TBUT, Schirmer tear testing, and corneal staining, as described in the DEWS criteria. However, conjunctival injection, conjunctival staining, and the presence of meibomian disease were not tested or used to characterize the severity of dry eye disease. Grade 0 (negative control) is when OSDSI is ≤13, TBUT is >10 seconds, Schirmer is >10mm, staining is

none. Grade 1 (mild) is when OSDI score is ≥ 13, TBUT is <10 seconds, Schirmer is <10 mm, staining is none. Grade 2 (moderate) is when OSDSI is ≥13, TBUT is ≤10 seconds, Schirmer is ≤10 mm, staining is 1-2. Grade 3 (moderately severe) is when OSDSI is ≥13, TBUT is <5 seconds, Schirmer is ≤5 mm, staining is 3. Grade 4 (severe) is when OSDSI is ≥13, TBUT is 0 seconds (immediate), Schirmer is ≤2 mm, staining is ≥4.

Site 1 Grade

Total 4 3 2 1 0

InflammaDry + 0 0 15 41 1 57

InflammaDry – 0 0 0 2 31 33

Total 0 0 15 43 32 90

Site 2 Grade

Total 4 3 2 1 0

InflammaDry + 0 7 21 1 1 30


Total 0 7 21 9 48 85

Site 3 Grade

Total 4 3 2 1 0

InflammaDry + 0 0 4 4 0 8


Total 0 0 7 5 0 12


Site 4 Grade

Total 4 3 2 1 0

InflammaDry + 1 11 20 1 0 33


Total 1 13 33 3 0 50

DEVICE PERFORMANCE The multicenter clinical study depicted below demonstrated the following range of performance positive agreement 66% to 97% and negative agreement 97% to 98%. At two (2) sites, negative agreement could not be calculated because there were no subjects without dry eye.

Multicenter Clinical Study N=237

Clinical Assessment OSDI** + TBUT + Schirmer + Staining

Positive % Agreement

95% / Confidence

Interval

Negative % Agreement

95% / Confidence

Interval Positive Negative

Site 1 InflammaDry

Positive 56 1 97% (56/58) (88%, 99%)

97% (31/32) (84%, 99%) Negative 2 31

Site 2 InflammaDry

Positive 29 1 78% (29/37) (63%, 89%)

98% (47/48 (89%, 100%) Negative 8 47

Site 3 InflammaDry

Positive 8 0 67% (8/12) (39%, 86%)

N/A*

Negative 4 0

Site 4 InflammaDry

Positive 33 0 66% (33/50) (52%, 78%)

N/A*

Negative 17 0 *N/A = Not available. Specificity cannot be calculated because there were no subjects without dry eye. **11 patients were assessed to be positive for mild dry eye based on the OSDI (OSDI ≥ 13) without any associated positive objective test results.

CUT-OFF STUDY A cut-off study was performed using increments from 5 ng/mL to 70 ng/mL. The study was conducted with ten (10) operators testing ten (10) replicates of stabilizing buffer samples spiked with MMP-9. The results are presented below.

Concentration (ng/mL) Negative Positive

5 100 0

10 (–75%) 93 7

20 (–50%) 97 3

30 (–25%) 83 17

35 65 35

40 (cut-off) 48 52

50 (25%) 5 95

60 (50%) 0 100

70 (75%) 0 100

CROSS-REACTIVITIES Various infectious ocular pathogens, generated in cell culture, and important ocular enzymes were applied in the laboratory to determine potential cross-reactivities with InflammaDry: Adenovirus IgE Staphylococcus aureus Methicillin-resistant Staphylococcus aureus (MRSA) Moraxella catarrhalis Haemophilus influenzae


Staphylococcus epidermis Streptococcus pneumoniae Pseudomonas aeroginosa Matrix metalloproteinase: 1, 2 and 3 Tissue inhibitor of MMP: MMP-1, MMP-2 All isolates were cultured from human specimens. The concentrations of the suspensions were between 500,000 and 1,500,000 microorganisms (virus, bacteria) per ml of supernatant. No positive test lines developed, and no cross-reactivities to these species occurred when 10 μL of the culture suspension was tested. No ocular enzymes caused any cross-reactivity. INTERFERING SUBSTANCES The following eye medications were tested for interference with InflammaDry near the cutoff level with the respective medication. The following medications did not show any interference: Alcon, Alcaine Alcon, Azopt Alcon, Econopred Alcon, Nevanac Alcon, Pataday Alcon, Systane Alcon, Tobra Dex Alcon, Travatan Alcon, Vigamox Allergan, Acular LS Allergan, Alphagan Allergan, Combigan Allergan, Elastat Allergan, FML Allergan, Lastacaft Allergan, Lumigan Allergan, Optive Allergan, Pred Forte Allergen, Refresh Liquigel Allergan, Refresh Tears Allergan, Zymar AMO, Blink Tears

AVS, Thera Tears Bausch + Lomb, Alrex Bausch + Lomb, Lotemax Bausch + Lomb, Zylet Falcon, Gentamicin Sulfate Falcon, Polymyxin B Sulfate Falcon, Timolol Inspire, AzaSite Ista, Bepreve Ista, Xibrom Medpoint, Optivar Novartis, GenTeal Novartis, Voltaren Novartis, Zaditor Pfizer, Visine Pfizer, Xalatan Sigma-Aldrich, Human IgA (1 mg/ml) Sigma-Aldrich, Human Lactoferrin (1 mg/ml) Sigma-Aldrich, Transferrin (1 mg/ml) Vistakon, Betimol

However, the following medications show false positive or false negative results; therefore, patients should not be tested with InflammaDry if the following medications were administered into the eyes within 2 hours of the testing of the InflammaDry. Interference medications: Merck, Trusopt Vistakon, Iquix

Vistakon, Quixin Wilson, Proparacaine

Caution: Topical ophthalmic medications come in different formulations and some formulations (i.e., gels, ointments, etc.) may persist on the tear film longer than others. Therefore, caution should be used when using the InflammaDry test on a subject who may be on such a medication, since certain medications may cause erroneous results if present on the ocular surface. In addition, certain medications may cause erroneous results if used immediately before taking a sample. If ocular anesthetic or any other topical medication has been applied to the eye, wait at least 2 hours before collecting a sample.


REPRODUCIBILITY STUDY A reproducibility study was performed in three (3) point-of-care sites using the intended operator over five (5) days. A total of 720 samples (120 samples for each of the six (6) concentrations) were prepared in stabilizing buffer containing six (6) different concentrations of purified MMP-9 protein. The concentrations were chosen to be close to the assay cutoff (40 ng/ml). The results for each sample over the entire study are summarized in the table below.

Reproducibility Study Negative – / +

Negative – / +

–50% – / +

–25% – / +

Cut-off – / +

+25% – / +

+50% – / +

Site 1 Operator 1 20/0 19/1 18/2 4/16 0/20 0/20

Operator 2 20/0 19/1 10/10 4/16 2/18 0/20

Site 2 Operator 1 20/0 20/0 17/3 10/10 3/17 0/20

Operator 2 20/0 20/0 18/2 12/8 2/18 3/17

Site 3 Operator 1 20/0 20/0 19/1 10/10 2/18 0/20

Operator 2 20/0 20/0 18/2 12/8 2/18 0/20

Combined 120/0 118/2 100/20 52/68 11/109 3/117

Lot-to-lot reproducibility was tested with three (3) different InflammaDry lots. There was no variability among the three (3) lots as assessed by testing in triplicates with seven (7) different concentrations of MMP-9 ranging from 0 to 160 ng/mL. ASSISTANCE If you have any questions regarding the use of this product, please call Quidel’s Technical Support Number 800.874.1517 (in the U.S.) or 858.552.1100 (outside the U.S.), Monday through Friday, from 7:00 a.m. to 5:00 p.m., Pacific Time. If outside the United States contact your local distributor or [email protected].

REFERENCES 1. Definition and Classification of Dry Eye. Report of the Diagnosis and Classification Subcommittee of the

Dry Eye Work Shop (DEWS II). Ocular Surface 2017;15:276-283. 2. Schiffman RM, Christianson MD, Jacobsen G, et al. Reliability and validity of the Ocular Surface Disease

Index. Arch Ophthalmol 2000;118(5):615-621. 3. Acera A, Rocha G, Vecino E, et al. Inflammatory markers in the tears of patients with ocular surface

disease. Ophthalmic Res. 2008 Oct; 40(6):315-21. 4. Chotikavanich S, de Paiva CS, Li de Q, et al. Production and activity of matrix metalloproteinase-9 on the

ocular surface increase in dysfunctional tear syndrome. Invest Ophthalmol Vis Sci. 2009 Jul; 50(7):3203-9.

5. Solomon A, Dursun D, Liu Z, et al. Pro- and anti-inflammatory forms of interleukin-1 in the tear fluid and conjunctiva of patients with dry-eye disease. Invest Ophthalmol Vis Sci. 2001;42(10):2283-92.

6. Leonardi A, Brun P, Abatangelo G, et al. Tear levels and activity of matrix metalloproteinase (MMP)-1 and MMP-9 in vernal keratoconjunctivitis. Invest Ophthalmol Vis Sci. 2003;44(7):3052-8.

7. Lema I, Sobrino T, Durán JA, et al. Subclinical keratoconus and inflammatory molecules from tears. Br J Ophthalmol. 2009;93(6):820-4.

8. Honda N, Miyai T, Nejima R, et al. Effect of latanoprost on the expression of matrixmetalloproteinases and tissue inhibitor of metalloproteinase 1 on the ocular surface. Arch Ophthalmol. 2010;128(4):466-71.

9. Markoulli M, Papas E, Cole N, et al. The effect of contact lens wear on the diurnal profile of matrix metalloproteinase-9 and its inhibitor in the tear film. Poster present edat the 6th International Conference on the Tear Film and Ocular Surface: Basic Science and Clinical Relevance. Florence, Italy. 24 Sept 2010.

10. Hadassah J, Bhuvaneshwari N, Rao U, et al. Evaluation of succinylated collagen bandage lenses in corneal healing by the expression of matrix metalloproteinases (MMP-2 and MMP-9) in tear fluid. Ophthalmic Res. 2009;42(2):64-72.


11. Sobrin L, Liu Z, Monroy DC, et al. Regulation of MMP-9 activity in human tear fluid and corneal epithelial culture supernatant. Invest Ophthalmol Vis Sci. 2000;41(7):1703-9.

12. Afonso AA, Sobrin L, Monroy DC, et al. Tear fluid gelatinase B activity correlates with IL-1alpha concentration and fluorescein clearance in ocular rosacea. Invest Ophthalmol Vis Sci. 1999;40(11):2506-12.

13. Oh JY, In YS, Kim MK, et al. Protective effect of uridine on cornea in a rabbit dry eye model. Invest Ophthalmol Vis Sci. 2007;48(3):1102-9.

14. Pflugfelder SC, de Paiva CS, Tong L, et al. Stress-activated protein kinase signaling pathways in dry eye and ocular surface disease. Ocul Surf. 2005;3(4 Suppl):S154-7.

15. Luo L, Li DQ, Corrales RM, et al. Hyperosmolar saline is a proinflammatory stress on the mouse ocular surface. Eye Contact Lens. 2005;31(5):186-93.

16. De Paiva CS, Corrales RM, Villarreal AL, et al. Corticosteroid and doxycycline suppress MMP-9 and inflammatory cytokine expression, MAPK activation in the corneal epithelium in experimental dry eye. Exp Eye Res. 2006 Sep; 83(3):526-35.

17. Luo L, Li DQ, Doshi A, et al. Experimental dry eye stimulates production of inflammatory cytokines and MMP-9 and activates MAPK signaling pathways on the ocular surface. Invest Ophthalmol Vis Sci. 2004;45(12):4293-301.

18. Pflugfelder SC, Farley W, Luo L, et al. Matrix metalloproteinase-9 knockout confers resistance to corneal epithelial barrier disruption in experimental dry eye. Am J Pathol. 2005;166(1):61-71.

19. Li DQ, Chen Z, Song XJ, et al. Stimulation of matrix metalloproteinases by hyper osmolarity via a JNK pathway in human corneal epithelial cells. Invest Ophthalmol Vis Sci. 2004;45(12):4302-11.

20. Market Scope. Report on the Global Dry Eye Market. St. Louis, Mo: Market Scope, 2004. 21. Multi-sponsor surveys, Inc. Gallup study of dry eye sufferers. Princeton, NJ, 2006. 22. Schaumberg, DA, Buring JE, Sullivan DA, et al. Hormone replacement therapy and dry eye syndrome.

JAMA 2001;286:2114-2119.


LOG SHEET

Record Built-in Procedural Controls on the first patient tested each day.

Date Patient ID Valid

Procedural Control

Test Results At 10 minutes

Lot Number and Expiration Date

Technician Initials

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15


QC LOG SHEET

Facility Name:

Quidel recommends that positive and negative controls be run once for each untrained operator, once for each new shipment of kits — provided that each different lot received in the shipment is tested — and as deemed additionally necessary by your internal quality control procedures, and in accordance with local, state, and federal regulations or accreditation requirements. If you have any questions or concerns, please contact Quidel Technical Support at 800.874.1517 or at [email protected].

Date

MM/DD/YY Kit Lot #

Positive Control passed?

Negative Control passed?

Comments Technician

Initials

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

CL1337401EN00 (11/17)

mailto:[email protected]

Training Form

Customer Training Sign-In Form

Practice Name City, State, Zip

Primary Contact Telephone

Address Date of Training

Product

First Name (PRINT)

Last Name (PRINT)

Signature MC/DO/

OD PA/NP RN/LVN

/LPN Eye

Tech Other

Pos/ Neg

Other

Safety Data

InflammaDry® Safety Data Sheet Revision Date: June26, 2017

Page 1 of 6

1.1 Manufacturer Information

Quidel Corporation Phone: 1.800.874.1517 Web: quidel.com

10165 McKellar Court Fax: 1.858.453.4338 E-mail: [email protected]

San Diego, CA 92121 Emergency (24-Hour): 1.866.519.4752

1.2 Product Information

Product Name: InflammaDry (Catalog #: RPS-ID-20-U)

Intended Use: A rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9

protein in human tears, from patients suspected of having dry eye. For in vitro diagnostic use only. For

prescription use. Single use only.

Components: Sample Collector, Test Cassette, Buffer Vial

2.1 Classification of the Substance of Mixture Not a hazardous substance or mixture.

2.2 GHS Label Elements, including Precautionary Statements Not a hazardous substance or mixture.

2.3 Supplemental Hazard Statements

- Refer to Universal Precautions information in Section 7, Handling and Storage.

- Avoid disposal of the Buffer solution down the sanitary or industrial plumbing systems. Refer to Section 13, Disposal

Considerations for further guidance.

▪ Sodium azide is used as a preservative (0.1%).

▪ Tergitol (0.8%) – Contains various components that are listed on the California Prop 65 list. Refer to Section 15.

▪ Gentamycin (0.0126%) – May act as a skin sensitizer in some individuals. Refer to Section 8 for appropriate personal

protection recommendations.

- The Dacron material used in the sampling fleece may cause allergic reactions for some people upon contact with the eye.

3.1 Mixtures

Contains non-hazardous quantities of proprietary ingredients according to OSHA (29 CFR 1910.1200).

Not a hazardous mixture according to Regulation (EC) No. 1272/2008.

3.2 No chemicals need to be disclosed according to the applicable regulations for the components in this kit.

4.1 Description of First Aid Measures

If inhaled: Move the person to fresh air and support breathing as required.

In case of skin contact: Wash affected area with soap and water. Seek medical advice if irritation develops.

In case of eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical attention.

If swallowed: Never give anything by mouth to an unconscious person. Rinse mouth with water. Seek medical advice if irritation develops.

4.2 Most Important Symptoms and Effects (both acute and delayed)

To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.

4.3 Indication of Any Immediate Medical Attention and Special Treatment Needed

No specific measures identified.

Section 1 – Product and Company Identification

Section 2 – Hazard Identification

Section 3 – Composition / Information on Ingredients

Section 4 – First Aid Measures

http://www.quidel.com/



Page 2 of 6

Only individuals properly trained and issued appropriate personal protective equipment should respond and attempt to extinguish a fire.

5.1 Suitable Extinguishing Media For small fires, use dry chemical, carbon dioxide or alcohol-resistant foam.

5.2 Special Hazards Arising from the Substance or Mixture Nature of decomposition products not known.

5.3 General Fire Hazards The components within this kit will not significantly contribute to the intensity of a fire.

5.4 Fire Fighting Equipment Firefighters should wear full protective gear when responding to fires.

Only individuals properly trained and issued appropriate personal protective equipment should respond and attempt to clean up a spill or release. A large spill of any of the components listed in this SDS is unlikely.

6.1 Personal Precautions Use personal protective equipment, including protective gloves and safety glasses when cleaning up small spills of the sample diluent. Avoid breathing vapors, mist or gas. Keep all unnecessary personnel away from the spill area.

6.2 Methods and Materials for Clean-Up Wipe up with inert absorbent material (e.g., paper towel, etc.). Thoroughly wash the area with soap and water after a spill or release clean-up.

6.3 Recovery and Neutralization Collect spilled material and clean-up supplies and place in a sealed container for disposal. Refer to Section 13 for disposal guidance.

6.4 Environmental Precautions Contain spill to prevent migration to drains, sewers or open water sources. Discharge to the environment must be avoided.

7.1 Specific Use For in vitro diagnostic use only. For prescription use.

7.2 Precautions for Safe Handling

As with all chemical and biological substances, avoid getting these components ON YOU or IN YOU. Wash exposed areas thoroughly after using these components. Do not eat or drink while using these components. These components should be handled only by qualified clinical or laboratory employees trained on the use of these antibodies and proteins and who are familiar with the potential hazards. Universal Precautions should be followed when handling and working with these components. Keep out of reach of the general public.

7.3 Universal Precautions No known test method can offer complete assurance that product(s) derived from human blood, serum or plasma used in components of this kit will not transmit infectious agents. All blood products should be treated as potentially infectious; use universal precautions. Users should ensure the use of proper personal protective equipment (PPE), covering of any cuts or abrasions on the skin (hands), and follow standard protocols for the decontamination of work surfaces when testing has been completed. Always wash hands thoroughly after handling the components within this kit.

7.4 Conditions for Safe Storage (including any incompatibilities) To maintain efficacy, store according to the Package Insert instructions.

7.5 Incompatibilities To maintain efficacy, store according to the Package Insert instructions.

Section 5 – Fire Fighting Measures

Section 6 – Accidental Release Measures

Section 7 – Handling and Storage


Page 3 of 6

8.1 Exposure Limits No data available for the specific components within this kit.

8.2 Exposure Controls

Engineering Measures Use with adequate ventilation.

Personal Protective Equipment

Respiratory Protection None needed under normal conditions of use.

Skin Protection Handle with appropriately rated chemical resistant gloves. Gloves should be inspected prior to use. Use proper glove technique to remove gloves to avoid contact with skin. Wash hands after handling these components.

Eye Protection Wear safety glasses with side shields or goggles to prevent eye contact.

Body Protection Use body protection appropriate for the task. A laboratory coat is recommended.

Hygiene Measures Wash hands before use, after use and at the end of the workday.

8.3 Environmental Exposure Controls No special environmental controls are required.

8.4 Special Notes No data available.

Characteristic Buffer Vial

Boiling Point (C) No data available

Melting Point (C) No data available

Specific Gravity (H20 = 1) No data available

Vapor Pressure (mm Hg) No data available

Vapor Density (Air = 1) No data available

Evaporation Rate (Ether = 1) No data available

pH 9.5

Solubility in Water Soluble

Appearance and Odor Clear, colorless, odorless

Characteristic Buffer Vial

Component Stability Stable

Hazard Reaction Potential No data available

Conditions to Avoid No data available

Materials to Avoid No data available

Hazardous Decomposition Products No data available

Section 8 – Exposure Controls and Personal Protection

Section 9 – Physical and Chemical Properties

Section 10 – Stability and Reactivity


Page 4 of 6

11.1 Information on Toxicological Effects Acute Toxicity No data available

Skin Corrosion / Irritation May cause irritation of eyes.

Respiratory or Skin Sensitization No data available

Generative Cell Mutagenicity No data available

Carcinogenicity No component of this kit is present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by the ACGIH, IARC, NTP or OSHA.

Reproductive Toxicity No data available

Teratogenicity No data available

Specified Target Organ Toxicity

Single Exposure: No data available Repeated Exposure: No data available

Aspiration Hazard No data available

Potential Health Effects

Inhalation: May cause respiratory tract irritation. Skin: May cause skin irritation upon contact.

Ingestion: May be harmful if swallowed. Eyes: May cause eye irritation.

11.2 Signs and Symptoms of Exposure To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated for the components within this kit.

11.3 Additional Information

To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated for the components within this kit.

12.1 Toxicity No data available

12.2 Persistence and Degradability No data available

12.3 Bioaccumulative Potential No data available

12.4 Mobility in Soil No data available

12.5 PBT and vPvB Assessment No data available

12.6 Other Adverse Effects An environmental hazard cannot be excluded in the event of unprofessional handling or disposal. Avoid disposal to the environment.

13.1 Waste Disposal Instructions

Utilize appropriate personal protective equipment and spill control when handling wastes generated from using this kit. Do not discharge any of the control stocks into drains, water courses or onto the ground.

13.2 Disposal of Product and Contaminated Packaging

Dispose of waste materials, unused components and contaminated packaging in compliance with country, federal, state and local regulations. If unsure of the applicable regulatory requirements, contact a licensed professional waste disposal service to dispose of this material.

Section 11 – Toxicological Properties

Section 12 – Ecological Information

Section 13 – Disposal Considerations


Page 5 of 6

14.1 U.S Department of Transportation (DOT) These components are not regulated for transport.

14.2 International Air Transportation Association (IATA) These components are not regulated for transport.

14.3 International Maritime Dangerous Goods (IMDG) These components are not regulated for transport.

15.1 U.S. Federal Regulations

OSHA Hazards None

SARA 302 The following chemicals are subject to reporting levels established by Sara Title III, Section 302:

No chemicals in this kit are subject to the reporting requirements of SARA Title III, Section 302.

SARA 313 The following chemicals are subject to reporting levels established by SARA Title III, Section 313:


SARA311/312 Hazards No SARA hazards.

15.2 State Regulations

The following chemicals appear on one or more of the following state hazardous substance lists:

Chemical Name CAS # CA MA MN NJ PA RI

α-(4-Nonylphenyl)-ω-hydroxy-poly(oxy-1,2-ethanediyl) branched

127087-87-0 No No No Yes Yes No

California Prop 65: Buffer Vial (Tergitol 0.8%) – WARNING! – This component contains a chemical known to the State of California to cause cancer. *Used in the manufacturing process of the Tergitol component.

Ethylene Oxide CAS#: 75-21-8 Revision Date: 2009-02-01

1,4-Dioxane CAS#: 123-91-1 Revision Date: 2007-09-28

Formaldehyde CAS#: 50-00-0 Revision Date: 2007-09-28

Acetaldehyde CAS#: 75-07-0 Revision Date: 2007-09-29

California Prop 65: Buffer Vial (Tergitol 0.8%) – WARNING! – This component contains a chemical known to the State of California to cause birth defects or other reproductive harm. *Used in the manufacturing process of the Tergitol component.

Ethylene Oxide CAS#: 75-21-8 Revision Date: 2009-02-01

15.3 Canadian – WHMIS Classification

Chemical Name CAS # Classification

-- -- --

15.4 Additional Regulatory Information

Safety, Health and Environmental Regulations/Legislation Specific for the Mixture No data available

Chemical Safety Assessment Not completed for the components contained within this kit.

NFPA Kit Classification:

Health Hazard (blue): 1 Fire Hazard (red): 0 Reactivity (yellow): 0 Special Hazards (white): None

Section 14 – Transportation Information

Section 15 – Regulatory Information

0

1 0

-

-


Page 6 of 6

PREPARED BY: Quidel Corporation SUPERSEDES: -- 12544 High Bluff Drive, Suite 200, San Diego, CA 92130

REVISIONS: New

The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to us. However, we make

no warranty of merchantability, fitness for a particular purpose or of any other type, expressed or implied, with respect to products described or data or

information provided, and we assume no liability resulting from the use of such products, data or information. Users should make their own investigations to

determine the suitability of the information for their particular purposes, and the user assumes all risk arising from their use of the material. The user is required

to comply with all laws and regulations relating to the purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted

safe handling procedures. In no event, shall Quidel be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect,

incidental, consequential or exemplary damages of any kind, howsoever arising, even if Quidel has been advised of the possibility of such damages.

SD1024000EN00 (06/17)

Section 16 – Other Information

InflammaDry® External Controls Safety Data Sheet Revision Date: June 27, 2017

Page 1 of 6

1.1 Manufacturer Information

Quidel Corporation Phone: 1.800.874.1517 Web: quidel.com

10165 McKellar Court Fax: 1.858.453.4338 E-mail: [email protected]

San Diego, CA 92121 Emergency (24-Hour): 1.866.519.4752

1.2 Product Information

Product Name: InflammaDry External Controls (Catalog #: RPS-DESTD)

Intended Use: External controls to be used with the InflammaDry Test (Catalog #: RPS-ID-20-U and RPS-ID-20) only and are

intended to verify that the test reagents are working and that the test is performed correctly.

Components: Positive Control (lyophilized), Negative Control (lyophilized), Diluent

2.1 Classification of the Substance of Mixture

Kit Component OSHA Hazards Target Organs GHS Classification

Negative Control (<0.05% Proclin 300)

Irritant Skin Skin Sensitizer (Category 1)

2.2 GHS Label Elements, including Precautionary Statements

Kit Component Pictogram Hazard Statements Precautionary Statements

Negative Control (<0.05% Proclin 300)

Warning

H317 May cause an allergic skin

reaction.

P264 Wash hands thoroughly after handling.

P303+P361+P353:

IF ON SKIN (or hair): Remove immediately all

contaminated clothing. Rinse skin with water.

P333+P313:

If skin irritation or rash occurs: Get medical

attention.

2.3 Supplemental Hazard Statements

- Refer to Universal Precautions information in Section 7, Handling and Storage.

- Avoid release to the environment.

3.1 Mixtures

Kit Component Chemical Name CAS # EINECS # Conc. (%) Component

Volume

Negative Control

Mixture for Proclin 300: 5-Chloro-2-methyl-2, 3-

dihydroisothiazol-3-one; 2-Methyl-

2, 3-dihydroisothiazol-3-one (3:1)

55965-84-9 -- <0.05

Section 1 – Product and Company Identification

Section 2 – Hazard Identification

Section 3 – Composition / Information on Ingredients

http://www.quidel.com/



Page 2 of 6

4.1 Description of First Aid Measures

If inhaled: Move the person to fresh air and support breathing as required.

In case of skin contact: Wash affected area with soap and water. Seek medical advice if irritation develops.

In case of eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical attention.

If swallowed: Never give anything by mouth to an unconscious person. Rinse mouth with water (do not swallow). Seek medical advice if irritation develops.

4.2 Most Important Symptoms and Effects (both acute and delayed)

To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.

4.3 Indication of Any Immediate Medical Attention and Special Treatment Needed

No specific measures identified.

Only individuals properly trained and issued appropriate personal protective equipment should respond and attempt to extinguish a fire.

5.1 Suitable Extinguishing Media For small fires, use dry chemical, carbon dioxide or alcohol-resistant foam.

5.2 Special Hazards Arising from the Substance or Mixture Nature of decomposition products not known.

5.3 General Fire Hazards The components within this kit will not significantly contribute to the intensity of a fire.

5.4 Fire Fighting Equipment Firefighters should wear full protective gear when responding to fires.

Only individuals properly trained and issued appropriate personal protective equipment should respond and attempt to clean up a spill or release. A large spill of any of the components listed in this SDS is unlikely.

6.1 Personal Precautions Use personal protective equipment, including protective gloves and safety glasses when cleaning up small spills of the sample diluent. Avoid breathing vapors, mist or gas. Keep all unnecessary personnel away from the spill area.

6.2 Methods and Materials for Clean-Up Wipe up with inert absorbent material (e.g., paper towel, etc.). Thoroughly wash the area with soap and water after a spill or release clean-up.

6.3 Recovery and Neutralization Collect spilled material and clean-up supplies and place in a sealed container for disposal. Refer to Section 13 for disposal guidance.

6.4 Environmental Precautions Contain spill to prevent migration to drains, sewers or open water sources. Discharge to the environment must be avoided.

7.1 Specific Use Refer to product specific package insert. For in vitro diagnostic use.

7.2 Precautions for Safe Handling

As with all chemical and biological substances, avoid getting these components ON YOU or IN YOU. Wash exposed areas thoroughly after using these components. Do not eat or drink while using these components. These components should be handled only by qualified clinical or laboratory employees trained on the use of these antibodies and proteins and who are

Section 4 – First Aid Measures

Section 5 – Fire Fighting Measures

Section 6 – Accidental Release Measures

Section 7 – Handling and Storage


Page 3 of 6

familiar with the potential hazards. Universal Precautions should be followed when handling and working with these components. Keep out of reach of the general public.

7.3 Universal Precautions No known test method can offer complete assurance that product(s) derived from human blood, serum or plasma used in components of this kit will not transmit infectious agents. All blood products should be treated as potentially infectious; use universal precautions. Users should ensure the use of proper personal protective equipment (PPE), covering of any cuts or abrasions on the skin (hands), and follow standard protocols for the decontamination of work surfaces when testing has been completed. Always wash hands thoroughly after handling the components within this kit.

7.4 Conditions for Safe Storage (including any incompatibilities) To maintain efficacy, store according to the Package Insert instructions.

7.5 Incompatibilities To maintain efficacy, store according to the Package Insert instructions.

8.1 Exposure Limits No data available for the specific components within this kit.

8.2 Exposure Controls

Engineering Measures Use with adequate ventilation.

Personal Protective Equipment

Respiratory Protection None needed under normal conditions of use.

Skin Protection Handle with appropriately rated chemical resistant gloves. Gloves should be inspected prior to use. Use proper glove technique to remove gloves to avoid contact with skin. Wash hands after handling these components.

Eye Protection Wear safety glasses with side shields or goggles to prevent eye contact.

Body Protection Use body protection appropriate for the task. A laboratory coat is recommended.

Hygiene Measures Wash hands before use, after use and at the end of the workday.

8.3 Environmental Exposure Controls No special environmental controls are required.

8.4 Special Notes No data available.

Characteristic Diluent Positive Control Negative Control

Boiling Point (C) No data available No data available No data available

Melting Point (C) No data available No data available No data available

Specific Gravity (H20 = 1) No data available No data available No data available

Vapor Pressure (mm Hg) No data available No data available No data available

Vapor Density (Air = 1) No data available No data available No data available

Evaporation Rate (Ether = 1) No data available No data available No data available

pH Neutral Neutral Neutral

Solubility in Water Soluble Soluble Soluble

Appearance and Odor Clear, colorless, odorless White powder, odorless White powder, odorless

Section 7 – Handling and Storage (cont’d)

Section 8 – Exposure Controls and Personal Protection

Section 9 – Physical and Chemical Properties


Page 4 of 6

Characteristic Diluent Positive Control Negative Control

Component Stability Stable Stable Stable

Hazard Reaction Potential No data available No data available No data available

Conditions to Avoid No data available No data available No data available

Materials to Avoid No data available No data available No data available

Hazardous Decomposition Products No data available No data available No data available

11.1 Information on Toxicological Effects

Acute Toxicity

Chemical Name CAS # RTECS # Information

Mixture for Proclin 300:

5-Chloro-2-methyl-2, 3-dihydroisothiazol-3-one; 2-Methyl-2, 3-dihydroisothiazol-3-one (3:1)

55965-84-9 -- Oral LD50 Rat 53 mg/kg

Inhalation LC50 No data available

Dermal LD50 No data available

Skin Corrosion / Irritation May cause irritation of eyes.

Respiratory or Skin Sensitization No data available

Generative Cell Mutagenicity No data available

Carcinogenicity No component of this kit present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by the ACGIH, IARC, NTP or OSHA.

Reproductive Toxicity No data available

Teratogenicity No data available

Specified Target Organ Toxicity

Single Exposure: No data available Repeated Exposure: No data available

Aspiration Hazard No data available

Potential Health Effects

Inhalation: May cause respiratory tract irritation. Skin: May cause skin irritation upon contact.

Ingestion: May be harmful if swallowed. Eyes: May cause serious eye irritation.

11.2 Signs and Symptoms of Exposure To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated for the components within this kit.

11.3 Additional Information

Sensitization: Contains a small volume of a very dilute, sensitizing preservative (Proclin 300). Though the potential for an allergic response is greatly reduced by the dilution, sensitization threshold is unknown; thus, handle accordingly.

Section 10 – Stability and Reactivity

Section 11 – Toxicological Properties


Page 5 of 6

12.1 Toxicity No data available

12.2 Persistence and Degradability No data available

12.3 Bioaccumulative Potential No data available

12.4 Mobility in Soil No data available

12.5 PBT and vPvB Assessment No data available

12.6 Other Adverse Effects An environmental hazard cannot be excluded in the event of unprofessional handling or disposal. Avoid disposal to the environment.

Proclin 300 is very toxic to aquatic life with long lasting effects.

13.1 Waste Disposal Instructions

Utilize appropriate personal protective equipment and spill control when handling wastes generated from using this kit. Do not discharge any of the control stocks into drains, water courses or onto the ground.

13.2 Disposal of Product and Contaminated Packaging

Dispose of waste materials, unused components and contaminated packaging in compliance with country, federal, state and local regulations. If unsure of the applicable regulatory requirements, contact a licensed professional waste disposal service to dispose of this material.

14.1 U.S Department of Transportation (DOT) These components are not regulated for transport.

14.2 International Air Transportation Association (IATA) These components are not regulated for transport.

14.3 International Maritime Dangerous Goods (IMDG) These components are not regulated for transport.

15.1 U.S. Federal Regulations

OSHA Hazards Negative Control: Sensitizer, irritant

SARA 302 The following chemicals are subject to reporting levels established by Sara Title III, Section 302:


SARA 313 The following chemicals are subject to reporting levels established by SARA Title III, Section 313:


SARA311/312 Hazards Proclin 300 CAS #: 55965-84-9 Acute Health Hazard

15.2 State Regulations

The following chemicals appear on one or more of the following state hazardous substance lists:

Chemical Name CAS # CA MA MN NJ PA RI

Mixture for Proclin 300: 5-Chloro-2-methyl-2, 3-dihydroisothiazol-3-one; 2-Methyl-2, 3-dihydroisothiazol-3-one (3:1)

55965-84-9 No No No Yes Yes No

California Prop 65: None of the components listed in this SDS contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.

Section 12 – Ecological Information

Section 13 – Disposal Considerations

Section 14 – Transportation Information

Section 15 – Regulatory Information


Page 6 of 6

15.3 Canadian – WHMIS Classification

Chemical Name CAS # Classification

Mixture for Proclin 300: 5-Chloro-2-methyl-2, 3-dihydroisothiazol-3-one; 2-Methyl-2, 3-dihydroisothiazol-3-one (3:1)

55965-84-9 No data available

15.4 Additional Regulatory Information

Safety, Health and Environmental Regulations/Legislation Specific for the Mixture No data available

Chemical Safety Assessment Not completed for the components contained within this kit.

NFPA Kit Classification:

Health Hazard (blue): 1 Fire Hazard (red): 0 Reactivity (yellow): 0 Special Hazards (white): None

PREPARED BY: Quidel Corporation SUPERSEDES: --

12544 High Bluff Drive, Suite 200, San Diego, CA 92130 REVISIONS: New

The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to us. However, we make

no warranty of merchantability, fitness for a particular purpose or of any other type, expressed or implied, with respect to products described or data or

information provided, and we assume no liability resulting from the use of such products, data or information. Users should make their own investigations to

determine the suitability of the information for their particular purposes, and the user assumes all risk arising from their use of the material. The user is required

to comply with all laws and regulations relating to the purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted

safe handling procedures. In no event, shall Quidel be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect,

incidental, consequential or exemplary damages of any kind, howsoever arising, even if Quidel has been advised of the possibility of such damages.

SD1024100EN00 (06/17)

Section 15 – Regulatory Information (cont’d)

Section 16 – Other Information

0

1 0

-

-

Coding Guidelines

Compliance Guidelines

Dry Eye

Quidel | Eye Health | quidel.com | quideleyehealth.com | 800.874.1517 | 858.552.1100

Reimbursement code The assigned CPT® (Current Procedural Terminology)1 code for the InflammaDry test is 83516, “immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semi-quantitative, multiple step method.” The 2019 CMS national limit for this code is $12.81. Offices submitting reimbursement for claims are required to have a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver.2

Compliance Concept of chief complaint and medical necessity In order to make your medical record compliant for clinical lab testing, it is important to have a complaint, symptom or clinical sign that is recorded in the record to provide the basis for ordering the test. This would help to establish a “chief complaint” for the lab test. It is also critical to have a statement of medical necessity in the file that ties together the basis for ordering and performing the tests. This carries additional weight when ordering sequential tests over time.

Modifiers and their use Medicare and Medicaid claims The modifier “QW” is added to the CPT code to report the use of a CLIA-waived test. The RT and LT modifiers are also used to specify laterality of the test to correspond with the appropriate ICD-10 codes used. CPT code 83516QW is paid from the Clinical Laboratory Fee Schedule (not the Physician Fee Schedule as with other CPT codes). Bilateral testing Ocular surface inflammation often presents asymmetrically, and therefore testing both eyes with the InflammaDry test is recommended. The InflammaDry test is a single use item, so bilateral testing requires two separate InflammaDry tests. When billing for bilateral testing, it is necessary to use a modifier. Given the many and varied payers and policies, it is possible that certain payers may have different coding requirements; Quidel offers reimbursement support to assist you with questions about InflammaDry coding, compliance and reimbursement.

2019 Medicare/Medicaid Commercial Payers National Limit

1st Eye 83516QW-RT/LT 83516-RT/LT $12.81

2nd Eye 83516QW-RT/LT 83516-RT/LT $12.81 Bilateral alternative 83516QW-50 (when using the -50 modifier, leave the number of units as “1” but double the price)

IN1024004EN00.qxp_Layout 1 6/14/19 9:49 AM Page 1

SL2505 | IN1024004EN00 (06/19)

1CPT is a copyright and registered trademark of the American Medical Association (AMA). Please consult the current CPT Manual for full descriptors and instructions regarding the use of CPT codes.

2CLIA stands for Clinical Laboratory Improvement Amendments and is a registration with the U.S. Department of Health and Human Services that allows physicians or medical office personnel to collect a sample and perform a laboratory test within their office.

Under Federal and State law, it is the individual provider’s responsibility to determine appropriate coding, charges and

claims for a particular service. Policies regarding appropriate coding and payment levels can vary greatly from payer to payer

and change over time. Quidel Corporation strongly recommends that providers contact their own regional payers to determine

appropriate coding and charge or payment levels prior to submitting claims.

Related diagnostic codes There can be many ICD-10 codes that will be related to your need to provide clinical lab testing for a dry eye diagnosis and/or dry eye symptoms. It is important when providing diagnoses related to the testing performed, that you provide the most specific diagnoses that you can in accordance with ICD rules and guidelines. That means relating both laterality and severity if possible. Generalized diagnoses may get reimbursed but are more difficult to defend should your record be scrutinized. Reimbursement support Quidel has a Reimbursement Support Team available to assist you with questions about InflammaDry coding and reimbursement. For reimbursement support, please contact [email protected] or call 800.874.1517. This information is being provided as a reference, for informational purposes only, with no expressed or implied warranty and does not purport to provide legal or

certified coding advice. It is the sole responsibility of the health care provider of service to verify reimbursement policies and select the appropriate CPT and ICD-10-

CM codes to accurately reflect patient condition(s) and testing procedure(s). Any review, retransmission, dissemination or other use of this information by persons or

entities other than the intended recipient is prohibited.

IN1024004EN00.qxp_Layout 1 6/14/19 9:49 AM Page 2

A. Notifier:

B. Patient Name: C. Identification Number:

Advance Beneficiary Notice of Noncoverage (ABN) NOTE: If your insurance carrier doesn’t pay for D. lab tests below, you may have to pay. Insurance does not pay for everything, even some care that you or your health care provider have good reason to think you need. We expect your insurance carrier may not pay for the D. lab tests listed below.

D. Checked Lab Tests Only:

□ MMP-9, 83516 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semi-quantitative, multiple step method.

________________

E. Reason Your Insurance May Not Pay:

They do not pay for these tests for your condition.

They do not pay for these tests as often as ordered for you.

They do not pay for experimental or research use tests.

F. Estimated Cost:

WHAT YOU NEED TO DO NOW: • Read this notice, so you can make an informed decision about your care. • Ask us any questions that you may have after you finish reading. • Choose an option below about whether to receive the D. lab tests listed above.

Note: If you choose Option 1 or 2, we may help you to use any other insurance that you might have, but your insurance carrier cannot require us to do this.

G. OPTIONS: Check only one box. We cannot choose a box for you.

□ OPTION 1. I want the D. lab tests listed above. You may ask to be paid now, but I also want my insurance billed for an official decision on payment. I understand that if my insurance carrier doesn't pay, I am responsiblefor payment, but I can appeal to my insurance carrier by following their policies for appeal. If my insurancedoes pay, you will refund any payments I made to you, less co-pays or deductibles. □ OPTION 2. I want the D. lab tests listed above, but do not bill my insurance carrier. You may ask to be paid now as I am responsible for payment. I cannot appeal if my insurance carrier is not billed. □ OPTION 3. I don’t want the D. lab tests listed above. I understand with this choice I am not responsible for payment, and I cannot appeal to see if my insurance carrier would pay.

H. Additional Information: This notice gives our opinion, not an official insurance carrier decision. If you have other questions on this notice or insurance billing, please call your insurance carrier. Signing below means that you have received and understand this notice. You also receive a copy.

I. Signature: J. Date:

Form (Exp. 03/2020) - Form Approved


Miscellaneous

Test Procedure

InflammaDry is a CLIA-waived test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. A CLIA Certificate of Waiver is required to perform the test in a waived setting. Laboratories with a CLIA Certificate of Waiver must follow the manufacturer’s instructions for performing the test. To obtain a Certificate of Waiver, please contact your state health department. Additional CLIA waiver information is available at the Centers for Medicare and Medicaid website at www.cms.hhs.gov/CUA or from your state health department. Failure to follow the instructions or modification to the test system instructions will result in the test no longer meeting the requirements for waived classification.

InflammaDry Sample Collector Test Cassette Buffer Vial

Gently dab the sampling fleece in multiple locations along the inside of the patient’s lower eyelid (palpebral conjunctiva), releasing the lid every 2 to 3 dabs to allow the patient to blink. Do not use a dragging motion when collecting the sample.

After completing a minimum of 6 to 8 dabs along the conjunctiva, allow the sampling fleece to rest against the conjunctiva for an additional 5 seconds. Upon saturation with tear fluid, the fleece will glisten and may turn patchy pink in color, depending on the patient’s tear composition.

Assemble the test by gently placing the sampling fleece of the Sample Collector into the sample transfer window of the Test Cassette body.

Press firmly where indicated until the test feels secure. A double click means the test is properly assembled.

Open the buffer vial and immerse the absorbent tip for a minimum of 20 seconds.

Remove the absorbent tip from the buffer vial, replace the protective cap, and lay the test flat on a horizontal surface for 10 minutes.

InflammaDry external controls are available directly through Quidel. InflammaDry external controls consist of two (2) vials (a positive control containing recombinant MMP-9 protein and a negative control) and diluent. InflammaDry external control testing should be performed with each new lot, each new shipment, and every 30 days.

Choose either the positive or negative control. Only one (1) control may be run on each InflammaDry test at a time.

Remove the cap and rubber stopper from the selected control vial and add 5 drops of diluent from the Diluent Bottle, 1 drop at a time.

Recap the control vial and gently shake the vial to dissolve the lyophilized powder. Let the vial with the liquid sit for at least 2 minutes prior to use.

Open the control vial and pour the entire liquid contents of the vial into the inside of the black cap.

Open the Sample Collector pouch from an unused InflammaDry Test.

Dip the sampling fleece into the control liquid in the black cap.

Run and read the InflammaDry results per the instructions provided in the InflammaDry Package Insert.

A positive control should show a positive result. A negative control should show a negative result.

When the correct control results are not obtained, repeat the test control or contact Quidel Technical Support at 800.874.1517 before testing patients.

1

2

3

4

5

6

2

1

CLIA Complexity: Waived for tear fluid samples. QUICK REFERENCE INSTRUCTIONS

Store between 39°F to 77°F (4°C to 25°C)

Test Contents

Sample Prep

Note: An unused InflammaDry device has two faint orange lines in the result window.

External Control Procedure

Assembly Snap Together Buffer Step Running the Test Sample Prep

http://www.cms.hhs.gov/CUA

Once the background within the result window is white and 10 minutes have elapsed, the test may be read. If there is a streaky fluid wave in the background, or if the test is negative after 10 minutes, allow an additional 5 to 10 minutes of running time prior to interpretation. The results of the test are indicated through two (2) lines which appear in the result window: the control line and the result line. The control line appears as a BLUE line in the control zone. It indicates the correct application and performance of the test, and must appear for the test to be valid.

POSITIVE RESULT The presence of both a BLUE line in the control zone and a RED line in the result zone indicates a positive result. Even if the RED line is faint in color, incomplete over the width of the test strip, or uneven in color, it must be interpreted as a positive. A positive result indicates the presence of MMP-9 ≥ 40 ng/mL.

NEGATIVE RESULT The presence of only a BLUE line in the control zone indicates a negative result. A negative result is indicative of an MMP-9 level < 40 ng/mL.

INVALID RESULT If a BLUE line does not appear, the test may be invalid. Re-immerse the absorbent tip into the Buffer Vial for an additional 10 seconds. If a BLUE line still does not appear, the test must be discarded and the subject retested by resampling the eye using a new InflammaDry test.

For in vitro diagnostic use only. For prescription use.

Keep the Test Cassette and Sample Collector in their foil pouches until just before use.

The Dacron® material used in the sampling fleece may cause allergic reactions for some people.

Do not use InflammaDry past the expiration date.

Follow Universal Precautions when handling patient samples.

Wear disposable gloves while handling samples and wash hands after the test is complete.

Both InflammaDry and the Buffer Vial are single-use items. Do not reuse with multiple specimens.

InflammaDry requires a visual readout. Do not interpret the test result if you have color-impaired vision.

Result interpretation requires a brightly lit environment.

ASSISTANCE

If the InflammaDry Test does not perform as expected, contact Quidel Technical Support 800.874.1517 (in the U.S.), 858.552.1100 (outside the U.S.), [email protected], or your local distributor.

Quidel Corporation San Diego, CA 92121 USA quidel.com

1344100EN00 (10/17)

Study the Package Insert and User Manual thoroughly before using Quick Reference Instructions. This is not a complete Package Insert.

Warnings and Precautions

Do not use the same InflammaDry Test on more than one patient.

Slit-lamp biomicroscopy is required to eliminate patients with active intraocular inflammation.

InflammaDry should be performed prior to instilling ocular anesthetic, topical dyes, or performing Schirmer testing.

Dispose of containers and unused contents in accordance with Federal, State and Local regulatory requirements.

For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS) located at quidel.com.

Reference the Package Insert for Warnings and Precautions, Specimen Collection and Handling, and Quality Control.

Interpretation of Results

InflammaDry® Patient Result Record Kit Lot Number: _____________________ Kit Expiration Date: _____________________

Record the date, patient’s name, patient test results, internal control results and the performer’s initial. Test Interpretation: Positive = Red Line + Blue Line Negative = Blue Line Only IC Line = Internal Control Line (blue line) present

Left Right

Date Patient ID Patient Name Positive Negative IC Line Positive Negative IC Line Initials

PL1024000EN00 (06/17)

Reviewed by ____________________________________ Date____________________

Positive

NOT FOR SALE IN THE U.S.

Tips for success with InflammaDry

1 Collect sample 2 Assemble test 3 Run test 4 Read results

Negative

Invalid

Quidel | Eye Health | quidel.com | 800.874.1517 | 858.552.1100

A Simple 4-Step Process to Aidin Dry Eye Diagnosis

Collecting the tear sample

To collect a tear sample, gentlydab the sample collector in 6-8 locations on the palpebral con-junctiva, until the fleece glistens(see tips below).

Snap the sample collector into theTest Cassette.

Press firmly where indicated whenassembling. A double-click meansthe test is properly assembled.

Immerse the absorbent tip into theprovided buffer vial for a minimumof 20 seconds until a purple fluidwave is observed moving across the result window.

Replace the protective cap and laythe test flat on a horizontal surface.

After 10 minutes, read the test results.

RED + BLUE = POSITIVEBLUE = NEGATIVE

Refer to the Package Insert for InflammaDry found on the InflammaDry product page under Product Documentation at: quidel.com/InflammaDry

Instruct the patient tolook up.

Gently lower the eye-lid to expose thepalpebral conjunctiva.

Dab the samplingfleece in multiple locations along theconjunctiva, releasingthe lid after every 2-3 dabs.

Allow the patient toblink.

After completing aminimum of 6-8 dabsalong the conjunctiva,allow the samplingfleece to rest on theconjunctiva for an additional 5 seconds,to ensure saturation.

Inspect the samplingfleece. The fleece willglisten when an ade-quate tear sample iscollected. Dependingon the patient’s tearcomposition, thefleece may also turnpatchy pink in color. If the fleece is NOTglistening, repeat the entire process.

A B C D E F

ImportantInflammaDry should be performed PRIOR to instilling ocular anesthetic, topical dyes, or performing Schirmer testing.If drops are used, wait 2 hours before collecting a tear sample.

Once opened, the Test Cassette should be used within 1 hour.

Reading the resultsWait a minimum of 10 minutes before reading test results.

If the test is negative after 10 minutes, allow an additional 5-10 minutes before reading test results.

Read any form of a red line, whether faint, broken, or shadow, as a positive test result.

SL2507| H

T1024000EN02 (10/17)

HT1024000EN02.qxp_Layout 1 10/18/17 2:17 PM Page 1

of 2

Technical Bulletin

Recommended Proficiency Testing Program

General Information Proficiency testing (PT) is a type of external quality control. The practice of testing unknown specimens from an outside source provides an additional means to ensure quality point-of-care testing results. The purpose of proficiency testing is to verify the testing personnel/site are proficient in performing the test and interpreting the results. InflammaDry is a CLIA-waived test; CLIA-waived tests have met specific clinical protocols required by the FDA. Proficiency testing is not mandatory in most states for CLIA-waived tests. However, some regulatory agencies and certain states do require proficiency testing. Please contact your state CLIA office for more information.

Procedure Quidel Technical Support handles the proficiency testing program, as there are no independent proficiency test providers currently available for InflammaDry. The testing personnel will order an InflammaDry Proficiency Test Kit from Quidel Customer Service. Quidel will send an InflammaDry Proficiency Test Kit, consisting of 5 blinded challenge samples, 5

InflammaDry tests, 1 InflammaDry Quick Reference Guide and 1 InflammaDry Profiency Testing Customer Instructions.

Once completed, the customer sends the results page back to Quidel Technical Support via e-mail to be scored. E-mail is [email protected].

The results are reviewed and scored by the Quidel Technical Support; performance levels established by federal and state agencies determine whether each participant passes or fails.

A completed certificate of proficiency, detailing the accuracy of the proficiency testing results, will be provided. This should be kept with all testing documents and provided to your state regulatory agency, if required.

Ordering Information Contact Customer Service at [email protected] or 800.874.1517 Product number: RPS-IDPT Description: InflammaDry Proficiency Test Kit Price: $300.00, plus Shipping & Handling

Tips for Successful Proficiency Testing Performance Strictly follow the PT provider’s storage or handling requirements before testing PT specimens. Analyze PT specimens within the time frame provided by the PT provider. Contact the PT provider promptly when specimens are received damaged. You may be able to receive a

replacement immediately.


of 2

Avoid clerical error when filling out PT answer sheets. Be sure to enter the correct result next to the correct sample number on the result form.

Please contact Quidel Technical Support at 800.874.1517 (in the U.S.), 858.552.1100 (outside the U.S.) or [email protected] if you have any questions regarding InflammaDry Tests, or any Quidel product. Our hours of operation are Monday through Friday, 7:00 a.m. to 5:00 p.m. Pacific Time. You may also visit our website at quidel.com for information on Quidel’s line of Rapid Diagnostics, Molecular Diagnostics, Cell Culture and Specialty Products (Bone Health and Autoimmune & Complement). Other product information available on our website includes: CPT codes, CLSI procedure guides, SDS, and Package Inserts.

TB1024001EN00 (11/18)


Practice Implementation - Eye Health Home - Quidel Eye Health€¦ · Dry eye may range in severity...

Documents

Transcript of Practice Implementation - Eye Health Home - Quidel Eye Health€¦ · Dry eye may range in severity...