LYMPHOCYTE TRANSFORMATION TESTING (LTT) AND/OR METAL ION ... · Please choose desired METAL ION...

www.orthopedicanalysis.com

Orthopedic Analysis LLC

Laboratory: 2201 W Campbell Park Dr, Suite 211, Chicago IL, 60612 Tel: 312-733-7121

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LYMPHOCYTE TRANSFORMATION TESTING (LTT) AND/OR METAL ION TESTING SERVICE (ALL FIELDS REQUIRED)

Patient Last, First Name, M.I.

Mail or e-mail Results to Patient:

Mailing Address (required):

e-mail:

Mail Blood To:

Orthopedic Analysis, LLC

Attn: Sample Receiving

2201 W, Campbell Park Dr. Suite 211

Chicago, IL 60612

Ordering Physician Name:

Address:

e-mail results to:

Physician Prescription or Signature Required __________________________

Collection Date:

( / / )

Collection Time: Ordering Physician Phone Number: Ordering Physician Fax Number:

Patient Date of Birth:

( / / )

Patient Phone #: Diagnosis (ICD-9) Code: Ordering Physician NPI #:

Please choose desired METAL ALLERGY TEST (lymphocyte transformation test panel):

Panel-1 M8 Metal Sensitivity Kit $ 398 (Includes overnight shipping label)

(Aluminum, Chromium, Cobalt, Iron, Molybdenum, Nickel, Vanadium, Zirconium)

Panel-2 P12 Metals + Particles (metals and polymers) Sensitivity Kit $ 573 (Includes overnight shipping label)

(Aluminum, Chromium, Cobalt, Iron, Molybdenum, Nickel, Vanadium, Zirconium, (Bone cement liquid and particles (PMMA),

Cobalt-alloy particles and Titanium-alloy Particles)

Dental Panel D12 Metals + Particles (metals and polymers) Sensitivity Kit $ 573 (Includes overnight shipping label)

(Aluminum, Chromium, Copper, Gold, Mercury, Nickel, Silver, Tin, Bone cement liquid and particles (PMMA), Cobalt-alloy

particles and Titanium-alloy Particles)

Please choose desired METAL ION TEST (amount of metal in blood): Special tubes need to be pre-ordered

CoCrS (Serum Cobalt/Chromium) $ 211 TiS (Serum Titanium) $ 230 NiS (Serum Nickel) $140 All kits include a FedEx pre-paid priority overnight shipping label back to Orthopedic Analysis

Payment method - payment required at time of service **Note: We do not bill insurance companies

P

Payment at www.orthopedicanalysis.com or by phone 312-733-7121

RELEASE OF INFORMATION AUTHORIZATION

I, , hereby authorize Orthopedic Analysis to release testing

information concerning Metal Lymphocyte Proliferation Testing to the above named physician.

Signature Date Please provide the following information (please circle appropriate category):

1. Gender: Male Female

2. Do you have an implant? No implant Hip Knee Spine Dental Other:

3. How long have you had your implant (years) : <1 1 2 3 4 5 6 7 8 9 10 > 10

4. Rate your implant-related pain: (No pain) 0 1 2 3 4 5 6 7 8 9 10 (Extreme pain)

5. Do you have any allergies? Penicillin Drugs Food Seasonal Jewelry

Other:

6. Are you currently taking any anti-inflammatory medication? yes no

(this includes cortico-steriods)

IMPORTANT DISCLAIMER - RESULTS FOR PERSONAL USE ONLY

It is uncertain to what extent metal hypersensitivity mediates the pathogenesis of implant failure or other adverse reactions

to metal, polymer and ceramic implant materials.




GENERAL INFORMATION

What is a metal-LTT Assay?

A metal-Lymphocyte Transformation Test (LTT) is also called a lymphocyte proliferation test. This

test measures the amount of reactivity (or proliferation) of immune cells called lymphocytes, after they

have been exposed to a particular challenge (such as a type of metal or a kind of drug). Lymphocytes

are central cells of our immune system and react to a threat in several ways. One way they do this is to

expand in number. People with a sensitivity to a particular metal will have lymphocytes that think the

metal is a threat and will mount a defense. This can cause unwanted inflammation to metals in some

people “allergic” to metals. The most common form of this is the skin reactions about 10-15% of

people get when they wear cheap jewelry with nickel or chromium in the metal alloy.

How is the metal-LTT test conducted? 1. A blood draw is necessary to collect the important immune cells (like lymphocytes and monocytes).

2. These important immune cells (PBMCs) are isolated from the blood and collected.

3. The collected immune cells (containing lymphocytes) are divided up and each group of cells are

cultured for a little less than 1 week with different types of implant metals (including Aluminum,

Cobalt, Chromium, Iron, Molybdenum, Nickel, Vanadium and Zirconium).

4. When the cells are sensitive to a particular metal they send out an “alarm” and start dividing and

proliferating. So, after the cells have been grown together with the metals for 5-6 days, the amount of

proliferation of the immune cells is measured.

5. The results are analyzed and sent out.

Why use metal-LTT? There are two kinds of people that can benefit from metal allergy testing.

1- Determine if someone with a history of metal allergy has a metal-specific hypersensitivity

before surgery: If you are someone with a history of metal allergy and are about to get an orthopedic

implant such as a hip replacement, then metal-LTT testing to the different kinds of metals that

orthopedic implants are made of can help you avoid the wrong one.

2-Determine if someone with a poorly functioning orthopedic implant is metal hypersensitive: If

you are someone with an orthopedic implant with unexplained pain, stiffness and/or skin rashes related

to the implant where the doctors have ruled out other causes such as infection, then metal-LTT will

help determine if you have a hypersensitivity to one of the metals used in your implant.

Current tests used to diagnose hypersensitivity reactions, such as patch testing (on the skin of the

patient), are not well accepted in orthopedic practice, and run the risk of sensitizing the patient prior to

receiving an implant. To address this need we have adapted standard LTT assays to a metal-LTT test

that is performed in our laboratory with the patient’s blood and not on the skin. The LTT assay is used

to test for metal sensitivity to Aluminum, Chromium, Cobalt, Iron, Molybdenum, Nickel, Vanadium,

and Zirconium. This test facilitates a dose response quantification of metal-induced hypersensitivity

responses in terms of generalized lymphocyte reactivity (i.e. proliferation). Issues of sensitivity and

specificity remain unresolved as well as how implant performance is related to positive reactivity

results. Metal-specific reactivity is gauged by comparing non-treated to treated lymphocytes from the

same individual and categorized using the following general criteria: 2-4 fold response =mild

reactivity, 5-8 fold =moderate reactivity, and >8 =high reactivity.




Metal-LTT Analysis ReportPanel 1

Report Date 1/1/2011

Report Time 12:00 AM Sample Collected 1/1/2011

Patient ID 1234 Sample Received 1/1/2011 10:00 AM

Report For Doe, John DOB xx/xx/xx

Attending Physician Dr. X

Control cpm 3122.0

Positive control (PHA) cpm 30358.3

Mildly Reactive 2 to 4

Reactive 4 to 8

Highly Reactive above 8

2201 W. Campbell Park Drive. Suite 211 Chicago, IL 60612 Results by: MC

www.orthopedicanalysis.com p: (312) 733-7121 Page-1 of 2

Mild Reactive Highly Reactive

1.3

0.7

2.6

0.9

0.6

0.7

0.0

0.9

0.7

11.2

5.8

2.3

4.8

2.4

2.0

0.3

0.4

0.7

0.0

0.2

0.8

3.5

1.2

1.7

9.7

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Iron 0.1 mM

Iron 0.01 mM

Iron 0.001 mM

Zirconium 0.1 mM

Zirconium 0.01 mM

Zirconium 0.001 mM

Vanadium 0.1 mM

Vanadium 0.01 mM

Vanadium 0.001 mM

Nickel 0.1 mM

Nickel 0.01 mM

Nickel 0.001mM

Molybdenum 0.1 mM

Molybdenum 0.01 mM

Molybdenum 0.001 mM

Chromium 0.1 mM

Chromium 0.01 mM

Chromium 0.001 mM

Cobalt 0.1 mM

Cobalt 0.01 mM

Cobalt 0.001 mM

Aluminum 0.1 mM

Aluminum 0.01 mM

Aluminum 0.001 mM

Known stimulant (PHA)

Lymphocyte Stimulation Index

SAMPLE REPORT




Report Date 1/1/2011

Report Time 12:00 AM Sample Collected 1/1/2011

Patient ID 1234 Sample Received 1/1/2011 10:00 AM

Report For Doe, John DOB xx/xx/xx

Attending Physician Dr. X

Control cpm 3122.0

Positive control (PHA) cpm 30358.3

Metal Challenge Stimulation Index Range (percentile based)

Known Stimulant (PHA) 9.7 Internal Control Passed

Aluminum 3.5 Mildly Reactive

Cobalt 0.8

Chromium 0.7

Molybdenum 4.8 Reactive

Nickel 11.2 Highly Reactive

Vanadium 0.9

Zirconium 0.9

Iron 2.6 Mildly Reactive

2201 W. Campbell Park Drive. Suite 211 Chicago, IL 60612 Results by: MC

www.orthopedicanalysis.com p: (312) 733-7121 Page-2 of 2

IMPORTANT DISCLAIMERMetal-LTT is a highly quantitative blood assay that has been used in manypublished scientific studies of metal allergy. This testing is performed

per-customer request . The results of this testing are the property of thecustomer and should be used in combination with patient evaluation for

diagnosis. It remains unclear if metal hypersensitivity in general is

etiologically linked to poor implant performance.

SAMPLE REPORT

LYMPHOCYTE TRANSFORMATION TESTING (LTT) AND/OR METAL ION ... · Please choose desired METAL ION...

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