www.orthopedicanalysis.com

Orthopedic Analysis LLC Laboratory: 2201 W Campbell Park Dr, Suite 215, Chicago IL, 60612 Tel: 312-733-7121 Fax: 312-733-7105

ATTENTION:

Winter kit “fee” now in effect for kits not

returned within 4 weeks

Othopedic Analysis, LLC has implemented the use of winter Blood

Collection Kits to assure blood samples maintain a stable room

temperature during transport through the mail in cold winter months.

Please be aware that all materials included in the kit are for blood

transport purposes ONLY and should NOT be used for any household or

other purpose other than the transport of blood tubes to Orthopedic

Analysis.

Time: Winter kits are tracked and must be used and returned

to Orthopedic Analysis within 4 weeks of receipt.

Fee Amount: A fee of $ 50.00 will be charged to the recipient

of a winter kit if it is not returned within 4 weeks of receipt.

Shipping empty kits back: If testing is not desired after

receiving a winter kit, the unused kit must be mailed back to

orthopedic analysis (postage must be paid by the patient) or a

$50 fee will be charged. DO NOT USE OVERNIGHT

STAMP.

STEP 1

- Activate Warmer by pressing firmly

with your fingers on “clicker” located

inside the Warmer. Warmer will

crystalize and warm up in seconds.

- Place activated Warmer next to Gel-

Pack in plastic bag provided. Seal the

bag and place it inside the Thermos.

(Do not cool or freeze Gel-Pack)

-

STEP 2

- Wrap absorbent towel around blood

tubes (filled with blood).

- Place blood tubes inside the thermos

next to Gel-Pack.

- IMPORTANT: Gel-Pack must be

between tubes and Warmer (DO NOT

place tubes in direct contact with

Warmer).

STEP 3

- Close Thermos and place it on top of

Styrofoam insert in the kit box.

- Close kit box and ship back to

Orthopedic Analysis using FedEx pre-

paid label provided.

CALL ORTHOPEDIC ANALYSIS AT 312-733-7121 FOR ANY SHIPPING QUESTIONS

THERMOS

BLOOD TUBES

GEL-PACK

WARMER (color may vary)

WINTER KIT

INSTRUCTIONS

(Follow pictures)

FOLLOW THESE INSTRUCTIONS ONLY AFTER BLOOD HAS BEEN DRAWN

CLICKER

WARMER BLOOD TUBES

GEL-PACK

(Between tubes and

Warmer)

WARMER

GEL-PACK

www.orthopedicanalysis.com

Orthopedic Analysis LLC

Laboratory: 2201 W Campbell Park Dr, Suite 215, Chicago IL, 60612 Tel: 312-733-7121

Personal

Check

Money

Order

Credit

Card

Account # _________

Visa

MC

Discover

Amex

Name on card_________________________________ Exp Date_______

Credit card # _________________________________ Billing Zip______

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:

Address (required):

e-mail:

Mail Blood To:

Orthopedic Analysis, LLC

Attn: Sample Receiving

2201 W, Campbell Park Dr. Suite 215

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-10) 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 immuno-suppressant medication? yes no

Medications that may affect test results: Mycophenolate /Azathioprine / Ciclosporine / Tracolimus / Prednisone

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.

(A) Notifier(s): Orthopedic Analysis LLC (B) Patient Name: (C) Identification Number:

ADVANCE BENEFICIARY NOTICE OF NONCOVERAGE (ABN) NOTE: If Medicare doesn’t pay for (D) LTT below, you may have to pay.

Medicare does not pay for everything, even some care that you or your health care provider have good reason to think you need. We expect Medicare may not pay for the (D) _Metal LTT__ below. (D) LTT

(E) Reason Medicare May Not Pay: (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)__LTT_______listed above.

Note: If you choose Option 1 or 2, we may help you to use any other insurance that you might have, but Medicare 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)_LTT_____ listed above. You may ask to be paid now, but I also want Medicare billed for an official decision on payment, which is sent to me on a Medicare Summary Notice (MSN). I understand that if Medicare doesn’t pay, I am responsible for payment, but I can appeal to Medicare by following the directions on the MSN. If Medicare does pay, you will refund any payments I made to you, less co-pays or deductibles.

! OPTION 2. I want the (D)__LTT____ listed above, but do not bill Medicare. You may ask to be paid now as I am responsible for payment. I cannot appeal if Medicare is not billed.

! OPTION 3. I don’t want the (D)_LTT_____listed above. I understand with this choice I am not responsible for payment, and I cannot appeal to see if Medicare would pay.

(H) Additional Information: IF OPTION 1, PLEASE SEND A COPY OF YOUR MEDICARE CARD. This notice gives our opinion, not an official Medicare decision. If you have other questions on this notice or Medicare billing, call 1-800-MEDICARE (1-800-633-4227/TTY: 1-877-486-2048). Signing below means that you have received and understand this notice. You also receive a copy.

(I) Signature:

(J) Date:

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0566. The time required to complete this information collection is estimated to average 7 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, Maryland 21244-1850.

Form CMS-R-131 (03/08) Form Approved OMB No. 0938-0566

www.orthopedicanalysis.com

Orthopedic Analysis LLC Laboratory: 2201 W Campbell Park Dr, Suite 215, Chicago IL, 60612 Tel: 312-733-7121

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 that 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 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 4:00 PM Sample Collected 1/1/2011 9:00 AM

Patient ID 12345 Sample Received 1/1/2011 10:50 AM

Report For Doe, John DOB 9/9/9999

Attending Physician Dr. X Gender F

Control cpm 702.0

Positive control (PHA) cpm 37837.3

53.9

37.9

33.4

Non Reactive less than 2

Mildly Reactive 2 to 4

Reactive 4 to 8

Highly Reactive above 8

2201 W. Campbell Park Drive. Suite 215 Chicago, IL 60612 Results by: MC

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

Mild Reactive Highly Reactive

0.2

1.4

0.6

0.3

0.9

0.8

1.2

1.3

1.5

3.8

4.2

4.8

2.2

1.1

0.7

1.9

0.3

1.7

2.3

1.1

1.1

1.1

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 0.01 mM

Vanadium 0.001 mM

Vanadium 0.0001 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 0.01 mM

Cobalt 0.001 mM

Cobalt 0.0001 mM

Aluminum 0.1 mM

Aluminum 0.01 mM

Aluminum 0.001 mM

Known Stimulant (PHA)

Lymphocyte Stimulation Index

Report Date 1/1/2011

Report Time 4:00 PM Sample Collected 1/1/2011 9:00 AM

Patient ID 12345 Sample Received 1/1/2011 10:50 AM

Report For Doe, John DOB 9/9/9999

Attending Physician Dr. X Gender F

Control cpm 702.0

Positive control (PHA) cpm 37837.3

Metal Challenge Stimulation Index Range (percentile based)

Known Stimulant (PHA) 53.9 Normal Response

Aluminum 1.1 Normal

Cobalt 2.3 Mildly Reactive

Chromium 1.9 Normal

Molybdenum 4.8 Reactive

Nickel 39.6 Highly Reactive

Vanadium 1.5 Normal

Zirconium 0.9 Normal

Iron 1.4 Normal

(Normal = Non-Reactive)

2201 W. Campbell Park Drive. Suite 215 Chicago, IL 60612 Results by: MC

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

IMPORTANT DISCLAIMER Metal-LTT is a diagnostic test for hypersensitivity responses.

It is a highly quantitative blood assay that has been used in many published scientific studies of metal allergy. The results of this testing are the property of the

patient and should be used in combination with patient evaluation for diagnosis. It remains unclear to what degree metal hypersensitivity in general is

etiologically linked to poor implant performance.