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 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.
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... 10 Blood Bank ABO Group... 15 Rh Factor (D Type)... 15 Unexpected Antibody Detection... 16 Antibody Identification... 16 Compatibility Testing... 17 Coagulation Prothrombin Time... 18 International Normalized Ratio (INR)... 21 Activated Partial Thromboplastin Time... 24 Fibrinogen... 26 Urinalysis Urinalysis Dipstick... 27 Specific Gravity... 27 ph... 28 Protein... 29 Glucose... 30 Ketones... 31 Bilirubin... 32 Urobilinogen... 33 Blood or Hemoglobin... 34 Leukocyte Esterase... 35 Nitrite... 36 Microalbumin (Dipstick Only)... 37 Urine hcg... 37 Microbiology Antimicrobial Susceptibility Testing... 38 Parasitology (PA Specimens)... 40 Parasitology (FP Specimens)... 42. 2 /2017 MLE-M2 International Data Supplement
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...78 2017 MLE-M2 International Data Supplement/ 3
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 0.010 Toxoplasma 2 SD White Blood Cell Count 15% 4 /2017 MLE-M2 International Data Supplement.
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 75 2.73 0.49 18.1 2.9 2.3-3.2 75 7.32 1.00 13.7 7.5 6.2-8.5 All Abbott Cell-Dyn Instruments 36 3.19 0.16 5.2 3.2 2.7-3.7 36 8.23 0.32 3.9 8.3 6.9-9.5 Abbott Cell-Dyn Ruby 30 3.21 0.15 4.6 3.2 2.7-3.7 30 8.26 0.29 3.6 8.3 7.0-9.5 Orphee Mythic 22 37 2.29 0.22 9.6 2.3 1.9-2.7 37 6.44 0.56 8.7 6.5 5.4-7.5 Specimen CL-8 Specimen CL-9 All Method 74 24.04 3.09 12.8 24.7 20.4-27.7 74 2.86 0.65 22.8 3.0 2.4-3.3 All Abbott Cell-Dyn Instruments 35 26.71 0.82 3.1 26.8 22.7-30.8 35 3.47 0.31 9.0 3.4 2.9-4.0 Abbott Cell-Dyn Ruby 29 26.86 0.81 3.0 27.0 22.8-30.9 30 3.48 0.32 9.1 3.5 2.9-4.1 Orphee Mythic 22 36 21.23 1.65 7.8 21.6 18.0-24.5 37 2.29 0.25 10.8 2.3 1.9-2.7 Specimen CL-10 All Method 75 7.31 1.04 14.2 7.5 6.2-8.5 All Abbott Cell-Dyn Instruments 35 8.28 0.26 3.1 8.3 7.0-9.6 Abbott Cell-Dyn Ruby 30 8.26 0.27 3.2 8.3 7.0-9.6 Orphee Mythic 22 36 6.34 0.52 8.3 6.5 5.3-7.3 2017 MLE-M2 International Data Supplement/ 5
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 74 2.114 0.061 2.9 2.12 1.98-2.25 75 4.479 0.145 3.2 4.51 4.21-4.75 All Abbott Cell-Dyn Instruments 37 2.134 0.057 2.7 2.14 2.00-2.27 36 4.521 0.096 2.1 4.54 4.24-4.80 Abbott Cell-Dyn Ruby 30 2.136 0.057 2.7 2.14 2.00-2.27 28 4.542 0.070 1.5 4.56 4.26-4.82 Orphee Mythic 22 37 2.087 0.067 3.2 2.10 1.96-2.22 38 4.433 0.181 4.1 4.44 4.16-4.70 Specimen CL-8 Specimen CL-9 All Method 73 6.283 0.224 3.6 6.30 5.90-6.66 74 2.102 0.056 2.7 2.10 1.97-2.23 All Abbott Cell-Dyn Instruments 36 6.379 0.156 2.4 6.44 5.99-6.77 36 2.121 0.053 2.5 2.12 1.99-2.25 Abbott Cell-Dyn Ruby 29 6.390 0.146 2.3 6.44 6.00-6.78 30 2.127 0.051 2.4 2.13 1.99-2.26 Orphee Mythic 22 36 6.183 0.242 3.9 6.14 5.81-6.56 39 2.070 0.067 3.2 2.08 1.94-2.20 Specimen CL-10 All Method 76 4.499 0.156 3.5 4.52 4.22-4.77 All Abbott Cell-Dyn Instruments 36 4.526 0.105 2.3 4.53 4.25-4.80 Abbott Cell-Dyn Ruby 30 4.531 0.090 2.0 4.53 4.25-4.81 Orphee Mythic 22 38 4.458 0.174 3.9 4.49 4.19-4.73 6 /2017 MLE-M2 International Data Supplement.
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 76 5.12 0.50 9.7 5.0 4.7-5.5 76 12.62 0.92 7.3 12.8 11.7-13.6 All Abbott Cell-Dyn Instruments 35 5.59 0.11 2.0 5.6 5.1-6.0 35 13.47 0.28 2.1 13.5 12.5-14.5 Abbott Cell-Dyn Ruby 30 5.58 0.11 2.0 5.6 5.1-6.0 30 13.50 0.29 2.2 13.5 12.5-14.5 Orphee Mythic 22 38 4.65 0.14 2.9 4.6 4.3-5.0 36 11.73 0.26 2.2 11.8 10.9-12.6 Specimen CL-8 Specimen CL-9 All Method 73 19.50 1.12 5.8 19.2 18.1-20.9 75 5.09 0.48 9.4 4.9 4.7-5.5 All Abbott Cell-Dyn Instruments 34 20.60 0.40 2.0 20.7 19.1-22.1 35 5.57 0.10 1.7 5.6 5.1-6.0 Abbott Cell-Dyn Ruby 29 20.62 0.28 1.4 20.7 19.1-22.1 30 5.56 0.09 1.7 5.6 5.1-6.0 Orphee Mythic 22 36 18.54 0.36 1.9 18.5 17.2-19.9 38 4.65 0.13 2.8 4.7 4.3-5.0 Specimen CL-10 All Method 76 12.64 0.96 7.6 12.3 11.7-13.6 All Abbott Cell-Dyn Instruments 34 13.47 0.23 1.7 13.5 12.5-14.5 Abbott Cell-Dyn Ruby 29 13.51 0.21 1.5 13.5 12.5-14.5 Orphee Mythic 22 38 11.77 0.27 2.3 11.8 10.9-12.6 2017 MLE-M2 International Data Supplement/ 7
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 74 16.01 0.71 4.4 16.0 15.0-17.0 74 38.19 1.67 4.4 38.2 35.8-40.5 All Abbott Cell-Dyn Instruments 35 15.57 0.34 2.2 15.6 14.6-16.6 35 37.22 1.04 2.8 37.3 34.9-39.5 Abbott Cell-Dyn Ruby 30 15.58 0.36 2.3 15.6 14.6-16.6 30 37.32 1.01 2.7 37.4 35.0-39.6 Orphee Mythic 22 38 16.38 0.71 4.3 16.3 15.3-17.4 38 38.98 1.61 4.1 39.2 36.6-41.4 Specimen CL-8 Specimen CL-9 All Method 70 55.78 2.27 4.1 55.3 52.4-59.2 74 15.92 0.70 4.4 15.9 14.9-16.9 All Abbott Cell-Dyn Instruments 33 54.66 1.29 2.4 54.5 51.3-58.0 34 15.48 0.37 2.4 15.4 14.5-16.5 Abbott Cell-Dyn Ruby 28 54.76 1.35 2.5 54.5 51.4-58.1 29 15.49 0.39 2.5 15.4 14.5-16.5 Orphee Mythic 22 36 56.64 2.35 4.2 56.5 53.2-60.1 39 16.25 0.66 4.1 16.2 15.2-17.3 Specimen CL-10 All Method 72 38.44 1.60 4.2 38.3 36.1-40.8 All Abbott Cell-Dyn Instruments 34 37.40 1.02 2.7 37.6 35.1-39.7 Abbott Cell-Dyn Ruby 29 37.50 0.97 2.6 37.6 35.2-39.8 Orphee Mythic 22 37 39.29 1.38 3.5 39.2 36.9-41.7 8 /2017 MLE-M2 International Data Supplement.
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 73 92.0 11.0 12.0 91 68-115 72 292.5 20.9 7.2 293 219-366 All Abbott Cell-Dyn Instruments 34 83.4 6.4 7.7 83 62-105 34 290.6 17.9 6.2 292 217-364 Abbott Cell-Dyn Ruby 28 83.3 5.8 7.0 83 62-105 28 293.8 15.4 5.2 293 220-368 Orphee Mythic 22 37 99.3 7.6 7.6 98 74-125 36 292.9 20.6 7.0 295 219-367 Specimen CL-8 Specimen CL-9 All Method 74 495.5 41.0 8.3 499 371-620 74 91.9 11.9 13.0 90 68-115 All Abbott Cell-Dyn Instruments 33 518.8 27.1 5.2 525 389-649 34 82.3 5.3 6.5 82 61-103 Abbott Cell-Dyn Ruby 27 526.4 18.1 3.4 529 394-658 28 82.8 4.6 5.6 82 62-104 Orphee Mythic 22 39 480.1 39.1 8.1 477 360-601 38 100.5 9.4 9.4 102 75-126 Specimen CL-10 All Method 73 293.5 19.3 6.6 295 220-367 All Abbott Cell-Dyn Instruments 35 293.7 15.9 5.4 296 220-368 Abbott Cell-Dyn Ruby 28 295.2 14.8 5.0 297 221-370 Orphee Mythic 22 37 294.5 21.4 7.3 295 220-369 2017 MLE-M2 International Data Supplement/ 9
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 73 49.93 2.21 4.4 50.2 43.2-56.6 71 61.72 3.28 5.3 62.1 51.8-71.6 All Abbott Cell-Dyn Instruments 35 51.47 1.30 2.5 51.4 47.5-55.4 36 63.92 1.38 2.2 64.0 59.7-68.1 Abbott Cell-Dyn Ruby 29 51.49 1.40 2.7 51.4 47.2-55.7 29 64.12 1.33 2.1 64.0 60.1-68.2 Orphee Mythic 22 36 48.48 1.89 3.9 48.7 42.8-54.2 37 58.32 4.70 8.1 60.1 44.2-72.5 Specimen CL-8 Specimen CL-9 All Method 74 74.51 2.02 2.7 74.6 68.4-80.6 75 50.91 2.80 5.5 50.7 42.5-59.3 All Abbott Cell-Dyn Instruments 35 76.13 1.14 1.5 76.1 72.7-79.6 36 52.78 2.29 4.3 52.5 45.9-59.7 Abbott Cell-Dyn Ruby 29 76.09 1.17 1.5 76.1 72.5-79.7 29 53.09 1.77 3.3 52.9 47.7-58.5 Orphee Mythic 22 37 73.07 1.44 2.0 73.6 68.7-77.4 38 49.13 2.02 4.1 49.5 43.0-55.2 Specimen CL-10 All Method 73 61.89 2.23 3.6 62.4 55.2-68.6 All Abbott Cell-Dyn Instruments 37 63.59 0.91 1.4 63.7 60.8-66.4 Abbott Cell-Dyn Ruby 30 63.67 0.88 1.4 63.8 61.0-66.4 Orphee Mythic 22 36 59.77 2.55 4.3 60.3 52.1-67.5 10 /2017 MLE-M2 International Data Supplement.
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 73 33.28 6.71 20.2 35.4 13.1-53.4 73 23.91 5.13 21.4 24.8 8.5-39.3 All Abbott Cell-Dyn Instruments 33 38.21 1.62 4.2 38.3 33.3-43.1 35 27.45 1.76 6.4 27.8 22.1-32.8 Abbott Cell-Dyn Ruby 27 38.28 1.71 4.5 38.3 33.1-43.5 29 27.32 1.81 6.6 27.6 21.8-32.8 Orphee Mythic 22 37 28.55 5.71 20.0 30.0 11.4-45.7 36 20.54 5.00 24.3 21.0 5.5-35.6 Specimen CL-8 Specimen CL-9 All Method 74 15.08 2.43 16.1 15.2 7.7-22.4 73 32.19 5.44 16.9 33.9 15.8-48.6 All Abbott Cell-Dyn Instruments 36 16.12 1.24 7.7 16.2 12.3-19.9 35 36.22 1.78 4.9 36.3 30.8-41.6 Abbott Cell-Dyn Ruby 29 16.18 1.12 6.9 16.0 12.8-19.6 29 36.05 1.54 4.3 36.1 31.4-40.7 Orphee Mythic 22 37 14.01 2.85 20.4 14.2 5.4-22.6 36 28.36 4.95 17.4 29.2 13.5-43.3 Specimen CL-10 All Method 72 24.21 5.01 20.7 26.4 9.1-39.3 All Abbott Cell-Dyn Instruments 34 27.99 1.08 3.9 28.1 24.7-31.3 Abbott Cell-Dyn Ruby 29 27.83 1.32 4.7 28.0 23.8-31.8 Orphee Mythic 22 35 20.65 4.72 22.9 20.9 6.4-34.9 2017 MLE-M2 International Data Supplement/ 11
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 74 12.82 7.55 58.9 12.1 0.0-35.5 74 9.02 5.76 63.8 7.0 0.0-26.3 All Abbott Cell-Dyn Instruments 33 6.13 0.82 13.4 5.9 3.6-8.6 34 3.71 0.60 16.1 3.7 1.9-5.5 Abbott Cell-Dyn Ruby 28 6.10 0.83 13.5 5.9 3.6-8.6 28 3.70 0.61 16.5 3.7 1.8-5.6 Orphee Mythic 22 38 19.13 5.09 26.6 18.7 3.8-34.4 38 13.96 3.65 26.1 13.7 3.0-25.0 Specimen CL-8 Specimen CL-9 All Method 74 6.25 3.78 60.4 5.6 0.0-17.6 73 12.78 7.03 55.0 10.2 0.0-33.9 All Abbott Cell-Dyn Instruments 33 2.88 0.28 9.6 2.9 2.0-3.8 35 6.65 0.98 14.7 6.5 3.7-9.6 Abbott Cell-Dyn Ruby 29 2.94 0.32 10.9 3.0 1.9-4.0 29 6.71 1.00 14.9 6.6 3.7-9.8 Orphee Mythic 22 38 9.43 2.57 27.2 8.8 1.7-17.2 37 18.72 4.93 26.4 17.9 3.9-33.6 Specimen CL-10 All Method 74 8.95 5.89 65.8 7.2 0.0-26.7 All Abbott Cell-Dyn Instruments 34 3.57 0.41 11.4 3.6 2.3-4.8 Abbott Cell-Dyn Ruby 28 3.60 0.40 11.0 3.6 2.4-4.8 Orphee Mythic 22 38 13.93 3.96 28.4 13.3 2.0-25.9 12 /2017 MLE-M2 International Data Supplement
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 70 3.14 0.69 22.1 3.3 1.0-5.3 72 4.71 1.65 35.1 4.3 0.0-9.7 All Abbott Cell-Dyn Instruments 34 3.41 0.31 9.0 3.5 2.4-4.4 35 4.30 0.23 5.4 4.3 3.5-5.1 Abbott Cell-Dyn Ruby 29 3.46 0.36 10.4 3.5 2.3-4.6 29 4.32 0.24 5.5 4.3 3.6-5.1 Orphee Mythic 22 36 2.86 1.02 35.6 2.9 0.0-6.0 35 5.27 2.14 40.7 4.6 0.0-11.7 Specimen CL-8 Specimen CL-9 All Method 73 3.49 0.91 26.1 3.7 0.7-6.3 73 3.33 0.58 17.5 3.4 1.5-5.1 All Abbott Cell-Dyn Instruments 34 4.29 0.22 5.2 4.3 3.6-5.0 35 3.41 0.27 7.9 3.5 2.6-4.3 Abbott Cell-Dyn Ruby 28 4.27 0.23 5.3 4.3 3.5-5.0 28 3.44 0.26 7.6 3.5 2.6-4.3 Orphee Mythic 22 37 2.76 0.69 24.9 2.9 0.6-4.9 37 3.25 0.82 25.1 3.1 0.7-5.8 Specimen CL-10 All Method 71 4.41 0.87 19.6 4.2 1.8-7.1 All Abbott Cell-Dyn Instruments 36 4.31 0.30 7.0 4.3 3.4-5.3 Abbott Cell-Dyn Ruby 29 4.30 0.29 6.8 4.3 3.4-5.2 Orphee Mythic 22 36 4.77 1.56 32.8 4.2 0.0-9.5 2017 MLE-M2 International Data Supplement/ 13
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 70 0.55 0.32 58.6 0.5 0.0-1.6 74 0.63 0.52 83.1 0.5 0.0-2.3 All Abbott Cell-Dyn Instruments 35 0.60 0.34 57.1 0.6 0.0-1.7 37 0.40 0.27 67.2 0.4 0.0-1.2 Abbott Cell-Dyn Ruby 29 0.60 0.36 59.9 0.6 0.0-1.7 30 0.39 0.24 60.4 0.4 0.0-1.2 Orphee Mythic 22 34 0.50 0.30 60.1 0.4 0.0-1.4 37 0.91 0.67 74.3 0.6 0.0-3.0 Specimen CL-8 Specimen CL-9 All Method 71 0.50 0.28 56.7 0.5 0.0-1.4 73 0.55 0.31 55.9 0.6 0.0-1.5 All Abbott Cell-Dyn Instruments 36 0.40 0.18 45.0 0.4 0.0-1.0 36 0.58 0.34 59.1 0.6 0.0-1.6 Abbott Cell-Dyn Ruby 29 0.41 0.18 43.0 0.4 0.0-1.0 30 0.61 0.34 55.8 0.7 0.0-1.7 Orphee Mythic 22 36 0.66 0.42 64.4 0.6 0.0-2.0 36 0.51 0.26 51.6 0.5 0.0-1.3 Specimen CL-10 All Method 72 0.56 0.42 74.9 0.4 0.0-1.9 All Abbott Cell-Dyn Instruments 36 0.36 0.21 57.7 0.3 0.0-1.0 Abbott Cell-Dyn Ruby 30 0.37 0.22 58.8 0.3 0.0-1.1 Orphee Mythic 22 35 0.77 0.55 71.4 0.7 0.0-2.5 14 /2017 MLE-M2 International Data Supplement
BLOOD BANK ABO GROUP Specimen Results Labs Percent Performance BB-6 Group AB 48 100% Acceptable BB-7 Group O 49 100% Acceptable BB-8 Group A 48 97.96% Acceptable Group AB 1 2.04% BB-9 Group AB 48 97.96% Acceptable Group A 1 2.04% BB-10 Group B 49 100% Acceptable RH FACTOR (D TYPE) Specimen Results Labs Percent Performance BB-6 Rh Positive 48 100% Acceptable BB-7 Rh Positive 49 100% Acceptable BB-8 Rh Negative 48 97.96% Acceptable Rh Positive 1 2.04% BB-9 Rh Positive 48 97.96% Acceptable Rh Negative 1 2.04% BB-10 Rh Negative 49 100% Acceptable 2017 MLE-M2 International Data Supplement/ 15
BLOOD BANK UNEXPECTED ANTIBODY DETECTION Specimen Results Labs Percent Performance AB-6 No unexpected antibody detected 27 96.43% Acceptable Unexpected antibody detected 1 3.57% AB-7 No unexpected antibody detected 27 96.43% Acceptable Unexpected antibody detected 1 3.57% AB-8 Unexpected antibody detected 28 100% Acceptable AB-9 No unexpected antibody detected 27 96.43% Acceptable Unexpected antibody detected 1 3.57% AB-10 Unexpected antibody detected 26 92.86% Acceptable No unexpected antibody detect 2 7.14% ANTIBODY IDENTIFICATION Specimen Identification Labs Percent Performance AB-6 No antibody detected 15 100% Acceptable AB-7 No antibody detected 15 100% Acceptable AB-8 Anti-E 15 100% Acceptable AB-9 No antibody detected 15 100% Acceptable AB-10 Anti-S 15 100% Acceptable 16 /2017 MLE-M2 International Data Supplement
BLOOD BANK COMPATIBILITY TESTING Specimen Results Labs Percent Performance AB-6 Compatible 32 100% Acceptable AB-7 Compatible 32 96.97% Acceptable Not Compatible 1 3.03% AB-8 Not Compatible 32 96.97% Acceptable Compatible 1 3.03% AB-9 Compatible 33 100% Acceptable AB-10 Compatible 33 100% Acceptable 2017 MLE-M2 International Data Supplement/ 17
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 111 13.16 1.50 11.4 13.6 11.1-15.2 105 25.81 4.95 19.2 25.7 21.9-29.7 Dade Innovin Dade Behring BFT II 5 10.54 0.18 1.7 10.6 8.9-12.2 5 21.58 1.86 8.6 20.6 18.3-24.9 Sysmex CA-500/600 series 20 11.40 0.23 2.0 11.4 9.6-13.2 18 20.30 1.45 7.2 20.1 17.2-23.4 All Coagulation Instruments 31 11.29 0.61 5.4 11.3 9.5-13.0 28 20.45 1.62 7.9 20.4 17.3-23.6 Diag Stago STA Neoplastine CI+ Diagnostica Stago STA Compact 6 13.80 0.33 2.4 13.9 11.7-15.9 6 27.58 2.13 7.7 27.5 23.4-31.8 Diagnostica Stago STart 4/8 6 14.08 0.64 4.5 14.0 11.9-16.2 5 29.58 4.55 15.4 32.1 25.1-34.1 RAL Clot-SP 18 14.45 0.58 4.0 14.3 12.2-16.7 18 27.83 2.21 8.0 27.8 23.6-32.1 All Coagulation Instruments 34 14.26 0.64 4.5 14.2 12.1-16.4 32 28.11 2.86 10.2 27.9 23.8-32.4 HemosIL RecombiPlasTin 2G IL ACL, all models 5 12.08 0.26 2.2 12.2 10.2-13.9 5 24.75 2.22 9.0 24.3 21.0-28.5 HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior 5 14.72 1.68 11.4 14.3 12.5-17.0 5 32.28 5.69 17.6 32.0 27.4-37.2 IL TEST PT Fibrinogen IL ACL, all models 6 12.68 0.90 7.1 12.5 10.7-14.6 5 20.82 1.59 7.7 21.4 17.6-24.0 All Coagulation Instruments 7 13.03 1.23 9.4 12.6 11.0-15.0 6 21.95 3.11 14.2 21.6 18.6-25.3 IL TEST PT-FIB HS PLUS IL ACL, all models 17 14.14 0.62 4.4 14.1 12.0-16.3 17 29.59 2.99 10.1 29.4 25.1-34.1 18 /2017 MLE-M2 International Data Supplement
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 110 22.07 3.12 14.1 22.4 18.7-25.4 109 12.48 1.27 10.2 12.8 10.6-14.4 Dade Innovin Dade Behring BFT II 5 20.30 0.87 4.3 20.3 17.2-23.4 5 10.04 0.36 3.6 10.0 8.5-11.6 Sysmex CA-500/600 series 20 19.90 0.69 3.5 19.9 16.9-22.9 20 11.19 0.28 2.5 11.1 9.5-12.9 All Coagulation Instruments 30 19.73 0.93 4.7 19.8 16.7-22.7 29 10.95 0.54 4.9 11.0 9.3-12.6 Diag Stago STA Neoplastine CI+ Diagnostica Stago STA Compact 6 23.20 1.79 7.7 23.9 19.7-26.7 6 12.93 0.29 2.3 13.1 10.9-14.9 Diagnostica Stago STart 4/8 6 26.33 3.22 12.2 25.6 22.3-30.3 6 13.48 0.51 3.8 13.5 11.4-15.6 RAL Clot-SP 18 24.92 0.93 3.7 25.0 21.1-28.7 18 13.81 0.48 3.5 13.8 11.7-15.9 All Coagulation Instruments 32 24.57 1.43 5.8 24.9 20.8-28.3 34 13.57 0.56 4.2 13.6 11.5-15.7 HemosIL RecombiPlasTin 2G IL ACL, all models 5 22.25 0.54 2.4 22.4 18.9-25.6 5 10.78 0.15 1.4 10.8 9.1-12.4 HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior 5 21.04 2.24 10.7 21.2 17.8-24.2 5 13.06 0.74 5.6 13.2 11.1-15.1 IL TEST PT Fibrinogen IL ACL, all models 6 16.98 0.87 5.1 16.7 14.4-19.6 6 11.83 0.71 6.0 11.8 10.0-13.7 All Coagulation Instruments 7 18.14 3.17 17.5 17.0 15.4-20.9 7 12.17 1.10 9.1 11.8 10.3-14.0 IL TEST PT-FIB HS PLUS IL ACL, all models 17 23.66 1.43 6.1 23.6 20.1-27.3 17 13.15 0.58 4.4 13.1 11.1-15.2 2017 MLE-M2 International Data Supplement/ 19
PROTHROMBIN TIME (seconds) Specimen CG-10 Reagent/Instrument Labs Mean SD CV Median Range All Method 111 29.29 5.07 17.3 30.1 24.8-33.7 Dade Innovin Dade Behring BFT II 5 29.68 1.45 4.9 29.7 25.2-34.2 Sysmex CA-500/600 series 21 26.56 1.19 4.5 26.5 22.5-30.6 All Coagulation Instruments 31 26.85 1.75 6.5 26.5 22.8-30.9 Diag Stago STA Neoplastine CI+ Diagnostica Stago STA Compact 6 30.77 3.21 10.4 31.7 26.1-35.4 Diagnostica Stago STart 4/8 6 34.50 4.16 12.0 33.2 29.3-39.7 RAL Clot-SP 18 33.34 1.44 4.3 33.1 28.3-38.4 All Coagulation Instruments 31 33.00 1.73 5.3 32.8 28.0-38.0 HemosIL RecombiPlasTin 2G IL ACL, all models 5 32.00 0.42 1.3 32.1 27.2-36.8 HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior 5 30.94 5.37 17.3 34.3 26.2-35.6 IL TEST PT Fibrinogen IL ACL, all models 6 19.82 0.94 4.7 19.6 16.8-22.8 All Coagulation Instruments 7 21.77 5.24 24.1 19.7 18.5-25.1 IL TEST PT-FIB HS PLUS IL ACL, all models 16 30.31 1.81 6.0 31.0 25.7-34.9 20 /2017 MLE-M2 International Data Supplement
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 109 1.08 0.09 8.1 1.1 0.8-1.3 101 2.34 0.44 18.6 2.3 1.8-2.9 Dade Innovin Dade Behring BFT II 5 1.18 0.04 3.8 1.2 0.9-1.5 5 2.14 0.26 12.2 2.1 1.7-2.6 Sysmex CA-500/600 series 21 1.10 0.05 4.5 1.1 0.8-1.4 18 1.99 0.18 8.9 1.9 1.5-2.4 All Coagulation Instruments 30 1.11 0.06 5.1 1.1 0.8-1.4 27 2.03 0.19 9.4 2.0 1.6-2.5 Diag Stago STA Neoplastine CI+ Diagnostica Stago STA Compact 5 1.08 0.05 4.7 1.1 0.8-1.3 5 2.73 0.28 10.1 2.8 2.1-3.3 Diagnostica Stago STart 4/8 6 1.12 0.15 13.2 1.2 0.8-1.4 4 2.43 0.47 19.5 2.3 1.9-3.0 RAL Clot-SP 17 1.09 0.07 6.4 1.1 0.8-1.4 17 2.52 0.27 10.6 2.5 2.0-3.1 All Coagulation Instruments 30 1.10 0.10 9.2 1.1 0.8-1.4 27 2.59 0.36 13.9 2.6 2.0-3.2 HemosIL RecombiPlasTin 2G IL ACL, all models 5 1.08 0.04 4.1 1.1 0.8-1.3 5 2.38 0.31 13.1 2.3 1.9-2.9 HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior 6 1.08 0.15 13.6 1.1 0.8-1.3 5 2.24 0.54 24.0 2.3 1.7-2.7 IL TEST PT Fibrinogen IL ACL, all models 6 1.15 0.05 4.8 1.2 0.9-1.4 5 2.80 0.37 13.4 2.9 2.2-3.4 All Coagulation Instruments 7 1.13 0.08 6.7 1.1 0.9-1.4 6 2.68 0.44 16.4 2.8 2.1-3.3 IL TEST PT-FIB HS PLUS IL ACL, all models 16 1.03 0.08 7.7 1.0 0.8-1.3 15 2.44 0.25 10.4 2.4 1.9-3.0 2017 MLE-M2 International Data Supplement/ 21
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 105 1.98 0.24 12.0 2.0 1.5-2.4 109 1.02 0.09 9.3 1.0 0.8-1.3 Dade Innovin Dade Behring BFT II 5 2.02 0.15 7.3 2.0 1.6-2.5 5 1.12 0.08 7.5 1.1 0.8-1.4 Sysmex CA-500/600 series 21 1.94 0.10 5.3 1.9 1.5-2.4 20 1.08 0.05 4.8 1.1 0.8-1.3 All Coagulation Instruments 30 1.93 0.12 6.1 1.9 1.5-2.4 30 1.09 0.06 5.6 1.1 0.8-1.4 Diag Stago STA Neoplastine CI+ Diagnostica Stago STA Compact 5 2.05 0.26 12.9 2.1 1.6-2.5 5 0.98 0.05 5.1 1.0 0.7-1.2 Diagnostica Stago STart 4/8 5 2.30 0.24 10.6 2.3 1.8-2.8 6 1.05 0.10 10.0 1.1 0.8-1.3 RAL Clot-SP 17 2.19 0.11 5.1 2.2 1.7-2.7 17 1.02 0.06 5.5 1.0 0.8-1.3 All Coagulation Instruments 28 2.20 0.19 8.7 2.2 1.7-2.7 30 1.03 0.07 7.3 1.0 0.8-1.3 HemosIL RecombiPlasTin 2G IL ACL, all models 5 2.08 0.15 7.1 2.1 1.6-2.5 5 0.96 0.05 5.7 1.0 0.7-1.2 HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior 5 1.46 0.25 17.2 1.6 1.1-1.8 6 0.92 0.12 12.8 0.9 0.7-1.2 IL TEST PT Fibrinogen IL ACL, all models 6 1.93 0.08 4.2 2.0 1.5-2.4 6 1.02 0.08 7.4 1.0 0.8-1.3 All Coagulation Instruments 7 1.93 0.08 3.9 1.9 1.5-2.4 7 1.00 0.08 8.2 1.0 0.8-1.2 IL TEST PT-FIB HS PLUS IL ACL, all models 16 1.90 0.16 8.4 1.9 1.5-2.3 16 0.95 0.06 6.7 0.9 0.7-1.2 22 /2017 MLE-M2 International Data Supplement
PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-10 Reagent/Instrument Labs Mean SD CV Median Range All Method 107 2.69 0.49 18.3 2.7 2.1-3.3 Dade Innovin Dade Behring BFT II 5 2.80 0.21 7.6 2.8 2.2-3.4 Sysmex CA-500/600 series 21 2.58 0.10 4.1 2.6 2.0-3.1 All Coagulation Instruments 30 2.60 0.15 5.9 2.6 2.0-3.2 Diag Stago STA Neoplastine CI+ Diagnostica Stago STA Compact 5 2.85 0.45 15.8 3.0 2.2-3.5 Diagnostica Stago STart 4/8 5 3.30 0.45 13.6 3.6 2.6-4.0 RAL Clot-SP 17 3.18 0.19 6.1 3.2 2.5-3.9 All Coagulation Instruments 28 3.17 0.33 10.5 3.2 2.5-3.9 HemosIL RecombiPlasTin 2G IL ACL, all models 5 2.92 0.13 4.5 3.0 2.3-3.6 HUMAN HemoStat Thromboplastin - SI Human HumaClot Junior 5 1.84 0.53 28.7 1.6 1.4-2.3 IL TEST PT Fibrinogen IL ACL, all models 6 2.53 0.22 8.5 2.6 2.0-3.1 All Coagulation Instruments 7 2.57 0.22 8.6 2.6 2.0-3.1 IL TEST PT-FIB HS PLUS IL ACL, all models 16 2.59 0.27 10.5 2.6 2.0-3.2 2017 MLE-M2 International Data Supplement/ 23
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 69 29.4 3.1 10.7 29 24-34 59 59.1 9.6 16.2 58 50-69 Dade Actin All Coagulation Instruments 5 29.7 2.1 7.0 29 25-35 5 89.0 13.5 15.2 90 75-103 Dade Actin FSL Sysmex CA-500/600 series 11 25.1 1.2 4.9 25 21-29 11 49.5 4.8 9.6 50 42-57 All Coagulation Instruments 13 25.2 1.2 4.6 25 21-30 13 51.2 6.3 12.2 51 43-59 Diagnostica Stago STA C.K. Prest biomerieux Thrombolyzer Compact X/XR 5 34.0 2.6 7.8 35 28-40 5 69.3 6.4 9.2 73 58-80 Diagnostica Stago STA Compact 5 31.2 0.8 2.7 31 26-36 5 64.8 4.0 6.1 64 55-75 Diagnostica Stago STart 4/8 5 31.8 3.0 9.4 32 27-37 5 69.1 15.5 22.4 63 58-80 All Coagulation Instruments 15 32.1 2.3 7.2 32 27-37 15 67.4 9.1 13.5 64 57-78 Diagnostica Stago STA-PTT All Coagulation Instruments 5 31.3 1.7 5.5 32 26-36 5 64.0 9.6 15.0 65 54-74 Hemoliance SynthASil IL ACL, all models 5 29.0 1.4 4.9 29 24-34 5 60.5 14.2 23.4 55 51-70 HUMAN HemoStat aptt - EL Human HumaClot Junior 5 26.0 2.1 8.2 26 22-30 5 58.6 9.1 15.5 53 49-68 All Coagulation Instruments 6 26.7 2.5 9.4 27 22-31 5 58.6 9.1 15.5 53 49-68 IL TEST APTT-SP IL ACL, all models 19 30.7 1.9 6.1 31 26-36 16 58.8 6.1 10.4 59 49-68 24 /2017 MLE-M2 International Data Supplement
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 67 38.7 4.8 12.4 38 32-45 68 29.4 5.3 18.1 29 24-34 Dade Actin All Coagulation Instruments 5 43.7 7.0 16.1 43 37-51 5 24.0 3.6 15.0 23 20-28 Dade Actin FSL Sysmex CA-500/600 series 11 35.4 5.8 16.5 33 30-41 10 23.6 0.5 2.2 24 20-28 All Coagulation Instruments 12 34.0 2.0 5.7 34 28-40 12 23.8 0.8 3.5 24 20-28 Diagnostica Stago STA C.K. Prest biomerieux Thrombolyzer Compact X/XR 5 45.0 5.6 12.4 44 38-52 5 34.0 2.6 7.8 35 28-40 Diagnostica Stago STA Compact 5 39.8 0.8 2.1 40 33-46 5 33.0 1.0 3.0 33 28-38 Diagnostica Stago STart 4/8 5 42.2 7.3 17.3 40 35-49 5 33.0 2.9 8.9 33 28-38 All Coagulation Instruments 15 41.9 5.0 12.0 40 35-49 15 33.3 2.1 6.2 33 28-39 Diagnostica Stago STA-PTT All Coagulation Instruments 5 40.5 1.3 3.2 41 34-47 5 31.5 1.3 4.1 32 26-37 Hemoliance SynthASil IL ACL, all models 5 38.8 4.9 12.5 37 32-45 5 40.5 3.7 9.1 41 34-47 HUMAN HemoStat aptt - EL Human HumaClot Junior 5 39.0 3.2 8.1 39 33-45 5 26.0 3.9 15.1 24 22-30 All Coagulation Instruments 5 40.4 4.2 10.3 40 34-47 5 26.0 3.9 15.1 24 22-30 IL TEST APTT-SP IL ACL, all models 18 37.6 2.7 7.1 37 31-44 19 29.0 1.7 5.7 29 24-34 Specimen CG-10 Reagent/Instrument Labs Mean SD CV Median Range All Method 68 44.1 5.0 11.5 44 37-51 Dade Actin All Coagulation Instruments 5 50.0 6.1 12.2 53 42-58 Dade Actin FSL Sysmex CA-500/600 series 11 38.3 2.1 5.5 38 32-45 All Coagulation Instruments 13 38.8 2.3 5.9 38 32-45 Diagnostica Stago STA C.K. Prest biomerieux Thrombolyzer Compact X/XR 5 52.0 5.6 10.7 51 44-60 Diagnostica Stago STA Compact 5 46.0 0.7 1.5 46 39-53 Diagnostica Stago STart 4/8 5 47.1 4.4 9.3 48 40-55 All Coagulation Instruments 15 47.9 4.2 8.8 47 40-56 Diagnostica Stago STA-PTT All Coagulation Instruments 5 47.0 2.4 5.2 47 39-55 Hemoliance SynthASil IL ACL, all models 5 44.3 2.1 4.7 44 37-51 HUMAN HemoStat aptt - EL Human HumaClot Junior 5 47.5 6.0 12.7 48 40-55 All Coagulation Instruments 5 47.8 5.3 11.0 49 40-55 IL TEST APTT-SP IL ACL, all models 18 43.2 2.6 6.1 43 36-50 2017 MLE-M2 International Data Supplement/ 25
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 36 313.9 42.6 13.6 310 251-377 32 116.4 25.7 22.0 108 93-140 Diagnostica Stago STA Fibrinogen Diagnostica Stago STA Compact 6 301.3 17.7 5.9 302 241-362 6 110.3 7.2 6.6 108 88-133 All Coagulation Instruments 10 291.7 19.4 6.7 295 233-351 9 112.8 15.7 13.9 106 90-136 IL Fibrinogen-C IL ACL, all models 6 330.5 51.2 15.5 337 264-397 6 96.7 15.1 15.6 105 77-117 IL TEST PT-FIB HS PLUS IL ACL, all models 13 329.1 43.9 13.3 329 263-395 10 133.7 21.5 16.1 133 106-161 Specimen CG-8 Specimen CG-9 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 36 303.3 50.0 16.5 298 242-364 35 446.5 55.0 12.3 442 357-536 Diagnostica Stago STA Fibrinogen Diagnostica Stago STA Compact 6 288.5 10.2 3.5 289 230-347 6 446.8 18.4 4.1 445 357-537 All Coagulation Instruments 10 283.1 13.7 4.8 286 226-340 10 450.5 27.9 6.2 442 360-541 IL Fibrinogen-C IL ACL, all models 6 308.3 45.0 14.6 312 246-370 6 484.2 76.5 15.8 499 387-582 IL TEST PT-FIB HS PLUS IL ACL, all models 13 342.2 44.6 13.0 334 273-411 11 448.8 43.0 9.6 445 359-539 Specimen CG-10 Reagent/Instrument Labs Mean SD CV Median Range All Method 34 312.1 47.9 15.3 308 249-375 Diagnostica Stago STA Fibrinogen Diagnostica Stago STA Compact 6 286.7 19.2 6.7 288 229-345 All Coagulation Instruments 10 281.4 16.8 6.0 278 225-338 IL Fibrinogen-C IL ACL, all models 6 317.5 46.8 14.7 327 254-381 IL TEST PT-FIB HS PLUS IL ACL, all models 12 352.3 43.2 12.3 347 281-423 26 /2017 MLE-M2 International Data Supplement
URINALYSIS DIPSTICK SPECIFIC GRAVITY Specimen UA-2 Method Labs Mean SD CV Median Range All Method 402 1.0202 0.0073 0.7 1.021 1.010-1.031 All Arkray Methods 11 1.0210 0.0015 0.1 1.020 1.011-1.031 All DIRUI Methods 20 1.0280 0.0034 0.3 1.030 1.017-1.038 All Iris Diagnostics Methods 13 1.0213 0.0016 0.2 1.022 1.011-1.032 All Refractive Index Methods 33 1.0222 0.0020 0.2 1.022 1.012-1.033 All Roche Methods 137 1.0136 0.0047 0.5 1.010 1.003-1.024 All Siemens Methods 46 1.0289 0.0021 0.2 1.030 1.018-1.039 77 Elektronika LabUMat/2 13 1.0222 0.0023 0.2 1.023 1.012-1.033 DIRUI H-100 / H-500 Urine Analyzer 16 1.0281 0.0032 0.3 1.030 1.018-1.039 Iris Diagnostics ichem Velocity Strips 11 1.0212 0.0018 0.2 1.020 1.011-1.032 Roche Chemstrips / Combur 17 1.0100 0.0025 0.2 1.010 1.000-1.020 Roche cobas u 411 84 1.0121 0.0028 0.3 1.010 1.002-1.023 Roche Urisys 51 1.0159 0.0062 0.6 1.015 1.005-1.026 SD UroColor Reagent Strips 34 1.0246 0.0043 0.4 1.025 1.014-1.035 Siemens Clinitek Advantus 32 1.0294 0.0016 0.2 1.030 1.019-1.040 UriScan Pro/II 17 1.0242 0.0057 0.6 1.025 1.014-1.035 UriScan Reagent Strips 32 1.0258 0.0039 0.4 1.025 1.015-1.036 2017 MLE-M2 International Data Supplement/ 27
URINALYSIS DIPSTICK ph Specimen UA-2 Participant Results Method Labs 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 ALL METHODS 429 - - - - 1-15 169 106 137 1-77 Elektronika LabUMat/2 13 - - - - - - 2 11 - - - - Acon Laboratories 8 - - - - - - - 3 1 3 1 - Analyticon CombiScan 500 3 - - - - - - - 3 - - - - Arkray Aution Jet 1 - - - - - - - - 1 - - - Arkray Aution Sticks 10 - - - - - - - 2 6 2 - - Arkray PocketChem UA 2 - - - - - - - - 2 - - - Combi-Screen Test Strips 9 - - - - - - 1 8 - - - - DIRUI H-100 / H-500 Urine Analyzer 16 - - - - - - 1 10 4 1 - - DIRUI H-800 Urine Analyzer 5 - - - - - - - 1 3 1 - - HUMAN Combilyzer 1 - - - - - - - 1 - - - - HUMAN COMBINA Test Strips 1 - - - - - - - 1 - - - - Iris Diagnostics Aution Max AX-4280 1 - - - - - - - - 1 - - - Iris Diagnostics ichem Velocity Strips 10 - - - - - - 1 9 - - - - Iris Ichem VELOCITY Urine Chemistry System 3 - - - - - - - 3 - - - - Other Analyzer Method 8 - - - - - - - 6 1 1 - - Other Dipstick Method 9 - - - - - - - 5 2 2 - - Plasmatec URIPATH 3 - - - - - - - 2-1 - - Roche Chemstrips / Combur 20 - - - - - - - 2 3 15 - - Roche cobas 6500 / u 601 6 - - - - - - - - - 6 - - Roche cobas u 411 82 - - - - - - - 23-59 - - Roche Miditron Junior/II 2 - - - - - - 1 - - 1 - - Roche Urilux S 1 - - - - - - - 1 - - - - Roche Urisys 53 - - - - - - 1 13-39 - - SD UroColor Reagent Strips 34 - - - - - - 1 20 12 1 - - Siemens Clinitek 500 2 - - - - - - - - 2 - - - Siemens Clinitek Advantus 34 - - - - - - 1 1 32 - - - Siemens Clinitek Atlas 5 - - - - - - 1-4 - - - Siemens Clinitek Status / Status+ 7 - - - - - - - 4 3 - - - Siemens Multistix Pro 1 - - - - - - - - 1 - - - Siemens Reagent Strips 13 - - - - - - - 1 12 - - - Siemens Uristix 1 - - - - - - - 1 - - - - THME UDC-2020 1 - - - - - - - 1 - - - - Urinometer 1 - - - - - - - - 1 - - - UriScan Pro/II 17 - - - - - - - 14 3 - - - UriScan Reagent Strips 35 - - - - 1-4 19 9 2 - - URIT Medical Uritest Analyzers 1 - - - - - - - - 1 - - - 28 /2017 MLE-M2 International Data Supplement
URINALYSIS DIPSTICK PROTEIN QUALITATIVE Specimen UA-2 Participant Results Method Labs Negative Trace (1+) (2+) (3+) (4+) 10-20 mg/dl 30-70 mg/dl 75 mg/dl 100-200 mg/dl 300-600 mg/dl >600 or 1000 mg/dl ALL METHODS 430 3 1 21 135 61 1-8 1 175 24-77 Elektronika LabUMat/2 13 - - - 10 1 - - - - 2 - - Acon Laboratories 8 - - 1 5 1 - - - - 1 - - Analyticon CombiScan 500 3 - - - - - - - - - 1 2 - Arkray Aution Jet 1 - - - 1 - - - - - - - - Arkray Aution Sticks 10 1 - - 6 - - - - - 3 - - Arkray PocketChem UA 2 - - - 1 - - - - - 1 - - Combi-Screen Test Strips 10 - - - 1-1 - - - 3 5 - DIRUI H-100 / H-500 Urine Analyzer 17 - - - 11 2 - - - - 3 1 - DIRUI H-800 Urine Analyzer 4 - - - - 3 - - - - - 1 - HUMAN Combilyzer 1 - - - 1 - - - - - - - - HUMAN COMBINA Test Strips 1 - - 1 - - - - - - - - - Iris Diagnostics Aution Max AX-4280 1 - - - 1 - - - - - - - - Iris Diagnostics ichem Velocity Strips 10 - - 3 2 - - - 4-1 - - Iris Ichem VELOCITY Urine Chemistry System 3 - - - - - - - 3 - - - - Other Analyzer Method 10 - - - 4 - - - - - 4 2 - Other Dipstick Method 9 - - - 5 1 - - - - 3 - - Plasmatec URIPATH 3 1 - - 2 - - - - - - - - Roche Chemstrips / Combur 22 - - - 12 4 - - - - 6 - - Roche cobas 6500 / u 601 6 - - - - - - - - - 6 - - Roche cobas u 411 82 - - - 2 14 - - - 1 65 - - Roche Miditron Junior/II 2 - - 1-1 - - - - - - - Roche Urilux S 1 - - - - 1 - - - - - - - Roche Urisys 52-1 - 1 13 - - - - 36 1 - SD UroColor Reagent Strips 34 - - 11 19 - - - 1-3 - - Siemens Clinitek 500 2 - - - - - - - - - 1 1 - Siemens Clinitek Advantus 34 - - - 18 4 - - - - 11 1 - Siemens Clinitek Atlas 5 - - - - 2 - - - - 2 1 - Siemens Clinitek Status / Status+ 7 - - - 2 4 - - - - - 1 - Siemens Multistix Pro 1 - - - - - - - - - 1 - - Siemens Reagent Strips 12 - - - 8 3 - - - - - 1 - Siemens Uristix 1 - - - - - - - - - 1 - - Urinometer 1 - - - 1 - - - - - - - - UriScan Pro/II 16 - - - 3 2 - - - - 8 3 - UriScan Reagent Strips 37 1-4 16 3 - - - - 9 4 - URIT Medical Uritest Analyzers 1 - - - 1 - - - - - - - - 2017 MLE-M2 International Data Supplement/ 29
URINALYSIS DIPSTICK GLUCOSE Specimen UA-2 Method Labs Negative or Normal Participant Results Trace (1+) (2+) (3+) (4+) 30-100 mg/dl 150-300 mg/dl 500 mg/dl >500 or 1000 or 2000 mg/dl ALL METHODS 430 429-1 - - - - - - - 77 Elektronika LabUMat/2 13 13 - - - - - - - - - Acon Laboratories 8 8 - - - - - - - - - Analyticon CombiScan 500 3 3 - - - - - - - - - Arkray Aution Jet 1 1 - - - - - - - - - Arkray Aution Sticks 10 10 - - - - - - - - - Arkray PocketChem UA 2 2 - - - - - - - - - Combi-Screen Test Strips 10 10 - - - - - - - - - DIRUI H-100 / H-500 Urine Analyzer 17 17 - - - - - - - - - DIRUI H-800 Urine Analyzer 4 4 - - - - - - - - - HUMAN Combilyzer 1 1 - - - - - - - - - HUMAN COMBINA Test Strips 1 1 - - - - - - - - - Iris Diagnostics Aution Max AX-4280 1 1 - - - - - - - - - Iris Diagnostics ichem Velocity Strips 10 10 - - - - - - - - - Iris Ichem VELOCITY Urine Chemistry System 3 3 - - - - - - - - - Other Analyzer Method 10 10 - - - - - - - - - Other Dipstick Method 9 9 - - - - - - - - - Plasmatec URIPATH 3 3 - - - - - - - - - Roche Chemstrips / Combur 20 20 - - - - - - - - - Roche cobas 6500 / u 601 6 6 - - - - - - - - - Roche cobas u 411 82 82 - - - - - - - - - Roche Miditron Junior/II 2 2 - - - - - - - - - Roche Urilux S 1 1 - - - - - - - - - Roche Urisys 53 53 - - - - - - - - - SD UroColor Reagent Strips 34 34 - - - - - - - - - Siemens Clinitek 500 2 2 - - - - - - - - - Siemens Clinitek Advantus 34 34 - - - - - - - - - Siemens Clinitek Atlas 5 5 - - - - - - - - - Siemens Clinitek Status / Status+ 8 8 - - - - - - - - - Siemens Multistix Pro 1 1 - - - - - - - - - Siemens Reagent Strips 12 12 - - - - - - - - - Siemens Uristix 1 1 - - - - - - - - - Urinometer 1 1 - - - - - - - - - UriScan Pro/II 17 16-1 - - - - - - - UriScan Reagent Strips 36 36 - - - - - - - - - URIT Medical Uritest Analyzers 1 1 - - - - - - - - - 30 /2017 MLE-M2 International Data Supplement
URINALYSIS DIPSTICK KETONES Specimen UA-2 Participant Results Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) 5-10 mg/dl 15-25 mg/dl 40-60 mg/dl 80-100 mg/dl 150 mg/dl ALL METHODS 427 10 1 1 - - 46 135 36-6 22 147 13 10 77 Elektronika LabUMat/2 13 - - - - - 6 4 1 - - 2 - - - Acon Laboratories 8 - - - - - 1 5 1 - - - 1 - - Analyticon CombiScan 500 3 - - - - - - 1 - - - - - 2 - Arkray Aution Jet 1 - - - - - - 1 - - - - - - - Arkray Aution Sticks 9 - - - - - 1 4 1 - - - 3 - - Arkray PocketChem UA 2 - - - - - - 1 - - - - 1 - - Combi-Screen Test Strips 10 - - - - - 1 2 - - - 2-5 - DIRUI H-100 / H-500 Urine Analyzer 17 2 - - - - 4 9 - - - - 2 - - DIRUI H-800 Urine Analyzer 4 - - - - - 1 2 - - 1 - - - - HUMAN Combilyzer 1 - - - - - - 1 - - - - - - - HUMAN COMBINA Test Strips 1 1 - - - - - - - - - - - - - Iris Diagnostics Aution Max AX-4280 1 - - - - - - 1 - - - - - - - Iris Diagnostics ichem Velocity Strips 10 - - - - - 2 1 - - - 3 4 - - Iris Ichem VELOCITY Urine Chemistry System 3 - - - - - - - - - - 3 - - - Other Analyzer Method 10 - - - - - 4 1 1 - - 1 3 - - Other Dipstick Method 9 - - - - - - 7 1 - - 1 - - - Plasmatec URIPATH 3 - - - - - 1 2 - - - - - - - Roche Chemstrips / Combur 20 1 - - - - 4 11 1 - - - 2-1 Roche cobas 6500 / u 601 6 - - - - - - - - - - - 6 - - Roche cobas u 411 83 1 1 - - - - 1 14 - - 2 58 1 5 Roche Miditron Junior/II 2 - - - - - - 1 - - - - 1 - - Roche Urisys 53 2 - - - - 2 8 4 - - 3 29 1 4 SD UroColor Reagent Strips 34 - - - - - 10 17 2-3 - - 2 - Siemens Clinitek 500 2 - - - - - - - - - - 1 1 - - Siemens Clinitek Advantus 34 - - 1 - - 5 16 - - - 3 9 - - Siemens Clinitek Atlas 5 - - - - - - 1 1 - - - 1 2 - Siemens Clinitek Status / Status+ 6 - - - - - - 5 - - - - 1 - - Siemens Multistix Pro 1 - - - - - - - - - - - 1 - - Siemens Reagent Strips 13 - - - - - - 6 6 - - - 1 - - Urinometer 1 - - - - - - - 1 - - - - - - UriScan Pro/II 16 - - - - - 1 4 1-2 - 8 - - UriScan Reagent Strips 37 3 - - - - 2 19 - - - 1 12 - - URIT Medical Uritest Analyzers 1 - - - - - - 1 - - - - - - - 2017 MLE-M2 International Data Supplement/ 31
URINALYSIS DIPSTICK BILIRUBIN Specimen UA-2 Participant Results Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) 0.5-1.0 mg/dl 2.0-4.0 mg/dl 6.0-10.0 mg/dl >10.0 mg/dl ALL METHODS 415 68 3 1 17 1 39 53 89 6 14 6 116 2 77 Elektronika LabUMat/2 13 - - - - - - - 11 - - - 2 - Acon Laboratories 8 1 - - - - 2 2 3 - - - - - Analyticon CombiScan 500 4 - - - - - - - - 2 2 - - - Arkray Aution Jet 1 - - - - - - 1 - - - - - - Arkray Aution Sticks 10 1 - - - - 5-1 - 2-1 - Arkray PocketChem UA 2 - - - - - - 1 - - 1 - - - Combi-Screen Test Strips 9 1 - - - - - - 1 3-4 - - DIRUI H-100 / H-500 Urine Analyzer 17 2 - - - - 10 2 1 - - 1 1 - DIRUI H-800 Urine Analyzer 4 - - - - - - 2 1 - - 1 - - HUMAN Combilyzer 1 - - - - - - - 1 - - - - - HUMAN COMBINA Test Strips 1 1 - - - - - - - - - - - - Iris Diagnostics Aution Max AX-4280 1 - - - - - 1 - - - - - - - Iris Diagnostics ichem Velocity Strips 10 10 - - - - - - - - - - - - Iris Ichem VELOCITY Urine Chemistry System 3 3 - - - - - - - - - - - - Other Analyzer Method 10 2 - - - - - 1 5-1 - 1 - Other Dipstick Method 9 1 - - - - 2 2 3 - - - - 1 Plasmatec URIPATH 3 - - - - - - 1 2 - - - - - Roche Chemstrips / Combur 19 1 - - - - - - 16 - - - 2 - Roche cobas 6500 / u 601 6 - - - - - - - - - - - 6 - Roche cobas u 411 83 1 - - - - - - 16 1 - - 65 - Roche Miditron Junior/II 2 1 - - - - - - 1 - - - - - Roche Urisys 52-1 - - - - - 15 - - - 36 - SD UroColor Reagent Strips 34 3 1 - - - 10 17 - - 2-1 - Siemens Clinitek 500 2 1 - - 1 - - - - - - - - - Siemens Clinitek Advantus 34 - - - 12 1-16 5 - - - - - Siemens Clinitek Atlas 5 1 - - 1-1 - 2 - - - - - Siemens Clinitek Status / Status+ 6 - - 1 2 - - 2 1 - - - - - Siemens Multistix Pro 1 - - - - - - - 1 - - - - - Siemens Reagent Strips 2 - - - 1 - - - 1 - - - - - Siemens Uristix 1 1 - - - - - - - - - - - - UriScan Pro/II 17 12 - - - - 2 - - - 3 - - - UriScan Reagent Strips 36 23 - - - - 5 4 1-3 - - - URIT Medical Uritest Analyzers 1 - - - - - - 1 - - - - - - 32 /2017 MLE-M2 International Data Supplement
URINALYSIS DIPSTICK UROBILINOGEN Specimen UA-2 Participant Results Method Labs Normal or 0.0-0.2 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 416 72 60 59 90 135 77 Elektronika LabUMat/2 12 - - - - 12 Acon Laboratories 8 2 3 1 1 1 Analyticon CombiScan 500 3 - - - - 3 Arkray Aution Jet 1 1 - - - - Arkray Aution Sticks 10 2 4 2 2 - Arkray PocketChem UA 2 1-1 - - Combi-Screen Test Strips 10 1 - - - 9 DIRUI H-100 / H-500 Urine Analyzer 17 11 4 1 1 - DIRUI H-800 Urine Analyzer 4 4 - - - - HUMAN Combilyzer 1 - - - - 1 HUMAN COMBINA Test Strips 1 1 - - - - Iris Diagnostics Aution Max AX-4280 1-1 - - - Iris Diagnostics ichem Velocity Strips 10 1-8 1 - Iris Ichem VELOCITY Urine Chemistry System 3-1 2 - - Other Analyzer Method 10-1 1 1 7 Other Dipstick Method 9 3-3 - 3 Plasmatec URIPATH 2 1-1 - - Roche Chemstrips / Combur 20 1 4-9 6 Roche cobas 6500 / u 601 6-1 - 4 1 Roche cobas u 411 82 1 2 3 26 50 Roche Miditron Junior/II 2 - - 2 - - Roche Urisys 53 2 5 4 26 16 SD UroColor Reagent Strips 34 23 8-2 1 Siemens Clinitek 500 2-1 1 - - Siemens Clinitek Advantus 34 4 12 17 1 - Siemens Clinitek Atlas 5 1 1 3 - - Siemens Clinitek Status / Status+ 6-2 2 2 - Siemens Multistix Pro 1-1 - - - Siemens Reagent Strips 2 - - 2 - - Siemens Uristix 1 - - - 1 - Urinometer 1-1 - - - UriScan Pro/II 17-2 1 4 10 UriScan Reagent Strips 35 7 3 3 8 14 URIT Medical Uritest Analyzers 1-1 - - - 2017 MLE-M2 International Data Supplement/ 33
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 50-100 Ery/µL 250 Ery/µL ±0.03 mg/dl 0.06-0.10 mg/ dl 0.2-0.5 mg/ dl 1.0 mg/ dl ALL METHODS 429 2 1 - - 5-10 159 60 14 1 2 170 1 - - 4 77 Elektronika LabUMat/2 12 - - - - - - - 12 - - - - - - - - - Acon Laboratories 8 - - - - - - - 2 6 - - - - - - - - Analyticon CombiScan 500 3 - - - - - - - - - 1 - - 2 - - - - Arkray Aution Jet 1 - - - - - - - 1 - - - - - - - - - Arkray Aution Sticks 10 - - - - - - 2 7 - - - - 1 - - - - Arkray PocketChem UA 2 - - - - - - - 2 - - - - - - - - - Combi-Screen Test Strips 10 - - - - - - - 1 1 - - - 7 1 - - - DIRUI H-100 / H-500 Urine Analyzer 17 - - - - - - - 15 - - - - 2 - - - - DIRUI H-800 Urine Analyzer 4 - - - - - - 1 2 - - - - 1 - - - - HUMAN Combilyzer 1 - - - - - - - 1 - - - - - - - - - HUMAN COMBINA Test Strips 1 - - - - - - - 1 - - - - - - - - - Iris Diagnostics Aution Max AX-4280 1 - - - - - - 1 - - - - - - - - - - Iris Diagnostics ichem Velocity Strips 10 - - - - - - - 7 - - - - - - - - 3 Iris Ichem VELOCITY Urine Chemistry System 3 - - - - - - - 1 1 - - - - - - - 1 Other Analyzer Method 10 - - - - - - 1 5 - - - - 4 - - - - Other Dipstick Method 9 - - - - - - - 6 1 - - - 2 - - - - Plasmatec URIPATH 3 - - - - - - - 3 - - - - - - - - - Roche Chemstrips / Combur 19 - - - - - - 1-14 - - - 4 - - - - Roche cobas 6500 / u 601 6 - - - - - - - - - - - - 6 - - - - Roche cobas u 411 83 - - - - - - - 1 4 10 - - 68 - - - - Roche Miditron Junior/II 3 - - - - - - - 1 2 - - - - - - - - Roche Urisys 53-1 - - - - - 1 11 3 - - 37 - - - - SD UroColor Reagent Strips 34 - - - - - - - 20 13 - - - 1 - - - - Siemens Clinitek 500 2 - - - - - - - 1 - - - - 1 - - - - Siemens Clinitek Advantus 34 - - - - 2 - - 22 - - - 1 9 - - - - Siemens Clinitek Atlas 5 - - - - - - - 1 1 - - - 3 - - - - Siemens Clinitek Status / Status+ 6 - - - - 3-1 2 - - - - - - - - - Siemens Multistix Pro 1 - - - - - - - - - - - - 1 - - - - Siemens Reagent Strips 13 1 - - - - - - 11 1 - - - - - - - - Siemens Uristix 1 - - - - - - - - - - - - 1 - - - - Urinometer 1 - - - - - - - 1 - - - - - - - - - UriScan Pro/II 17 1 - - - - - 1 5 - - 1 1 8 - - - - UriScan Reagent Strips 36 - - - - - - 2 21 3 - - - 10 - - - - URIT Medical Uritest Analyzers 1 - - - - - - - 1 - - - - - - - - - 34 /2017 MLE-M2 International Data Supplement
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 414 402 3 - - - 6 2 - - 1 - - 77 Elektronika LabUMat/2 13 13 - - - - - - - - - - - Acon Laboratories 7 7 - - - - - - - - - - - Analyticon CombiScan 500 3 3 - - - - - - - - - - - Arkray Aution Jet 1 1 - - - - - - - - - - - Arkray Aution Sticks 9 9 - - - - - - - - - - - Arkray PocketChem UA 2 2 - - - - - - - - - - - Combi-Screen Test Strips 11 11 - - - - - - - - - - - DIRUI H-100 / H-500 Urine Analyzer 17 17 - - - - - - - - - - - DIRUI H-800 Urine Analyzer 4 4 - - - - - - - - - - - HUMAN Combilyzer 1 1 - - - - - - - - - - - HUMAN COMBINA Test Strips 1 - - - - - 1 - - - - - - Iris Diagnostics Aution Max AX-4280 1 1 - - - - - - - - - - - Iris Diagnostics ichem Velocity Strips 10 10 - - - - - - - - - - - Iris Ichem VELOCITY Urine Chemistry System 3 3 - - - - - - - - - - - Other Analyzer Method 10 10 - - - - - - - - - - - Other Dipstick Method 9 9 - - - - - - - - - - - Plasmatec URIPATH 3 3 - - - - - - - - - - - Roche Chemstrips / Combur 20 19 - - - - - 1 - - - - - Roche cobas 6500 / u 601 6 6 - - - - - - - - - - - Roche cobas u 411 82 82 - - - - - - - - - - - Roche Miditron Junior/II 2 2 - - - - - - - - - - - Roche Urisys 53 51 - - - - 1 - - - 1 - - SD UroColor Reagent Strips 33 27 3 - - - 2 1 - - - - - Siemens Clinitek 500 2 2 - - - - - - - - - - - Siemens Clinitek Advantus 34 34 - - - - - - - - - - - Siemens Clinitek Atlas 5 5 - - - - - - - - - - - Siemens Clinitek Status / Status+ 7 7 - - - - - - - - - - - Siemens Multistix Pro 1 1 - - - - - - - - - - - Siemens Reagent Strips 2 2 - - - - - - - - - - - Siemens Uristix 1 1 - - - - - - - - - - - Urinometer 1 1 - - - - - - - - - - - UriScan Pro/II 16 16 - - - - - - - - - - - UriScan Reagent Strips 35 33 - - - - 2 - - - - - - URIT Medical Uritest Analyzers 1 1 - - - - - - - - - - - 2017 MLE-M2 International Data Supplement/ 35
URINALYSIS DIPSTICK NITRITE Specimen UA-2 Participant Results Method Labs Positive Negative ALL METHODS 419 416 3 77 Elektronika LabUMat/2 13 13 - Acon Laboratories 9 9 - Analyticon CombiScan 500 3 2 1 Arkray Aution Jet 1 1 - Arkray Aution Sticks 10 10 - Arkray PocketChem UA 2 2 - Combi-Screen Test Strips 10 10 - DIRUI H-100 / H-500 Urine Analyzer 17 16 1 DIRUI H-800 Urine Analyzer 4 4 - HUMAN Combilyzer 1 1 - HUMAN COMBINA Test Strips 1 1 - Iris Diagnostics Aution Max AX-4280 1 1 - Iris Diagnostics ichem Velocity Strips 10 10 - Iris Ichem VELOCITY Urine Chemistry System 3 3 - Other Analyzer Method 10 10 - Other Dipstick Method 9 9 - Plasmatec URIPATH 3 3 - Roche Chemstrips / Combur 20 20 - Roche cobas 6500 / u 601 6 6 - Roche cobas u 411 82 82 - Roche Miditron Junior/II 2 2 - Roche Urisys 53 53 - SD UroColor Reagent Strips 35 35 - Siemens Clinitek 500 2 2 - Siemens Clinitek Advantus 34 34 - Siemens Clinitek Atlas 4 3 1 Siemens Clinitek Status / Status+ 7 7 - Siemens Multistix Pro 1 1 - Siemens Reagent Strips 2 2 - Siemens Uristix 1 1 - Urinometer 1 1 - UriScan Pro/II 17 17 - UriScan Reagent Strips 36 36 - URIT Medical Uritest Analyzers 1 1-36 /2017 MLE-M2 International Data Supplement
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 14 1 1 - - - 1 1 4-6 Beckman Coulter ICON microalb 2 - - - - - - - 1-1 Other Dipstick Method 1 1 - - - - - - - - - Roche Micral - 1 minute 3-1 - - - - 1 - - 1 URINALYSIS URINE hcg Specimen UA-2 Participant Results Method Labs Positive Negative ALL METHODS 112-112 Acon Laboratories 8-8 Alere Acceava hcg-urine 2-2 Alere Clearview hcg Cassette 14-14 Biotron 1-Step 5-5 Medline hcg Test Strip 1-1 Other Dipstick Method 3-3 Quidel QuickVue One-Step Combo 19-19 RefuAH hcg Dipstick 1-1 SD Bioline hcg 3-3 Stanbio QuStick 1-1 Sure-Vue hcg - 25mIU 1-1 2017 MLE-M2 International Data Supplement/ 37
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 45 44 1-116 115-1 98.84% Amoxicillin/Clavulanate 35 15 2 18 21 5 2 14 85.00% 1 Ampicillin 31 20 1 10 61 5-56 85.00% 1 Ampicillin/Sulbactam 28 23 1 4 69 44-25 94.00% 1 Aztreonam 15 15 - - 35 30-5 88.46% Cefaclor 4 2 1 1 - - - - Ungraded 2 Cefazolin 20 9-11 33 3-30 83.00% Cefepime 35 35 - - 124 124 - - 100.00% Cefixime 24 24 - - 6 6 - - 100.00% Cefoperazone 8 8 - - - - - - 100.00% Cefotaxime 32 32 - - 47 45-2 97.62% Cefotetan 1 1 - - - - - - Ungraded 2 Cefpodoxime 6 5 1-1 1 - - 85.71% Ceftazidime 34 82 80-2 96.77% Ceftizoxime 1 1 - - - - - - Ungraded 2 Ceftriaxone 42 42 - - 77 75 1 1 97.67% Cefuroxime 44 44 - - 50 35-15 82.83% Cephalexin 3 2-1 2 - - 2 Inappropriate drug 3 Cephalothin 5 1-4 25 - - 25 Inappropriate drug 3 Ciprofloxacin 53 53 - - 141 141 - - 100.00% Colistin 1 - - 1 12 1-11 92.31% Daptomycin - - - - 1 1 - - Inappropriate drug 3 Doripenem 2 2 - - 6 6 - - 100.00% Doxycycline 1 1 - - 1 - - 1 Ungraded 2 Ertapenem 15 15 - - 107 107 - - 100.00% Fosfomycin 8 7-1 18 11-7 Inappropriate drug 3 Gatifloxacin 1 1 - - 1 1 - - Ungraded 2 Gentamicin 33 29-4 80 31-49 Ungraded 4 Imipenem 35 32 1 2 78 73 5-92.31% Kanamycin 1 1 - - - - - - 100.00% 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