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 Total Commitment to Education and Service Provided by ACP, Inc. Immunology MLE-M2
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 Qualitative... 8 Complement C Complement C Antinuclear Antibody (ANA [AN-6 AN-10]) Qualitative C-Reactive Protein, Regular Qualitative Quantitative C-Reactive Protein, High Sensitivity Quantitative Antinuclear Antibody (ANA [AE-6 AE-10]) Qualitative Quantitative (Titer) Anti-dsDNA Anti-RNP Anti-RNP/Sm Anti-SSA Anti-SSB Anti-SSA/SSB Anti-Sm Rubella Qualitative Quantitative Anti-HIV Total IgE Quantitative Allergen Specific IgE Antibodies IgA IgG IgM Syphilis Serology Qualitative: VDRL Qualitative: Treponema pallidum antibodies Qualitative: RPR Quantitative: RPR (Titer) H. pylori Antibody Detection Lyme Disease Serology Mycoplasma Antibody Viral Markers Anti-HBc Anti-HIV HAV HBeAg HBsAb HBsAg 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. Infectious Mononucleosis Rheumatoid Factor Anti-Streptolysin O (ASO) Antinuclear Antibody (ANA) Anti-dsDNA Anti-RNP Anti-RNP/Sm Anti-SSA Anti-SSB Anti-SSA/SSB Anti-Sm C-Reactive Protein Rubella Antibody H. pylori Antibody Detection Total IgE Diagnostic Allergy Syphilis Serology Lyme Disease Serology Mycoplasma Antibody Anti-HIV 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." Rheumatoid Factor (International Units) 2 SD Rheumatoid Factor (Titer) Not Evaluated Anti-Streptolysin O (ASO) Titer Not Evaluated Complement C3 3 SD Complement C4 3 SD Antinuclear Antibody (ANA) Titer Not Evaluated C-Reactive Protein 3 SD High Sensitivity C-Reactive Protein 3 SD Rubella (International Units) 3 SD Total IgE 3 SD Total IgA 3 SD Total IgG 25% Total IgM 3 SD 2013 MLE-M2 Participant Summary/ 3
4 Infectious Mononucleosis Specimen IM-6 Specimen IM-7 ALL METHODS 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 Genzyme OSOM Genzyme OSOM (waived) Henry Schein OneStep+ - waived Inverness (Wampole) Clearview Inverness Clearview Mono Plus II Inverness Signify Mono Test LifeSign Status LifeSign Status - waived McKesson Medi-Lab Performance - waived Meridian ImmunoCard STAT! Other Moderate method Other Waived method Polymedco Poly stat - waived Quidel QuickVue Quidel QuickVue+ - waived Seradyn Wampole ColorCard Wampole Mono-Plus II /2013 MLE-M2 Participant Summary
5 Infectious Mononucleosis Specimen IM-8 Specimen IM-9 Specimen IM-10 Positive Negative ALL METHODS 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 Genzyme OSOM Genzyme OSOM (waived) Henry Schein OneStep+ - waived Inverness (Wampole) Clearview Inverness Clearview Mono Plus II LifeSign Status LifeSign Status - waived Meridian ImmunoCard STAT! Other Moderate method Other Waived method Quidel QuickVue Quidel QuickVue+ - 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 Synchron Biokit Rheumajet Diamedix Fisher HealthCare Sure-Vue Immunostics Inc JAS Diagnostics, Inc Remel SeraTest Teco Diagnostics TheraTest Wampole ColorCard Wampole Rheumatex Specimen RF-9 Specimen RF-10 ALL METHODS Abbott Architect ASI Beckman Synchron Biokit Rheumajet Diamedix Fisher HealthCare Sure-Vue Immunostics Inc JAS Diagnostics, Inc Remel SeraTest Teco Diagnostics TheraTest Wampole ColorCard Wampole Rheumatex /2013 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 Biokit Rheumajet Fisher HealthCare Sure-Vue Remel SeraTest Wampole ColorCard Specimen RF-9 ALL METHODS Biokit Rheumajet Fisher HealthCare Sure-Vue Remel SeraTest Wampole ColorCard Specimen RF-10 ALL METHODS Biokit Rheumajet Fisher HealthCare Sure-Vue Remel SeraTest 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 /2013 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 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 /2013 MLE-M2 Participant Summary
11 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 Kallestad TheraTest Wampole Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix GenBio ImmunoDOT Panel Immuno Concepts INOVA Diagnostics Kallestad TheraTest Wampole MLE-M2 Participant Summary/ 11
12 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-7 ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad Specimen AE-8 ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad Specimen AE-9 ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad Anti-dsDNA Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix Kallestad TheraTest Wampole Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix Kallestad TheraTest Wampole /2013 MLE-M2 Participant Summary
13 Anti-RNP Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS INOVA Diagnostics Specimen AE-9 Specimen AE-10 ALL METHODS INOVA Diagnostics Anti-RNP/Sm Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix GenBio ImmunoDOT Panel TheraTest Wampole Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix GenBio ImmunoDOT Panel TheraTest Wampole Specimen AE-8 is an ungraded challenge due to less than 80% participant consensus MLE-M2 Participant Summary/ 13
14 Anti-SSA Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Anti-SSB Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole /2013 MLE-M2 Participant Summary
15 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 Anti-Sm Specimen AE-6 Specimen AE-7 Specimen AE-8 Positive Negative ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Specimen AE-9 Specimen AE-10 ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole MLE-M2 Participant Summary/ 15
16 Rubella Qualitative Specimen RU-6 Specimen RU-7 Specimen RU-8 Positive Negative ALL METHODS Bayer ADVIA Centaur biomerieux Vidas, Mini Vidas DiaSorin Specimen RU-9 Specimen RU-10 ALL METHODS Bayer ADVIA Centaur biomerieux Vidas, Mini Vidas DiaSorin Rubella Quantitative (IU/mL) Two labs reported results for Rubella Quantitative (IU/mL). The vendor assay values for specimens RU-6 through RU-10 are: 49 IU/mL, 0 IU/mL, 0 IU/mL, 26 IU/mL and 117 IU/mL, respectively. 16 /2013 MLE-M2 Participant Summary
17 Anti-HIV Specimen HIV-6 Specimen HIV-7 ALL METHODS Abbott Architect BD LINK Inverness Clearview Complete HIV 1/ Orasure OraQuick Advance Rapid HIV-1/2 - waived Other Moderate method Other Waived method Specimen HIV-8 Specimen HIV-9 Specimen HIV-10 Positive Negative ALL METHODS Abbott Architect Inverness Clearview Complete HIV 1/ Orasure OraQuick Advance Rapid HIV-1/2 - waived Other Moderate method Other Waived method 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 MLE-M2 Participant Summary/ 17
18 Allergen Specific IgE Antibodies Specimen AL-6 Meadow Fescue Allergen Perennial Rye Allergen Method 0 0/ / ALL METHODS Hitachi CLA Phadia UniCap 100 (% ref) Perennial Rye Allergen is an ungraded challenge due to less than 80% participant consensus. Silver Birch Tree Allergen Maple (Box Elder) Allergen 0 0/ / ALL METHODS DPC Immulite 2000/ DPC-Standard Microplate Hitachi CLA Phadia UniCap 100 (% ref) Common (Short) Ragweed Allergen Cat Epithelium Allergen 0 0/ / ALL METHODS DPC Immulite 2000/ DPC-Standard Microplate Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (% ref) House Dust Mite Allergen 0 0/ ALL METHODS DPC Immulite 2000/ DPC-Standard Microplate Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (% ref) /2013 MLE-M2 Participant Summary
19 Allergen Specific IgE Antibodies Specimen AL-7 Sweet Vernal Grass Allergen Meadow, Kentucky Blue, June Grass Allergens Method 0 0/ / ALL METHODS DPC Immulite 2000/ DPC-Standard Microplate Hitachi CLA Phadia UniCap 100 (% ref) House Dust Mite Allergen White Oak Allergen 0 0/ / ALL METHODS DPC Immulite 2000/ DPC-Standard Microplate Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (% ref) Common (Short) Ragweed Allergen Russian Thistle Allergen 0 0/ / ALL METHODS DPC Immulite 2000/ DPC-Standard Microplate Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (% ref) Russian Thistle Allergen is an ungraded challenge due to less than 80% participant consensus. Peanut Allergen 0 0/ ALL METHODS DPC Immulite 2000/ Hitachi CLA Phadia UniCap 100 (% ref) MLE-M2 Participant Summary/ 19
20 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 /2013 MLE-M2 Participant Summary
21 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/ 21
22 Syphilis Serology Qualitative: VDRL Slide Method Specimen SY-6 Specimen SY-7 Specimen SY-8 Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS ASI Method Specimen SY-9 Specimen SY-10 Reactive Non-Reactive Reactive Non-Reactive ALL METHODS ASI 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 DPC Immulite 2000/ Specimen SY-9 Specimen SY-10 Method Reactive Non-Reactive Reactive Non-Reactive ALL METHODS DPC Immulite 2000/ 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 Specimen SY-7 was graded by 83% referee consensus. 22 /2013 MLE-M2 Participant Summary
23 Syphilis Serology Quantitative: RPR (Titer) Specimen/Method >64 Specimen SY-6 ALL METHODS ASI Becton Dickinson Specimen SY-7 ALL METHODS ASI Becton Dickinson Specimen SY-9 ALL METHODS ASI Becton Dickinson H. pylori Antibody Detection Specimen HP-3 Specimen HP-4 ALL METHODS Alfa Scientific Instant-View Beckman Coulter ICON HP Cardinal Health SP Brand Consult Diagnostics DPC Immulite 2000/ Fisher HealthCare Sure-Vue Henry Schein OneStep+ - waived Inverness (Wampole) Clearview McKesson Medi-Lab Performance - waived Polymedco Poly stat PSS Select Diagnostics Quidel QuickVue SDI Biomed, Inc MLE-M2 Participant Summary/ 23
24 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 Specimen VM-6 Specimen VM-7 Specimen VM-8 Positive Negative ALL METHODS Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total VITROS ECi - Total Specimen VM-9 Specimen VM-10 ALL METHODS Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total VITROS ECi - Total Specimens VM-6 and VM-10 are ungraded challenges due to less than 80% consensus. 24 /2013 MLE-M2 Participant Summary
25 Viral Markers Anti-HIV Specimen VM-6 Specimen VM-7 Specimen VM-8 Positive Negative ALL METHODS Bayer ADVIA Centaur - Total Orasure OraQuick Advance Rapid HIV-1/2 - moderate Orasure OraQuick Advance Rapid HIV-1/2 - waived Other IgG Method Specimen VM-9 Specimen VM-10 ALL METHODS Bayer ADVIA Centaur - Total Orasure OraQuick Advance Rapid HIV-1/2 - moderate Orasure OraQuick Advance Rapid HIV-1/2 - waived Other IgG Method Specimen VM-9 is an ungraded challenge due to less than 80% consensus. Viral Markers HAV Specimen VM-6 Specimen VM-7 Specimen VM-8 Positive Negative ALL METHODS Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total Specimen VM-9 Specimen VM-10 ALL METHODS Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total MLE-M2 Participant Summary/ 25
26 Viral Markers HBeAg The vendor assay for specimens VM-6 through VM-10 is: Negative, Positive, Negative, Negative, and Positive, respectively. Viral Markers HBsAb Specimen VM-6 Specimen VM-7 Specimen VM-8 Positive Negative ALL METHODS Abbott Architect - Total Bayer ADVIA Centaur - Total Specimen VM-9 Specimen VM-10 ALL METHODS Abbott Architect - Total Bayer ADVIA Centaur - Total Viral Markers HBsAg Specimen VM-6 Specimen VM-7 Specimen VM-8 Positive Negative ALL METHODS Abbott Architect - Total Bayer ADVIA Centaur - Total Other IgG Method Specimen VM-9 Specimen VM-10 ALL METHODS Abbott Architect - Total Bayer ADVIA Centaur - Total Other IgG Method /2013 MLE-M2 Participant Summary
27 Viral Markers HCV Specimen VM-6 Specimen VM-7 Specimen VM-8 Positive Negative ALL METHODS Abbott Architect - Total Bayer ADVIA Centaur - Total OraSure OraQuick HCV Specimen VM-9 Specimen VM-10 ALL METHODS Abbott Architect - Total Bayer ADVIA Centaur - Total OraSure OraQuick HCV Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: MLE-M2 Participant Summary/ 27
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