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 Immunology 2017 MLE-M3 Total Commitment to Education and Service Provided by ACP, Inc.
2 Table of Contents Evaluation Criteria... 3 Immunology Infectious Mononucleosis... 4 Rheumatoid Factor... 6 Qualitative... 6 Quantitative (Titer)... 7 Quantitative (IU)... 8 Anti-Streptolysin O (ASO)... 8 Complement C Complement C IgA IgG IgM C-Reactive Protein, Regular Qualitative Quantitative C-Reactive Protein, High Sensitivity Antinuclear Antibody Qualitative Quantitative (Titer) Anti-dsDNA Anti-RNP Anti-RNP/Sm Anti-SSA Anti-SSB Anti-SSA/SSB Anti-Sm Rubella Qualitative Quantitative Anti-HIV Allergen Specific IgE Antibodies Total IgE VDRL Slide Syphilis Serology Qualitative: Treponema pallidum antibodies Qualitative: RPR Quantitative: RPR (Titer) H. pylori Antibody Detection Mycoplasma Antibody Viral Markers Anti-HBc (IgM) Anti-HBc (Total/IgG) Anti-HIV Anti-HAV (IgM) Anti-HAV (Total/IgG) HBeAg Anti-HBs HBsAg Anti-HCV 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.
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. Anti-dsDNA Anti-HIV Antinuclear Antibody (ANA) Anti-RNP Anti-RNP/Sm Anti-Sm Anti-SSA Anti-SSA/SSB Anti-SSB Anti-Streptolysin O (ASO) C-Reactive Protein Diagnostic Allergy H. pylori Antibody Detection Infectious Mononucleosis Mycoplasma Antibody Rheumatoid Factor Rubella Antibody Syphilis Serology Viral Markers 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." Antinuclear Antibody (ANA) Titer Not Evaluated Anti-Streptolysin O (ASO) Titer Not Evaluated Complement C3 3 SD Complement C4 3 SD C-Reactive Protein 3 SD High Sensitivity C-Reactive Protein 3 SD Rheumatoid Factor (International Units) 2 SD Rheumatoid Factor (Titer) Not Evaluated Rubella (International Units) 3 SD Total IgA 3 SD Total IgE 3 SD Total IgG 25% Total IgM 3 SD 2017 MLE-M3 Participant Summary/ 3
4 Infectious Mononucleosis Specimen IM-11 Specimen IM-12 ALL METHODS Alere Clearview - moderate Alere Clearview - waived Alere Clearview Mono Plus II - moderate Alere Clearview Mono Plus II - waived ASI Beckman Coulter ICON Mono - waived BioStar Acceava Mono Test BioStar Acceava Mono-whole bld BTNX Rapid Response moderate Cardinal Health SP Brand Cardinal Health SP Brand - waived Consult Diagnostics Fisher HealthCare Sure-Vue Henry Schein OneStep+ - waived LifeSign Status - waived McKesson Medi-Lab Performance - waived Other Moderate method Other Waived method Quidel QuickVue Quidel QuickVue+ - waived Sekisui OSOM Sekisui OSOM (waived) Seradyn Wampole ColorCard /2017 MLE-M3 Participant Summary
5 Infectious Mononucleosis Specimen IM-13 Specimen IM-14 Specimen IM-15 Positive Negative ALL METHODS Alere Clearview - moderate Alere Clearview Mono Plus II - moderate Alere Clearview Mono Plus II - waived ASI Beckman Coulter ICON Mono - waived BioStar Acceava Mono-whole bld BTNX Rapid Response moderate Cardinal Health SP Brand Cardinal Health SP Brand - waived Consult Diagnostics Fisher HealthCare Sure-Vue Henry Schein OneStep+ - waived LifeSign Status - waived McKesson Medi-Lab Performance - waived Other Moderate method Other Waived method Quidel QuickVue Quidel QuickVue+ - waived Sekisui OSOM Sekisui OSOM (waived) Seradyn Wampole ColorCard MLE-M3 Participant Summary/ 5
6 Rheumatoid Factor Qualitative Specimen RF-11 Specimen RF-12 Specimen RF-13 Positive Negative ALL METHODS Abbott Architect ASI Biokit Rheumajet Diamedix Fisher HealthCare Sure-Vue Immunostics Inc INOVA Diagnostics TheraTest Wampole ColorCard Wampole Rheumatex Specimen RF-14 Specimen RF-15 ALL METHODS Abbott Architect ASI Biokit Rheumajet Diamedix Fisher HealthCare Sure-Vue Immunostics Inc INOVA Diagnostics TheraTest Wampole ColorCard Wampole Rheumatex /2017 MLE-M3 Participant Summary
7 Rheumatoid Factor Quantitative (Titer) Specimen/Method N/A (Neg) 2/ 4 8/ 10 16/ 20 32/ 40 64/ / / / / / Specimen RF-11 ALL METHODS ASI Fisher HealthCare Sure-Vue Wampole ColorCard Specimen RF-12 ALL METHODS ASI Fisher HealthCare Sure-Vue Wampole ColorCard Specimen RF-13 ALL METHODS ASI Fisher HealthCare Sure-Vue Wampole ColorCard Specimen RF-14 ALL METHODS ASI Fisher HealthCare Sure-Vue Wampole ColorCard Specimen RF-15 ALL METHODS ASI Fisher HealthCare Sure-Vue Wampole ColorCard MLE-M3 Participant Summary/ 7
8 Rheumatoid Factor Quantitative (IU/mL) Specimen/Method Labs Mean SD CV Median Range Specimen RF-11 All Method Specimen RF-12 All Method Specimen RF-13 All Method Specimen RF-14 All Method Specimen RF-15 All Method Anti-Streptolysin O (ASO) Qualitative Specimen AS-11 Specimen AS-12 Specimen AS-13 Positive Negative ALL METHODS Method Specimen AS-14 Specimen AS-15 Positive Negative Positive Negative ALL METHODS /2017 MLE-M3 Participant Summary
9 Complement C3 (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-11 All Method Specimen IMP-12 All Method Specimen IMP-13 All Method Specimen IMP-14 All Method Specimen IMP-15 All Method Complement C4 (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-11 All Method Specimen IMP-12 All Method Specimen IMP-13 All Method Specimen IMP-14 All Method Specimen IMP-15 All Method MLE-M3 Participant Summary/ 9
10 IgA (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-11 All Method Specimen IMP-12 All Method Specimen IMP-13 All Method Specimen IMP-14 All Method Specimen IMP-15 All Method IgG (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-11 All Method Specimen IMP-12 All Method Specimen IMP-13 All Method Specimen IMP-14 All Method Specimen IMP-15 All Method /2017 MLE-M3 Participant Summary
11 IgM (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-11 All Method Specimen IMP-12 All Method Specimen IMP-13 All Method Specimen IMP-14 All Method Specimen IMP-15 All Method C-Reactive Protein Qualitative, Regular Specimen CR-5 Specimen CR-6 ALL METHODS Beckman Synchron Fisher HealthCare Sure-Vue Siemens Dimension/AR/ES/RxL/Xpand C-Reactive Protein Quantitative (mg/dl), Regular Specimen/Method Labs Mean SD CV Median Range Specimen CR-5 mg/dl - units All Immunology Methods mg/l - units All Immunology Methods Specimen CR-6 mg/dl - units All Immunology Methods mg/l - units All Immunology Methods MLE-M3 Participant Summary/ 11
12 C-Reactive Protein Quantitative (mg/dl), High Sensitivity Specimen/Method Labs Mean SD CV Median Range Specimen HCR-5 All Method Specimen HCR-6 All Method Antinuclear Antibody (ANA) - Qualitative Specimen AE-11 Specimen AE-12 Specimen AE-13 Positive Negative ALL METHODS ASI Bio-Rad Immuno Concepts INOVA Diagnostics Teco Diagnostics TheraTest Specimen AE-14 Specimen AE-15 ALL METHODS ASI Bio-Rad Immuno Concepts INOVA Diagnostics Teco Diagnostics TheraTest /2017 MLE-M3 Participant Summary
13 Antinuclear Antibody (ANA) Quantitative (Titer) Specimen/Method N/A (Neg) 8/ 10 16/ 20 32/ 40 64/ / / / 640 > / / Specimen AE-11 ALL METHODS Bio-Rad Immuno Concepts INOVA Diagnostics Specimen AE-12 ALL METHODS Bio-Rad Immuno Concepts INOVA Diagnostics Specimen AE-13 ALL METHODS Bio-Rad Immuno Concepts INOVA Diagnostics Specimen AE-14 ALL METHODS Bio-Rad Immuno Concepts INOVA Diagnostics Specimen AE-15 ALL METHODS Bio-Rad Immuno Concepts INOVA Diagnostics MLE-M3 Participant Summary/ 13
14 Anti-dsDNA Specimen AE-11 Specimen AE-12 Specimen AE-13 Positive Negative ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest Specimen AE-14 Specimen AE-15 ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest Anti-RNP Specimen AE-11 Specimen AE-12 Specimen AE-13 Positive Negative ALL METHODS Immuno Concepts Specimen AE-14 Specimen AE-15 ALL METHODS Immuno Concepts /2017 MLE-M3 Participant Summary
15 Anti-RNP/Sm Specimen AE-11 Specimen AE-12 Specimen AE-13 Positive Negative ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest Specimen AE-14 Specimen AE-15 ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest Anti-SSA Specimen AE-11 Specimen AE-12 Specimen AE-13 Positive Negative ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest Specimen AE-14 Specimen AE-15 ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest Anti-SSB Specimen AE-11 Specimen AE-12 Specimen AE-13 Positive Negative ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest Specimen AE-14 Specimen AE-15 ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest MLE-M3 Participant Summary/ 15
16 Anti-SSA/SSB Specimen AE-11 Specimen AE-12 Specimen AE-13 Positive Negative ALL METHODS Immuno Concepts Specimen AE-14 Specimen AE-15 ALL METHODS Immuno Concepts Anti-Sm Specimen AE-11 Specimen AE-12 Specimen AE-13 Positive Negative ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest Specimen AE-14 Specimen AE-15 ALL METHODS Immuno Concepts INOVA Diagnostics TheraTest /2017 MLE-M3 Participant Summary
17 Rubella Qualitative Specimen RU-11 Specimen RU-12 Specimen RU-13 Positive Negative ALL METHODS biomerieux Vidas, Mini Vidas DiaSorin INOVA Diagnostics Centaur Specimen RU-14 Specimen RU-15 ALL METHODS biomerieux Vidas, Mini Vidas DiaSorin Roche cobas e Centaur Rubella Quantitative (IU/mL) One lab reported results for Rubella Quantitative (IU/mL). The vendor assay values for specimens RU-11 through RU-15 are: 19.0 IU/mL, <10.0 IU/mL, <10.0 IU/mL, <10.0 IU/mL, and 31.7 IU/mL, respectively. Anti-HIV Specimen HIV-11 Specimen HIV-12 ALL METHODS Alere Clearview Complete HIV 1/ Alere Clearview HIV1/2 STAT-PAK Alere Determine HIV 1/2 Ag/Ab Combo BD LINK Chembio HIV 1/2 Assay - moderate Chembio HIV 1/2 Assay - waived Orasure OraQuick Advance Rapid HIV-1/2 - waived Other Waived method Specimen HIV-13 Specimen HIV-14 Specimen HIV-15 Positive Negative ALL METHODS Chembio HIV 1/2 Assay - moderate MLE-M3 Participant Summary/ 17
18 Allergen Specific IgE Antibodies Specimen AL-11 Peanut (f13) Allergen White Oak (t7) Allergen Method 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Hycor RAST (Ru/mL) Phadia UniCap 100 (% ref) Phadia UniCap 100 (KU/L) Olive (t9) Allergen Common (Short) Ragweed (w1) Allergen 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Hycor RAST (Ru/mL) Phadia UniCap 100 (% ref) Phadia UniCap 100 (KU/L) House Dust Mite (D. farinae) (d2) Dog Dander (e5) Allergen Allergen 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Hycor RAST (Ru/mL) Phadia UniCap 100 (% ref) Phadia UniCap 100 (KU/L) Meadow, Kentucky Blue, June Grass (g8) Allergens 0 0/ ALL METHODS DPC-Standard Microplate Hitachi CLA Hycor RAST (Ru/mL) Phadia UniCap 100 (% ref) Phadia UniCap 100 (KU/L) /2017 MLE-M3 Participant Summary
19 Allergen Specific IgE Antibodies Specimen AL-12 Wheat (f4) Allergen Soybean (f14) Allergen Method 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Hycor RAST (Ru/mL) Phadia UniCap 100 (% ref) Phadia UniCap 100 (KU/L) House Dust Mite (D. pteronyssinus) Cat Epithelium (e1) Allergen (d1) Allergen 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Hycor RAST (Ru/mL) Phadia UniCap 100 (% ref) Phadia UniCap 100 (KU/L) Timothy Grass (g6) Allergen Meadow Fescue (g4) Allergen 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Hycor RAST (Ru/mL) Phadia UniCap 100 (% ref) Phadia UniCap 100 (KU/L) Alternaria alternata (m6) Allergen 0 0/ ALL METHODS DPC-Standard Microplate Hitachi CLA Hycor RAST (Ru/mL) Phadia UniCap 100 (% ref) Phadia UniCap 100 (KU/L) MLE-M3 Participant Summary/ 19
20 Total IgE Quantitative (U/mL) Specimen/Method Labs Mean SD CV Median Range Specimen AL-11 All Method Specimen AL-12 All Method Specimen AL-13 All Method Specimen AL-14 All Method Specimen AL-15 All Method VDRL Slide Specimen SY-11 Method Reactive Weakly Reactive Non-Reactive Reactive Weakly Reactive Specimen SY-12 Non-Reactive ALL METHODS Reactive Specimen SY-13 Weakly Reactive Non-Reactive Reactive Weakly Reactive Specimen SY-14 Non-Reactive ALL METHODS Reactive Specimen SY-15 Weakly Non-Reactive Reactive ALL METHODS /2017 MLE-M3 Participant Summary
21 Syphilis Serology Qualitative: Treponema pallidum antibodies Specimen SY-11 Specimen SY-12 Specimen SY-13 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS diagnostics direct Syphilis Health Check INOVA Diagnostics Centaur Specimen SY-14 Specimen SY-15 Method Reactive Non-Reactive Reactive Non-Reactive ALL METHODS diagnostics direct Syphilis Health Check INOVA Diagnostics Centaur Syphilis Serology Qualitative: RPR Specimen SY-11 Specimen SY-12 Specimen SY-13 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS ASI Becton Dickinson Fisher HealthCare Sure-Vue Wampole Impact RPR Specimen SY-14 Specimen SY-15 Method Reactive Non-Reactive Reactive Non-Reactive ALL METHODS ASI Becton Dickinson Fisher HealthCare Sure-Vue Wampole Impact RPR MLE-M3 Participant Summary/ 21
22 Syphilis Serology Quantitative: RPR (Titer) Specimen/Method Specimen SY-11 N/A (Neg) 1:1 1:2 1:4 1:8 1:16 1:32 1:64 1:>64 ALL METHODS ASI Becton Dickinson Specimen SY-12 ALL METHODS ASI Becton Dickinson Specimen SY-13 ALL METHODS ASI Becton Dickinson Specimen SY-14 ALL METHODS ASI Becton Dickinson Specimen SY-15 ALL METHODS ASI Becton Dickinson /2017 MLE-M3 Participant Summary
23 H. pylori Antibody Detection Specimen HP-5 Specimen HP-6 ALL METHODS Alere Clearview - moderate Alfa Scientific Instant-View Beckman Coulter ICON HP Cardinal Health SP Brand Consult Diagnostics Fisher HealthCare Sure-Vue Henry Schein OneStep+ - waived Immunostics Inc McKesson Medi-Lab Performance - waived Quidel QuickVue Sekisui OSOM Mycoplasma Antibody Specimen MY-5 Specimen MY-6 ALL METHODS Meridian ImmunoCard MLE-M3 Participant Summary/ 23
24 Viral Markers Anti-HBc (IgM) Specimen VM-11 Specimen VM-12 Specimen VM-13 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur VITROS Specimen VM-14 Specimen VM-15 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur VITROS Viral Markers Anti-HBc (Total/IgG) Specimen VM-11 Specimen VM-12 Specimen VM-13 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur Specimen VM-14 Specimen VM-15 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur /2017 MLE-M3 Participant Summary
25 Viral Markers Anti-HIV Specimen VM-11 Specimen VM-12 Specimen VM-13 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Orasure OraQuick Advance Rapid HIV- 1/2 - waived Centaur Specimen VM-14 Specimen VM-15 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Orasure OraQuick Advance Rapid HIV- 1/2 - waived Centaur Viral Markers Anti-HAV (IgM) Specimen VM-11 Specimen VM-12 Specimen VM-13 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur VITROS Specimen VM-14 Specimen VM-15 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur VITROS MLE-M3 Participant Summary/ 25
26 Viral Markers Anti-HAV (Total/IgG) Specimen VM-11 Specimen VM-12 Specimen VM-13 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur Specimen VM-14 Specimen VM-15 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur Viral Markers HBeAg One participant reported results for HBeAg. The vendor assay values for specimens VM-11 through VM-15 are: Negative, Negative, Negative, Negative, and Negative, respectively. Viral Markers Anti-HBs Specimen VM-11 Specimen VM-12 Specimen VM-13 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur Specimen VM-14 Specimen VM-15 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur /2017 MLE-M3 Participant Summary
27 Viral Markers HBsAg Specimen VM-11 Specimen VM-12 Specimen VM-13 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Centaur VITROS Specimen VM-14 Specimen VM-15 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Centaur VITROS Specimen VM-14 is an ungraded challenge due to lack of consensus. Viral Markers Anti-HCV Specimen VM-11 Specimen VM-12 Specimen VM-13 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect OraSure OraQuick HCV Centaur VITROS Specimen VM-14 Specimen VM-15 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect OraSure OraQuick HCV Centaur VITROS Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: MLE-M3 Participant Summary/ 27
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