70-6552 QRG RevC3:Layout 1 - Improve your screening rates with The LeadCare® II...

Quick Reference Guide

LeadCare® IIB L O O D L E A D A N A L Y Z E R

70-6552 QRG RevC3:Layout 1 7/6/2007 10:50 AM

• The LeadCare II Blood Lead Analyzer is a CLIA-waived device. Facilities that perform tests with the LeadCare II System must have a CLIA Certificate of Waiveras issued under the authority of the Public Health Service Act (PHSA) (42 U.S.C.263(a). In addition to a waiver certificate, laboratories performing this test mustcomply with all applicable state and local laws.

• Any modifications by the laboratory to the test system or the manufacturer’sinstructions will result in the test no longer meeting the requirements of the waivedcategory.

• All laboratories eligible for a CLIA Certificate of Waiver must follow the manu-facturer's instructions as specified in the LeadCare II User's Guide, LeadCare IIQuick Reference Guide and LeadCare II Test Kit package insert.

• Observe universal precautions for handling blood samples as defined by the U.S. Public Health Service, Centers for Disease Control. Refer to the LeadCare IIUser's Guide for information about where to find this document.

• The LeadCare treatment reagent contains dilute hydrochloric acid solution. The reagent is harmful if swallowed. Keep out of reach of children. If swallowed,consult a physician. If the reagent contacts eyes, flush immediately with waterand consult a physician.

• Do not mix components from different lots of test kits.

• Test kit components (kit box, sensors, controls, and treatment reagent tubes) arelabeled with expiration dates. Using any item with an expired date may produceinaccurate results. Do not use any component with an expiration date that haspassed. Check the expiration on the kit box as this is the earliest date.

• Proper sample preparation is essential for accurate results. Take precautions toensure that the sample collection area is not contaminated by environmentalsources of lead. Refer to Collecting and Handling Blood Lead Samples—2004 published by the Department of Health and Human Services, Centers for Disease Control.

• Use only fresh, whole blood. Mix the blood with treatment reagent within 24 hours of collection. Follow sample collection instructions exactly.

Precautions

Wear protective gloves,safety glasses and labcoats.

Dispose of materialsin appropriate bio-hazard containers.

Allow analyzer, test kitand samples to reachroom temperaturebefore testing.

Caution

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97°F

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Analyzer Kit Contents

Power on the Analyzer

Required Materials

Connect the analyzer toan outlet using the ACpower cord or install bat-teries as shown below.

Push white tab up and pull blue cover off. Insert batteries as shown and replace cover.

To turn ON the analyzer,move the switch to the left.

RequiredM

aterials

User's guideCalibration button readerLeadCare II Blood Lead AnalyzerSensor retainerAC power cordInstructional CD-ROM

Quick reference guideAA batteries

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To turn the analyzer OFF,move the switch to the right.

POWER

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LeadCare II

B L O O D L E A D A N A LY Z E R

LeadCare II

LeadCare II

Blood Lead Testing System

erence Card

LeadCBlood Test ing Sy

Battery Installation (Optional)

DroppersTreatment reagent tubesCapillary tubes and plungersCalibration button

Control solutionsBlood lead sensorsLabelsPackage insertLeadCare II worksheet

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Test Kit Contents


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LeadCare II

CALIBRATION

SUCCESSFUL

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LeadCare II

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The first time you turn on the analyzer,you will see the PLEASE CALIBRATEmessage.

Remove the calibration button fromthe Test Kit.

Hold the calibration button to thebutton reader until you hear a beep.

NOTE: Button must touch both thecenter contact and metal side ofbutton reader.

Make sure the number on the buttonmatches the display.

The analyzer is ready when thePREPARE SAMPLE message appears.

Analyzer Calibration and Quality Control

Quality ControlLeadCare II Blood Lead Controls are intended to monitor the accuracy and precision of your blood lead testing using the LeadCare II Blood Lead TestingSystem.

How Often to Test with ControlsTest two levels of quality control:

• on each new lot of test kits received• on each new shipment of test kits received• to test the technique of new users• if you suspect that the test kit may not have been stored properly• at any time you think that the system may not be working properly

Results obtained on control samples that are within the expected ranges meansthat your LeadCare II System is operating properly. Refer to the LeadCare IIUser's Guide for additional important information on quality control.

Perform this calibration procedure each time you open a new Test Kit.

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Label a fresh treatmentreagent tube “Level 1 Control”.

After thorough mixing,remove the cap from theLevel 1 control vial andplace it top down on aclean laboratory wipe.

Holding the capillary tubealmost horizontally with thegreen band on top, fill thetube to the 50 µL black line.Replace the cap on thecontrol vial.

Wipe the outside of thecapillary to remove anyexcess control.

Inspect the capillary tube to confirm that it isproperly filled.

Place the capillary tubeinto the treatment reagenttube. Insert a plunger intothe top of the capillarytube. Dispense the entirevolume of control into thereagent.

Replace the tube cap. Invertthe tube 8 to 10 times to mixthe sample completely. Control material in treatmentreagent tube will appear red.

Using the Controls (See Prepare the Sample for Additional Information)Treat the controls as you would a patient blood sample. Refer to the LeadCare IIUser's Guide for detailed instructions on how to perform blood lead testing.

Calibration &

Quality C

ontrol

Analyze the control sample according to the instructions provided in the Analyze theSample section. Repeat this process for the Level 2 control.

Lead Control Test Results: Expected ResultsControl target values and acceptable ranges are provided on the control vial label.The blood lead result you obtain for a control should be within the acceptable range.If the results are not within the listed range, refer to the Troubleshooting section of theUser's Guide. If, after following the instructions, the controls are still out of range, callESA Technical Support at 1-800-275-0102.CAUTION: Do NOT proceed to patient samples unless both Level 1 and Level 2 controlresults are within the acceptable ranges.

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Label the tube with the patient IDusing the labels provided.

Holding the capillary tube almosthorizontally with the green band ontop, fill the capillary to the 50 µLblack line.

Note: The CDC’s Steps for CollectingFingerstick Blood Samples for LeadTesting is provided in Appendix C ofthe User’s Guide.

If using blood from a tube, make surethe blood is well mixed by invertingthe tube 8 to 10 times before sam-pling.

Hold the capillary tube almost horizontally with the green band ontop, fill the tube to the 50 µL blackline.

Remove excess blood from the out-side of the tube with a clean wipe or gauze.

Use caution not to drain the bloodfrom the end of the capillary tube.

Prepare the Sample

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Inspect the capillary tube for properfilling. Make sure there are no gaps or bubbles, or any excess blood on theoutside of the capillary.

Place the capillary tube into thetreatment reagent tube. Insert aplunger into the top of the capillarytube. Dispense the entire volume intothe bottom of the tube.

Replace the tube cap. Invert thetube 8 to 10 times to mix the samplecompletely.

The sample is ready when the mix-ture turns brown. Samples may bestored up to one week if refrigerated.

CAUTION: Any visual impairment,such as color blindness may affectthe operator's ability to detect thesample color change. Operators withvision deficiencies should invert thetube 8 to 10 times to ensure that thesample is properly mixed.

Preparethe Sam

ple

Wrong WrongWrong Air Excess

Correct Underfilled Bubbles Blood


LeadCare II2

LeadCare II

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5 adCare II

Remove a sensor from the sensorcontainer. Close the container.

Insert the sensor (with black bars facing up) completely into the analyzer until you hear a beep.

Make sure the sensor lot numbermatches the display.

Make sure the sample is thoroughlymixed. Allow samples that werestored refrigerated to reach roomtemperature before use.

Remove the cap from the tube.Squeeze the walls of the dropperand insert into the sample. Releasethe pressure to draw some sampleinto the dropper.

Touch the dropper tip to the X on the sensor and squeeze the walls todispense the sample.

Analyze the Sample

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Wait 3 minutes until the test is done.The analyzer will beep and displaythe lead result in µg/dL Pb.

Record the test results on theLeadCare II worksheet provided.

Remove the used sensor. Discard materials in appropriate containers.

The analyzer is ready for the nextsample.

Analyzethe Sam

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The analyzer displays “Low” when it detects a blood lead level below 3.3 ug/dL. “Low” results should berecorded as “< 3.3 µg/dL”. Themajority of your patient samplesshould produce “Low” results.


Interpreting Patient Test ResultsInterpreting Patient Test Results

The analyzer’s display window shows the blood lead result. The result is in micrograms(µg) of lead per deciliter (dL) of whole blood. No calculation is needed. Results aredisplayed to one decimal place. The reportable range of the test is 3.3 to 65 µg/dL.

“Low” in the display window indicates a blood lead test result less than 3.3 µg/dL.When this occurs, report the blood lead result as less than (<) 3.3 µg/dL.

“High” in the display windows indicates a blood lead test result greater than 65.0 µg/dL. When this occurs, report the blood lead result as greater than (>) 65 µg/dL.

Blood lead test results should be shared with the patient’s physician for interpretationand to determine when retesting and follow-up care are necessary.

Blood lead levels less than 10 µg/dL are below the “level of concern”.

Blood lead levels above 10 µg/dL indicate possible lead poisoning, which is a serious medical condition. Patients with blood lead levels above 10 µg/dL must beconfirmed with a venous sample. The following table shows when to test patientsagain if the result is above 10 µg/dL.1

Retesting Guidelines

If blood lead result of Perform diagnostic test on screening test is: venous blood within:

10 – 19 µg/dL 3 months

20 – 44 µg/dL 1 month to 1 week (the higher the result, the more urgent the need for follow-up testing)

45 – 59 µg/dL 48 hours

60 – 69 µg/dL 24 hours

Greater than or equal to 70 µg/dL Immediately as an emergency lab test

When the LeadCare II display reads “High”, the analyzer has detected a blood leadlevel greater than 65 µg/dL. “High” results on LeadCare II should be followed upimmediately as an emergency laboratory test.

Venous confirmation samples can be tested on the LeadCare II System to rule outcontamination in the first sample. However, if the result of the venous sample is alsoabove 10 µg/dL, ESA recommends that you send the venous sample to a referencelaboratory for confirmation by another method.

NOTE: If you are concerned about the accuracy of results near the 10 µg/dL thresh-old, ESA recommends that you set the confirmation threshold at 8 µg/dL, and havevenous samples sent out for confirmation by a reference laboratory.

Report all blood lead test results to the appropriate state or federal agency.

Contact your State Childhood Lead Poisoning Prevention Program for the specificcase management guidelines that apply to your patients.

1CDC (Centers for Disease Control). Screening Young Children for Lead Poisoning: Guidance for Stateand Local Public Health Officials. Atlanta: CDC, 1997.


MaintenanceMaintaining the Analyzer

• Clean the analyzer with a damp cloth and warm, soapy water. Do not immersein water.

• Disinfect with dilute (10%) bleach solution.

• Do not leave any soap film on the analyzer.

• Do not allow liquid of any kind into the sensor connector.

• Do not wash the inside of the calibration button reader.

• Remove the sensor retainer to clean. Dry thoroughly before reinstalling.

ESA Biosciences Technical Support Number 1-800-275-0102

Interpreting ResultsM

aintenance


STARTUP MESSAGES DEFINITION WHAT TO DO

PLEASE CALIBRATE Analyzer must be calibrated the first Calibrate the analyzer. Refer to the ANALYZER WITH BUTTON time you use it. calibration instructions in this guide.

TEMP IS TOO HOT The temperature is too hot for testing. Wait until the screen displays PLEASE WAIT UNTIL the PREPARE SAMPLE message.

ANALYZER IS IN TEMP RANGE

TEMP IS TOO COLD The temperature is too cold for testing. Wait until the screen displays PLEASE WAIT UNTIL the PREPARE SAMPLE message.

ANALYZER IS INTEMP RANGEELECTRONIC The internal quality control check Call ESA Biosciences Technical

QC CHECK FAILED failed. Support at 1-800-275-0102. CALL TECH SERVICE

ERROR X

PROCESSING MESSAGES DEFINITION WHAT TO DO

WARNING The temperature is changing rapidly. Allow system temperature to stabilize.TEMP IS UNSTABLE This message flashes for 2 seconds.

TEST MAY FAILTHIS IS A USED SENSOR The sensor in the analyzer is wet Remove the used sensor or adjust the

PLEASE REMOVE SENSOR or previously used. new sensor until the screen displays the PREPARE SAMPLE message.

PLEASE REMOVE SENSOR A sensor was left in the analyzer. Remove the sensor.SENSOR OUT OF VIAL The sensor in the analyzer has been Remove the sensor and insert a new

TOO LONG out of the container too long and sensor.PLEASE REMOVE SENSOR cannot be used.

TEST FAILED There is not enough sample on the Remove the sensor, discard it and PLEASE REMOVE SENSOR sensor or the sensor failed. insert a new sensor. When adding the

sample to the sensor, make sure the sample covers the X area.

SENSOR REMOVED TOO SOON The sensor was removed from the Remove the sensor, discard it, insert aanalyzer before the end of the test. new sensor and add another drop of

sample. Wait 180 seconds (3 minutes) for the test to finish.

TEMP IS UNSTABLE The temperature in the room is too Move the analyzer to an area where RESULT DISCARDED unstable to yield accurate test results. there are fewer temperature changes

PLEASE REMOVE SENSOR (away from sources of cold or heat). The temperature is stable enough when the PREPARE SAMPLE messageindicates that the Analyzer is ready.

PLEASE RECALIBRATE There was a problem with transferring Repeat the calibration procedure. the calibration data to the analyzer Refer to the calibration procedure from the calibration button. in this guide.

SYSTEM FAILURE One of the main system Call ESA Biosciences Technical CALL TECH SERVICE components failed. Service at 1-800-275-0102.PLEASE CALIBRATE The analyzer must be calibrated Calibrate the analyzer. Refer to the

ANALYZER WITH BUTTON before you can use it. calibration instructions in this guide. The PREPARE SAMPLE message indi-cates that the analyzer is ready to use.

SENSOR LOT TOO OLD The sensor is from a lot that has Discard the sensor and the expired PLEASE RECALIBRATE expired. lot. Use a sensor from a new lot and

recalibrate the analyzer. CHANGE BATTERIES SOON Message flashes before or after a Change the batteries. Use four 1.5 V

test. Voltage is too low for the AA alkaline batteries.analyzer to run a test.

Troubleshooting


Troubleshooting of Inaccurate Results

Scenario 1: Troubleshooting results below the target or expected value• Make sure the analyzer is calibrated to the sensor lot in use.• Check the expiration date on the test kit box. Do NOT use a test kit that is beyond the

expiration date. Note: the analyzer will not perform a test when it is calibrated for a sensor lot that has expired.

• Use only fresh, whole blood from patients. Do NOT use plasma or serum.• Less than 50 µL in the capillary tube will tend to produce lower blood lead results.• Make sure that there are no clots or bubbles in the capillary tube.• Always mix the blood sample with treatment reagent. Results generated with untreated

blood are not accurate.• Do NOT use clotted blood. If there are clots in the blood, obtain a new sample.• Operate the analyzer only within the specified humidity range – 12 to 80% relative humidity.• Make sure that the analyzer, test kit, and sample are all at the same temperature before

testing. Note: The analyzer will not initiate a test if the temperature is changing too rapid-ly, or if the temperature is outside of the operating range.

• Avoid operating the LeadCare II System in drafts.• Make sure the blood and treatment reagent is thoroughly mixed before placing onto

the sensor. • Keep the lid on the sensor container closed to protect unused sensors.• Do NOT touch the sensor while running a test.

Scenario 2: Troubleshooting results above the target or expected value• Make sure the analyzer is calibrated to the sensor lot in use.• Check the expiration date on the test kit box. Do NOT use a test kit that is beyond the

expiration date. • To avoid contamination, thoroughly clean the sample site prior to puncture. Use clean

gloves during testing and keep your gloved hands clean.• Make sure you are using lead-free collection devices.• Do NOT touch the ends of the capillary tubes or the plungers. This could cause

contamination.• Excess blood on capillary tube. Be sure to wipe excess blood from the tube with a

downward motion. The accuracy of the test depends on filling the capillary tube with 50 µL. Excess blood on the outside of the tube will tend to produce higher blood leadresults.

• Do NOT use clotted blood. If there are clots in the blood, obtain a new sample.• Do NOT leave the treatment reagent tube uncapped other than to add the blood

sample and remove the blood sample/treatment reagent mixture.• Make sure to thoroughly mix blood with the treatment reagent. The mixture should turn

brown before you place it on the sensor.• Operate the analyzer only within the specified humidity range – 12 to 80% relative humidity.• Make sure that the analyzer, test kit, and sample are all at the same temperature

before testing.• Do NOT use a sensor that has been dropped on the floor or exposed to contaminants. • Do NOT touch the sensor while running a test.

If you have any doubt about the accuracy of your results, refer to the Troubleshooting section of the User's Guide. If, after following the instructions, the problem persists, call ESA Biosciences Technical Support at 1-800-275-0102.

Troubleshooting


ESA Biosciences, Inc.22 Alpha Road, Chelmsford, MA 01824 USA(800) 275-0102www.esainc.com

Copyright© 2005-2007. ESA Biosciences Inc.Produced under the following U.S. Patent Numbers:5,368,707; 5,468,366; 5,217,594; 5,873,990Part Number: 70-6552 Rev C

ESA Biosciences Technical Support Number 1-800-275-0102

LeadCare II Serial Number: _______________________

To place an order, call 1-800-959-5095.

Analyzer:LeadCare® II Analyzer Kit 70-6760

Reagents:LeadCare® II Test Kit 70-6762

Parts and Accessories:Label Printer (U.S. only) 70-3447

Printer Labels 70-3443

AA Batteries (4 Pack) 50-0005

Sensor Retainer 70-6543

Quick Reference Guide 70-6552

User’s Guide 70-6551

Instructional CD-ROM 70-6554

AC Power Cord 70-6692

International Power Plug Set 70-6693


70-6552 QRG RevC3:Layout 1 - Improve your screening rates with The LeadCare® II...

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