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 M1
2 Table of Contents 2011 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-1 AN-5]) Qualitative C-Reactive Protein, Regular Qualitative Quantitative C-Reactive Protein, High Sensitivity Quantitative Antinuclear Antibody (ANA [AE-1 AE-5]) 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: TPA 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 2011 Evaluation Criteria The evaluation criteria used in the 2011 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 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 pages under the heading "Acceptable Ranges for Quantitative Results." Rheumatoid Factor (International Units) 3 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 2011 MLE-M1 Participant Summary/ 3
4 Infectious Mononucleosis Specimen IM-1 Specimen IM-2 ALL METHODS ASI Beckman Coulter ICON Mono - waived BioStar Acceava Mono Test BioStar Acceava Mono-whole bld Cardinal Health SP Brand Cardinal Health SP Brand - waived 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 Polymedco Poly stat - waived Quidel QuickVue Quidel QuickVue+ - waived Remel SeraTest Seradyn Wampole ColorCard Wampole Mono-Plus II /2011 MLE-M1 Participant Summary
5 Infectious Mononucleosis cont d Specimen IM-3 Specimen IM-4 Specimen IM- 5 Positive Negative ALL METHODS ASI Beckman Coulter ICON Mono - waived BioStar Acceava Mono Test BioStar Acceava Mono-whole bld Cardinal Health SP Brand Cardinal Health SP Brand - waived 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 McKesson Medi-Lab Performance - waived Meridian ImmunoCard STAT! Other Moderate method Other Waived method Polymedco Poly stat Polymedco Poly stat - waived Quidel QuickVue Remel SeraTest Seradyn Wampole ColorCard Wampole Mono-Plus II MLE-M1 Participant Summary/ 5
6 Rheumatoid Factor Qualitative Specimen RF-1 Specimen RF-2 Specimen RF-3 Positive Negative ALL METHODS ASI Beckman Synchron Beckman Synchron LX / Pro / DxC Biokit Rheumajet Cardinal Health SP Brand Diagnostic Technology Diamedix Fisher HealthCare Sure-Vue Immunostics Inc JAS Diagnostics, Inc Remel SeraTest Seradyn Siemens Dimension/AR/ES/RxL/Xpand Stanbio Laboratory TheraTest Wampole ColorCard Wampole Rheumatex Wampole Rheumaton Specimen RF-4 Specimen RF-5 ALL METHODS ASI Beckman Synchron Beckman Synchron LX / Pro / DxC Biokit Rheumajet Cardinal Health SP Brand Diagnostic Technology Diamedix Fisher HealthCare Sure-Vue Immunostics Inc JAS Diagnostics, Inc Remel SeraTest Seradyn Siemens Dimension/AR/ES/RxL/Xpand Stanbio Laboratory TheraTest Wampole ColorCard Wampole Rheumatex Wampole Rheumaton /2011 MLE-M1 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-1 ALL METHODS ASI Biokit Rheumajet Fisher HealthCare Sure-Vue Remel SeraTest Wampole ColorCard Wampole Rheumatex Specimen RF-3 ALL METHODS ASI Biokit Rheumajet Fisher HealthCare Sure-Vue Remel SeraTest Wampole ColorCard Wampole Rheumatex Specimen RF-5 ALL METHODS ASI Biokit Rheumajet Fisher HealthCare Sure-Vue Remel SeraTest Wampole ColorCard Wampole Rheumatex MLE-M1 Participant Summary/ 7
8 Rheumatoid Factor Quantitative (IU) Specimen/Method Labs Mean SD CV Median Range Specimen RF-1 All Method Specimen RF-2 All Method Specimen RF-3 All Method Specimen RF-4 All Method Specimen RF-5 All Method Anti-Streptolysin O (ASO) Qualitative Specimen AS-1 Specimen AS-2 Specimen AS-3 Positive Negative ALL METHODS Immunostics Inc Method Specimen AS-4 Specimen AS-5 Positive Negative Positive Negative ALL METHODS Immunostics Inc /2011 MLE-M1 Participant Summary
9 Complement C3 (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-1 All Method Specimen IMP-2 All Method Specimen IMP-3 All Method Specimen IMP-4 All Method Specimen IMP-5 All Method Complement C4 (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-1 All Method Specimen IMP-2 All Method Specimen IMP-3 All Method Specimen IMP-4 All Method Specimen IMP-5 All Method MLE-M1 Participant Summary/ 9
10 Antinuclear Antibody (ANA) Qualitative Latex Methods Specimen AN-1 Specimen AN-2 Specimen AN-3 Positive Negative ALL METHODS Alpha Scientific Medical, Inc Diagnostic Technology Wampole Specimen AN-4 Specimen AN-5 ALL METHODS Alpha Scientific Medical, Inc Diagnostic Technology Wampole C-Reactive Protein Qualitative, Regular Specimen CR-1 Specimen CR-2 ALL METHODS ASI Biokit Rheumajet Diagnostic Technology Fisher HealthCare Sure-Vue Immunostics Inc Siemens Dimension/AR/ES/RxL/Xpand Wampole C-Reactive Protein Quantitative (mg/dl), Regular Specimen/Method Labs Mean SD CV Median Range Specimen CR-1 mg/dl - units All Chemistry Reagents mg/l - units All Chemistry Reagents Specimen CR-2 mg/dl - units All Chemistry Reagents mg/l - units All Chemistry Reagents /2011 MLE-M1 Participant Summary
11 C-Reactive Protein Quantitative (mg/dl), High Sensitivity Specimen/Method Labs Mean SD CV Median Range Specimen HCR-1 All Method Specimen HCR-2 All Method Antinuclear Antibody (ANA) Qualitative IFA/ELISA Methods Specimen AE-1 Specimen AE-2 Specimen AE-3 Positive Negative ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad TheraTest Wampole Zeus Specimen AE-4 Specimen AE-5 ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad TheraTest Zeus MLE-M1 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-2 ALL METHODS Immuno Concepts Kallestad TheraTest Specimen AE-3 ALL METHODS Immuno Concepts Kallestad TheraTest Specimen AE-4 ALL METHODS Immuno Concepts Kallestad TheraTest Anti-dsDNA Specimen AE-1 Specimen AE-2 Specimen AE-3 Positive Negative ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad TheraTest Wampole Zeus Specimen AE-4 Specimen AE-5 ALL METHODS Immuno Concepts INOVA Diagnostics Kallestad TheraTest Wampole Zeus Specimen AE-2 is an ungraded challenge due to lack of 80% participant consensus. 12 /2011 MLE-M1 Participant Summary
13 Anti-RNP Specimen AE-1 Specimen AE-2 Specimen AE-3 Positive Negative ALL METHODS INOVA Diagnostics TheraTest Zeus Specimen AE-4 Specimen AE-5 ALL METHODS INOVA Diagnostics TheraTest Zeus Specimen AE-1 is an ungraded challenge due to lack of 80% participant consensus. Anti-RNP/Sm Specimen AE-1 Specimen AE-2 Specimen AE-3 Positive Negative ALL METHODS Diamedix Immuno Concepts TheraTest Wampole Specimen AE-4 Specimen AE-5 ALL METHODS Diamedix Immuno Concepts TheraTest Wampole MLE-M1 Participant Summary/ 13
14 Anti-SSA Specimen AE-1 Specimen AE-2 Specimen AE-3 Positive Negative ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Zeus Specimen AE-4 Specimen AE-5 ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Zeus Anti-SSB Specimen AE-1 Specimen AE-2 Specimen AE-3 Positive Negative ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Zeus Specimen AE-4 Specimen AE-5 ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Zeus /2011 MLE-M1 Participant Summary
15 Anti-SSA/SSB Specimen AE-1 Specimen AE-2 Specimen AE-3 Positive Negative ALL METHODS Immuno Concepts TheraTest Specimen AE-4 Specimen AE-5 ALL METHODS Immuno Concepts TheraTest Specimen AE-1 is an ungraded challenge due to lack of 80% participant consensus. Anti-Sm Specimen AE-1 Specimen AE-2 Specimen AE-3 Positive Negative ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Zeus Specimen AE-4 Specimen AE-5 ALL METHODS Diamedix INOVA Diagnostics TheraTest Wampole Zeus Specimen AE-2 is an ungraded challenge due to lack of 80% participant consensus MLE-M1 Participant Summary/ 15
16 Rubella Qualitative Specimen RU-1 Specimen RU-2 Specimen RU-3 Positive Negative ALL METHODS Bayer ADVIA Centaur biomerieux Vidas, Mini Vidas Specimen RU-4 Specimen RU-5 ALL METHODS Bayer ADVIA Centaur biomerieux Vidas, Mini Vidas Rubella Quantitative (IU/mL) Only one lab reported results for Rubella Quantitative (IU/mL). The vendor assay values for specimens RU-1 through RU-5 are: 49.3 IU/mL, 0.0 IU/mL, 0.0 IU/mL, 24.0 IU/mL and IU/mL, respectively. 16 /2011 MLE-M1 Participant Summary
17 Anti-HIV Specimen HIV-1 Specimen HIV-2 ALL METHODS Inverness Clearview Complete HIV 1/ Orasure OraQuick Advance Rapid HIV-1/2 - moderate Orasure OraQuick Advance Rapid HIV-1/2 - waived Other Moderate method Other Waived method Method Specimen HIV-3 Specimen HIV-4 Specimen HIV-5 Positive Negative Positive Negative Positive Positive ALL METHODS Orasure OraQuick Advance Rapid HIV-1/2 - waived Other Moderate method Total IgE Quantitative (U/mL) Specimen/Method Labs Mean SD CV Median Range Specimen AL-1 All Method Specimen AL-2 All Method Specimen AL-3 All Method Specimen AL-4 All Method Specimen AL-5 All Method MLE-M1 Participant Summary/ 17
18 Allergen Specific IgE Antibodies Specimen AL-1 House Dust Mite Allergen Cat Epithelium Allergen Method 0 0/ / ALL METHODS Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (KU/L) Alternaria alternate Allergen Peanut Allergen 0 0/ / ALL METHODS Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (KU/L) Cow s Milk Allergen Bermuda Grass Allergen 0 0/ / ALL METHODS Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (KU/L) English Plantain Allergen 0 0/ ALL METHODS Hitachi CLA Phadia UniCap 100 (KU/L) English Plantain Allergen is an ungraded challenge due to lack of 80% participant consensus. 18 /2011 MLE-M1 Participant Summary
19 Allergen Specific IgE Antibodies (cont d) Specimen AL-2 Dog Dander Allergen Timothy Grass Allergen Method 0 0/ / ALL METHODS Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (KU/L) Meadow Fescue Allergen Alternaria alternate Allergen 0 0/ / ALL METHODS Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (KU/L) House Dust Mite Allergen Peanut Allergen 0 0/ / ALL METHODS Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (KU/L) White Oak Allergen 0 0/ ALL METHODS Hitachi CLA Phadia ImmunoCAP Rapid Phadia UniCap 100 (KU/L) MLE-M1 Participant Summary/ 19
20 IgA (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-1 All Method Specimen IMP-2 All Method Specimen IMP-3 All Method Specimen IMP-4 All Method Specimen IMP-5 All Method IgG (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-1 All Method Specimen IMP-2 All Method Specimen IMP-3 All Method Specimen IMP-4 All Method Specimen IMP-5 All Method /2011 MLE-M1 Participant Summary
21 IgM (mg/dl) Specimen/Method Labs Mean SD CV Median Range Specimen IMP-1 All Method Specimen IMP-2 All Method Specimen IMP-3 All Method Specimen IMP-4 All Method Specimen IMP-5 All Method Syphilis Serology Qualitative: VDRL Slide Specimen SY-1 Specimen SY-2 Specimen SY-3 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS Fisher HealthCare Sure-Vue Specimen SY-4 Specimen SY-5 Method Reactive Non-Reactive Wk. Reactive Non-Reactive ALL METHODS Fisher HealthCare Sure-Vue Syphilis Serology Qualitative: Treponema pallidum antibodies (TPA) Specimen SY-1 Specimen SY-2 Specimen SY-3 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS DPC Immulite 2000/ Specimen SY-4 Specimen SY-5 Method Reactive Non-Reactive Reactive Non-Reactive ALL METHODS DPC Immulite 2000/ MLE-M1 Participant Summary/ 21
22 Syphilis Serology Qualitative: RPR Specimen SY-1 Specimen SY-2 Specimen SY-3 Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive ALL METHODS ASI Becton Dickinson Fisher HealthCare Sure-Vue Thermo Fisher Accutex Wampole Impact RPR Specimen SY-4 Specimen SY-5 Method Reactive Non-Reactive Reactive Non-Reactive ALL METHODS ASI Becton Dickinson Fisher HealthCare Sure-Vue Thermo Fisher Accutex Wampole Impact RPR Syphilis Serology Quantitative: RPR (Titer) Specimen/Method Specimen SY-1 ALL METHODS ASI Becton Dickinson Specimen SY-2 ALL METHODS ASI Becton Dickinson Specimen SY-4 ALL METHODS ASI Becton Dickinson /2011 MLE-M1 Participant Summary
23 H. pylori Antibody Detection Specimen HP-1 Specimen HP-2 ALL METHODS Alfa Scientific Instant-View Beckman Coulter ICON HP biomerieux Vidas, Mini Vidas Cardinal Health SP Brand Consult Diagnostics DPC Immulite 2000/ Fisher HealthCare Sure-Vue Henry Schein OneStep+ - waived Inverness (Wampole) Clearview LifeSign Status McKesson Medi-Lab Performance - waived Polymedco Poly stat PSS Select Diagnostics Quidel QuickVue SDI Biomed, Inc Lyme Disease Serology Specimen LY-1 Specimen LY-2 ALL METHODS biomerieux Vidas, Mini Vidas Immunostics Inc Mycoplasma Antibody Specimen MY-1 Specimen MY-2 ALL METHODS Meridian ImmunoCard Remel ELISA MLE-M1 Participant Summary/ 23
24 Viral Markers Anti-HBc Specimen VM-1 Specimen VM-2 Specimen VM-3 Positive Negative ALL METHODS Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total VITROS ECi - Total Specimen VM-4 Specimen VM-5 ALL METHODS Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total VITROS ECi - Total Specimens VM-1 and VM-2 are ungraded challenges due to lack of 80% participant consensus. Viral Markers Anti-HIV Specimen VM-1 Specimen VM-2 Specimen VM-3 Positive Negative ALL METHODS Bayer ADVIA Centaur - Total Inverness Clearview Complete HIV 1/ Orasure OraQuick Advance Rapid HIV-1/2 - moderate Orasure OraQuick Advance Rapid HIV-1/2 - waived Specimen VM-4 Specimen VM-5 ALL METHODS Bayer ADVIA Centaur - Total Inverness Clearview Complete HIV 1/ Orasure OraQuick Advance Rapid HIV-1/2 - moderate Orasure OraQuick Advance Rapid HIV-1/2 - waived /2011 MLE-M1 Participant Summary
25 Viral Markers HAV Specimen VM-1 Specimen VM-2 Specimen VM-3 Positive Negative ALL METHODS Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total Specimen VM-4 Specimen VM-5 ALL METHODS Bayer ADVIA Centaur - IgM Bayer ADVIA Centaur - Total Specimens VM-2, VM-3 and VM-5 are ungraded challenges due to lack of 80% participant consensus. Viral Markers HBeAg The vendor assay for specimens VM-1 through VM-5 is: Negative, Negative, Negative, Positive, and Negative, respectively. Viral Markers HBsAb Specimen VM-1 Specimen VM-2 Specimen VM-3 Positive Negative ALL METHODS Abbott AxSYM - Total Bayer ADVIA Centaur - Total VITROS ECi - Total Specimen VM-4 Specimen VM-5 ALL METHODS Abbott AxSYM - Total Bayer ADVIA Centaur - Total VITROS ECi - Total Specimen VM-1 is an ungraded challenge due to lack of 80% participant consensus MLE-M1 Participant Summary/ 25
26 Viral Markers HBsAg Specimen VM-1 Specimen VM-2 Specimen VM-3 Positive Negative ALL METHODS Abbott AxSYM - Total Bayer ADVIA Centaur - Total VITROS ECi - Total Specimen VM-4 Specimen VM- 5 ALL METHODS Abbott AxSYM - Total Bayer ADVIA Centaur - Total VITROS ECi - Total Viral Markers HCV Specimen VM-1 Specimen VM-2 Specimen VM-3 Positive Negative ALL METHODS Abbott AxSYM - Total Bayer ADVIA Centaur - Total VITROS ECi - IgG Specimen VM-4 Specimen VM-5 ALL METHODS Abbott AxSYM - Total Bayer ADVIA Centaur - Total VITROS ECi - IgG Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: /2011 MLE-M1 Participant Summary
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