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. International Data Supplement 2017 MLE-M2 Total Commitment to Education and Service Provided by ACP, Inc. COPYRIGHT ACP, Inc. Single copies of all material subject to this copyright may be photocopied for the non-commercial use of scientific or educational advancement.
2 Table of Contents Evaluation Criteria... 4 Hematology Hematology with 5-part Automated Differential (CL Samples Module 223)... 5 White Blood Cell Count... 5 Red Blood Cell Count... 6 Hemoglobin... 7 Hematocrit... 8 Platelet Count... 9 Automated Differential Blood Bank ABO Group Rh Factor (D Type) Unexpected Antibody Detection Antibody Identification Compatibility Testing Coagulation Prothrombin Time 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) /2017 MLE-M2 International Data Supplement
3 Immunology Table of Contents (cont d) Antinuclear Antibody...47 Qualitative...47 Quantitative...47 Anti-dsDNA...49 Anti-RNP...49 Anti-RNP/Sm...50 Anti-SSA...50 Anti-SSB...51 Anti-SSA/SSB...51 Anti-Sm...52 Rubella...53 Qualitative...53 Quantitative...54 Syphilis Serology...55 VDRL Slide...55 VDRL Slide (Titer)...56 MHA-TP...58 TPA...59 RPR...60 RPR (Titer)...61 Viral Markers...64 Anti-HBc (IgM)...64 Anti-HBc (Total/IgG)...65 Anti-HIV...66 Anti-HAV (IgM)...68 Anti-HAV (Total/IgG)...69 HBeAg...70 Anti-HBs...71 HBsAg...72 Anti-HCV...73 Toxoplasma gondii...74 Qualitative (IgG)...74 Quantitative (IgG)...74 Qualitative (IgM)...75 Quantitative (IgM)...75 Cytomegalovirus (CMV)...76 Qualitative (IgG)...76 Quantitative (IgG)...76 Qualitative (IgM)...77 Quantitative (IgM)...77 Chemistry CK-MB MLE-M2 International Data Supplement/ 3
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% Automated Differential 3 SD CK-MB (U/L) 3 SD Cytomegalovirus 2 SD Fibrinogen 20% Hematocrit 6% Hemoglobin 7% International Normalized Ratio (INR) 20% Platelet Count 25% Prothrombin Time 15% Red Blood Cell Count 6% Rubella 3 SD Specific Gravity Toxoplasma 2 SD White Blood Cell Count 15% 4 /2017 MLE-M2 International Data Supplement.
5 HEMATOLOGY W/ 5-PART DIFFERENTIAL WHITE BLOOD CELL COUNT (x K/uL) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic MLE-M2 International Data Supplement/ 5
6 HEMATOLOGY W/ 5-PART DIFFERENTIAL RED BLOOD CELL COUNT (x M/uL) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic /2017 MLE-M2 International Data Supplement.
7 HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMOGLOBIN (g/dl) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic MLE-M2 International Data Supplement/ 7
8 HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMATOCRIT (percent) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic /2017 MLE-M2 International Data Supplement.
9 HEMATOLOGY W/ 5-PART DIFFERENTIAL PLATELET COUNT (x K/uL) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic MLE-M2 International Data Supplement/ 9
10 HEMATOLOGY W/ 5-PART DIFFERENTIAL NEUTROPHILS (percent) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic /2017 MLE-M2 International Data Supplement.
11 HEMATOLOGY W/ 5-PART DIFFERENTIAL LYMPHOCYTES (percent) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic MLE-M2 International Data Supplement/ 11
12 HEMATOLOGY W/ 5-PART DIFFERENTIAL MONOCYTES (percent) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic /2017 MLE-M2 International Data Supplement
13 HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic MLE-M2 International Data Supplement/ 13
14 HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent) Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-8 Specimen CL-9 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic Specimen CL-10 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Ruby Orphee Mythic /2017 MLE-M2 International Data Supplement
15 BLOOD BANK ABO GROUP Specimen Results Labs Percent Performance BB-6 Group AB % Acceptable BB-7 Group O % Acceptable BB-8 Group A % Acceptable Group AB % BB-9 Group AB % Acceptable Group A % BB-10 Group B % Acceptable RH FACTOR (D TYPE) Specimen Results Labs Percent Performance BB-6 Rh Positive % Acceptable BB-7 Rh Positive % Acceptable BB-8 Rh Negative % Acceptable Rh Positive % BB-9 Rh Positive % Acceptable Rh Negative % BB-10 Rh Negative % Acceptable 2017 MLE-M2 International Data Supplement/ 15
16 BLOOD BANK UNEXPECTED ANTIBODY DETECTION Specimen Results Labs Percent Performance AB-6 No unexpected antibody detected % Acceptable Unexpected antibody detected % AB-7 No unexpected antibody detected % Acceptable Unexpected antibody detected % AB-8 Unexpected antibody detected % Acceptable AB-9 No unexpected antibody detected % Acceptable Unexpected antibody detected % AB-10 Unexpected antibody detected % Acceptable No unexpected antibody detect % ANTIBODY IDENTIFICATION Specimen Identification Labs Percent Performance AB-6 No antibody detected % Acceptable AB-7 No antibody detected % Acceptable AB-8 Anti-E % Acceptable AB-9 No antibody detected % Acceptable AB-10 Anti-S % Acceptable 16 /2017 MLE-M2 International Data Supplement
17 BLOOD BANK COMPATIBILITY TESTING Specimen Results Labs Percent Performance AB-6 Compatible % Acceptable AB-7 Compatible % Acceptable Not Compatible % AB-8 Not Compatible % Acceptable Compatible % AB-9 Compatible % Acceptable AB-10 Compatible % Acceptable 2017 MLE-M2 International Data Supplement/ 17
18 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 Dade Behring BFT II Sysmex CA-500/600 series All Coagulation Instruments Diag Stago STA Neoplastine CI+ Diagnostica Stago STA Compact Diagnostica Stago STart 4/ RAL Clot-SP All Coagulation Instruments HemosIL RecombiPlasTin 2G IL ACL, all models HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior IL TEST PT Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models /2017 MLE-M2 International Data Supplement
19 PROTHROMBIN TIME (seconds) Specimen CG-8 Specimen CG-9 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+ Diagnostica Stago STA Compact Diagnostica Stago STart 4/ RAL Clot-SP All Coagulation Instruments HemosIL RecombiPlasTin 2G IL ACL, all models HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior IL TEST PT Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models MLE-M2 International Data Supplement/ 19
20 PROTHROMBIN TIME (seconds) Specimen CG-10 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+ Diagnostica Stago STA Compact Diagnostica Stago STart 4/ RAL Clot-SP All Coagulation Instruments HemosIL RecombiPlasTin 2G IL ACL, all models HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior IL TEST PT Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models /2017 MLE-M2 International Data Supplement
21 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 Dade Innovin Dade Behring BFT II Sysmex CA-500/600 series All Coagulation Instruments Diag Stago STA Neoplastine CI+ Diagnostica Stago STA Compact Diagnostica Stago STart 4/ RAL Clot-SP All Coagulation Instruments HemosIL RecombiPlasTin 2G IL ACL, all models HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior IL TEST PT Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models MLE-M2 International Data Supplement/ 21
22 PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-8 Specimen CG-9 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+ Diagnostica Stago STA Compact Diagnostica Stago STart 4/ RAL Clot-SP All Coagulation Instruments HemosIL RecombiPlasTin 2G IL ACL, all models HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior IL TEST PT Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models /2017 MLE-M2 International Data Supplement
23 PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-10 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+ Diagnostica Stago STA Compact Diagnostica Stago STart 4/ RAL Clot-SP All Coagulation Instruments HemosIL RecombiPlasTin 2G IL ACL, all models HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior IL TEST PT Fibrinogen IL ACL, all models All Coagulation Instruments IL TEST PT-FIB HS PLUS IL ACL, all models MLE-M2 International Data Supplement/ 23
24 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 Dade Actin All Coagulation Instruments Dade Actin FSL Sysmex CA-500/600 series All Coagulation Instruments Diagnostica Stago STA C.K. Prest biomerieux Thrombolyzer Compact X/XR Diagnostica Stago STA Compact Diagnostica Stago STart 4/ All Coagulation Instruments Diagnostica Stago STA-PTT All Coagulation Instruments Hemoliance SynthASil IL ACL, all models HUMAN HemoStat aptt - EL Human HumaClot Junior All Coagulation Instruments IL TEST APTT-SP IL ACL, all models /2017 MLE-M2 International Data Supplement
25 ACTIVATED PARTIAL THROMBOPLASTIN (seconds) Specimen CG-8 Specimen CG-9 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method Dade Actin All Coagulation Instruments Dade Actin FSL Sysmex CA-500/600 series All Coagulation Instruments Diagnostica Stago STA C.K. Prest biomerieux Thrombolyzer Compact X/XR Diagnostica Stago STA Compact Diagnostica Stago STart 4/ All Coagulation Instruments Diagnostica Stago STA-PTT All Coagulation Instruments Hemoliance SynthASil IL ACL, all models HUMAN HemoStat aptt - EL Human HumaClot Junior All Coagulation Instruments IL TEST APTT-SP IL ACL, all models Specimen CG-10 Reagent/Instrument Labs Mean SD CV Median Range All Method Dade Actin All Coagulation Instruments Dade Actin FSL Sysmex CA-500/600 series All Coagulation Instruments Diagnostica Stago STA C.K. Prest biomerieux Thrombolyzer Compact X/XR Diagnostica Stago STA Compact Diagnostica Stago STart 4/ All Coagulation Instruments Diagnostica Stago STA-PTT All Coagulation Instruments Hemoliance SynthASil IL ACL, all models HUMAN HemoStat aptt - EL Human HumaClot Junior All Coagulation Instruments IL TEST APTT-SP IL ACL, all models MLE-M2 International Data Supplement/ 25
26 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 Diagnostica Stago STA Fibrinogen Diagnostica Stago STA Compact All Coagulation Instruments IL Fibrinogen-C IL ACL, all models 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 Diagnostica Stago STA Fibrinogen Diagnostica Stago STA Compact All Coagulation Instruments IL Fibrinogen-C IL ACL, all models IL TEST PT-FIB HS PLUS IL ACL, all models Specimen CG-10 Reagent/Instrument Labs Mean SD CV Median Range All Method Diagnostica Stago STA Fibrinogen Diagnostica Stago STA Compact All Coagulation Instruments IL Fibrinogen-C IL ACL, all models IL TEST PT-FIB HS PLUS IL ACL, all models /2017 MLE-M2 International Data Supplement
27 URINALYSIS DIPSTICK SPECIFIC GRAVITY Specimen UA-2 Method Labs Mean SD CV Median Range All Method All Arkray Methods All DIRUI Methods All Iris Diagnostics Methods All Refractive Index Methods All Roche Methods All Siemens Methods Elektronika LabUMat/ DIRUI H-100 / H-500 Urine Analyzer Iris Diagnostics ichem Velocity Strips Roche Chemstrips / Combur Roche cobas u Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Advantus UriScan Pro/II UriScan Reagent Strips MLE-M2 International Data Supplement/ 27
28 URINALYSIS DIPSTICK ph Specimen UA-2 Participant Results Method Labs ALL METHODS Elektronika LabUMat/ 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 HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Iris Ichem VELOCITY Urine Chemistry System Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrips / Combur Roche cobas 6500 / u Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Siemens Uristix THME UDC Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers /2017 MLE-M2 International Data Supplement
29 URINALYSIS DIPSTICK PROTEIN QUALITATIVE Specimen UA-2 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 Elektronika LabUMat/ 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 HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Iris Ichem VELOCITY Urine Chemistry System Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrips / Combur Roche cobas 6500 / u Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Siemens Uristix Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers MLE-M2 International Data Supplement/ 29
30 URINALYSIS DIPSTICK GLUCOSE Specimen UA-2 Method Labs Negative or Normal Participant Results Trace (1+) (2+) (3+) (4+) mg/dl mg/dl 500 mg/dl >500 or 1000 or 2000 mg/dl ALL METHODS Elektronika LabUMat/ 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 HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Iris Ichem VELOCITY Urine Chemistry System Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrips / Combur Roche cobas 6500 / u Roche cobas u Roche Miditron Junior/II Roche Urilux S Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Siemens Uristix Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers /2017 MLE-M2 International Data Supplement
31 URINALYSIS DIPSTICK KETONES Specimen UA-2 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 Elektronika LabUMat/ 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 HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Iris Ichem VELOCITY Urine Chemistry System Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrips / Combur Roche cobas 6500 / u Roche cobas u Roche Miditron Junior/II Roche Urisys SD UroColor Reagent Strips 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 MLE-M2 International Data Supplement/ 31
32 URINALYSIS DIPSTICK BILIRUBIN Specimen UA-2 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 Elektronika LabUMat/ 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 HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Iris Ichem VELOCITY Urine Chemistry System Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrips / Combur Roche cobas 6500 / u Roche cobas u Roche Miditron Junior/II Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Siemens Uristix UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers /2017 MLE-M2 International Data Supplement
33 URINALYSIS DIPSTICK UROBILINOGEN Specimen UA-2 Participant Results Method Labs Normal 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 Elektronika LabUMat/ 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 HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Iris Ichem VELOCITY Urine Chemistry System Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrips / Combur Roche cobas 6500 / u Roche cobas u Roche Miditron Junior/II Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Siemens Uristix Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers MLE-M2 International Data Supplement/ 33
34 URINALYSIS DIPSTICK BLOOD/HEMOGLOBIN Specimen UA-2 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 Elektronika LabUMat/ 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 HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Iris Ichem VELOCITY Urine Chemistry System Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrips / Combur Roche cobas 6500 / u Roche cobas u Roche Miditron Junior/II Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Siemens Uristix Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers /2017 MLE-M2 International Data Supplement
35 URINALYSIS DIPSTICK LEUKOCYTE ESTERASE Specimen UA-2 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 Elektronika LabUMat/ 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 HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Iris Ichem VELOCITY Urine Chemistry System Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrips / Combur Roche cobas 6500 / u Roche cobas u Roche Miditron Junior/II Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Siemens Uristix Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers MLE-M2 International Data Supplement/ 35
36 URINALYSIS DIPSTICK NITRITE Specimen UA-2 Participant Results Method Labs Positive Negative ALL METHODS Elektronika LabUMat/ 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 HUMAN Combilyzer HUMAN COMBINA Test Strips Iris Diagnostics Aution Max AX Iris Diagnostics ichem Velocity Strips Iris Ichem VELOCITY Urine Chemistry System Other Analyzer Method Other Dipstick Method Plasmatec URIPATH Roche Chemstrips / Combur Roche cobas 6500 / u Roche cobas u Roche Miditron Junior/II Roche Urisys SD UroColor Reagent Strips Siemens Clinitek Siemens Clinitek Advantus Siemens Clinitek Atlas Siemens Clinitek Status / Status Siemens Multistix Pro Siemens Reagent Strips Siemens Uristix Urinometer UriScan Pro/II UriScan Reagent Strips URIT Medical Uritest Analyzers /2017 MLE-M2 International Data Supplement
37 URINALYSIS MICROALBUMIN (dipstick only) Specimen UA-2 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 Other Dipstick Method Roche Micral - 1 minute URINALYSIS URINE hcg Specimen UA-2 Participant Results Method Labs Positive Negative ALL METHODS Acon Laboratories 8-8 Alere Acceava hcg-urine 2-2 Alere Clearview hcg Cassette Biotron 1-Step 5-5 Medline hcg Test Strip 1-1 Other Dipstick Method 3-3 Quidel QuickVue One-Step Combo RefuAH hcg Dipstick 1-1 SD Bioline hcg 3-3 Stanbio QuStick 1-1 Sure-Vue hcg - 25mIU MLE-M2 International Data Supplement/ 37
38 ANTIMICROBIAL SUSCEPTIBILIY TESTING Specimen UC-6, CC-6 (SUS-6) Disk Diffusion MIC Interpretative category data Interpretative category data Antimicrobial Labs S I R Labs S I R Acceptable (%) Amikacin % Amoxicillin/Clavulanate % 1 Ampicillin % 1 Ampicillin/Sulbactam % 1 Aztreonam % Cefaclor Ungraded 2 Cefazolin % Cefepime % Cefixime % Cefoperazone % Cefotaxime % Cefotetan Ungraded 2 Cefpodoxime % Ceftazidime % Ceftizoxime Ungraded 2 Ceftriaxone % Cefuroxime % Cephalexin Inappropriate drug 3 Cephalothin Inappropriate drug 3 Ciprofloxacin % Colistin % Daptomycin Inappropriate drug 3 Doripenem % Doxycycline Ungraded 2 Ertapenem % Fosfomycin Inappropriate drug 3 Gatifloxacin Ungraded 2 Gentamicin Ungraded 4 Imipenem % Kanamycin % 1 This drug graded by referee consensus. 2 This drug is ungraded due to lack of comparison group. 3 This is an inappropriate drug for organism and/or source. 4 This drug is ungraded due to less than 80% participant consensus; Vendor Assay Resistant. 38 /2017 MLE-M2 International Data Supplement
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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