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 M2
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)... 32
3 Table of Contents (cont d) Viral Markers...34 Anti-HBc...34 Anti-HIV...36 HAV...38 HBeAg...40 HBsAb...41 HBsAg...43 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-M2 International Data Supplement
5 BLOOD BANK ABO GROUP Specimen Results Labs Percent Performance BB-6 Group A % Acceptable BB-7 Group O % Acceptable Group AB % BB-8 Group AB % Acceptable Group O % BB-9 Group O % Acceptable Group B % BB-10 Group B % Acceptable Group A % RH FACTOR (D TYPE) Specimen Results Labs Percent Performance BB-6 Rh Positive % Acceptable BB-7 Rh Positive % Acceptable Rh Negative % BB-8 Rh Negative % Acceptable BB-9 Rh Negative % Acceptable Rh Positive % BB-10 Rh Positive % Acceptable Rh Negative % ANTIBODY DETECTION Specimen Results Labs Percent Performance AB-6 Unexpected antibody detected % Acceptable AB-7 Unexpected antibody detected % Acceptable No unexpected antibody detected % AB-8 Unexpected antibody detected % Acceptable AB-9 No unexpected antibody detected % No unexpected antibody detected % Acceptable AB-10 No unexpected antibody detected % Acceptable Specimen AB-7 is graded by 100% referee consensus MLE-M2 International Data Supplement/ 5
6 BLOOD BANK ANTIBODY IDENTIFICATION Specimen Identification Labs Percent Performance AB-6 Anti-k % Acceptable Unable to identify, referred % Acceptable Anti-K % No antibody detected % AB-6 Anti-E % Acceptable Anti-D AB-8 Anti-Jk a % Acceptable AB-9 No antibody detected % Acceptable AB-10 No antibody detected % Acceptable Specimen AB-6 is graded by 100% referee consensus. COMPATIBILITY TESTING Specimen Results Labs Percent Performance AB-6 Not Compatible % Acceptable AB-7 Compatible % Acceptable AB-8 Not Compatible % Acceptable Compatible % AB-9 Compatible % Acceptable AB-10 Compatible % Acceptable Not Compatible % Specimen AB-8 is graded by 100% referee consensus. 6 /2011 MLE-M2 International Data Supplement
7 Coagulation PROTHROMBIN TIME (seconds) Specimen CG-6 Specimen CG-7 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Dade Innovin 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-FIB HS PLUS IL ACL, all models Specimen CG-8 Specimen CG-9 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Dade Innovin 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-FIB HS PLUS IL ACL, all models Specimen CG-10 Reagent/Instrument Labs Mean SD CV Median Range All Method Dade Innovin 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-FIB HS PLUS IL ACL, all models MLE-M2 International Data Supplement/ 7
8 PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-6 Specimen CG-7 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-8 Specimen CG-9 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-10 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 /2011 MLE-M2 International Data Supplement
9 ACTIVATED PARTIAL THROMBOPLASTIN (seconds) Specimen CG-6 Specimen CG-7 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method HUMAN HemoStat aptt - EL biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST APTT-SP IL ACL, all models Specimen CG-8 Specimen CG-9 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method HUMAN HemoStat aptt - EL biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST APTT-SP IL ACL, all models Specimen CG-10 Reagent/Instrument Labs Mean SD CV Median Range All Method HUMAN HemoStat aptt - EL biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST APTT-SP IL ACL, all models MLE-M2 International Data Supplement/ 9
10 FIBRINOGEN (mg/dl) Specimen CG-6 Specimen CG-7 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method HUMAN HemoStat Fibrinogen biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models Specimen CG-8 Specimen CG-9 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method HUMAN HemoStat Fibrinogen biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models Specimen CG-10 Reagent/Instrument Labs Mean SD CV Median Range All Method HUMAN HemoStat Fibrinogen biomerieux Thrombolyzer Compact X/XR All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models URINALYSIS DIPSTICK SPECIFIC GRAVITY Specimen UA-2 Method Labs Mean SD CV Median Range All Method Arkray Aution Sticks Bayer Clinitek Advantus Other Analyzer Method Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche SuperUA/ChemstripUA Roche Urisys SD UroColor Reagent Strips UriScan Reagent Strips /2011 MLE-M2 International Data Supplement
11 URINALYSIS DIPSTICK ph Specimen UA-2 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 Multistix Pro Bayer Reagent Strips Bayer Uristix Combi-Screen Test Strips CYBOW Urine Reagent Strips HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Other Analyzer Method Other Dipstick Method Plasmatec URIPATH 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 Urinometer UriScan Pro/II UriScan Reagent Strips MLE-M2 International Data Supplement/ 11
12 URINALYSIS DIPSTICK PROTEIN QUALITATIVE Specimen UA-2 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 Multistix Pro Bayer Reagent Strips Bayer Uristix Combi-Screen Test Strips CYBOW Urine Reagent Strips HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Other Analyzer Method Other Dipstick Method Plasmatec URIPATH 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 Sulfosalicylic Acid TECO URS Strips THME UDC UriScan Pro/II UriScan Reagent Strips /2011 MLE-M2 International Data Supplement
13 URINALYSIS DIPSTICK GLUCOSE Specimen UA-2 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 Multistix Pro Bayer Reagent Strips Bayer Uristix Combi-Screen Test Strips CYBOW Urine Reagent Strips HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Other Analyzer Method Other Dipstick Method Plasmatec URIPATH 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 Urinometer UriScan Pro/II UriScan Reagent Strips MLE-M2 International Data Supplement/ 13
14 URINALYSIS DIPSTICK KETONES Specimen UA-2 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 Multistix Pro Bayer Reagent Strips Bayer Uristix Combi-Screen Test Strips CYBOW Urine Reagent Strips HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Other Analyzer Method Other Dipstick Method Plasmatec URIPATH 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 Urinometer UriScan Pro/II UriScan Reagent Strips /2011 MLE-M2 International Data Supplement
15 URINALYSIS DIPSTICK BILIRUBIN Specimen UA-2 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 Multistix Pro Bayer Reagent Strips Bayer Uristix Combi-Screen Test Strips CYBOW Urine Reagent Strips HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Other Analyzer Method Other Dipstick Method Plasmatec URIPATH 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 Urinometer UriScan Pro/II UriScan Reagent Strips MLE-M2 International Data Supplement/ 15
16 URINALYSIS DIPSTICK UROBILINOGEN Specimen UA-2 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 Multistix Pro Bayer Reagent Strips Bayer Uristix Combi-Screen Test Strips CYBOW Urine Reagent Strips HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Other Analyzer Method Other Dipstick Method Plasmatec URIPATH 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 Urinometer UriScan Pro/II UriScan Reagent Strips /2011 MLE-M2 International Data Supplement
17 URINALYSIS DIPSTICK BLOOD/HEMOGLOBIN Specimen UA-2 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 Multistix Pro Bayer Reagent Strips Bayer Uristix Combi-Screen Test Strips CYBOW Urine Reagent Strips HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Other Analyzer Method Other Dipstick Method Plasmatec URIPATH 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 Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Reagent Strips MLE-M2 International Data Supplement/ 17
18 URINALYSIS DIPSTICK LEUKOCYTE ESTERASE Specimen UA-2 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 Multistix Pro Bayer Reagent Strips Bayer Uristix Combi-Screen Test Strips CYBOW Urine Reagent Strips HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Other Analyzer Method Other Dipstick Method Plasmatec URIPATH 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 Urinometer UriScan Pro/II UriScan Reagent Strips /2011 MLE-M2 International Data Supplement
19 URINALYSIS DIPSTICK NITRITE Specimen UA-2 Participant Results Method Labs Positive Negative ALL METHODS Acon Laboratories 2-2 Arkray Aution Jet 1-1 Arkray Aution Sticks Arkray PocketChem UA 2-2 Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas 2-2 Bayer Clinitek Status / Status+ 3-3 Bayer Multistix Pro 1-1 Bayer Reagent Strips 8-8 Bayer Uristix 1-1 Combi-Screen Test Strips 1-1 CYBOW Urine Reagent Strips 2-2 HUMAN Combilyzer 1-1 HUMAN COMBINA Test Strips 6-6 Iris Diagnostics Aution Max AX Other Analyzer Method Other Dipstick Method 8-8 Plasmatec URIPATH 1-1 Roche Chemstrips / Combur Roche cobas u Roche Miditron Junior/II Roche Mini UA 1-1 Roche SuperUA/ChemstripUA Roche Urilux S 1-1 Roche Urisys SD UroColor Reagent Strips TECO URS Strips 1-1 THME UDC Urinometer 1-1 UriScan Pro/II 5-5 UriScan Reagent Strips MLE-M2 International Data Supplement/ 19
20 URINALYSIS MICROALBUMIN (dipstick only) Specimen UA-2 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 Roche Urisys URINALYSIS URINE hcg Specimen UA-2 Participant Results Method Labs Positive Negative ALL METHODS Acon Laboratories 9-9 Biotron 1-Step 8-8 Inverness Acceva hcg-urine 1-1 Inverness Clearview25 hcg Combo 1-1 Quidel QuickVue One-Step Combo Stanbio QuStick 1-1 Sure-Vue hcg - 25mIU 1-1 Veda lab /2011 MLE-M2 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 % Ampicillin % Ampicillin/Sulbactam Not graded 1 Aztreonam % Carbenicillin % Cefaclor Not graded 1 Cefazolin % Cefepime % Cefixime Not graded 1 Cefoperazone % Cefotaxime % Cefotetan Not graded 1 Cefoxitin % Cefpodoxime % Ceftazidime % Ceftizoxime Not graded 1 Ceftriaxone % Cefuroxime % Cephalexin % Cephalothin % Ciprofloxacin % Clindamycin Not graded 1 Doxycycline % Ertapenem % Fosfomycin % Gatifloxacin % Gentamicin % Imipenem % Kanamycin % 1 This is an ungraded challenge due to less than 80% participant consensus MLE-M2 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 (%) Levofloxacin % Linezolid Not graded 1 Lomefloxacin % Meropenem % Moxifloxacin % Nalidixic Acid % Netilmicin % Nitrofurantoin % Norfloxacin % Ofloxacin % Oxacillin Not graded 1 Penicillin Not graded 1 Piperacillin % Piperacillin/Tazobactam % Rifampin Not graded 1 Sulfisoxazole % Tetracycline % Ticarcillin % Ticarcillin/Clavulanate % Tigecycline % Tobramycin % Trimethoprim % Trimethoprim/Sulfamethoxazole % Vancomycin Not graded 1 Organism present in specimen SUS-6: Citrobacter freundii. 22 /2011 MLE-M2 International Data Supplement
23 PARASITOLOGY (PA Specimens) Specimen PA-6 Identification Labs Percent Performance Giardia lamblia % Acceptable Entamoeba histolytica % Parasite present in specimen PA-6: Giardia lamblia. Specimen PA-7 Identification Labs Percent Performance Endolimax nana % Acceptable No parasite seen % Trichomonas hominis % Parasite present in specimen PA-7: Endolimax nana. Specimen PA-8 Identification Labs Percent Performance No parasite seen % Acceptable Entamoeba histolytica % Hymenolepis diminuta eggs % Parasite present in specimen PA-8: No parasite seen MLE-M2 International Data Supplement/ 23
24 PARASITOLOGY (PA Specimens) cont d Specimen PA-9 Identification Labs Percent Performance Strongyloides stercoralis larvae % Acceptable Taenia sp. eggs % Parasite present in specimen PA-9: Strongyloides stercoralis larvae. Specimen PA-10 Identification Labs Percent Performance Hymenolepis nana eggs % Acceptable Hookworm % Parasite present in specimen PA-10: Hymenolepis nana eggs. 24 /2011 MLE-M2 International Data Supplement
25 PARASITOLOGY (FP Specimens) Specimen FP-6 Identification Labs Percent Performance No parasite seen % Acceptable Ascaris lumbricoides eggs % Endolimax nana % Parasite present in specimen FP-6: No parasite seen. Specimen FP-7 Identification Labs Percent Performance Strongyloides stercoralis larvae % Acceptable Parasite larva seen but no ID % Acceptable No parasite seen % Parasite egg seen but no ID % Hookworm % Parasite present in specimen FP-7: Strongyloides stercoralis larvae. Specimen FP-8 Identification Labs Percent Performance Hymenolepis nana eggs % Acceptable Hymenolepis diminuta eggs % Acceptable Taenia sp. eggs % No parasite seen % Entamoeba coli % Ascaris lumbricoides eggs % Endolimax nana % Giardia lamblia % Blastocystis hominis % Parasite present in specimen FP-8: Hymenolepis nana eggs MLE-M2 International Data Supplement/ 25
26 PARASITOLOGY (FP Specimens) Specimen FP-9 Identification Labs Percent Performance Entamoeba coli % Acceptable Endolimax nana % Acceptable Entamoeba histolytica % No parasite seen % Hymenolepis nana eggs % Parasite present in specimen FP-9: Entamoeba coli. Specimen FP-10 Identification Labs Percent Performance Plasmodium falciparum % Acceptable Plasmodium sp., NOS % Acceptable Plasmodium vivax % Plasmodium sp., not falciparum % Parasite present in specimen FP-10: Plasmodium falciparum. Specimen FP-10 was graded by 92% referee consensus. 26 /2011 MLE-M2 International Data Supplement
27 Rubella Qualitative Specimen RU-6 Specimen RU-7 Specimen RU-8 Method Positive Negative Positive Negative Positive Negative ALL METHODS Bayer ADVIA Centaur Roche Modular Analytics VITROS ECi Specimen RU-9 Specimen RU-10 Method Positive Negative Positive Negative ALL METHODS biomerieux Vidas, Mini Vidas Roche Modular Analytics VITROS ECi MLE-M2 International Data Supplement/ 27
28 Rubella Quantitative (IU/mL) Specimen/Method Labs Mean SD CV Median Range Specimen RU-6 All Method Specimen RU-7 All Method Specimen RU-8 All Method Specimen RU-9 All Method Specimen RU-10 All Method /2011 MLE-M2 International Data Supplement
29 Syphilis Serology Qualitative: VDRL Slide Method Specimen SY-6 Specimen SY-7 Specimen SY-8 Weakly Non- Weakly Non- Weakly Non- Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive ALL METHODS biomerieux Wiener Lab Specimen SY-9 Specimen SY-10 ALL METHODS biomerieux 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-7 ALL METHODS biomerieux Wiener Lab Specimen SY-8 ALL METHODS biomerieux Wiener Lab Specimen SY-9 ALL METHODS biomerieux Wiener Lab MLE-M2 International Data Supplement/ 29
30 Syphilis Serology Qualitative: MHA-TP Specimen SY-6 Specimen SY-7 Specimen SY-8 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Biokit Human Omega Diagnostics Serodia Specimen SY-9 Specimen SY-10 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Biokit Human Omega Diagnostics Serodia Syphilis Serology Qualitative: FTA-ABS (Treponema pallidum Antibodies) Specimen SY-6 Specimen SY-7 Specimen SY-8 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Abbott Architect biomerieux Human Omega Diagnostics Specimen SY-9 Specimen SY-10 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Abbott Architect biomerieux Human Omega Diagnostics /2011 MLE-M2 International Data Supplement
31 Syphilis Serology Qualitative: RPR Specimen SY-6 Specimen SY-7 Specimen SY-8 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Abbott Syfacard-R Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Plasmatec Serodia SPINREACT Wampole Impact RPR Specimen SY-9 Specimen SY-10 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Abbott Syfacard-R Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Plasmatec Serodia SPINREACT Wampole Impact RPR MLE-M2 International Data Supplement/ 31
32 Syphilis Serology Quantitative: RPR (Titer) Specimen/Method >64 Specimen SY-7 ALL METHODS Abbott Syfacard-R Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Plasmatec Serodia SPINREACT Wampole Impact RPR Specimen SY-8 ALL METHODS Abbott Syfacard-R Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Plasmatec Serodia SPINREACT Wampole Impact RPR /2011 MLE-M2 International Data Supplement
33 Syphilis Serology Quantitative: RPR (Titer) cont d Specimen/Method >64 Specimen SY-9 ALL METHODS Abbott Syfacard-R Becton Dickinson biomerieux biomerieux Vidas, Mini Vidas BioSystems Human Immunostics Inc Omega Diagnostics Plasmatec Serodia SPINREACT Wampole Impact RPR MLE-M2 International Data Supplement/ 33
34 Viral Markers Anti-HBc Specimen VM-6 Specimen VM-7 Specimen VM-8 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 biomerieux Vidas - IgM biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other IgG Method Other IgM 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-M2 International Data Supplement
35 Viral Markers Anti-HBc (cont d) Specimen VM-9 Specimen VM-10 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 biomerieux Vidas - IgM biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other IgG Method Other IgM 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-M2 International Data Supplement/ 35
36 Viral Markers Anti-HIV Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative 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 Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Bio-Rad Evolis biomerieux Vidas - IgG biomerieux Vidas - Total biomerieux Vidas, Mini Vidas BioSystems Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total /2011 MLE-M2 International Data Supplement
37 Viral Markers Anti-HIV (cont d) Specimen VM-9 Specimen VM-10 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 Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI Bio-Rad Evolis biomerieux Vidas - IgG biomerieux Vidas - Total biomerieux Vidas, Mini Vidas BioSystems Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total MLE-M2 International Data Supplement/ 37
38 Viral Markers HAV Specimen VM-6 Specimen VM-7 Specimen VM-8 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 - IgM Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI biomerieux Vidas - IgM biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other IgG Method Other IgM method Other Total Method Roche Elecsys - IgG Roche Elecsys - IgM Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total /2011 MLE-M2 International Data Supplement
39 Viral Markers HAV (cont d) Specimen VM-9 Specimen VM-10 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 - IgM Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI biomerieux Vidas - IgM biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other IgG Method Other IgM method Other Total Method Roche Elecsys - IgG Roche Elecsys - IgM Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total MLE-M2 International Data Supplement/ 39
40 Viral Markers HBeAg Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Bayer ADVIA Centaur - Total biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other Total Method Roche cobas 6000 / e Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total Specimen VM-9 Specimen VM-10 ALL METHODS Abbott Architect - Total Abbott AxSYM Abbott AxSYM - Total Bayer ADVIA Centaur - Total biomerieux Vidas - Total biomerieux Vidas, Mini Vidas Other Total Method Roche cobas 6000 / e Roche Elecsys - Total Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total /2011 MLE-M2 International Data Supplement
41 Viral Markers HBsAb Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM Abbott AxSYM - IgG Abbott AxSYM - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI biomerieux Vidas - IgG biomerieux Vidas - Total BioSystems DPC Immulite Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total MLE-M2 International Data Supplement/ 41
42 Viral Markers HBsAb (cont d) Specimen VM-9 Specimen VM-10 ALL METHODS Abbott Architect Abbott Architect - IgG Abbott Architect - Total Abbott AxSYM Abbott AxSYM - IgG Abbott AxSYM - Total Bayer ADVIA Centaur Bayer ADVIA Centaur - Total Beckman ACCESS / 2 / DxI biomerieux Vidas - IgG biomerieux Vidas - Total BioSystems DPC Immulite Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total /2011 MLE-M2 International Data Supplement
43 Viral Markers HBsAg Specimen VM-6 Specimen VM-7 Specimen VM-8 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 DPC Immulite Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total MLE-M2 International Data Supplement/ 43
44 Viral Markers HBsAg (cont d) Specimen VM-9 Specimen VM-10 Method 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 DPC Immulite Other IgG Method Other Total Method Roche Elecsys - IgG Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgM VITROS ECi - Total Specimen VM-9 is not graded due to lack of participant consensus. The vendor assay for VM-9 is negative, following neutralization. If you receive a positive Hepatitis B Surface Antigen result, it is recommended that this be confirmed by a neutralization test. If you do not perform a neutralization confirmation test, you may be reporting false positive results on your patients. 44 /2011 MLE-M2 International Data Supplement
45 Viral Markers HCV Specimen VM-6 Specimen VM-7 Specimen VM-8 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 biomerieux Vidas - Total Other IgG Method Other Total Method Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgG VITROS ECi - IgM VITROS ECi - Total MLE-M2 International Data Supplement/ 45
46 Viral Markers HCV (cont d) Specimen VM-9 Specimen VM-10 Method 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 biomerieux Vidas - Total Other IgG Method Other Total Method Roche Elecsys - Total Roche Elecsys 1010 / Roche Modular Analytics VITROS ECi - IgG VITROS ECi - IgM VITROS ECi - Total /2011 MLE-M2 Participant Summary
47 Toxoplasma gondii Antibody Specimen TOX-6 Specimen TOX-7 Specimen TOX-8 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect - IgG Abbott Architect - IgM Other IgM method VITROS ECi - IgG VITROS ECi - IgM Specimen TOX-9 Specimen TOX-10 ALL METHODS Abbott Architect IgG Abbott Architect IgM Other IgM method VITROS ECi - IgG VITROS ECi - IgM Cytomegalovirus (CMV) Antibodies Specimen CMV-6 Specimen CMV-7 Specimen CMV-8 Method Positive Negative Positive Negative Positive Negative ALL METHODS Abbott Architect - IgG Other IgM method VITROS ECi - IgG VITROS ECi - IgM Specimen CMV-9 Specimen CMV-10 ALL METHODS Abbott Architect - IgG Other IgM method VITROS ECi - IgG VITROS ECi - IgM MLE-M2 International Data Supplement/ 47
48 Toxoplasma gondii Antibody Quantitative (IU/mL) Specimen/Method Labs Mean SD CV Median Range Specimen TOX-6 All Method Specimen TOX-7 All Method Specimen TOX-8 All Method Not graded Specimen TOX-9 All Method Not graded Specimen TOX-10 All Method Not graded 48 /2011 MLE-M2 Participant Summary
49 Cytomegalovirus (CMV) Antibodies Quantitative (U/mL) Specimen/Method Labs Mean SD CV Median Range Specimen CMV-6 All Method Specimen CMV-7 All Method Specimen CMV-8 All Method Not graded Specimen CMV-9 All Method Not graded Specimen CMV-10 All Method Not graded 2011 MLE-M2 International Data Supplement/ 49
50 CK-MB - Quantitative (U/L) Specimen/Method Labs Mean SD CV Median Range Specimen CK-6 All Method Specimen CK-7 All Method Specimen CK-8 All Method Specimen CK-9 All Method Specimen CK-10 All Method Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: /2011 MLE-M2 Participant Summary
M E D I C A L L A B O R A T O R Y
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M E D I C A L L A B O R A T O R Y
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 2 0 1 2 Please see the corresponding US participant summary for any statistics not represented in this supplement. Total Commitment
M E D I C A L L A B O R A T O R Y
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 2 0 1 7 Please see the corresponding US participant summary for any statistics not represented in this supplement. International
M E D I C A L L A B O R A T O R Y
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 2 0 1 3 Please see the corresponding US participant summary for any statistics not represented in this supplement. Total Commitment
M E D I C A L L A B O R A T O R Y
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 2 0 1 5 Please see the corresponding US participant summary for any statistics not represented in this supplement. International
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