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1 Personal Check Money Order Credit Card Visa MC Discover Amex LYMPHOCYTE TRANSFORMATION TESTING (LTT) AND/OR METAL ION TESTING SERVICE (ALL FIELDS REQUIRED) Patient Last, First Name, M.I. Mail or Results to Patient: Mailing Address (required): Mail Blood To: Orthopedic Analysis, LLC Attn: Sample Receiving 2201 W, Campbell Park Dr. Suite 211 Chicago, IL Collection Date: ( / / ) Patient Date of Birth: ( / / ) Collection Time: Ordering Physician Name: Address: results to: Physician Prescription or Signature Required Ordering Physician Phone Number: Ordering Physician Fax Number: 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 P Payment at or by phone **Note: We do not bill insurance companies Name on card Exp Date Credit card # Billing Zip Account # 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): < > Rate your implant-related pain: (No pain) (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.

2 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.

3 Metal-LTT Analysis Report Panel 1 Report Date 1/1/2011 Report Time 12:00 AM Sample Collected 1/1/2011 Patient ID 1234 Sample Received 1/1/ :00 AM Report For Doe, John DOB xx/xx/xx Attending Physician Dr. X Control cpm Positive control (PHA) cpm Known stimulant (PHA) Mild Reactive Highly Reactive 9.7 Aluminum mm Aluminum 0.01 mm Aluminum 0.1 mm Cobalt mm 0.8 Cobalt 0.01 mm 0.2 Cobalt 0.1 mm 0.0 Chromium SAMPLE mm REPORT Chromium 0.01 mm 0.4 Chromium 0.1 mm 0.3 Molybdenum mm Molybdenum 0.01 mm Molybdenum 0.1 mm Nickel 0.001mM Nickel 0.01 mm Nickel 0.1 mm Vanadium mm Vanadium 0.01 mm Vanadium 0.1 mm Zirconium mm Zirconium 0.01 mm Zirconium 0.1 mm Iron mm Iron 0.01 mm Iron 0.1 mm Lymphocyte Stimulation Index Mildly Reactive 2 to 4 Reactive 4 to 8 Highly Reactive above W. Campbell Park Drive. Suite 211 Chicago, IL Results by: MC w w w.orthopedicanalysis.com p: (312) Page-1 of 2

4 Report Date 1/1/2011 Report Time 12:00 AM Sample Collected 1/1/2011 Patient ID 1234 Sample Received 1/1/ :00 AM Report For Doe, John DOB xx/xx/xx Attending Physician Dr. X Control cpm Positive control (PHA) cpm Metal Challenge Stimulation Index Range (percentile based) Known Stimulant (PHA) 9.7 Internal Control Passed Aluminum 3.5 Mildly Reactive Cobalt 0.8 SAMPLE REPORT Chromium Molybdenum 4.8 Reactive Nickel 11.2 Highly Reactive Vanadium 0.9 Zirconium 0.9 Iron 2.6 Mildly Reactive IMPORTANT DISCLAIMER Metal-LTT is a highly quantitative blood assay that has been used in many published scientific studies of metal allergy. This testing is performed per-customer request. The results of this testing are the property of the customer 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 W. Campbell Park Drive. Suite 211 Chicago, IL Results by: MC w w w.orthopedicanalysis.com p: (312) Page-2 of 2

TEST REQUISITION, PATIENT INFORMATION, AND CONSENT HUDSONALPHA CLINICAL SERVICES LAB

1. Patient Information Patient Name Last TEST REQUISITION, PATIENT INFORMATION, AND CONSENT HUDSONALPHA CLINICAL SERVICES LAB HUDSONALPHA CLINICAL SERVICES LAB CANNOT ACCEPT SAMPLES FROM FLORIDA, NEW YORK,