M E D I C A L L A B O R A T O R Y

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1 M E D I C A L L A B O R A T O R Y E V A L U A T I O N PARTICIPANT SUMMARY Please see the corresponding US participant summary for any statistics not represented in this supplement. Total Commitment to Education and Service Provided by ACP, Inc. International Data Supplement MLE M1

2 Table of Contents 2011 Evaluation Criteria... 4 Blood Bank ABO Group... 5 Rh Factor (D Type)... 5 Antibody Detection... 5 Antibody Identification... 6 Compatibility Testing... 6 Coagulation Prothrombin Time... 7 International Normalized Ratio (INR)... 8 Activated Partial Thromboplastin Time... 9 Fibrinogen Urinalysis Urinalysis Dipstick Specific Gravity ph Protein Glucose Ketones Bilirubin Urobilinogen Blood or Hemoglobin Leukocyte Esterase Nitrite Microalbumin (Dipstick Only) Urine hcg Microbiology Antimicrobial Susceptibility Testing Parasitology (PA Specimens) Parasitology (FP Specimens) Immunology Rubella Qualitative Quantitative Syphilis Serology VDRL Slide VDRL Slide (Titer) MHA-TP FTA-ABS RPR RPR (Titer)... 33

3 Table of Contents (cont d) Viral Markers...35 Anti-HBc...35 Anti-HIV...37 HAV...39 HBeAg...41 HBsAb...42 HBsAg...44 HCV...45 Toxoplasma gondii...47 Qualitative...47 Quantitative...48 Cytomegalovirus (CMV)...47 Qualitative...47 Quantitative...49 CK-MB...50

4 2011 Evaluation Criteria The evaluation criteria used in the 2011 MLE Program is in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) federal requirements for proficiency testing. The criteria are included below. Qualitative For qualitative procedures, evaluation is based on participant consensus. A minimum percentage of participants must receive a passing score or the challenge is not evaluated due to lack of consensus. These percentages are listed below. Blood Bank Antimicrobial Susceptibility Testing Cytomegalovirus Microalbumin (Semi-Quantitative) Parasite Identification Rubella Syphilis Serology Toxoplasma Urine Dipstick Urine hcg Viral Markers 95% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus Quantitative For quantitative procedures, a mean and standard deviation (SD) are calculated for each peer group consisting of 5 or more laboratories. Acceptable performance is established based on a target value the intervals below. An explanation on how to calculate the range of acceptability based upon these limits is also provided in your MLE Program Guide on pages under the heading "Acceptable Ranges for Quantitative Results." Activated Partial Thromboplastin Time 15 percent CK-MB (U/L) 3 SD Cytomegalovirus 3 SD Fibrinogen 20 percent International Normalized Ratio (INR) 3 SD Prothrombin Time 15 percent Rubella 3 SD Specific Gravity Toxoplasma 3 SD 4 /2011 MLE-M1 International Data Supplement

5 BLOOD BANK ABO GROUP Specimen Results Labs Percent Performance BB-1 Group O % Acceptable BB-2 Group A % Acceptable Group O % BB-3 Group B % Acceptable BB-4 Group AB % Acceptable BB-5 Group A % Acceptable Group B % RH FACTOR (D TYPE) Specimen Results Labs Percent Performance BB-1 Rh Positive % Acceptable BB-2 Rh Negative % Acceptable Rh Positive % BB-3 Rh Negative % Acceptable Rh Positive % BB-4 Rh Negative % Acceptable Rh Positive % BB-5 Rh Positive % Acceptable ANTIBODY DETECTION Specimen Results Labs Percent Performance AB-1 No unexpected antibody detected % Acceptable AB-2 Unexpected antibody detected % Unexpected antibody detected % Acceptable No unexpected antibody detected % AB-3 Unexpected antibody dectected % Acceptable AB-4 No unexpected antibody detected % No unexpected antibody detected % Acceptable Unexpected antibody detected % AB-5 No unexpected antibody detected % Acceptable 2011 MLE-M1 International Data Supplement/ 5

6 BLOOD BANK ANTIBODY IDENTIFICATION Specimen Identification Labs Percent Performance AB-1 No antibody detected % Acceptable AB-2 Anti-Fy(a) % Acceptable AB-3 Anti-D % Acceptable AB-4 No antibody detected % Acceptable AB-5 No antibody detected % Acceptable COMPATIBILITY TESTING Specimen Results Labs Percent Performance AB-1 Compatible % AB-2 Not Compatible % Acceptable Acceptable Compatible % AB-3 Not Compatible % Acceptable Compatible % AB-4 Compatible % Acceptable Not Compatible % AB-5 Compatible % Acceptable Not Compatible % 6 /2011 MLE-M1 International Data Supplement

7 Coagulation PROTHROMBIN TIME (seconds) Specimen CG-1 Specimen CG-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Diag Stago STA Neoplastine CI+ RAL Clot-SP All Coagulation Instruments HUMAN HemoStat Thromboplastin - SI biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models Specimen CG-3 Specimen CG-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Diag Stago STA Neoplastine CI+ RAL Clot-SP All Coagulation Instruments HUMAN HemoStat Thromboplastin - SI biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method Diag Stago STA Neoplastine CI+ RAL Clot-SP All Coagulation Instruments HUMAN HemoStat Thromboplastin - SI biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models MLE-M1 International Data Supplement/ 7

8 PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-1 Specimen CG-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Diag Stago STA Neoplastine CI+ RAL Clot-SP All Coagulation Instruments HUMAN HemoStat Thromboplastin - SI biomerieux Thrombolyzer Compact X/XR IL TEST PT-FIB HS PLUS IL ACL, all models Specimen CG-3 Specimen CG-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Diag Stago STA Neoplastine CI+ RAL Clot-SP All Coagulation Instruments HUMAN HemoStat Thromboplastin - SI biomerieux Thrombolyzer Compact X/XR IL TEST PT-FIB HS PLUS IL ACL, all models Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method Diag Stago STA Neoplastine CI+ RAL Clot-SP All Coagulation Instruments HUMAN HemoStat Thromboplastin - SI biomerieux Thrombolyzer Compact X/XR IL TEST PT-FIB HS PLUS IL ACL, all models /2011 MLE-M1 International Data Supplement

9 ACTIVATED PARTIAL THROMBOPLASTIN (seconds) Specimen CG-1 Specimen CG-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Dade Actin FSL All Coagulation Instruments HUMAN HemoStat aptt - EL biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST APTT-SP IL ACL, all models Specimen CG-3 Specimen CG-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Dade Actin FSL All Coagulation Instruments HUMAN HemoStat aptt - EL biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST APTT-SP IL ACL, all models Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method Dade Actin FSL All Coagulation Instruments HUMAN HemoStat aptt - EL biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST APTT-SP IL ACL, all models MLE-M1 International Data Supplement/ 9

10 FIBRINOGEN (mg/dl) Specimen CG-1 Specimen CG-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method HUMAN HemoStat Fibrinogen biomerieux Thrombolyzer Compact X/XR IL TEST PT-FIB HS PLUS IL ACL, all models Specimen CG-3 Specimen CG-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method HUMAN HemoStat Fibrinogen biomerieux Thrombolyzer Compact X/XR IL TEST PT-FIB HS PLUS IL ACL, all models Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method HUMAN HemoStat Fibrinogen biomerieux Thrombolyzer Compact X/XR IL TEST PT-FIB HS PLUS IL ACL, all models URINALYSIS DIPSTICK SPECIFIC GRAVITY Specimen UA-1 Method Labs Mean SD CV Median Range All Method Arkray Aution Sticks Bayer Clinitek Advantus Bayer Reagent Strips Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urisys UriScan Reagent Strips /2011 MLE-M1 International Data Supplement

11 URINALYSIS DIPSTICK ph Specimen UA-1 Participant Results Method Labs 3.5 or less ALL METHODS Acon Laboratories Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips BioScan Reagent Strips CYBOW Urine Reagent Strips HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips MLE-M1 International Data Supplement/ 11

12 URINALYSIS DIPSTICK PROTEIN QUALITATIVE Specimen UA-1 Participant Results Method Labs Negative Trace 30mg/dL (1+) 100 mg/dl (2+) mg/dL (3+) >300mg/dl >1000mg/dL (4+) ALL METHODS Acon Laboratories Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips CYBOW Urine Reagent Strips HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips Specimen UA-1 is an ungraded challenge due to less than 80% participant consensus. 12 /2011 MLE-M1 International Data Supplement

13 URINALYSIS DIPSTICK GLUCOSE Specimen UA-1 Participant Results Method Labs Negative mg/dl (Trace) 150 mg/dl 250 mg/dl 500 mg/dl 1000 mg/dl >1000 mg/dl >2000 mg/dl ALL METHODS Acon Laboratories Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips CYBOW Urine Reagent Strips HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips MLE-M1 International Data Supplement/ 13

14 URINALYSIS DIPSTICK KETONES Specimen UA-1 Participant Results Method Labs Negative Trace (5 mg/dl) Small (1+, 15 mg/dl) Moderate (2+, 40 mg/dl) Large (3+, 80 mg/dl) 150 mg/dl 160 mg/dl ALL METHODS Acon Laboratories Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips CYBOW Urine Reagent Strips HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips /2011 MLE-M1 International Data Supplement

15 URINALYSIS DIPSTICK BILIRUBIN Specimen UA-1 Participant Results Method Labs Negative Small (1+) Moderate (2+) Large (3+) ALL METHODS Acon Laboratories Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips CYBOW Urine Reagent Strips HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips MLE-M1 International Data Supplement/ 15

16 URINALYSIS DIPSTICK UROBILINOGEN Specimen UA-1 Participant Results Method Labs 0.2/Normal mg/dl 1.0 mg/dl 2.0 mg/dl 4.0 mg/dl >8.0 mg/dl ALL METHODS Acon Laboratories Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips CYBOW Urine Reagent Strips HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips /2011 MLE-M1 International Data Supplement

17 URINALYSIS DIPSTICK BLOOD/HEMOGLOBIN Specimen UA-1 Participant Results Method Labs Negative Trace Small (1+) Moderate (2+) Large (3+) ALL METHODS Acon Laboratories Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips CYBOW Urine Reagent Strips HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips MLE-M1 International Data Supplement/ 17

18 URINALYSIS DIPSTICK LEUKOCYTE ESTERASE Specimen UA-1 Participant Results Method Labs Negative Trace Small (1+) Moderate (2+) Large (3+) ALL METHODS Acon Laboratories Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips CYBOW Urine Reagent Strips HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips /2011 MLE-M1 International Data Supplement

19 URINALYSIS DIPSTICK NITRITE Specimen UA-1 Participant Results Method Labs Positive Negative ALL METHODS Acon Laboratories Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips BioScan Reagent Strips CYBOW Urine Reagent Strips HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips MLE-M1 International Data Supplement/ 19

20 URINALYSIS MICROALBUMIN (dipstick only) Specimen UA-1 Participant Results Method Labs Negative 10 mg/l(pos) 20/30 mg/l 50 mg/l (+) 80 mg/l 100 mg/l (++) 150 mg/l ALL METHODS Bayer Clinitek Microalbumin Beckman Coulter ICON mircoalb Roche Micral - 1 minute URINALYSIS URINE hcg Specimen UA-1 Participant Results Method Labs Positive Negative ALL METHODS Acon Laboratories Biotron 1-Step Genzyme OSOM hcg Combo Test Inverness Acceva hcg-urine Inverness Clearview hcg Combo II Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Stanbio QuStick Sure-Vue hcg - 25mIU Veda lab /2011 MLE-M1 International Data Supplement

21 ANTIMICROBIAL SUSCEPTIBILIY TESTING Specimen SUS Disk Diffusion MIC Interpretative category data Interpretative category data Antimicrobial Labs S I R Labs S I R Acceptable (%) Amikacin % Amoxicillin/Clavulanate Ungraded 1 Ampicillin % Ampicillin/Sulbactam Ungraded 1 Aztreonam % Carbenicillin % Cefaclor Ungraded 1 Cefamandole % Cefazolin % Cefepime % Cefixime % Cefoperazone % Cefotaxime % Cefotetan % Cefoxitin % Cefpodoxime % Ceftazidime % Ceftizoxime % Ceftriaxone % Cefuroxime % Cephalexin % Cephalothin Ungraded 1 Ciprofloxacin % Clindamycin % Doxycycline % Ertapenem % Fosfomycin % Gatifloxacin % Gentamicin % Imipenem % 1 This is an ungraded challenge due to less than 80% participant consensus MLE-M1 International Data Supplement/ 21

22 ANTIMICROBIAL SUSCEPTIBILIY TESTING (cont d) Specimen SUS Disk Diffusion MIC Interpretative category data Interpretative category data Antimicrobial Labs S I R Labs S I R Acceptable (%) Kanamycin % Levofloxacin % Linezolid Ungraded 1 Lomefloxacin % Meropenem % Moxifloxacin % Nalidixic Acid % Netilmicin % Nitrofurantoin % Norfloxacin % Ofloxacin % Oxacillin % Penicillin % Piperacillin % Piperacillin/Tazobactam % Rifampin % Tetracycline % Ticarcillin/Clavulanate Ungraded 1 Tobramycin % Trimethoprim % Trimethoprim/Sulfamethoxazole % Vancomycin % Organism present in specimen SUS-1: Escherichia coli. 1 This is an ungraded challenge due to less than 80% participant consensus. 22 /2011 MLE-M1 International Data Supplement

23 PARASITOLOGY (PA Specimens) Specimen PA-1 Identification Labs Percent Performance No parasite seen 4 80% Acceptable Entamoeba histolytica 1 20% Parasite present in specimen PA-1: No parasite seen. Specimen PA-2 Identification Labs Percent Performance Entamoeba histolytica 3 60% Not graded Entamoeba hartmanni 1 20% Giardia lamblia 1 20% Parasite present in specimen PA-2: Entamoeba coli. This is an ungraded challenge due to less than 80% participant consensus. Specimen PA-3 Identification Labs Percent Performance Ascaris lumbricoides eggs % Acceptable Trichuris trichiura eggs % Acceptable No parasite seen % Schistosoma mansoni eggs % Parasite present in specimen PA-3: Ascaris lumbricoides eggs MLE-M1 International Data Supplement/ 23

24 PARASITOLOGY (PA Specimens) cont d Specimen PA-4 Identification Labs Percent Performance Diphyllobothrium latum % Not graded Endolimax nana % Fasciola hepatica eggs % Trichuris trichiura eggs % Ascaris lumbricoides eggs % Parasite present in specimen PA-4: Diphyllobothrium latum. This is an ungraded challenge due to less than 80% participant consensus. Specimen PA-5 Identification Labs Percent Performance Microfilaria, sheathed, NOS % Not graded Microfilaria, unsheathed, NOS % Microfilaria-Brugia species % Microfilaria-Wuchereria Bancrofti % Plasmodium vivax % Microfilaria-Loa loa % No parasite seen % Parasite present in specimen PA-5: Brugia malayi. This is an ungraded challenge due to less than 80% participant consensus. 24 /2011 MLE-M1 International Data Supplement

25 PARASITOLOGY (FP Specimens) Specimen FP-1 Identification Labs Percent Performance Hookworm % Acceptable Parasite egg seen but no ID % Acceptable Other parasite seen but no ID % Acceptable No parasite seen % Entamoeba coli % Ascaris lumbricoides eggs % Parasite present in specimen FP-1: Hookworm eggs. Specimen FP-2 Identification Labs Percent Performance Ascaris lumbricoides eggs % Acceptable Trichuris trichiura eggs % Acceptable No parasite seen % Endolimax nana % Parasite present in specimen FP-2: Ascaris lumbricoides eggs MLE-M1 International Data Supplement/ 25

26 PARASITOLOGY (FP Specimens) cont d Specimen FP-3 Identification Labs Percent Performance Diphyllobothrium latum % Not graded Fasciola hepatica eggs % Endolimax nana % Paragonimus westermani eggs % No parasite seen % Ascaris lumbricoides eggs % Blastocystis hominis % Parasite present in specimen FP-3: Diphyllobothrium latum. This is an ungraded challenge due to less than 80% participant consensus. Specimen FP-4 Identification Labs Percent Performance No parasite seen Acceptable Parasite present in specimen FP-4: No parasite seen. 26 /2011 MLE-M1 International Data Supplement

27 PARASITOLOGY (FP Specimens) cont d Specimen FP-5 Identification Labs Percent Performance Microfilaria, NOS % Not graded Microfilaria-Brugia species % Microfilaria, sheathed, NOS % Other parasite seen but no ID % No parasite seen % Plasodium falciparum % Plasmodium sp., NOS % Microfilaria-Onchocerca volvu % Plasmodium vivax % Babesia sp % Parasite present in specimen FP-5: Micofilaria-Brugia species. This is an ungraded challenge due to less than 80% participant consensus MLE-M1 International Data Supplement/ 27

28 Rubella Qualitative Specimen RU-1 Specimen RU-2 Specimen RU-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS biomerieux Vidas, Mini Vidas Roche Modular Analytics VITROS ECi Specimen RU-4 Specimen RU-5 Method Positive Negative Positive Negative ALL METHODS biomerieux Vidas, Mini Vidas Roche Modular Analytics VITROS ECi /2011 MLE-M1 International Data Supplement

29 Rubella Quantitative (IU/mL) Specimen/Method Labs Mean SD CV Median Range Specimen RU-1 All Method Specimen RU-2 All Method Specimen RU-3 All Method Specimen RU-4 All Method Specimen RU-5 All Method MLE-M1 International Data Supplement/ 29

30 Syphilis Serology Qualitative: VDRL Slide Method Specimen SY-1 Specimen SY-2 Specimen SY-3 Weakly Non- Weakly Non- Weakly Non- Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive ALL METHODS Omega Diagnostics Wiener Lab Specimen SY-4 Specimen SY-5 ALL METHODS Omega Diagnostics Wiener Lab Syphilis Serology Quantitative: VDRL Slide Titer Specimen/Method 0 dils 1 dil 2 dils 4 dils 8 dils 16 dils 32 dils >32 dils Specimen SY-1 ALL METHODS Omega Diagnostics Wiener Lab Specimen SY-2 ALL METHODS Omega Diagnostics Wiener Lab Specimen SY-4 ALL METHODS Omega Diagnostics Wiener Lab /2011 MLE-M1 International Data Supplement

31 Syphilis Serology Qualitative: MHA-TP Specimen SY-1 Specimen SY-2 Specimen SY-3 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Biokit Human Omega Diagnostics Serodia SPINREACT Specimen SY-4 Specimen SY-5 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Biokit biomerieux Human Omega Diagnostics Serodia Syphilis Serology Qualitative: FTA-ABS (Treponema pallidum Antibodies) Specimen SY-1 Specimen SY-2 Specimen SY-3 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Abbott Architect biomerieux Serodia Specimen SY-4 Specimen SY-5 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Abbott Architect biomerieux Serodia MLE-M1 International Data Supplement/ 31

32 Syphilis Serology Qualitative: RPR Specimen SY-1 Specimen SY-2 Specimen SY-3 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Serodia SPINREACT Wiener Lab Specimen SY-4 Specimen SY-5 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Serodia SPINREACT Wiener Lab /2011 MLE-M1 International Data Supplement

33 Syphilis Serology Quantitative: RPR (Titer) Specimen/Method >64 Specimen SY-1 ALL METHODS Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Serodia SPINREACT Wiener Lab Specimen SY-2 ALL METHODS Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Serodia SPINREACT Wiener Lab MLE-M1 International Data Supplement/ 33

34 Syphilis Serology Quantitative: RPR (Titer) cont d Specimen/Method >64 Specimen SY-4 ALL METHODS Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Serodia SPINREACT Wiener Lab /2011 MLE-M1 International Data Supplement

35 Viral Markers Anti-HBc Specimen VM-1 Specimen VM-2 Specimen VM-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM - IgG Abbott AxSYM - IgM Abbott AxSYM - Total Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Bio-Rad Evolis biomerieux Vidas - IgM biomerieux Vidas - Total Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - IgM Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgG VITROS ECi - IgM VITROS ECi - Total MLE-M1 International Data Supplement/ 35

36 Viral Markers Anti-HBc (cont d) Specimen VM-4 Specimen VM-5 Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM - IgG Abbott AxSYM - IgM Abbott AxSYM - Total Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Bio-Rad Evolis biomerieux Vidas - IgM biomerieux Vidas - Total Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - IgM Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgG VITROS ECi - IgM VITROS ECi - Total /2011 MLE-M1 International Data Supplement

37 Viral Markers Anti-HIV Specimen VM-1 Specimen VM-2 Specimen VM-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Bio-Rad Evolis biomerieux Vidas - IgG biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - Total MLE-M1 International Data Supplement/ 37

38 Viral Markers Anti-HIV (cont d) Specimen VM-4 Specimen VM-5 Method Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Bio-Rad Evolis biomerieux Vidas - IgG biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - Total /2011 MLE-M1 International Data Supplement

39 Viral Markers HAV Specimen VM-1 Specimen VM-2 Specimen VM-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect - IgG Abbott Architect - IgM Abbott Architect - Total Abbott AxSYM - IgG Abbott AxSYM - IgM Abbott AxSYM - Total Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI biomerieux Vidas - IgM biomerieux Vidas - Total Other IgG Method Other IgM method Other Total Method Roche Elecsys - IgG Roche Elecsys - IgM Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgG VITROS ECi - Total MLE-M1 International Data Supplement/ 39

40 Viral Markers HAV (cont d) Specimen VM-4 Specimen VM-5 Method Positive Negative Positive Negative ALL METHODS Abbott Architect - IgG Abbott Architect - IgM Abbott Architect - Total Abbott AxSYM - IgG Abbott AxSYM - IgM Abbott AxSYM - Total Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI biomerieux Vidas - IgM biomerieux Vidas - Total Other IgG Method Other IgM method Other Total Method Roche Elecsys - IgG Roche Elecsys - IgM Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgG VITROS ECi - Total /2011 MLE-M1 International Data Supplement

41 Viral Markers HBeAg Specimen VM-1 Specimen VM-2 Specimen VM-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other Total Method Roche cobas 6000 / e Roche Elecsys - Total Roche Modular Analytics VITROS ECi - Total Specimen VM-4 Specimen VM-5 ALL METHODS Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other Total Method Roche cobas 6000 / e Roche Elecsys - Total Roche Modular Analytics VITROS ECi - Total MLE-M1 International Data Supplement/ 41

42 Viral Markers HBsAb Specimen VM-1 Specimen VM-2 Specimen VM-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM - IgG Abbott AxSYM - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI biomerieux Vidas - IgG biomerieux Vidas - Total Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - Total /2011 MLE-M1 International Data Supplement

43 Viral Markers HBsAb (cont d) Specimen VM-4 Specimen VM-5 ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM - IgG Abbott AxSYM - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI biomerieux Vidas - IgG biomerieux Vidas - Total Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - Total MLE-M1 International Data Supplement/ 43

44 Viral Markers Anti-HBsAg Specimen VM-1 Specimen VM-2 Specimen VM-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Bio-Rad Evolis biomerieux Vidas - IgG biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - Total /2011 MLE-M1 International Data Supplement

45 Viral Markers Anti-HBsAg (cont d) Specimen VM-4 Specimen VM-5 Method Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - IgM Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Bayer ADVIA Centaur - Total Bio-Rad Evolis biomerieux Vidas - IgG biomerieux Vidas - IgM biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - Total MLE-M1 International Data Supplement/ 45

46 Viral Markers HCV Specimen VM-1 Specimen VM-2 Specimen VM-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - IgG Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Bio-Rad Evolis Other IgG Method Other Total Method Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgG VITROS ECi - Total Specimen VM-4 Specimen VM-5 ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - IgG Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Bio-Rad Evolis Other IgG Method Other Total Method Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgG VITROS ECi - Total /2011 MLE-M1 Participant Summary

47 Toxoplasma gondii Antibody Specimen TOX-1 Specimen TOX-2 Specimen TOX-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect - IgG Other IgM method VITROS ECi - IgG VITROS ECi - IgM Specimen TOX-4 Specimen TOX-5 ALL METHODS Other IgM method VITROS ECi - IgG Cytomegalovirus (CMV) Antibodies Specimen CMV-1 Specimen CMV-2 Specimen CMV-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect - IgG Other IgM method VITROS ECi - IgG Specimen CMV-4 Specimen CMV-5 ALL METHODS Other IgM method VITROS ECi - IgG MLE-M1 International Data Supplement/ 47

48 Toxoplasma gondii Antibody Quantitative (IU/mL) Specimen/Method Labs Mean SD CV Median Range Specimen TOX-1 All Method Specimen TOX-2 All Method Specimen TOX-3 All Method Not graded Specimen TOX-4 All Method Not graded Specimen TOX-5 All Method Not graded 48 /2011 MLE-M1 Participant Summary

49 Cytomegalovirus (CMV) Antibodies Quantitative (U/mL) Specimen/Method Labs Mean SD CV Median Range Specimen CMV-1 All Method Specimen CMV-2 All Method Specimen CMV-3 All Method Not graded Specimen CMV-4 All Method Not graded Specimen CMV-5 All Method Not graded 2011 MLE-M1 International Data Supplement/ 49

50 CK-MB - Quantitative (U/L) Specimen/Method Labs Mean SD CV Median Range Specimen CK-1 All Method Specimen CK-2 All Method Specimen CK-3 All Method Specimen CK-4 All Method Specimen CK-5 All Method Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: /2011 MLE-M1 Participant Summary