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. International Data Supplement MLE-M1 Total Commitment to Education and Service Provided by ACP, Inc.

2 Table of Contents Evaluation Criteria... 4 Blood Bank ABO Group... 5 Rh Factor (D Type)... 5 Unexpected 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 Antinuclear Antibody Qualitative Quantitative Anti-dsDNA Anti-RNP Anti-RNP/Sm Anti-SSA Anti-SSB Anti-SSA/SSB Anti-Sm Rubella Qualitative Quantitative... 42

3 Table of Contents (cont d) Syphilis Serology VDRL Slide VDRL Slide (Titer) MHA-TP TPA RPR RPR (Titer) Viral Markers Anti-HBc (IgM) Anti-HBc (Total/IgG) Anti-HIV Anti-HAV (IgM) Anti-HAV (Total/IgG) HBeAg Anti-HBs...57 HBsAg Anti-HCV Toxoplasma gondii Qualitative (IgG) Quantitative (IgG) Qualitative (IgM) Quantitative (IgM) Cytomegalovirus (CMV) Qualitative (IgG) Quantitative (IgG) Qualitative (IgM) Quantitative (IgM) CK-MB... 64

4 EVALUATION CRITERIA The evaluation criteria used in the 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. Antimicrobial Susceptibility Testing Antinuclear Antibody Blood Bank Cytomegalovirus Microalbumin (Semi-Quantitative) Parasite Identification Rubella Syphilis Serology Toxoplasma Urine Dipstick Urine hcg Viral Markers 80% Consensus 80% Consensus 95% 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% CK-MB (U/L) 3 SD Cytomegalovirus 2 SD Fibrinogen 20% International Normalized Ratio (INR) 20% Prothrombin Time 15% Rubella 3 SD Specific Gravity Toxoplasma 2 SD 4 /2015 MLE-M1 International Data Supplement

5 BLOOD BANK ABO GROUP Specimen Results Labs Percent Performance BB-1 Group O % Acceptable Group AB % BB-2 Group O % Acceptable BB-3 Group A % Acceptable BB-4 Group B % Acceptable Group AB % BB-5 Group A % Acceptable RH FACTOR (D TYPE) Specimen Results Labs Percent Performance BB-1 Rh Positive % Acceptable Rh Negative % BB-2 Rh Negative % Acceptable Rh Positive % BB-3 Rh Negative % Acceptable BB-4 Rh Positive % Acceptable BB-5 Rh Positive % Acceptable UNEXPECTED ANTIBODY DETECTION Specimen Results Labs Percent Performance AB-1 No unexpected antibody detect % Acceptable AB-2 Unexpected antibody detected % Acceptable AB-3 No unexpected antibody detected % Acceptable Unexpected antibody detected % AB-4 No unexpected antibody detected % Acceptable Unexpected antibody detected % AB-5 Unexpected antibody detected % Acceptable No unexpected antibody detected % 2015 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-D % Acceptable AB-3 No antibody detected % Acceptable AB-4 No antibody detected % Acceptable AB-5 Anti-K % Acceptable COMPATIBILITY TESTING Specimen Results Labs Percent Performance AB-1 Compatible % Acceptable AB-2 Not Compatible % Acceptable Compatible % AB-3 Compatible % Acceptable Not Compatible % AB-4 Compatible % Acceptable Not Compatible % AB-5 Compatible % Acceptable Not Compatible % 6 /2015 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 Dade Behring BFT II Sysmex CA-500/600 series All Coagulation Instruments Diag Stago STA Neoplastine CI+ biomerieux Thrombolyzer Compact X/XR Diagnostica Stago STart 4/ Human HumaClot Junior RAL Clot-SP All Coagulation Instruments Diagon Dia-PT Coalyzer HemosIL RecombiPlasTin 2G IL ACL, all models IL TEST PT Fibrinogen IL ACL, all models IL TEST PT-FIB HS PLUS IL ACL, all models IL TEST PT-FIB Recombinant IL ACL, all models 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 Dade Behring BFT II Sysmex CA-500/600 series All Coagulation Instruments Diag Stago STA Neoplastine CI+ biomerieux Thrombolyzer Compact X/XR Diagnostica Stago STart 4/ Human HumaClot Junior RAL Clot-SP All Coagulation Instruments Diagon Dia-PT Coalyzer HemosIL RecombiPlasTin 2G IL ACL, all models IL TEST PT Fibrinogen IL ACL, all models IL TEST PT-FIB HS PLUS IL ACL, all models IL TEST PT-FIB Recombinant IL ACL, all models /2015 MLE-M1 International Data Supplement

9 PROTHROMBIN TIME (seconds) Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method Dade Innovin Dade Behring BFT II Sysmex CA-500/600 series All Coagulation Instruments Diag Stago STA Neoplastine CI+ biomerieux Thrombolyzer Compact X/XR Diagnostica Stago STart 4/ Human HumaClot Junior RAL Clot-SP All Coagulation Instruments Diagon Dia-PT Coalyzer HemosIL RecombiPlasTin 2G IL ACL, all models IL TEST PT Fibrinogen IL ACL, all models IL TEST PT-FIB HS PLUS IL ACL, all models IL TEST PT-FIB Recombinant IL ACL, all models 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 Dade Behring BFT II Sysmex CA-500/600 series All Coagulation Instruments Diag Stago STA Neoplastine CI+ biomerieux Thrombolyzer Compact X/XR Diagnostica Stago STart 4/ RAL Clot-SP All Coagulation Instruments HemosIL RecombiPlasTin 2G IL ACL, all models IL TEST PT Fibrinogen IL ACL, all models IL TEST PT-FIB HS PLUS IL ACL, all models IL TEST PT-FIB Recombinant IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments /2015 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 Dade Behring BFT II Sysmex CA-500/600 series All Coagulation Instruments Diag Stago STA Neoplastine CI+ biomerieux Thrombolyzer Compact X/XR Diagnostica Stago STart 4/ RAL Clot-SP All Coagulation Instruments HemosIL RecombiPlasTin 2G IL ACL, all models IL TEST PT Fibrinogen IL ACL, all models IL TEST PT-FIB HS PLUS IL ACL, all models IL TEST PT-FIB Recombinant IL ACL, all models PH/CMS Thromboplastin-D 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 Dade Behring BFT II Sysmex CA-500/600 series All Coagulation Instruments Diag Stago STA Neoplastine CI+ biomerieux Thrombolyzer Compact X/XR Diagnostica Stago STart 4/ RAL Clot-SP All Coagulation Instruments HemosIL RecombiPlasTin 2G IL ACL, all models IL TEST PT Fibrinogen IL ACL, all models IL TEST PT-FIB HS PLUS IL ACL, all models IL TEST PT-FIB Recombinant IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments /2015 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 FSL Sysmex CA-500/600 series All Coagulation Instruments Diagnostica Stago STA C.K. Prest Diagnostica Stago STart 4/ All Coagulation Instruments Diagnostica Stago STA-PTT 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 FSL Sysmex CA-500/600 series All Coagulation Instruments Diagnostica Stago STA C.K. Prest Diagnostica Stago STart 4/ All Coagulation Instruments Diagnostica Stago STA-PTT All Coagulation Instruments IL TEST APTT-SP IL ACL, all models All Coagulation Instruments Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method Dade Actin FSL Sysmex CA-500/600 series All Coagulation Instruments Diagnostica Stago STA C.K. Prest Diagnostica Stago STart 4/ All Coagulation Instruments Diagnostica Stago STA-PTT All Coagulation Instruments IL TEST APTT-SP IL ACL, all models All Coagulation Instruments MLE-M1 International Data Supplement/ 13

14 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 Diagnostica Stago STA Fibrinogen All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models IL TEST PT-FIB Recombinant 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 Diagnostica Stago STA Fibrinogen All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models IL TEST PT-FIB Recombinant IL ACL, all models Specimen CG-5 Reagent/Instrument Labs Mean SD CV Median Range All Method Diagnostica Stago STA Fibrinogen All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models IL TEST PT-FIB Recombinant IL ACL, all models /2015 MLE-M1 International Data Supplement

15 URINALYSIS DIPSTICK SPECIFIC GRAVITY Specimen UA-1 Method Labs Mean SD CV Median Range All Method All Refractive Index Methods All Roche Methods All Siemens Methods Arkray Aution Sticks DIRUI H-100 / H-500 Urine Analyzer Other Analyzer Method Roche Chemstrips / Combur Roche cobas u Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Advantus Siemens Clinitek Status / Status UriScan Pro/II UriScan Reagent Strips MLE-M1 International Data Supplement/ 15

16 URINALYSIS DIPSTICK ph Specimen UA-1 Participant Results Method Labs ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Combi-Screen Test Strips DIRUI H-100 / H-500 Urine Analyzer DIRUI H-800 Urine Analyzer Erba Mannheim Uro-dipcheck 400e HUMAN Combilyzer Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers URIT Medical Uritest Reagent Strips /2015 MLE-M1 International Data Supplement

17 URINALYSIS DIPSTICK PROTEIN QUALITATIVE Specimen UA-1 Participant Results Method Labs Negative Trace (1+) (2+) (3+) (4+) mg/dl mg/dl 75 mg/dl mg/dl mg/dl >600 or 1000 mg/dl ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Combi-Screen Test Strips DIRUI H-100 / H-500 Urine Analyzer DIRUI H-800 Urine Analyzer Erba Mannheim Uro-dipcheck 400e HUMAN Combilyzer Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers URIT Medical Uritest Reagent Strips MLE-M1 International Data Supplement/ 17

18 URINALYSIS DIPSTICK GLUCOSE Specimen UA-1 Participant Results Method Labs Negative Trace (1+) (2+) (3+) (4+) mg/dl mg/dl 500 mg/dl >500 or 1000 or 2000 mg/dl ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Combi-Screen Test Strips DIRUI H-100 / H-500 Urine Analyzer DIRUI H-800 Urine Analyzer Erba Mannheim Uro-dipcheck 400e HUMAN Combilyzer Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers URIT Medical Uritest Reagent Strips /2015 MLE-M1 International Data Supplement

19 URINALYSIS DIPSTICK KETONES Specimen UA-1 Participant Results Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) 5-10 mg/dl mg/dl mg/dl mg/dl 150 mg/dl ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Combi-Screen Test Strips DIRUI H-100 / H-500 Urine Analyzer DIRUI H-800 Urine Analyzer Erba Mannheim Uro-dipcheck 400e HUMAN Combilyzer Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers URIT Medical Uritest Reagent Strips MLE-M1 International Data Supplement/ 19

20 URINALYSIS DIPSTICK BILIRUBIN Specimen UA-1 Participant Results Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) mg/dl mg/dl mg/dl >10.0 mg/dl ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Combi-Screen Test Strips DIRUI H-100 / H-500 Urine Analyzer DIRUI H-800 Urine Analyzer Erba Mannheim Uro-dipcheck 400e HUMAN Combilyzer Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers URIT Medical Uritest Reagent Strips /2015 MLE-M1 International Data Supplement

21 URINALYSIS DIPSTICK UROBILINOGEN Specimen UA-1 Participant Results Method Labs Neg or mg/dl 1.0 or <2.0 mg/dl 2.0/3.0 mg/dl 4.0 or 4.0/6.0 mg/dl 8.0 or 12.0 mg/dl ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Combi-Screen Test Strips DIRUI H-100 / H-500 Urine Analyzer DIRUI H-800 Urine Analyzer Erba Mannheim Uro-dipcheck 400e HUMAN Combilyzer Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers URIT Medical Uritest Reagent Strips MLE-M1 International Data Supplement/ 21

22 URINALYSIS DIPSTICK BLOOD/HEMOGLOBIN Specimen UA-1 Participant Results Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) (5+) 5-25 Ery/µL Ery/µL 250 Ery/µL ±0.03 mg/dl mg/ dl mg/ dl 1.0 mg/ dl ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Combi-Screen Test Strips DIRUI H-100 / H-500 Urine Analyzer DIRUI H-800 Urine Analyzer Erba Mannheim Uro-dipcheck 400e HUMAN Combilyzer Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers URIT Medical Uritest Reagent Strips /2015 MLE-M1 International Data Supplement

23 URINALYSIS DIPSTICK LEUKOCYTE ESTERASE Specimen UA-1 Participant Results Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) 25 µl 75 or 100 µl 250 or 500 µl ALL METHODS Acon Laboratories Analyticon CombiScan Arkray Aution Jet Arkray Aution Sticks Arkray PocketChem UA Combi-Screen Test Strips DIRUI H-100 / H-500 Urine Analyzer DIRUI H-800 Urine Analyzer Erba Mannheim Uro-dipcheck 400e HUMAN Combilyzer Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers URIT Medical Uritest Reagent Strips MLE-M1 International Data Supplement/ 23

24 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 Combi-Screen Test Strips DIRUI H-100 / H-500 Urine Analyzer DIRUI H-800 Urine Analyzer Erba Mannheim Uro-dipcheck 400e HUMAN Combilyzer Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrip Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers URIT Medical Uritest Reagent Strips /2015 MLE-M1 International Data Supplement

25 URINALYSIS MICROALBUMIN (dipstick only) Specimen UA-1 Participant Results Method Labs Negative 10 mg/l 20 mg/l 30 mg/l 50 mg/l 80 mg/l 100 mg/l 150 mg/l + (4-8 mg/dl) ++ (>8 mg/dl) ALL METHODS Beckman Coulter ICON microalb DIRUI H-100 / H-500 Urine Analyzer Other Dipstick Method Roche Micral - 1 minute Siemens Clinitek Microalbumin URINALYSIS URINE hcg Specimen UA-1 Participant Results Method Labs Positive Negative ALL METHODS Acon Laboratories Alere Clearview hcg Cassette Beckman Coulter ICON 25 hcg biomerieux VIKIA hcg-d Biotron 1-Step Henry Schein One Step PEP (Lab Supply) HCG Quidel QuickVue + One-Step Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Stanbio QuStick Sure-Vue hcg - 25mIU MLE-M1 International Data Supplement/ 25

26 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 % 1 Aztreonam Inappropriate drug 2 Carbenicillin Not graded 3 Cefaclor % Cefamandole Not graded 3 Cefazolin % Cefepime % 1 Cefixime Inappropriate drug 2 Cefoperazone % Cefotaxime % 1 Cefotetan Not graded 3 Cefoxitin % Cefpodoxime % Ceftazidime Inappropriate drug 2 Ceftizoxime Not graded 3 Ceftriaxone % Cefuroxime % 1 Cephalexin Inappropriate drug 2 Cephalothin Not graded 4 Ciprofloxacin % Clarithromycin Inappropriate drug 2 Clindamycin Inappropriate drug 2 Daptomycin % Doxycycline % Ertapenem Not graded 4 Erythromycin Inappropriate drug 2 Fosfomycin Inappropriate drug 2 Gatifloxacin Not graded 3 Gentamicin % 1 This drug is graded by referee consensus. 2 This is an inappropriate drug for organism and/or source. 3 This is an ungraded drug due to lack of comparison group. 4 This is an ungraded drug due to lack of referee group. 26 /2015 MLE-M1 International Data Supplement

27 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 (%) Imipenem % 1 Kanamycin Not graded 3 Levofloxacin % Linezolid % Lomefloxacin Not graded 3 Meropenem Not graded 4 Methicillin % Minocycline Inappropriate drug 2 Moxifloxacin % 1 Nalidixic Acid Inappropriate drug 2 Netilmicin % Nitrofurantoin % Norfloxacin % 1 Ofloxacin % Oxacillin % Penicillin % Piperacillin Inappropriate drug 2 Piperacillin/Tazobactam % Quinupristin/Dalfopristin % Rifampin % Sulfisoxazole Not graded 3 Teicoplanin % Tetracycline % Ticarcillin Not graded 3 Ticarcillin/Clavulanate Not graded 3 Tigecycline Inappropriate drug 2 Tobramycin % Trimethoprim % Trimethoprim/Sulfamethoxazole % Vancomycin % Organism present in specimen SUS-1: Staphylococcus aureus Methicillin resistant MLE-M1 International Data Supplement/ 27

28 PARASITOLOGY (PA Specimens) Specimen PA-1 Identification Labs Percent Performance No parasite seen % Acceptable Endolimax nana % Giardia lamblia % Parasite present in specimen PA-1: No parasite seen. (Graded by US consensus) Specimen PA-2 Identification Labs Percent Performance Entamoeba coli % Acceptable No parasite coli % Entamoebia histolytica % Parasite present in specimen PA-2: Entamoeba coli. (Graded by US consensus) 28 /2015 MLE-M1 International Data Supplement

29 PARASITOLOGY (PA Specimens) cont d Specimen PA-3 Identification Labs Percent Performance Ascaris lumbricoides eggs % Acceptable Trichuris trichiura eggs % Acceptable Entamoeba histolytica % Hymenolepis nana eggs % Iodamoeba butschlii % Parasites present in specimen PA-3: Ascaris lumbricoides eggs and Trichuris trichiura eggs. Specimen PA-4 Identification Labs Percent Performance Balantidium coli % Acceptable No parasite seen % Taenia sp. eggs % Nonpathogenic Protozoan present % Chilomastix mesnili % Diphyllobothrium latum % Parasite present in specimen PA-4: Balantidium coli. (Graded by US consensus) 2015 MLE-M1 International Data Supplement/ 29

30 PARASITOLOGY (PA Specimens) cont d Specimen PA-5 Identification Labs Percent Performance Trypanosoma cruzi % Acceptable Trypanosoma sp., NOS % Acceptable Plasmodium falciparum % Parasite present in specimen PA-5: Trypanosoma cruzi. 30 /2015 MLE-M1 International Data Supplement

31 PARASITOLOGY (FP Specimens) Specimen FP-1 Identification Labs Percent Performance No parasite seen % Acceptable Ascaris lumbricoides % Trichuris trichiura eggs % Strongyloides stercoralis larvae % Endolimax nana % Giardia lamblia % Parasite egg seen but no ID % Parasite larva seen but no ID % Other parasite seen but no ID % Nonpath, protoaoan present % Hymenolepis diminuta eggs % Iodamoeba butschlii % Isospora belli oocysts % Taenia sp. eggs % Protozoan seen but no ID % Balantidium coli % Diphyllobothrium latum % Plasmodium vivax % Parasite present in specimen FP-1: No parasite present MLE-M1 International Data Supplement/ 31

32 PARASITOLOGY (FP Specimens) cont d Specimen FP-2 Identification Labs Percent Performance Taenia sp. eggs % Acceptable Giardia lamblia % Acceptable Blastocystis hominis % Endolimax nana % Ascaris lumbricoides eggs % No parasite seen % Entamoeba histolytica % Strongyloides stercoralis larvae % Hymenolepis diminuta eggs % Enterobius vermicularis eggs % Iodamoeba butschlii % Entamoeba hartmanni % Hymenolepis nana eggs % Nonpathogenic protozoan present % Parasites present in specimen FP-2: Taenia sp. eggs and Giardia lamblia. This challenge was graded by 80% referee consensus. 32 /2015 MLE-M1 International Data Supplement

33 PARASITOLOGY (FP Specimens) cont d Specimen FP-3 Identification Labs Percent Performance Hymenolepis nana eggs % Acceptable Parasite egg seen but no ID % Acceptable Hymenolepis diminuta eggs % Ascaris lumbricoides eggs % Taenia sp. eggs % Endolimax nana % Enterobius vermicularis eggs % No parasite seen % Trichuris trichiura eggs % Trichostrongylus sp. eggs % Schistosoma mansoni eggs % Giardia lamblia % Entamoeba histolytica % Chilomastix mesnili % Diphyllobothrium latum % Parasite present in specimen FP-3: Hymenolepis nana eggs MLE-M1 International Data Supplement/ 33

34 PARASITOLOGY (FP Specimens) cont d Specimen FP-4 Identification Labs Percent Performance Ascaris lumbricoides eggs % Acceptable Trichuris trichiura eggs % No parasite seen % Hookworm % Hymenolepis nana eggs % Entamoeba coli % Clonorchis sinensis % Taenia sp. eggs % Parasite egg seen but no ID % Parasite present in specimen FP-4: Ascaris lumbricoides eggs. This challenge was graded by 80% referee consensus. Specimen FP-5 Identification Labs Percent Performance Plasmodium falciparum % Acceptable Plasmodium sp., NOS % Acceptable Plasmodium vivax % Plasmodium sp., not falciparum % Plasmodium malariae % Plasmodium ovale % No parasite seen % Trypanosoma cruzi % Babesia sp % Parasite present in specimen FP-5: Plasmodium falciparum. This challenge was graded by 80% referee consensus. 34 /2015 MLE-M1 International Data Supplement

35 Antinuclear Antibody (ANA) - Qualitative Specimen AE-1 Specimen AE-2 Specimen AE-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS BioSystems Immuno Concepts INOVA Diagnostics Kallestad Zeus Specimen AE-4 Specimen AE-5 Method Positive Negative Positive Negative ALL METHODS BioSystems Immuno Concepts INOVA Diagnostics Kallestad Zeus Specimen AE-3 is graded by 82% referee consensus MLE-M1 International Data Supplement/ 35

36 Antinuclear Antibody (ANA) Quantitative (Titer) This portion is not evaluated. Titers reported are as follows: Specimen/Method 8/ 10 16/ 20 32/ 40 64/ / / / 640 > / / Specimen AE-2 ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad Zeus Specimen AE-3 ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad Zeus Specimen AE-5 ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad Zeus /2015 MLE-M1 International Data Supplement

37 Anti-dsDNA Specimen AE-1 Specimen AE-2 Specimen AE-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS BioSystems INOVA Diagnostics Zeus Specimen AE-4 Specimen AE-5 Method Positive Negative Positive Negative ALL METHODS BioSystems INOVA Diagnostics Zeus Anti-RNP Specimen AE-1 Specimen AE-2 Specimen AE-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS INOVA Diagnostics Specimen AE-4 Specimen AE-5 Method Positive Negative Positive Negative ALL METHODS INOVA Diagnostics MLE-M1 International Data Supplement/ 37

38 Anti-RNP/Sm Specimen AE-1 Specimen AE-2 Specimen AE-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Specimen AE-4 Specimen AE-5 Method Positive Negative Positive Negative ALL METHODS Anti-SSA Specimen AE-1 Specimen AE-2 Specimen AE-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS INOVA Diagnostics Specimen AE-4 Specimen AE-5 Method Positive Negative Positive Negative ALL METHODS INOVA Diagnostics /2015 MLE-M1 International Data Supplement

39 Anti-SSB Specimen AE-1 Specimen AE-2 Specimen AE-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS INOVA Diagnostics Specimen AE-4 Specimen AE-5 Method Positive Negative Positive Negative ALL METHODS INOVA Diagnostics Anti-SSA/SSB Specimen AE-1 Specimen AE-2 Specimen AE-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Specimen AE-4 Specimen AE-5 Method Positive Negative Positive Negative ALL METHODS MLE-M1 International Data Supplement/ 39

40 Anti-Sm Specimen AE-1 Specimen AE-2 Specimen AE-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS INOVA Diagnostics Specimen AE-4 Specimen AE-5 Method Positive Negative Positive Negative ALL METHODS INOVA Diagnostics /2015 MLE-M1 International Data Supplement

41 Rubella Qualitative Specimen RU-1 Specimen RU-2 Specimen RU-3 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect biomerieux Vidas, Mini Vidas DiaSorin DPC Immulite Roche cobas 6000 / c Roche cobas 6000 / e Roche cobas 6000/e601 - IgG Roche cobas e Siemens ADVIA Centaur - IgG VITROS ECi Specimen RU-4 Specimen RU-5 Method Positive Negative Positive Negative ALL METHODS Abbott Architect biomerieux Vidas, Mini Vidas DiaSorin DPC Immulite Roche cobas 6000 / c Roche cobas 6000 / e Roche cobas 6000/e601 - IgG Roche cobas e Siemens ADVIA Centaur - IgG VITROS ECi MLE-M1 International Data Supplement/ 41

42 Rubella Quantitative (IU/mL) Specimen/Method Labs Mean SD CV Median Range Specimen RU-1 All Method Abbott Architect Roche cobas e Specimen RU-2 All Method Abbott Architect Roche cobas e Specimen RU-3 All Method Abbott Architect Roche cobas e Specimen RU-4 All Method Abbott Architect Roche cobas e Specimen RU-5 All Method Abbott Architect Roche cobas e /2015 MLE-M1 International Data Supplement

43 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 Acon Laboratories BioSystems Omega Diagnostics Plasmatec Standard Diagnostics Wiener Lab Method Reactive Specimen SY-4 Weakly Non- Reactive Reactive Specimen SY-5 Weakly Non- Reactive Reactive Reactive ALL METHODS Acon Laboratories BioSystems Omega Diagnostics Plasmatec Standard Diagnostics Wiener Lab MLE-M1 International Data Supplement/ 43

44 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-2 ALL METHODS BioSystems Omega Diagnostics Plasmatec Wiener Lab Specimen SY-4 ALL METHODS BioSystems Omega Diagnostics Plasmatec Wiener Lab Specimen SY-5 ALL METHODS BioSystems Omega Diagnostics Plasmatec Wiener Lab /2015 MLE-M1 International Data Supplement