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

Transcription

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 2012 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) Activated Partial Thromboplastin Time 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)... 40

3 Table of Contents (cont d) Viral Markers...42 Anti-HBc...42 Anti-HIV...44 HAV...46 HBeAg...48 HBsAb...49 HBsAg...51 HCV...53 Toxoplasma gondii...55 Qualitative...55 Quantitative...56 Cytomegalovirus (CMV)...55 Qualitative...55 Quantitative...57 CK-MB...58

4 2012 Evaluation Criteria The evaluation criteria used in the 2012 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 or referee 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 10 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 page 37 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 /2012 MLE-M1 International Data Supplement

5 BLOOD BANK ABO GROUP Specimen Results Labs Percent Performance BB-1 Group A % Acceptable Group B % Group O % BB-2 Group B % Acceptable Group AB % Group O % BB-3 Group AB % Acceptable Group O % Group B % Group A % BB-4 Group O % Acceptable BB-5 Group A % Acceptable Group AB % Group O % RH FACTOR (D TYPE) Specimen Results Labs Percent Performance BB-1 Rh Negative % Acceptable Rh Positive % BB-2 Rh Positive % Acceptable Rh Negative % BB-3 Rh Negative % Acceptable Rh Positive % BB-4 Rh Positive % Acceptable Rh Negative % BB-5 Rh Positive % Acceptable ANTIBODY DETECTION Specimen Results Labs Percent Performance AB-1 No unexpected antibody detected % Acceptable AB-2 No unexpected antibody detected % Acceptable AB-3 Unexpected antibody detected % Acceptable AB-4 Unexpected antibody detected % Acceptable No unexpected antibody detected % AB-5 No unexpected antibody detected % Acceptable Unexpected antibody detected % 2012 MLE-M1 International Data Supplement/ 5

6 BLOOD BANK ANTIBODY IDENTIFICATION Specimen Identification Labs Percent Performance AB-1 No antibody detected % Acceptable Anti-Lu(a) % Acceptable AB-2 No antibody detected % Acceptable Anti-Lu(a) % AB-3 Anti-D % Acceptable Unable to indentify, referred % Acceptable Anti-E % AB-4 Other antibody listed % Anti-E % Acceptable Unable to indentify, referred % Acceptable No antibody detected % AB-5 Anti-e % No antibody detected % Acceptable Anti-E % COMPATIBILITY TESTING Specimen Results Labs Percent Performance AB-1 Compatible % Acceptable Not Compatible % AB-2 Compatible % Acceptable Not Compatible % AB-3 Not Compatible % Acceptable Compatible % AB-4 Compatible % Acceptable Not Compatible % AB-5 Compatible % Acceptable Not Compatible % 6 /2012 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 Dade Innovin Sysmex CA-500/ All Coagulation Instruments Dade Thromborel S Sysmex CA-500/ All Coagulation Instruments 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 Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments TriniCLOT PT Excel OTC Coag-A-Mate XM All Coagulation Instruments MLE-M1 International Data Supplement/ 7

8 PROTHROMBIN TIME (seconds) Specimen CG-3 Specimen CG-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Dade Innovin Sysmex CA-500/ All Coagulation Instruments Dade Thromborel S Sysmex CA-500/ All Coagulation Instruments 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 Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments TriniCLOT PT Excel OTC Coag-A-Mate XM All Coagulation Instruments /2012 MLE-M1 International Data Supplement

9 PROTHROMBIN TIME (seconds) Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method Dade Innovin Sysmex CA-500/ All Coagulation Instruments Dade Thromborel S Sysmex CA-500/ All Coagulation Instruments 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 Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments TriniCLOT PT Excel OTC Coag-A-Mate XM All Coagulation Instruments MLE-M1 International Data Supplement/ 9

10 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 Dade Innovin Sysmex CA-500/ All Coagulation Instruments Dade Thromborel S Sysmex CA-500/ All Coagulation Instruments 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 Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments TriniCLOT PT Excel OTC Coag-A-Mate XM All Coagulation Instruments /2012 MLE-M1 International Data Supplement

11 PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-3 Specimen CG-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Dade Innovin Sysmex CA-500/ All Coagulation Instruments Dade Thromborel S Sysmex CA-500/ All Coagulation Instruments 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 Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments TriniCLOT PT Excel OTC Coag-A-Mate XM All Coagulation Instruments MLE-M1 International Data Supplement/ 11

12 PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method Dade Innovin Sysmex CA-500/ All Coagulation Instruments Dade Thromborel S Sysmex CA-500/ All Coagulation Instruments 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 Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments TriniCLOT PT Excel OTC Coag-A-Mate XM All Coagulation Instruments /2012 MLE-M1 International Data Supplement

13 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 Sysmex CA-500/ Dade Actin FSL Sysmex CA-500/ All Coagulation Instruments Hemoliance SynthASil All Coagulation Instruments HUMAN HemoStat aptt - EL biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST APTT-SP IL ACL, all models All Coagulation Instruments Specimen CG-3 Specimen CG-4 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Dade Actin Sysmex CA-500/ Dade Actin FSL Sysmex CA-500/ All Coagulation Instruments Hemoliance SynthASil All Coagulation Instruments HUMAN HemoStat aptt - EL biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST APTT-SP IL ACL, all models All Coagulation Instruments MLE-M1 International Data Supplement/ 13

14 ACTIVATED PARTIAL THROMBOPLASTIN (seconds) Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method Dade Actin Sysmex CA-500/ Dade Actin FSL Sysmex CA-500/ All Coagulation Instruments Hemoliance SynthASil All Coagulation Instruments HUMAN HemoStat aptt - EL biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST APTT-SP IL ACL, all models All Coagulation Instruments /2012 MLE-M1 International Data Supplement

15 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 MLE-M1 International Data Supplement/ 15

16 URINALYSIS DIPSTICK SPECIFIC GRAVITY Specimen UA-1 Method Labs Mean SD CV Median Range All Method All PSS Select Methods All Refractive Index Methods All Roche Instruments Arkray Aution Sticks Bayer Clinitek 10 / Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Reagent Strips Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Hypoguard DiaScreen Other Analyzer Method Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Criterion Analyzer Roche Miditron Junior/II Roche Urisys SD UroColor Reagent Strips UriScan Reagent Strips /2012 MLE-M1 International Data Supplement

17 URINALYSIS DIPSTICK ph Specimen UA-1 Participant Results Method Labs 3.5 or less ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Multistix Pro Bayer Reagent Strips Combi-Screen Test Strips CYBOW Urine Reagent Strips DIRUI H-800 Urine Analyzer Germaine Laboratories AimStrip HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method ph Paper Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA 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 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 Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Multistix Pro Bayer Reagent Strips Combi-Screen Test Strips CYBOW Urine Reagent Strips DIRUI H-800 Urine Analyzer Germaine Laboratories AimStrip HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips /2012 MLE-M1 International Data Supplement

19 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 Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Multistix Pro Bayer Reagent Strips Combi-Screen Test Strips CYBOW Urine Reagent Strips DIRUI H-800 Urine Analyzer Germaine Laboratories AimStrip HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA 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 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 Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Multistix Pro Bayer Reagent Strips Combi-Screen Test Strips CYBOW Urine Reagent Strips DIRUI H-800 Urine Analyzer Germaine Laboratories AimStrip HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips /2012 MLE-M1 International Data Supplement

21 URINALYSIS DIPSTICK BILIRUBIN Specimen UA-1 Participant Results Method Labs Negative Small (1+) Moderate (2+) Large (3+) ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Multistix Pro Bayer Reagent Strips Combi-Screen Test Strips CYBOW Urine Reagent Strips DIRUI H-800 Urine Analyzer Germaine Laboratories AimStrip HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA 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/ 21

22 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 Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Multistix Pro Bayer Reagent Strips Combi-Screen Test Strips CYBOW Urine Reagent Strips DIRUI H-800 Urine Analyzer Germaine Laboratories AimStrip HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips /2012 MLE-M1 International Data Supplement

23 URINALYSIS DIPSTICK BLOOD/HEMOGLOBIN Specimen UA-1 Participant Results Method Labs Negative Trace Small (1+) Moderate (2+) Large (3+) ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Multistix Pro Bayer Reagent Strips Combi-Screen Test Strips CYBOW Urine Reagent Strips DIRUI H-800 Urine Analyzer Germaine Laboratories AimStrip HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA 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/ 23

24 URINALYSIS DIPSTICK LEUKOCYTE ESTERASE Specimen UA-1 Participant Results Method Labs Negative Trace Small (1+) Moderate (2+) Large (3+) ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Multistix Pro Bayer Reagent Strips Combi-Screen Test Strips CYBOW Urine Reagent Strips DIRUI H-800 Urine Analyzer Germaine Laboratories AimStrip HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA Roche SuperUA/ChemstripUA Roche Urilux S Roche Urisys SD UroColor Reagent Strips TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips /2012 MLE-M1 International Data Supplement

25 URINALYSIS DIPSTICK NITRITE Specimen UA-1 Participant Results Method Labs Positive Negative ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Multistix Pro Bayer Reagent Strips Combi-Screen Test Strips CYBOW Urine Reagent Strips DIRUI H-800 Urine Analyzer Germaine Laboratories AimStrip HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA 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/ 25

26 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 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 - Urine Test Genzyme OSOM hcg Combo Test Henry Schein One Step Inverness Acceava hcg Combo / II Inverness Acceva hcg-urine Inverness Clearview hcg Cassette Inverness Clearview25 hcg Combo Quidel QuickVue + One-Step Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Stanbio QuStick Sure-Vue hcg - 25mIU Veda lab /2012 MLE-M1 International Data Supplement

27 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 % Ampicillin % Ampicillin/Sulbactam % Aztreonam % Cefaclor % Cefazolin % Cefepime % Cefixime % Cefoperazone % Cefotaxime % Cefotetan % Cefoxitin % Cefpodoxime Not graded 1 Ceftazidime % Ceftriaxone % Cefuroxime % Cephalexin Not graded 1 Cephalothin % Ciprofloxacin % Clindamycin Inappropriate drug 2 Daptomycin Inappropriate drug 2 Doxycycline Not graded1 Ertapenem % Fosfomycin Inappropriate drug 2 Gentamicin % Imipenem % Kanamycin Not graded Levofloxacin % Linezolid Inappropriate drug 2 1 This is an ungraded challenge due to less than 80% participant consensus. 2 This is an inappropriate drug for organism and/or source MLE-M1 International Data Supplement/ 27

28 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 (%) Lomefloxacin Not graded 1 Meropenem % Minocycline Not graded 1 Moxifloxacin Inappropriate drug 2 Nalidixic Acid % Netilmicin % Nitrofurantoin % Norfloxacin % Ofloxacin % Oxacillin Inappropriate drug 2 Penicillin Inappropriate drug 2 Piperacillin Not graded Piperacillin/Tazobactam % Rifampin Inappropriate drug 2 Tetracycline % Ticarcillin Inappropriate drug 2 Ticarcillin/Clavulanate % Tigecycline Inappropriate drug 2 Tobramycin % Trimethoprim % Trimethoprim/Sulfamethoxazole % Vancomycin Inappropriate drug 2 Organism present in specimen SUS-1: Klebsiella pneumoniae. 28 /2012 MLE-M1 International Data Supplement

29 PARASITOLOGY (PA Specimens) NOTE: ALL SPECIMENS ARE GRADED TO US STATS FOR CONSENSUS. Specimen PA-1 Identification Labs Percent Performance Giardia lamblia % Acceptable No parasite seen % Ascaris lumbricoides eggs % Cryptosporidium sp., oocysts % Parasite present in specimen PA-1: Giardia lamblia. (Graded exclusively to US Consensus) Specimen PA-2 Identification Labs Percent Performance Entamoeba histolytica % Acceptable No parasite seen % Cryptosporidium sp., oocysts % Entamoeba coli % Giardia lamblia % Balantidium coli % Parasite present in specimen PA-2: Entamoeba histolytica. (Graded exclusively to US Consensus) 2012 MLE-M1 International Data Supplement/ 29

30 PARASITOLOGY (PA Specimens) cont d NOTE: ALL SPECIMENS ARE GRADED TO US STATS FOR CONSENSUS. Specimen PA-3 Identification Labs Percent Performance Diphyllobothrium latum % Acceptable Parasite egg seen but no ID % Acceptable Paragonimus westermani eggs % Trichostrongylus sp. eggs % Ascaris lumbricoides eggs % Hookworm % No parasite seen % Schistosoma sp. eggs, NOS % Entamoeba coli % Fasciola hepatica eggs % Blastocystis hominis % Cryptosporidium sp., oocysts % Parasite present in specimen PA-3: Diphyllobothrium latum. (Graded exclusively to US Consensus) Specimen PA-4 Identification Labs Percent Performance No parasite seen % Acceptable Cryptosporidium sp., oocysts % Endolimax nana % Entamoeba histolytica % Giardia lamblia % Clonorchis sinesis % Strongyloides stercoralis larvae % Parasite egg seen but no ID % Parasite present in specimen PA-4: No parasite seen. 30 /2012 MLE-M1 International Data Supplement

31 PARASITOLOGY (PA Specimens) cont d NOTE: ALL SPECIMENS ARE GRADED TO US STATS FOR CONSENSUS. Specimen PA-5 Identification Labs Percent Performance Plasmodium falciparum % Acceptable Plasmodium sp., NOS % Acceptable Plasmodium vivax % Babesia sp % No parasite seen % Plasmodium malariae % Plasmodium sp., not falciparum % Parasite present in specimen PA-5: Plasmodium falciparum. (Graded exclusively to US Consensus) PARASITOLOGY (FP Specimens) Specimen FP-1 Identification Labs Percent Performance Strongyloides stercoralis larvae % Acceptable No parasite seen % Hookworm % Blastocystis hominis % Endolimax nana % Parasite present in specimen FP-1: Strongyloides stercoralis larvae MLE-M1 International Data Supplement/ 31

32 PARASITOLOGY (FP Specimens) Specimen FP-2 Identification Labs Percent Performance Hymenolepis nana eggs % Acceptable Hymenolepis diminuta eggs % Acceptable Parasite seen but no ID % Acceptable Taenia sp. eggs % Parasite present in specimen FP-2: Hymenolepis nana eggs. Specimen FP-3 Identification Labs Percent Performance No parasite seen % Acceptable Giardia lamblia % Parasite present in specimen FP-3: No parasite seen. Specimen FP-4 Identification Labs Percent Performance Ascaris lumbricoides eggs % Acceptable Trichuris trichiura eggs % Acceptable Parasite seen but no ID % Acceptable No parasite seen % Parasite present in specimen FP-4: Ascaris lumbricoides eggs. Specimen FP-5 Identification Labs Percent Performance Plasmodium falciparum % Acceptable Plasmodium sp., NOS % Acceptable Plasmodium vivax % Plasmodium sp., not falciparum % Parasite present in specimen FP-5: Plasmodium falciparum. This challenge was graded by 100% referee lab consensus. 32 /2012 MLE-M1 International Data Supplement

33 Rubella Qualitative Specimen RU-1 Specimen RU-2 Specimen RU-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott AxSYM Bayer ADVIA Centaur biomerieux Vidas, Mini Vidas DiaSorin Roche Modular Analytics VITROS ECi Specimen RU-4 Specimen RU-5 Method Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott AxSYM Bayer ADVIA Centaur Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi MLE-M1 International Data Supplement/ 33

34 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 /2012 MLE-M1 International Data Supplement

35 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 Becton Dickinson biomerieux Human Omega Diagnostics SPINREACT Wiener Lab Specimen SY-4 Specimen SY-5 ALL METHODS Becton Dickinson biomerieux Human Omega Diagnostics SPINREACT Wiener Lab MLE-M1 International Data Supplement/ 35

36 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-3 ALL METHODS biomerieux SPINREACT Wiener Lab Specimen SY-4 ALL METHODS biomerieux SPINREACT Wiener Lab Specimen SY-5 ALL METHODS biomerieux SPINREACT Wiener Lab /2012 MLE-M1 International Data Supplement

37 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 biomerieux Human Omega Diagnostics Serodia Specimen SY-4 Specimen SY-5 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Biokit biomerieux Human Omega Diagnostics Serodia MLE-M1 International Data Supplement/ 37

38 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 Human Omega Diagnostics Serodia Veda Lab Specimen SY-4 Specimen SY-5 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Abbott Architect biomerieux Human Omega Diagnostics Serodia Veda Lab /2012 MLE-M1 International Data Supplement

39 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 ASI Becton Dickinson biomerieux BioSystems Fisher HealthCare Sure-Vue Human Immunostics Inc Omega Diagnostics Plasmatec SPINREACT Wampole Impact RPR Specimen SY-4 Specimen SY-5 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS ASI Becton Dickinson biomerieux BioSystems Fisher HealthCare Sure-Vue Human Immunostics Inc Omega Diagnostics Plasmatec SPINREACT Wampole Impact RPR MLE-M1 International Data Supplement/ 39

40 Syphilis Serology Quantitative: RPR (Titer) Specimen/Method >64 Specimen SY-3 ALL METHODS Becton Dickinson biomerieux BioSystems Fisher HealthCare Sure-Vue Human Immunostics Inc Omega Diagnostics Plasmatec SPINREACT Wampole Impact RPR Specimen SY-4 ALL METHODS Becton Dickinson biomerieux BioSystems Fisher HealthCare Sure-Vue Human Immunostics Inc Omega Diagnostics Plasmatec SPINREACT Wampole Impact RPR /2012 MLE-M1 International Data Supplement

41 Syphilis Serology Quantitative: RPR (Titer) Specimen/Method >64 Specimen SY-5 ALL METHODS Becton Dickinson biomerieux BioSystems Fisher HealthCare Sure-Vue Human Immunostics Inc Omega Diagnostics Plasmatec SPINREACT Wampole Impact RPR MLE-M1 International Data Supplement/ 41

42 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 - IgM Abbott Architect - Total Abbott AxSYM - Total Bayer ADVIA Centaur - IgG Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total Bio-Rad Evolis biomerieux Vidas - IgM biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other IgG Method Other Total Method Roche cobas 6000 / e Roche Elecsys - IgG Roche Elecsys - IgM Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgG VITROS ECi - IgM VITROS ECi - Total /2012 MLE-M1 International Data Supplement

43 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 - IgM Abbott Architect - Total Abbott AxSYM - Total Bayer ADVIA Centaur - IgG Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total Bio-Rad Evolis biomerieux Vidas - IgM biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other IgG Method Other Total Method Roche cobas 6000 / e 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/ 43

44 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 - IgG Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Abbott IMx - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Beckman ACCESS / 2 / DxI - Total Bio-Rad Evolis biomerieux Vidas - IgG biomerieux Vidas - Total biomerieux Vidas, Mini Vidas BioSystems Other Total Method Roche cobas 6000 / e Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi VITROS ECi - IgG VITROS ECi - IgM VITROS ECi - Total /2012 MLE-M1 International Data Supplement

45 Viral Markers Anti-HIV (cont d) Specimen VM-4 Specimen VM-5 Method Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Abbott IMx - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Beckman ACCESS / 2 / DxI - Total Bio-Rad Evolis biomerieux Vidas - IgG biomerieux Vidas - Total biomerieux Vidas, Mini Vidas BioSystems Other Total Method Roche cobas 6000 / e Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi VITROS ECi - IgG VITROS ECi - IgM VITROS ECi - Total MLE-M1 International Data Supplement/ 45

46 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 Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total biomerieux Vidas - IgM biomerieux Vidas - Total Other IgG Method Other IgM method Other Total Method Roche cobas 6000 / e Roche Elecsys - IgG Roche Elecsys - IgM Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total /2012 MLE-M1 International Data Supplement

47 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 Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total biomerieux Vidas - IgM biomerieux Vidas - Total Other IgG Method Other IgM method Other Total Method Roche cobas 6000 / e Roche Elecsys - IgG Roche Elecsys - IgM Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total MLE-M1 International Data Supplement/ 47