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 MLE-M2 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 Antinuclear Antibody (AN Specimens) C-Reactive Protein, Regular Qualitative Quantitative C-Reactive Protein, High Sensitivity Antinuclear Antibody (AE Specimens) 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 Syphilis Serology Qualitative: VDRL Slide Qualitative: Treponema pallidum antibodies Qualitative: RPR Quantitative: RPR (Titer) Syphilis Serology diagnostics direct Syphilis Health Check (TPA) H. pylori Antibody Detection Lyme Disease Serology 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 Lyme Disease Serology 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 2015 MLE-M2 Participant Summary/ 3
4 Infectious Mononucleosis Specimen IM-6 Specimen IM-7 ALL METHODS Alere Clearview Alere Clearview Mono Plus II ASI Beckman Coulter ICON Mono - waived BioStar Acceava Mono Test BioStar Acceava Mono-whole bld 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 Wampole Mono-Plus II /2015 MLE-M2 Participant Summary
5 Infectious Mononucleosis Specimen IM-8 Specimen IM-9 Specimen IM-10 Positive Negative ALL METHODS Alere Clearview Alere Clearview Mono Plus II ASI Beckman Coulter ICON Mono - waived BioStar Acceava Mono-whole bld 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 Wampole Mono-Plus II MLE-M2 Participant Summary/ 5
6 Rheumatoid Factor Qualitative Specimen RF-6 Specimen RF-7 Specimen RF-8 Positive Negative ALL METHODS Abbott Architect ASI Beckman AU Biokit Rheumajet Diamedix Fisher HealthCare Sure-Vue Immunostics Inc Remel SeraTest Siemens RapiTex Sterling Diagnostics, Inc Teco Diagnostics TheraTest Wampole ColorCard Wampole Rheumatex Specimen RF-9 Specimen RF-10 ALL METHODS Abbott Architect ASI Beckman AU Biokit Rheumajet Diamedix Fisher HealthCare Sure-Vue Immunostics Inc Remel SeraTest Siemens RapiTex Sterling Diagnostics, Inc Teco Diagnostics TheraTest Wampole ColorCard Wampole Rheumatex /2015 MLE-M2 Participant Summary
7 Rheumatoid Factor Quantitative (Titer) This portion is not evaluated. Results reported are as follows: Specimen/Method 2/ 4 8/ 10 16/ 20 32/ 40 64/ / / / / / Specimen RF-7 ALL METHODS Fisher HealthCare Sure-Vue Siemens RapiTex Wampole ColorCard Specimen RF-9 ALL METHODS Fisher HealthCare Sure-Vue Siemens RapiTex Wampole ColorCard MLE-M2 Participant Summary/ 7
8 Rheumatoid Factor Quantitative (IU/mL) Specimen/Method Labs Mean SD CV Median Range Specimen RF-6 All Method Specimen RF-7 All Method Specimen RF-8 All Method Specimen RF-9 All Method Specimen RF-10 All Method Anti-Streptolysin O (ASO) Qualitative Specimen AS-6 Specimen AS-7 Specimen AS-8 Positive Negative ALL METHODS ASI Method Specimen AS-9 Specimen AS-10 Positive Negative Positive Negative ALL METHODS ASI /2015 MLE-M2 Participant Summary
9 Complement C3 (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-6 All Method Specimen IMP-7 All Method Specimen IMP-8 All Method Specimen IMP-9 All Method Specimen IMP-10 All Method Complement C4 (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-6 All Method Specimen IMP-7 All Method Specimen IMP-8 All Method Specimen IMP-9 All Method Specimen IMP-10 All Method MLE-M2 Participant Summary/ 9
10 IgA (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-6 All Method Specimen IMP-7 All Method Specimen IMP-8 All Method Specimen IMP-9 All Method Specimen IMP-10 All Method IgG (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-6 All Method Specimen IMP-7 All Method Specimen IMP-8 All Method Specimen IMP-9 All Method Specimen IMP-10 All Method /2015 MLE-M2 Participant Summary
11 IgM (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-6 All Method Specimen IMP-7 All Method Specimen IMP-8 All Method Specimen IMP-9 All Method Specimen IMP-10 All Method MLE-M2 Participant Summary/ 11
12 Antinuclear Antibody (ANA) Qualitative Latex Methods Specimen AN-6 Specimen AN-7 Specimen AN-8 Positive Negative ALL METHODS ASI Diagnostic Technology Wampole Specimen AN-9 Specimen AN-10 ALL METHODS ASI Diagnostic Technology Wampole C-Reactive Protein Qualitative, Regular Specimen CR-3 Specimen CR-4 ALL METHODS ASI Biokit Rheumajet Fisher HealthCare Sure-Vue Siemens Dimension/AR/ES/RxL/Xpand Teco Diagnostics Wampole C-Reactive Protein Quantitative (mg/dl), Regular Specimen/Method Labs Mean SD CV Median Range Specimen CR-3 mg/dl - units All Immunology Methods mg/l - units All Immunology Methods Specimen CR-4 mg/dl - units All Immunology Methods mg/l - units All Immunology Methods /2015 MLE-M2 Participant Summary
13 C-Reactive Protein Quantitative (mg/dl), High Sensitivity Specimen/Method Labs Mean SD CV Median Range Specimen HCR-3 All Method Specimen HCR-4 All Method Antinuclear Antibody (ANA) Qualitative IFA/ELISA Methods Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix GenBio ImmunoDOT Panel Immuno Concepts INOVA Diagnostics Phadia EliA TheraTest Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix GenBio ImmunoDOT Panel Immuno Concepts INOVA Diagnostics Phadia EliA TheraTest Specimen AE-6 is graded by 80% referee consensus MLE-M2 Participant Summary/ 13
14 Antinuclear Antibody (ANA) Quantitative (Titer) This portion is not evaluated. Titers reported are as follows: Specimen/Method 8/ 10 16/ 20 32/ 40 64/ / / / 640 > / / Specimen AE-6 ALL METHODS Immuno Concepts INOVA Diagnostics Specimen AE-8 ALL METHODS Immuno Concepts INOVA Diagnostics Specimen AE-9 ALL METHODS Immuno Concepts INOVA Diagnostics Anti-dsDNA Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix GenBio ImmunoDOT Panel Phadia EliA TheraTest Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix GenBio ImmunoDOT Panel Phadia EliA TheraTest Specimen AE-9 is an ungraded challenge due to less than 80% participant consensus. 14 /2015 MLE-M2 Participant Summary
15 Anti-RNP Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Phadia EliA Specimen AE-9 Specimen AE-10 ALL METHODS Phadia EliA Specimen AE-9 is an ungraded challenge due to less than 80% participant consensus. Anti-RNP/Sm Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix GenBio ImmunoDOT Panel TheraTest Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix GenBio ImmunoDOT Panel TheraTest MLE-M2 Participant Summary/ 15
16 Anti-SSA Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix Phadia EliA TheraTest Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix Phadia EliA TheraTest Specimen AE-6 is an ungraded challenge due to less than 80% participant consensus. Anti-SSB Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix Phadia EliA TheraTest Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix Phadia EliA TheraTest /2015 MLE-M2 Participant Summary
17 Anti-SSA/SSB Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS GenBio ImmunoDOT Panel Specimen AE-9 Specimen AE-10 ALL METHODS GenBio ImmunoDOT Panel Specimen AE-6 is an ungraded challenge due to less than 80% participant consensus. Anti-Sm Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix Phadia EliA TheraTest Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix Phadia EliA TheraTest MLE-M2 Participant Summary/ 17
18 Rubella Qualitative Specimen RU-6 Specimen RU-7 Specimen RU-8 Positive Negative ALL METHODS biomerieux Vidas, Mini Vidas DiaSorin Centaur Specimen RU-9 Specimen RU-10 ALL METHODS biomerieux Vidas, Mini Vidas DiaSorin Centaur Rubella Quantitative (IU/mL) One lab reported results for Rubella Quantitative (IU/mL). The vendor assay values for specimens RU-6 through RU-10 are: 40 IU/ml, <10 IU/mL, 88.3 IU/mL, 22 IU/mL and <10 IU/mL, respectively. Anti-HIV Specimen HIV-6 Specimen HIV-7 ALL METHODS Alere Clearview Complete HIV 1/ Alere Clearview HIV1/2 STAT-PAK Orasure OraQuick Advance Rapid HIV-1/2 - moderate Orasure OraQuick Advance Rapid HIV-1/2 - waived Other Waived method Specimen HIV-8 Specimen HIV-9 Specimen HIV-10 Positive Negative ALL METHODS Alere Clearview Complete HIV 1/ /2015 MLE-M2 Participant Summary
19 Allergen Specific IgE Antibodies Specimen AL-6 Bermuda Grass Allergen Perennial Rye Allergen Method 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Phadia Unicap Cockroach - German Allergen Aspergillus fumigatus Allergen 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Phadia UniCap 100 (% ref) Maple (Box Elder) Allergen English Plantain Allergen 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Phadia UniCap 100 (% ref) Common (Short) Ragweed Allergen 0 0/ ALL METHODS DPC-Standard Microplate Hitachi CLA Phadia UniCap 100 (% ref) MLE-M2 Participant Summary/ 19
20 Allergen Specific IgE Antibodies Specimen AL-7 House Dust Mite (D. farinae) Allergen Cat Epithelium Allergen Method 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Phadia UniCap 100 (% ref) Dog Dander Allergen Cow's Milk Allergen 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Phadia UniCap 100 (% ref) Timothy Grass Allergen Meadow Fescue Allergen 0 0/ / ALL METHODS DPC-Standard Microplate Hitachi CLA Phadia UniCap 100 (% ref) Mugwort Allergen 0 0/ ALL METHODS DPC-Standard Microplate Hitachi CLA Phadia UniCap 100 (% ref) /2015 MLE-M2 Participant Summary
21 Total IgE Quantitative (U/mL) Specimen/Method Labs Mean SD CV Median Range Specimen AL-6 All Method Specimen AL-7 All Method Specimen AL-8 All Method Specimen AL-9 All Method Specimen AL-10 All Method Syphilis Serology Qualitative: VDRL Slide Method Specimen SY-6 Specimen SY-7 Specimen SY-8 Weakly Non- Weakly Non- Weakly Non- Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive ALL METHODS Method Reactive Specimen SY-9 Weakly Non- Reactive Reactive Specimen SY-10 Weakly Non- Reactive Reactive Reactive ALL METHODS Syphilis Serology Qualitative: Treponema pallidum antibodies Specimen SY-6 Specimen SY-7 Specimen SY-8 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Centaur Specimen SY-9 Specimen SY-10 Method Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Centaur MLE-M2 Participant Summary/ 21
22 Syphilis Serology Qualitative: RPR Specimen SY-6 Specimen SY-7 Specimen SY-8 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS ASI Becton Dickinson Fisher HealthCare Sure-Vue Wampole Impact RPR Specimen SY-9 Specimen SY-10 Method Reactive Non-Reactive Reactive Non-Reactive ALL METHODS ASI Becton Dickinson Fisher HealthCare Sure-Vue Wampole Impact RPR Syphilis Serology Quantitative: RPR (Titer) Specimen/Method 1:1 1:2 1:4 1:8 1:16 1:32 1:64 1:>64 Specimen SY-6 ALL METHODS ASI Becton Dickinson Specimen SY-8 ALL METHODS ASI Becton Dickinson Specimen SY-10 ALL METHODS ASI Becton Dickinson Syphilis Serology Qualitative: diagnostics direct Syphilis Health Check Treponema pallidum antibodies Specimen SHC-6 Specimen SHC-7 Specimen SHC-8 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive diagnostics direct Syphilis Health Check Specimen SHC-9 Specimen SHC-10 Method Reactive Non-Reactive Reactive Non-Reactive diagnostics direct Syphilis Health Check /2015 MLE-M2 Participant Summary
23 H. pylori Antibody Detection Specimen HP-3 Specimen HP-4 ALL METHODS Alere Clearview Alfa Scientific Instant-View Beckman Coulter ICON HP Cardinal Health SP Brand Consult Diagnostics Fisher HealthCare Sure-Vue Henry Schein OneStep+ - waived McKesson Medi-Lab Performance - waived Other Waived method Polymedco Poly stat PSS Select Diagnostics Quidel QuickVue SDI Biomed, Inc Lyme Disease Serology Specimen LY-3 Specimen LY-4 ALL METHODS biomerieux Vidas, Mini Vidas DiaSorin Mycoplasma Antibody Specimen MY-3 Specimen MY-4 ALL METHODS Meridian ImmunoCard Viral Markers Anti-HBc (IgM) Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur Specimen VM-9 Specimen VM-10 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur MLE-M2 Participant Summary/ 23
24 Viral Markers Anti-HBc (Total/IgG) Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Roche cobas e Centaur Specimen VM-9 Specimen VM-10 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Roche cobas e Centaur Specimen VM-10 is an ungraded challenge due to less than 80% participant consensus. Viral Markers Anti-HIV Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Alere Clearview HIV1/2 STAT-PAK Centaur Specimen VM-9 Specimen VM-10 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Alere Clearview HIV1/2 STAT-PAK Centaur /2015 MLE-M2 Participant Summary
25 Viral Markers Anti-HAV (IgM) Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Centaur Specimen VM-9 Specimen VM-10 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Centaur Viral Markers Anti-HAV (Total/IgG) Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Centaur Specimen VM-9 Specimen VM-10 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-6 through VM-10 are: Positive, Negative, Negative, Negative, and Negative, respectively MLE-M2 Participant Summary/ 25
26 Viral Markers Anti-HBs Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Centaur Specimen VM-9 Specimen VM-10 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Centaur Viral Markers HBsAg Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Roche cobas e Centaur Specimen VM-9 Specimen VM-10 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect Roche cobas e Centaur /2015 MLE-M2 Participant Summary
27 Viral Markers Anti-HCV Specimen VM-6 Specimen VM-7 Specimen VM-8 Method Positive Negative Equivocal Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect OraSure OraQuick HCV Roche cobas e Centaur Specimen VM-9 Specimen VM-10 Method Positive Negative Equivocal Positive Negative Equivocal ALL METHODS Abbott Architect OraSure OraQuick HCV Roche cobas e Centaur Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: MLE-M2 Participant Summary/ 27
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