M E D I C A L L A B O R A T O R Y E VV AAA LLL UUU AA TT II OOO … · LifeSign Status - waived - 7...
Transcript of M E D I C A L L A B O R A T O R Y E VV AAA LLL UUU AA TT II OOO … · LifeSign Status - waived - 7...
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M E D I C A L L A B O R A T O R Y
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PARTICIPANT SUMMARY
2 • 0 • 1 •3
Immunology MLE-M2
Total Commitment to Education and Service
Provided by ACP, Inc.
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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 ...................................................................................................................... 3 Immunology
Infectious Mononucleosis ..................................................................................................... 4 Rheumatoid Factor................................................................................................................. 6
Qualitative .......................................................................................................................... 6 Quantitative (Titer) .............................................................................................................. 7 Quantitative (IU) ................................................................................................................. 8
Anti-Streptolysin O (ASO)...................................................................................................... 8 Qualitative .......................................................................................................................... 8
Complement C3 ...................................................................................................................... 9 Complement C4 ...................................................................................................................... 9 Antinuclear Antibody (ANA [AN-6 – AN-10]) ...................................................................... 10
Qualitative ........................................................................................................................ 10 C-Reactive Protein, Regular ................................................................................................ 10
Qualitative ........................................................................................................................ 10 Quantitative ...................................................................................................................... 10
C-Reactive Protein, High Sensitivity ................................................................................... 11 Quantitative ...................................................................................................................... 11
Antinuclear Antibody (ANA [AE-6 – AE-10]) ....................................................................... 11 Qualitative ........................................................................................................................ 11 Quantitative (Titer) ............................................................................................................ 12
Anti-dsDNA ........................................................................................................................... 12 Anti-RNP ............................................................................................................................... 13 Anti-RNP/Sm ......................................................................................................................... 13 Anti-SSA ............................................................................................................................... 14 Anti-SSB ............................................................................................................................... 14 Anti-SSA/SSB ....................................................................................................................... 15 Anti-Sm ................................................................................................................................. 15 Rubella .................................................................................................................................. 16
Qualitative ........................................................................................................................ 16 Quantitative ...................................................................................................................... 16
Anti-HIV ................................................................................................................................. 17 Total IgE ................................................................................................................................ 17
Quantitative ...................................................................................................................... 17 Allergen Specific IgE Antibodies ........................................................................................ 18 IgA ......................................................................................................................................... 20 IgG ......................................................................................................................................... 20 IgM ......................................................................................................................................... 21 Syphilis Serology ................................................................................................................. 22
Qualitative: VDRL ............................................................................................................. 22 Qualitative: Treponema pallidum antibodies ..................................................................... 22 Qualitative: RPR ............................................................................................................... 22 Quantitative: RPR (Titer) .................................................................................................. 23
H. pylori Antibody Detection ............................................................................................... 23 Lyme Disease Serology ....................................................................................................... 24 Mycoplasma Antibody ......................................................................................................... 24 Viral Markers ........................................................................................................................ 24
Anti-HBc ........................................................................................................................... 24 Anti-HIV ............................................................................................................................ 25 HAV .................................................................................................................................. 25 HBeAg .............................................................................................................................. 26 HBsAb .............................................................................................................................. 26 HBsAg .............................................................................................................................. 26 HCV ................................................................................................................................. 27
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2013 MLE-M2 Participant Summary/ 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 80% Participant Consensus
Rheumatoid Factor 80% Participant Consensus
Anti-Streptolysin O (ASO) 80% Participant Consensus
Antinuclear Antibody (ANA) 80% Participant Consensus
Anti-dsDNA 80% Participant Consensus
Anti-RNP 80% Participant Consensus
Anti-RNP/Sm 80% Participant Consensus
Anti-SSA 80% Participant Consensus
Anti-SSB 80% Participant Consensus
Anti-SSA/SSB 80% Participant Consensus
Anti-Sm 80% Participant Consensus
C-Reactive Protein 80% Participant Consensus
Rubella Antibody 80% Participant Consensus
H. pylori Antibody Detection 80% Participant Consensus
Total IgE 80% Participant Consensus
Diagnostic Allergy 80% Participant Consensus
Syphilis Serology 80% Participant Consensus
Lyme Disease Serology 80% Participant Consensus
Mycoplasma Antibody 80% Participant Consensus
Anti-HIV 80% Participant Consensus
Viral Markers 80% Participant 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."
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
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4 /2013 MLE-M2 Participant Summary
Infectious Mononucleosis
Specimen IM-6 Specimen IM-7
Method Positive Negative Positive Negative
ALL METHODS - 233 233 -
ASI - 1 1 -
Beckman Coulter ICON Mono - waived - 9 9 -
BioStar Acceava Mono Test - 3 3 -
BioStar Acceava Mono-whole bld - 6 6 -
Cardinal Health SP Brand - waived - 8 8 -
Consult Diagnostics - 2 2 -
Fisher HealthCare Sure-Vue - 9 9 -
Genzyme OSOM - 9 9 -
Genzyme OSOM (waived) - 79 79 -
Henry Schein OneStep+ - waived - 13 13 -
Inverness (Wampole) Clearview - 7 7 -
Inverness Clearview Mono Plus II - 9 9 -
Inverness Signify Mono Test - 2 2 -
LifeSign Status - 1 1 -
LifeSign Status - waived - 7 7 -
McKesson Medi-Lab Performance - waived - 10 10 -
Meridian ImmunoCard STAT! - 1 1 -
Other Moderate method - 11 11 -
Other Waived method - 29 29 -
Polymedco Poly stat - waived - 2 2 -
Quidel QuickVue+ - 2 2 -
Quidel QuickVue+ - waived - 9 9 -
Seradyn - 1 1 -
Wampole ColorCard - 1 1 -
Wampole Mono-Plus II - 2 2 -
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2013 MLE-M2 Participant Summary/ 5
Infectious Mononucleosis
Specimen IM-8 Specimen IM-9 Specimen IM-10
Method Positive Negative Positive Negative Positive Negative
ALL METHODS 96 1 97 - - 97
ASI 1 - 1 - - 1
Beckman Coulter ICON Mono - waived 9 - 9 - - 9
BioStar Acceava Mono Test 2 - 2 - - 2
BioStar Acceava Mono-whole bld - 1 1 - - 1
Cardinal Health SP Brand - waived 1 - 1 - - 1
Consult Diagnostics 1 - 1 - - 1
Fisher HealthCare Sure-Vue 5 - 5 - - 5
Genzyme OSOM 9 - 9 - - 9
Genzyme OSOM (waived) 29 - 29 - - 29
Henry Schein OneStep+ - waived 4 - 4 - - 4
Inverness (Wampole) Clearview 5 - 5 - - 5
Inverness Clearview Mono Plus II 4 - 4 - - 4
LifeSign Status 1 - 1 - - 1
LifeSign Status - waived 2 - 2 - - 2
Meridian ImmunoCard STAT! 1 - 1 - - 1
Other Moderate method 10 - 10 - - 10
Other Waived method 5 - 5 - - 5
Quidel QuickVue+ 2 - 2 - - 2
Quidel QuickVue+ - waived 2 - 2 - - 2
Seradyn 1 - 1 - - 1
Wampole ColorCard 1 - 1 - - 1
Wampole Mono-Plus II 1 - 1 - - 1
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Rheumatoid Factor—Qualitative
Specimen RF-6 Specimen RF-7 Specimen RF-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 61 61 - - 61
Abbott Architect - 1 1 - - 1
ASI - 9 9 - - 9
Beckman Synchron - 1 1 - - 1
Biokit Rheumajet - 10 10 - - 10
Diamedix - 2 2 - - 2
Fisher HealthCare Sure-Vue - 7 7 - - 7
Immunostics Inc. - 4 4 - - 4
JAS Diagnostics, Inc. - 1 1 - - 1
Remel SeraTest - 2 2 - - 2
Teco Diagnostics - 4 4 - - 4
TheraTest - 4 4 - - 4
Wampole ColorCard - 10 10 - - 10
Wampole Rheumatex - 4 4 - - 4
Specimen RF-9 Specimen RF-10
Method Positive Negative Positive Negative
ALL METHODS 60 1 61 - Abbott Architect 1 - 1 -
ASI 9 - 9 -
Beckman Synchron 1 - 1 -
Biokit Rheumajet 10 - 10 -
Diamedix 2 - 2 -
Fisher HealthCare Sure-Vue 7 - 7 -
Immunostics Inc. 4 - 4 -
JAS Diagnostics, Inc. 1 - 1 -
Remel SeraTest 2 - 2 -
Teco Diagnostics 4 - 4 -
TheraTest 4 - 4 -
Wampole ColorCard 10 - 10 -
Wampole Rheumatex 3 1 4 -
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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/ 80
128/ 160
256/ 320
512/ 640
1024/ 1280
2048/ 2560
2560
Specimen RF-7
ALL METHODS - 2 5 - 1 1 - - - - -
Biokit Rheumajet - - 1 - - - - - - - -
Fisher HealthCare Sure-Vue - - 4 - 1 - - - - - -
Remel SeraTest - - - - - 1 - - - - -
Wampole ColorCard - 1 - - - - - - - - -
Specimen RF-9
ALL METHODS 1 5 - 2 1 - - - - - -
Biokit Rheumajet - - - 1 - - - - - - -
Fisher HealthCare Sure-Vue - 4 - 1 - - - - - - -
Remel SeraTest - - - - 1 - - - - - -
Wampole ColorCard - 1 - - - - - - - - -
Specimen RF-10
ALL METHODS - 6 - 1 1 1 - - - - -
Biokit Rheumajet - - - 1 - - - - - - -
Fisher HealthCare Sure-Vue - 4 - - 1 - - - - - -
Remel SeraTest - - - - - 1 - - - - -
Wampole ColorCard - 1 - - - - - - - - -
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Rheumatoid Factor—Quantitative (IU/mL)
Specimen/Method
Labs
Mean
SD
CV
Median Range
Specimen RF-6
All Method 16 4.3 4.6 105.7 3 0 - 14
Specimen RF-7
All Method 13 115.5 10.9 9.5 118 93 - 138
Specimen RF-8
All Method 16 4.5 4.8 106.4 2 0 - 15
Specimen RF-9
All Method 13 70.6 6.1 8.6 72 58 - 83
Specimen RF-10
All Method 13 70.7 7.2 10.2 71 56 - 86
Anti-Streptolysin O (ASO)—Qualitative
Specimen AS-6 Specimen AS-7 Specimen AS-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS 1 - - 1 1 -
ASI 1 - - 1 1 -
Method Specimen AS-9 Specimen AS-10
Positive Negative Positive Negative
ALL METHODS
ASI - 1 1 -
- 1 1 -
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2013 MLE-M2 Participant Summary/ 9
Complement C3 (mg/dL)
Specimen/Method
Labs
Mean
SD
CV
Median Range
Specimen IMP-6
All Method 14 57.9 4.4 7.6 60 44 - 72
Specimen IMP-7
All Method 14 189.2 13.8 7.3 190 147 - 231
Specimen IMP-8
All Method 14 224.4 14.6 6.5 226 180 - 269
Specimen IMP-9
All Method 14 62.4 3.5 5.6 62 51 - 73
Specimen IMP-10
All Method 14 169.0 12.4 7.3 169 131 - 207
Complement C4 (mg/dL)
Specimen/Method
Labs
Mean
SD
CV
Median Range
Specimen IMP-6
All Method 14 11.6 1.4 12.0 12 7 - 16
Specimen IMP-7
All Method 14 33.9 3.7 11.0 34 22 - 46
Specimen IMP-8
All Method 14 40.7 4.6 11.4 40 26 - 55
Specimen IMP-9
All Method 14 11.9 1.3 10.9 12 7 - 16
Specimen IMP-10
All Method 14 31.5 3.7 11.7 31 20 - 43
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Antinuclear Antibody (ANA)—Qualitative Latex Methods
Specimen AN-6 Specimen AN-7 Specimen AN-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 5 5 - 5 -
ASI - 1 1 - 1 -
Diagnostic Technology - 2 2 - 2 -
Wampole - 1 1 - 1 -
Specimen AN-9 Specimen AN-10
Method Positive Negative Positive Negative
ALL METHODS - 5 4 1
ASI - 1 - 1
Diagnostic Technology - 2 2 -
Wampole - 1 1 -
C-Reactive ProteinQualitative, Regular
Specimen CR-3 Specimen CR-4
Method Positive Negative Positive Negative
ALL METHODS 16 - - 16
ASI 1 - - 1
Biokit Rheumajet 1 - - 1
Fisher HealthCare Sure-Vue 8 - - 8
Siemens Dimension/AR/ES/RxL/Xpand 1 - - 1
Teco Diagnostics 4 - - 4
Wampole 1 - - 1
C-Reactive ProteinQuantitative (mg/dL), Regular Specimen/Method
Labs
Mean
SD
CV
Median Range
Specimen CR-3
mg/dL - units
All Immunology Methods 19 3.146 0.433 13.8 3.10 1.84 - 4.45
mg/L - units
All Immunology Methods 10 34.719 4.857 14.0 33.34 20.14 - 49.30
Specimen CR-4
mg/dL - units
All Immunology Methods 18 0.186 0.166 89.2 0.20 0.00 - 0.69
mg/L - units
All Immunology Methods 10 2.671 2.278 85.3 2.81 0.00 - 9.51
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2013 MLE-M2 Participant Summary/ 11
C-Reactive ProteinQuantitative (mg/dL), High Sensitivity Specimen/Method
Labs
Mean
SD
CV
Median Range
Specimen HCR-3
All Method 45 0.956 0.311 32.5 0.95 0.02 - 1.89
Specimen HCR-4
All Method 44 15.222 1.492 9.8 15.06 10.74 - 19.70
Antinuclear Antibody (ANA)—Qualitative IFA/ELISA Methods
Specimen AE-6 Specimen AE-7 Specimen AE-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 18 18 - 18 -
Diamedix - 2 2 - 2 -
GenBio ImmunoDOT Panel 1 - 1 1 - 1 -
Immuno Concepts - 4 4 - 4 -
INOVA Diagnostics - 3 3 - 3 -
Kallestad - 2 2 - 2 -
TheraTest - 4 4 - 4 -
Wampole - 1 1 - 1 -
Specimen AE-9 Specimen AE-10
Method Positive Negative Positive Negative
ALL METHODS 17 1 1 17
Diamedix 2 - - 2
GenBio ImmunoDOT Panel 1 1 - - 1
Immuno Concepts 3 1 - 4
INOVA Diagnostics 3 - 1 2
Kallestad 2 - - 2
TheraTest 4 - - 4
Wampole 1 - - 1
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Antinuclear Antibody (ANA)Quantitative (Titer)
This portion is not evaluated. Titers reported are as follows:
Specimen/Method
8/ 10
16/ 20
32/ 40
64/ 80
128/ 160
256/ 320
512/ 640
>640
1024/ 1280
2048/ 2560
2560
Specimen AE-7
ALL METHODS - - 1 - 3 1 - - - - -
Immuno Concepts - - - - 2 1 - - - - -
INOVA Diagnostics - - 1 - - - - - - - -
Kallestad - - - - 1 - - - - - -
Specimen AE-8
ALL METHODS - - - - 3 1 - 1 - - -
Immuno Concepts - - - - 2 - - 1 - - -
INOVA Diagnostics - - - - - 1 - - - - -
Kallestad - - - - 1 - - - - - -
Specimen AE-9
ALL METHODS - - - 2 1 1 1 - - - -
Immuno Concepts - - - 1 1 1 - - - - -
INOVA Diagnostics - - - - - - 1 - - - -
Kallestad - - - 1 - - - - - - -
Anti-dsDNA
Specimen AE-6 Specimen AE-7 Specimen AE-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 12 - 12 10 2
Diamedix - 3 - 3 3 -
Kallestad - 2 - 2 2 -
TheraTest - 4 - 4 3 1
Wampole - 1 - 1 - 1
Specimen AE-9 Specimen AE-10
Method Positive Negative Positive Negative
ALL METHODS - 12 - 12
Diamedix - 3 - 3
Kallestad - 2 - 2
TheraTest - 4 - 4
Wampole - 1 - 1
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2013 MLE-M2 Participant Summary/ 13
Anti-RNP
Specimen AE-6 Specimen AE-7 Specimen AE-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 2 2 - - 2
INOVA Diagnostics - 1 1 - - 1 Specimen AE-9 Specimen AE-10
Method Positive Negative Positive Negative
ALL METHODS 2 - - 2
INOVA Diagnostics 1 - - 1
Anti-RNP/Sm
Specimen AE-6 Specimen AE-7 Specimen AE-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 11 11 - 5 6
Diamedix - 4 4 - - 4
GenBio ImmunoDOT Panel 1 - 1 1 - - 1
TheraTest - 4 4 - 4 -
Wampole - 1 1 - - 1 Specimen AE-9 Specimen AE-10
Method Positive Negative Positive Negative
ALL METHODS 11 - - 11
Diamedix 4 - - 4
GenBio ImmunoDOT Panel 1 1 - - 1
TheraTest 4 - - 4
Wampole 1 - - 1
Specimen AE-8 is an ungraded challenge due to less than 80% participant consensus.
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Anti-SSA
Specimen AE-6 Specimen AE-7 Specimen AE-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS 1 11 12 - 12 -
Diamedix - 4 4 - 4 -
INOVA Diagnostics - 1 1 - 1 -
TheraTest 1 3 4 - 4 -
Wampole - 1 1 - 1 -
Specimen AE-9 Specimen AE-10
Method Positive Negative Positive Negative
ALL METHODS 12 - - 12
Diamedix 4 - - 4
INOVA Diagnostics 1 - - 1
TheraTest 4 - - 4
Wampole 1 - - 1
Anti-SSB
Specimen AE-6 Specimen AE-7 Specimen AE-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 12 12 - 12 -
Diamedix - 4 4 - 4 -
INOVA Diagnostics - 1 1 - 1 -
TheraTest - 4 4 - 4 -
Wampole - 1 1 - 1 -
Specimen AE-9 Specimen AE-10
Method Positive Negative Positive Negative
ALL METHODS - 12 - 12
Diamedix - 4 - 4
INOVA Diagnostics - 1 - 1
TheraTest - 4 - 4
Wampole - 1 - 1
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2013 MLE-M2 Participant Summary/ 15
Anti-SSA/SSB
Specimen AE-6 Specimen AE-7 Specimen AE-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 1 1 - 1 -
GenBio ImmunoDOT Panel 1 - 1 1 - 1 -
Specimen AE-9 Specimen AE-10
Method Positive Negative Positive Negative
ALL METHODS 1 - - 1
GenBio ImmunoDOT Panel 1 1 - - 1
Anti-Sm
Specimen AE-6 Specimen AE-7 Specimen AE-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 12 - 12 - 12
Diamedix - 4 - 4 - 4
INOVA Diagnostics - 1 - 1 - 1
TheraTest - 4 - 4 - 4
Wampole - 1 - 1 - 1
Specimen AE-9 Specimen AE-10
Method Positive Negative Positive Negative
ALL METHODS 12 - - 12
Diamedix 4 - - 4
INOVA Diagnostics 1 - - 1
TheraTest 4 - - 4
Wampole 1 - - 1
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RubellaQualitative
Specimen RU-6 Specimen RU-7 Specimen RU-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS 6 - - 6 - 6
Bayer ADVIA Centaur 2 - - 2 - 2
bioMerieux Vidas, Mini Vidas 2 - - 2 - 2
DiaSorin 2 - - 2 - 2
Specimen RU-9 Specimen RU-10
Method Positive Negative Positive Negative
ALL METHODS 6 - 6 -
Bayer ADVIA Centaur 2 - 2 -
bioMerieux Vidas, Mini Vidas 2 - 2 -
DiaSorin 2 - 2 -
RubellaQuantitative (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.
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2013 MLE-M2 Participant Summary/ 17
Anti-HIV
Specimen HIV-6 Specimen HIV-7
Method Positive Negative Positive Negative
ALL METHODS - 40 39 -
Abbott Architect - 1 1 -
BD LINK 2 - 1 - -
Inverness Clearview Complete HIV 1/2 - 11 11 -
Orasure OraQuick Advance Rapid HIV-1/2 - waived - 15 15 -
Other Moderate method - 1 1 -
Other Waived method - 8 8 -
Specimen HIV-8 Specimen HIV-9 Specimen HIV-10
Method Positive Negative Positive Negative Positive Negative
ALL METHODS 7 - - 7 7 -
Abbott Architect 1 - - 1 1 -
Inverness Clearview Complete HIV 1/2 1 - - 1 1 -
Orasure OraQuick Advance Rapid HIV-1/2 - waived 3 - - 3 3 -
Other Moderate method 1 - - 1 1 -
Other Waived method 1 - - 1 1 -
Total IgEQuantitative (U/mL)
Specimen/Method
Labs
Mean
SD
CV
Median Range
Specimen AL-6
All Method 5 118.4 17.3 14.6 114 66 - 171
Specimen AL-7
All Method 5 152.6 33.5 22.0 167 51 - 254
Specimen AL-8
All Method 5 48.6 5.9 12.1 45 30 - 67
Specimen AL-9
All Method 5 21.8 3.4 15.7 20 11 - 33
Specimen AL-10
All Method 5 22.2 3.5 15.7 20 11 - 33
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Allergen Specific IgE Antibodies
Specimen AL-6
Meadow Fescue Allergen Perennial Rye Allergen
CLASS RESULT CLASS RESULT
Method 0 0/1 1 2 3 4 5 6 0 0/1 1 2 3 4 5 6
ALL METHODS - - - - - - - - - - - 1 - 1 - -
Hitachi CLA-1 - - - - - - - - - - - - - 1 - -
Phadia UniCap 100 (% ref) - - - - - - - - - - - 1 - - - -
Perennial Rye Allergen is an ungraded challenge due to less than 80% participant consensus.
Silver Birch Tree Allergen Maple (Box Elder) Allergen
CLASS RESULT CLASS RESULT
0 0/1 1 2 3 4 5 6 0 0/1 1 2 3 4 5 6
ALL METHODS - 1 1 2 - - - - 4 3 1 - - - - -
DPC Immulite 2000/2500 - - - 1 - - - - - 1 - - - - - -
DPC-Standard Microplate - - - 1 - - - - - 1 - - - - - -
Hitachi CLA-1 - 1 1 - - - - - 4 1 - - - - - -
Phadia UniCap 100 (% ref) - - - - - - - - - - 1 - - - - -
Common (Short) Ragweed Allergen Cat Epithelium Allergen
CLASS RESULT CLASS RESULT
0 0/1 1 2 3 4 5 6 0 0/1 1 2 3 4 5 6
ALL METHODS - - 1 5 4 - - - - 1 3 6 - - - -
DPC Immulite 2000/2500 - - - - 1 - - - - - - 1 - - - -
DPC-Standard Microplate - - - - 1 - - - - - - 1 - - - -
Hitachi CLA-1 - - 1 2 2 - - - - 1 1 3 - - - -
Phadia ImmunoCAP Rapid - - - 2 - - - - - - 1 1 - - - -
Phadia UniCap 100 (% ref) - - - 1 - - - - - - 1 - - - - -
House Dust Mite Allergen
CLASS RESULT
0 0/1 1 2 3 4 5 6
ALL METHODS - 1 1 6 - 1 - -
DPC Immulite 2000/2500 - - - 1 - - - -
DPC-Standard Microplate - - - 1 - - - -
Hitachi CLA-1 - 1 1 1 - 1 - -
Phadia ImmunoCAP Rapid - - - 2 - - - -
Phadia UniCap 100 (% ref) - - - 1 - - - -
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2013 MLE-M2 Participant Summary/ 19
Allergen Specific IgE Antibodies
Specimen AL-7
Sweet Vernal Grass Allergen Meadow, Kentucky Blue, June Grass Allergens
CLASS RESULT CLASS RESULT
Method 0 0/1 1 2 3 4 5 6 0 0/1 1 2 3 4 5 6
ALL METHODS - - - - - - - - - - - 1 2 2 - -
DPC Immulite 2000/2500 - - - - - - - - - - - - 1 - - -
DPC-Standard Microplate - - - - - - - - - - - - 1 - - -
Hitachi CLA-1 - - - - - - - - - - - - - 2 - -
Phadia UniCap 100 (% ref) - - - - - - - - - - - 1 - - - -
House Dust Mite Allergen White Oak Allergen
CLASS RESULT CLASS RESULT
0 0/1 1 2 3 4 5 6 0 0/1 1 2 3 4 5 6
ALL METHODS - - 2 6 - 1 - - - - 3 3 - - - -
DPC Immulite 2000/2500 - - - 1 - - - - - - 1 - - - - -
DPC-Standard Microplate - - - 1 - - - - - - - - - - - -
Hitachi CLA-1 - - 2 1 - 1 - - - - 2 2 - - - -
Phadia ImmunoCAP Rapid - - - 2 - - - - - - - - - - - -
Phadia UniCap 100 (% ref) - - - 1 - - - - - - - 1 - - - -
Common (Short) Ragweed Allergen Russian Thistle Allergen
CLASS RESULT CLASS RESULT
0 0/1 1 2 3 4 5 6 0 0/1 1 2 3 4 5 6
ALL METHODS 1 1 5 2 - - - - 2 1 - - - - - -
DPC Immulite 2000/2500 - - 1 - - - - - - 1 - - - - - -
DPC-Standard Microplate - - 1 - - - - - - - - - - - - -
Hitachi CLA-1 1 1 3 - - - - - 2 - - - - - - -
Phadia ImmunoCAP Rapid - - - 1 - - - - - - - - - - - -
Phadia UniCap 100 (% ref) - - - 1 - - - - - - - - - - - -
Russian Thistle Allergen is an ungraded challenge due to less than 80% participant consensus.
Peanut Allergen
CLASS RESULT
0 0/1 1 2 3 4 5 6
ALL METHODS - - - 2 - 3 - -
DPC Immulite 2000/2500 - - - 1 - - - -
Hitachi CLA-1 - - - - - 3 - -
Phadia UniCap 100 (% ref) - - - 1 - - - -
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20 /2013 MLE-M2 Participant Summary
IgA (mg/dL)
Specimen/Method
Labs
Mean
SD
CV
Median Range
Specimen IMP-6
All Method 13 95.1 3.6 3.8 95 84 - 106
Specimen IMP-7
All Method 14 474.0 25.8 5.5 477 396 - 552
Specimen IMP-8
All Method 14 316.9 13.0 4.1 319 277 - 356
Specimen IMP-9
All Method 13 94.5 4.3 4.5 94 81 - 108
Specimen IMP-10
All Method 14 248.3 10.4 4.2 252 217 - 280
IgG (mg/dL)
Specimen/Method
Labs
Mean
SD
CV
Median Range
Specimen IMP-6
All Method 14 444.6 27.6 6.2 447 333 - 556
Specimen IMP-7
All Method 14 1276.6 55.9 4.4 1281 957 - 1596
Specimen IMP-8
All Method 14 1938.1 126.4 6.5 1966 1453 - 2423
Specimen IMP-9
All Method 14 441.6 33.7 7.6 440 331 - 552
Specimen IMP-10
All Method 14 1261.1 47.0 3.7 1265 945 - 1577
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2013 MLE-M2 Participant Summary/ 21
IgM (mg/dL)
Specimen/Method
Labs
Mean
SD
CV
Median Range
Specimen IMP-6
All Method 14 43.0 4.0 9.2 42 31 - 55
Specimen IMP-7
All Method 14 145.6 16.5 11.3 147 96 - 195
Specimen IMP-8
All Method 14 260.9 13.5 5.2 259 220 - 302
Specimen IMP-9
All Method 14 45.3 4.0 8.9 45 33 - 58
Specimen IMP-10
All Method 14 130.2 10.8 8.3 130 97 - 163
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22 /2013 MLE-M2 Participant Summary
Syphilis SerologyQualitative: VDRL Slide
Method Specimen SY-6 Specimen SY-7 Specimen SY-8
Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive
ALL METHODS 1 - 1 - - 1
ASI 1 - 1 - - 1
Method Specimen SY-9 Specimen SY-10
Reactive Non-Reactive Reactive Non-Reactive
ALL METHODS 1 - - 1
ASI 1 - - 1
Syphilis SerologyQualitative: Treponema pallidum antibodies
Specimen SY-6 Specimen SY-7 Specimen SY-8
Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive
ALL METHODS 1 - 1 - - 1
DPC Immulite 2000/2500 1 - 1 - - 1
Specimen SY-9 Specimen SY-10
Method Reactive Non-Reactive Reactive Non-Reactive
ALL METHODS 1 - - 1
DPC Immulite 2000/2500 1 - - 1
Syphilis SerologyQualitative: RPR
Specimen SY-6 Specimen SY-7 Specimen SY-8
Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive
ALL METHODS 23 - 14 9 1 22
ASI 9 - 4 5 1 8
Becton Dickinson 11 - 8 3 - 11
Fisher HealthCare Sure-Vue 2 - 1 1 - 2
Wampole Impact RPR 1 - 1 - - 1
Specimen SY-9 Specimen SY-10
Method Reactive Non-Reactive Reactive Non-Reactive
ALL METHODS 23 - 2 21
ASI 9 - 1 8
Becton Dickinson 11 - - 11
Fisher HealthCare Sure-Vue 2 - 1 1
Wampole Impact RPR 1 - - 1
Specimen SY-7 was graded by 83% referee consensus.
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2013 MLE-M2 Participant Summary/ 23
Syphilis SerologyQuantitative: RPR (Titer)
Specimen/Method 1 2 4 8 16 32 64 >64
Specimen SY-6
ALL METHODS 7 4 1 - - - - -
ASI 3 2 1 - - - - -
Becton Dickinson 4 2 - - - - - -
Specimen SY-7
ALL METHODS 7 - - - - - - -
ASI 4 - - - - - - -
Becton Dickinson 3 - - - - - - -
Specimen SY-9
ALL METHODS 8 2 2 - - - - -
ASI 4 1 1 - - - - -
Becton Dickinson 4 1 1 - - - - -
H. pylori Antibody Detection
Specimen HP-3 Specimen HP-4
Method Positive Negative Positive Negative
ALL METHODS 100 1 1 100
Alfa Scientific Instant-View 1 - - 1
Beckman Coulter ICON HP 2 - - 2
Cardinal Health SP Brand 7 - - 7
Consult Diagnostics 13 1 1 13
DPC Immulite 2000/2500 1 - - 1
Fisher HealthCare Sure-Vue 3 - - 3
Henry Schein OneStep+ - waived 7 - - 7
Inverness (Wampole) Clearview 10 - - 10
McKesson Medi-Lab Performance - waived 10 - - 10
Polymedco Poly stat 3 - - 3
PSS Select Diagnostics 1 - - 1
Quidel QuickVue 39 - - 39
SDI Biomed, Inc. 1 - - 1
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24 /2013 MLE-M2 Participant Summary
Lyme Disease Serology
Specimen LY-3 Specimen LY-4
Method Positive Negative Positive Negative
ALL METHODS - 5 5 -
bioMerieux Vidas, Mini Vidas - 1 1 -
DiaSorin - 2 2 -
Mycoplasma Antibody
Specimen MY-3 Specimen MY-4
Method Positive Negative Positive Negative
ALL METHODS - 1 1 -
Meridian ImmunoCard - 1 1 -
Viral Markers – Anti-HBc
Specimen VM-6 Specimen VM-7 Specimen VM-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 2 2 - - 2
Bayer ADVIA Centaur - IgM - 1 1 - - 1
Bayer ADVIA Centaur - Total - 1 1 - - 1 VITROS ECi - Total 1 - 1 - - 1
Specimen VM-9 Specimen VM-10
Method Positive Negative Positive Negative
ALL METHODS - 2 - 2
Bayer ADVIA Centaur - IgM - 1 - 1
Bayer ADVIA Centaur - Total - 1 - 1
VITROS ECi - Total - 1 1 -
Specimens VM-6 and VM-10 are ungraded challenges due to less than 80% consensus.
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2013 MLE-M2 Participant Summary/ 25
Viral Markers – Anti-HIV
Specimen VM-6 Specimen VM-7 Specimen VM-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS 9 - - 9 9 -
Bayer ADVIA Centaur - Total 2 - - 2 2 - Orasure OraQuick Advance Rapid HIV-1/2 - moderate 3 - - 3 3 - Orasure OraQuick Advance Rapid HIV-1/2 - waived 3 - - 3 3 -
Other IgG Method 1 - - 1 1 -
Specimen VM-9 Specimen VM-10
Method Positive Negative Positive Negative
ALL METHODS 2 7 9 -
Bayer ADVIA Centaur - Total 2 - 2 -
Orasure OraQuick Advance Rapid HIV-1/2 - moderate - 3 3 -
Orasure OraQuick Advance Rapid HIV-1/2 - waived - 3 3 -
Other IgG Method - 1 1 -
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
Method Positive Negative Positive Negative Positive Negative
ALL METHODS 1 1 2 - 1 1
Bayer ADVIA Centaur - IgM - 1 1 - - 1
Bayer ADVIA Centaur - Total 1 - 1 - 1 -
Specimen VM-9 Specimen VM-10
Method Positive Negative Positive Negative
ALL METHODS - 2 1 1
Bayer ADVIA Centaur - IgM - 1 - 1
Bayer ADVIA Centaur - Total - 1 1 -
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26 /2013 MLE-M2 Participant Summary
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
Method Positive Negative Positive Negative Positive Negative
ALL METHODS 5 - - 5 5 -
Abbott Architect - Total 1 - - 1 1 -
Bayer ADVIA Centaur - Total 3 - - 3 3 - Specimen VM-9 Specimen VM-10
Method Positive Negative Positive Negative
ALL METHODS 5 - - 5
Abbott Architect - Total 1 - - 1
Bayer ADVIA Centaur - Total 3 - - 3
Viral Markers – HBsAg
Specimen VM-6 Specimen VM-7 Specimen VM-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 5 5 - - 5
Abbott Architect - Total - 1 1 - - 1
Bayer ADVIA Centaur - Total - 2 2 - - 2
Other IgG Method - 1 1 - - 1
Specimen VM-9 Specimen VM-10
Method Positive Negative Positive Negative
ALL METHODS - 5 5 -
Abbott Architect - Total - 1 1 -
Bayer ADVIA Centaur - Total - 2 2 -
Other IgG Method - 1 1 -
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2013 MLE-M2 Participant Summary/ 27
Viral Markers – HCV
Specimen VM-6 Specimen VM-7 Specimen VM-8
Method Positive Negative Positive Negative Positive Negative
ALL METHODS - 6 - 6 - 6
Abbott Architect - Total - 2 - 2 - 2
Bayer ADVIA Centaur - Total - 3 - 3 - 3
OraSure OraQuick HCV - 1 - 1 - 1
Specimen VM-9 Specimen VM-10
Method Positive Negative Positive Negative
ALL METHODS 6 - 1 5
Abbott Architect - Total 2 - - 2
Bayer ADVIA Centaur - Total 3 - 1 -
OraSure OraQuick HCV 1 - - 1
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