PRELIMINARY REPORT HEPATITIS SEROLOGY (HEPM4310, HEPC4310, HEPM435) HIV SEROLOGY (HIVC4310, HIVC435) HTLV SEROLOGY (HTLV4310, HTLV435) MULTIMARKER BLOOD SCREENING SEROLOGY (MMBS4320) SYPHILIS SEROLOGY (TREP4310, TREP435) TORC SEROLOGY (TORC435)
Panel ID: 2014-04-16
NRL is: • •
Accredited for compliance with ISO 17043, with NATA Accreditation Number 14253; A World Health Organisation (WHO) Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and Other Bloodborne Infections.
Report prepared by Kathy Smeh and distributed in the week beginning 2014-05-19
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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1 INTRODUCTION NRL distributes three Serology External Quality Assessment Scheme (EQAS) panels to participants for each program each year. NRL manages NRL EQAS using the online informatics system (OASYS) developed and operated by Oneworld Accuracy Collaboration. All participants in NRL EQAS are provided with a unique and confidential identifier. This identifier is known only by the participant, NRL and Oneworld Accuracy Collaboration. This preliminary report presents the composition of the following panels with the ID 2014-04-16: •
HIVC435, 4310;
•
HEPM435, 4310, HEPC4310;
•
MMBS4320;
•
TREP435, 4310;
•
HTLV435, 4310;
•
TORC435.
The information in this report will allow your laboratory to assess its own performance. In the near future you will receive reports which will present your laboratory’s performance relative to that of others. The overall performance of all laboratories will also be presented.
1.1
Copyright
The information and data included in this report are the intellectual property of NRL, a division of St. Vincent’s Institute. This report and its contents may not be reproduced, in whole or in part, for any purpose without the written permission of NRL; nor may they be used in any type of advertising or sales promotion.
2 METHODS 2.1 Panel composition, preparation and distribution EQAS panels where the program code ended in 4310 consisted of ten plasma samples. EQAS panels where the program code ended in 435 consisted of five samples which were the same as the first five samples included in the panel for program code 4310 for the same EQAS. Some of the panels contained one or more pooled samples. A pooled sample was prepared by mixing volumes of at least two samples that had similar antibody and antigen profiles. NRL EQAS samples stored and transported according to NRL guidelines have been extensively validated to assure stability for the duration of the test event period. All samples were manufactured according to NRL procedures, ensuring homogeneity, and were subjected to 0.2 µm filtration prior to aliquotting. The samples were tested in a range of assays to confirm their reactivity (APPENDIX A).
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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3 ACKNOWLEDGEMENTS Comments or queries about this report, or about any problems you might experience with Hepatitis, HIV, HTLV, Blood Screening, Syphilis, Toxoplasma, Rubella and CMV serology testing, will be welcomed by Kathy Smeh on +61 3 9418 1110 or via email to
[email protected]. NRL thanks our colleagues who supply samples for NRL EQAS. Various aspects of NRL EQAS may be subcontracted. When subcontracting occurs competent subcontractors are selected to maintain the quality required of NRL EQAS. We thank all our participants for their cooperation.
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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APPENDIX A Information for specific EQAS can be found in this appendix as follows: EQAS ID
Tables
Pages
HEPM4310, 435
1–7
5 – 11
(incl HEPC4310)
(1, 6, 7)
(5, 10 – 11)
HIVC4310, 435
8, 9
12 - 13
HTLV4310, 435
10, 11
14 - 15
MMBS4320
12 - 15
16 - 19
TORC435
16 - 22
20 - 23
TREP4310, 435
23
24
Table A1. Composition of Hepatitis Serology EQAS Panel ID 2014-04-16 Sample Identification by Program
Sample Origin
Sample Type
HEPM4310
HEPM435
A
A
African blood donors
Pooled plasma
B
B
Australian blood donors
Pooled plasma
C
C
African blood donors
Pooled plasma
D
D
Southeast Asian blood donors
Pooled plasma
E
E
African, Australian, Southeast Asian and Western Pacific blood donors
Pooled plasma
Southeast Asian and Western Pacific blood donors
Pooled plasma
G
Southeast Asian blood donors
Pooled plasma
H
Western Pacific blood donors
Pooled plasma
I
Southeast Asian blood donors
Pooled plasma
J
Australian blood donors
Pooled plasma
F
Not applicable
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A2. Characterisation of the Hepatitis EQAS Panel ID 2014-04-16 when testing for HAV Serology Sample Identification by Program
DiaSorin ETI-ABHAVK PLUS AntiHAV EIA (Qualitative) Assay Interpretation
Abbott ARCHITECT HAVAb-IgG CMIA#
DiaSorin ETI-HAIGMK PLUS AntiHAV IgM EIA
Assay Interpretation
Assay Interpretation
HEPM4310
HEPM435
A
A
Negative
Negative
Negative
B
B
Negative
Negative
Negative
C
C
Reactive
Reactive
Negative
D
D
Reactive
Reactive
Negative
E
E
Reactive
Reactive
Negative
F
Not applicable
Reactive
Reactive
Negative
Reactive
Reactive
Negative
H
Negative
Negative
Negative
I
Reactive
Reactive
Negative
J
Reactive
Reactive
Negative
G
Note:
#
This testing was performed externally. All other testing was performed by NRL.
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A3. Possible serology statuses for Hepatitis EQAS Panel ID 2014-04-16 when testing for HAV Serology Sample Identification by Program
HAV Status (Anti-HAV total ± anti-HAV IgM)
HAV Status (Anti-HAV IgG only)
HAV Status (Anti-HAV IgM only)
HEPM4310
HEPM435
A
A
a
a, d
e, f
B
B
a
a, d
e, f
C
C
b, d
b, d
e, f
D
D
b, d
b, d
e, f
E
E
b, d
b, d
e, f
F
Not applicable
b, d
b, d
e, f
b, d
b, d
e, f
H
a
a, d
e, f
I
b, d
b, d
e, f
J
b, d
b, d
e, f
G
Note: a) No evidence of immunity/past infection with HAV; b) Evidence of immunity/past infection with HAV; c) Evidence of recent infection with HAV; d) Recent HAV infection cannot be excluded (where anti-HAV IgM is not tested); e) No evidence of recent infection with HAV; f)
Immunity/past infection with HAV cannot be excluded (where anti-HAV IgM only is tested).
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A4. Characterisation of the Hepatitis EQAS Panel ID 2014-04-16 when testing for HBV Serology Sample Identification by Program
HEPM4310
HEPM435
bioMerieux VIDAS HBsAg Ultra ELFA (Long protocol) AI
bioMerieux VIDAS HBsAg Ultra Confirmation
% Reduction
AI
bioMerieux VIDAS HBeAg/Anti-HBe ELFA
HBeAg
Anti-HBe
AI
AI
bioMerieux VIDAS anti-HBs Total Quick ELFA
Test Result (mIU/mLˆ)
AI
bioMerieux VIDAS Anti-HBc Total II ELFA
bioMerieux VIDAS HBc IgM II ELFA
AI
AI
A
A
Negative
≤ 5
Negative
Negative
B
B
Negative
477
Reactive
Negative
C
C
Reactive
98.79
Positive
Negative
Reactive
≤ 5
Negative
Reactive
Negative
D
D
Reactive
96.67
Positive
Negative
Reactive
≤ 5
Negative
Reactive
Negative
E
E
Negative
≤ 5
Negative
Negative
F
Not applicable
Negative
≥ 500
Reactive
Negative
Negative
246
Reactive
Reactive
G H
Reactive
99.65
Positive
Negative
Reactive
≤ 5
Negative
Reactive
Negative
I
Reactive
91.64
Positive
Reactive
Negative
≤ 5
Negative
Reactive
Negative
J
Reactive
99.64
Positive
Negative
Reactive
≤ 5
Negative
Reactive
Negative
Note: HBsAg HBeAg Anti-HBe Anti-HBs Anti-HBc Total HBc IgM AI ˆ
Hepatitis B surface antigen. Hepatitis B e antigen. Antibody to Hepatitis B e antigen. Antibody to Hepatitis B surface antigen. Total antibody to Hepatitis B core antigen. IgM antibody to Hepatitis B core antigen. Assay interpretation. mIU/mL (milli-International Units per millilitre), where > 12 is reactive.
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A5. Possible serology statuses for Hepatitis EQAS Panel ID 2014-04-16 when testing for HBV Serology Sample Identification by Program
HBV Status
HEPM4310
HEPM435
A
A
a, b, h
B
B
a, b, g
C
C
c, h
D
D
c, h
E
E
a, b, h
F
Not applicable
a, b, g
G
a, d, g
H
c, h
I
c, h
J
c, h
Note: a) No evidence of current HBV infection; b) No evidence of past or current with HBV infection; c) Evidence of current HBV infection; d) Evidence of past, resolved HBV infection; e) Evidence of recent HBV infection; f)
No evidence of recent HBV infection;
g) Evidence of immunity to HBV; h) No evidence of immunity to HBV.
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A6. Characterisation of the Hepatitis Serology EQAS Panel ID 2014-04-16 when testing for HCV Serology Sample Identification by Program
Abbott ARCHITECT HCV Ag CMIA#
DiaSorin Murex antiHCV (version 4.0) EIA
Bio-Rad MONOLISA anti-HCV Plus Version 2 EIA
MP Diagnostics HCV BLOT 3.0 WB
HEPM4310 and HEPC4310
HEPM435
A
A
241.03
Reactive
Reactive
Reactive
B
B
0.00
Negative
Negative
Negative
C
C
0.00
Negative
Negative
Negative
D
D
0.00
Negative
Negative
Negative
E
E
1554.37
Reactive
Reactive
Reactive
Positive
F
Not applicable
1515.81
Reactive
Reactive
Reactive
Positive
0.00
Negative
Negative
Negative
H
0.00
Negative
Negative
Negative
I
0.00
Negative
Negative
Negative
J
0.00
Negative
Negative
Negative
G
Note:
Test Assay Assay Assay Assay Result Interpretation Interpretation Interpretation Interpretation (fmol/L▲)
#
This testing was performed externally. All other testing was performed by NRL.
▲
fmol/L, where ≥ 3.00 is reactive.
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Positive
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Table A7. Serology statuses for Hepatitis EQAS Panel ID 2014-04-16 when testing for HCV Serology Sample Identification by Program
HCV Status
HEPM4310 or HEPC4310
HEPM435
A
A
Positive
B
B
Negative
C
C
Negative
D
D
Negative
E
E
Positive
F
Not applicable
Positive
G
Negative
H
Negative
I
Negative
J
Negative
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A8. Composition of HIV Serology EQAS Panel ID 2014-04-16 Sample Identification by Program
Sample Origin
Sample Type
HIV Status
HIVC4310
HIVC435
A
A
African blood donors
Pooled plasma
Positive
B
B
African blood donors
Pooled plasma
Positive
C
C
Australian blood donor
Plasma
Negative
D
D
Australian blood donor
Plasma
Negative
E
E
Australian blood donor
Plasma
Negative
F
Not applicable
African blood donors
Pooled plasma
G
Australian blood donor
Plasma
Negative
H
Australian blood donor
Plasma
Negative
I
Australian blood donor
Plasma
Negative
J
Southeast Asian blood donors
Pooled plasma
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Positive
Positive
Page 12 of 26
Table A9. Characterisation of the samples that comprised HIV Serology EQAS Panel ID 2014-04-16 Sample Identification by Program
DiaSorin Murex HIV-1.2.O EIA
HIVC4310
Assay Assay % Assay Interpretation Interpretation Reduction Interpretation
HIVC435
Bio-Rad Genscreen HIV-1 Ag EIA
Bio-Rad Genscreen HIV-1 Ag Confirmatory
Bio-Rad Multispot HIV-1/2 Rapid Test HIV-1
HIV-2
Assay Assay Interpretation Interpretation
NRL In-house HIV-1 WB
HIV Status
Assay Interpretation
A
A
Reactive
Negative
Positive
Negative
Positive
Positive
B
B
Reactive
Negative
Positive
Negative
Positive
Positive
C
C
Negative
Negative
Negative
D
D
Negative
Negative
Negative
E
E
Negative
Negative
Negative
F
Not applicable
Reactive
Negative
Negative
Negative
Negative
H
Negative
Negative
Negative
I
Negative
Negative
Negative
J
Reactive
Negative
G
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Positive
Positive
Negative
Negative
Positive
Positive
Positive
Positive
Page 13 of 26
Table A10. Composition of HTLV Serology EQAS Panel ID 2014-04-16 Sample Identification by Program
Sample Origin
Sample Type
HTLV Status
HTLV4310
HTLV435
A
A
Australian blood donor
Plasma
Negative
B
B
Western Pacific blood donor
Plasma
Positive
C
C
Western Pacific blood donors
Pooled plasma
Positive
D
D
Australian blood donor
Plasma
Negative
E
E
Australian blood donors
Plasma
Positive
F
Not applicable
Western Pacific blood donors
Pooled plasma
Positive
G
Australian blood donor
Plasma
H
Western Pacific blood donors
Pooled plasma
I
Australian blood donor
Plasma
Negative
J
Western Pacific blood donor
Plasma
Negative
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Negative Positive
Page 14 of 26
Table A11. Characterisation of the samples that comprised HTLV Serology EQAS Panel ID 2014-04-16 Sample Identification by Program
DiaSorin Murex HTLV I+II EIA
MP Diagnostics HTLV BLOT 2.4 WB
Assay Interpretation
Assay Interpretation
HTLV Status
HTLV4310
HTLV435
A
A
Negative
B
B
Reactive
Positive
Positive
C
C
Reactive
Positive
Positive
D
D
Negative
E
E
Reactive
Positive
Positive
F
Not applicable
Reactive
Positive
Positive
G
Negative
Negative
Negative
Negative
H
Reactive
I
Negative
Negative
J
Negative
Negative
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Positive
Positive
Page 15 of 26
Table A12. Composition of Multimarker Blood Screening Serology EQAS Panel ID 2014-04-16 Sample Identification by Program
Sample Origin
Sample Type
MMBS4320 A
Southeast Asian blood donors
Pooled plasma
B
Southeast Asian blood donors
Pooled plasma
C
Australian blood donor
Plasma
D
African blood donors
Pooled plasma
E
African blood donors
Pooled plasma
F
African blood donors
Pooled plasma
G
Southeast Asian blood donors
Pooled plasma
H
Western Pacific blood donors
Pooled plasma
I
African blood donors
Pooled plasma
J
Australian blood donor
Plasma
K
Southeast Asian blood donors
Pooled plasma
L
African blood donors
Pooled plasma
M
Australian blood donor
Plasma
N
Southeast Asian blood donors
Pooled plasma
O
Southeast Asian blood donors
Pooled plasma
P
Australian blood donor
Plasma
Q
Southeast Asian blood donors
Pooled plasma
R
Southeast Asian blood donors
Pooled plasma
S
Australian blood donor
Plasma
T
African blood donors
Pooled plasma
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A13. Characterisation of the Multimarker Blood Screening Serology EQAS Panel ID 2014-04-16 when testing for HBV Serology Sample Identification by Program
bioMerieux VIDAS HBsAg Ultra ELFA (Long protocol)
MMBS4320
Assay Interpretation
bioMerieux VIDAS HBsAg Ultra Confirmation % Reduction
Assay Interpretation
bioMerieux VIDAS Anti-HBc Total II ELFA Assay Interpretation
A
Reactive
97.75
Positive
Reactive
B
Reactive
89.00
Positive
Reactive
C
Negative
Negative
D
Negative
Negative
E
Negative
Reactive
F
Negative
Negative
G
Reactive
H
Negative
Negative
I
Negative
Negative
J
Negative
Negative
K
Reactive
L
Negative
Negative
M
Negative
Negative
N
Reactive
O
Negative
Negative
P
Negative
Negative
Q
Negative
Reactive
R
Reactive
S
Negative
Negative
T
Negative
Negative
99.30
98.33
99.12
98.03
Positive
Positive
Positive
Positive
Note:
HBsAg
Hepatitis B surface antigen
.
Anti-HBc Total
Total antibody to Hepatitis B core antigen.
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Reactive
Reactive
Reactive
Reactive
Page 17 of 26
Table A14. Characterisation of the Multimarker Blood Screening Serology EQAS Panel ID 2014-04-16 when testing for HCV Serology Sample Identification by Program
Abbott ARCHITECT HCV Ag CMIA#
DiaSorin Murex anti-HCV (version 4.0) EIA
Bio-Rad MONOLISA anti-HCV Plus Version 2 EIA
MP Diagnostics HCV BLOT 3.0 WB
MMBS4320
Assay Interpretation
Assay Interpretation
Assay Interpretation
Assay Interpretation
Note:
#
HCV Status
A
Negative
Negative
Negative
Negative
B
Negative
Negative
Negative
Negative
C
Negative
Negative
Negative
Negative
D
Negative
Negative
Negative
Negative
E
Reactive
Reactive
Reactive
F
Negative
Negative
Negative
Negative
G
Negative
Negative
Negative
Negative
H
Reactive
Reactive
Reactive
I
Negative
Negative
Negative
Negative
J
Negative
Negative
Negative
Negative
K
Negative
Negative
Negative
Negative
L
Reactive
Reactive
Reactive
M
Negative
Negative
Negative
N
Reactive
Reactive
Reactive
O
Negative
Negative
Negative
Negative
P
Negative
Negative
Negative
Negative
Q
Reactive
Reactive
Reactive
R
Negative
Negative
Negative
Negative
S
Negative
Negative
Negative
Negative
T
Negative
Negative
Negative
Negative
Positive
Positive
Positive
Positive
Positive
Positive Negative
Positive
Positive
Positive
Positive
This testing was performed externally. All other testing was performed by NRL.
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A15. Characterisation of the Multimarker Blood Screening Serology EQAS Panel ID 2014-04-16 when testing for HIV serology Sample Identification by Program
DiaSorin Murex HIV-1.2.O EIA
Bio-Rad Genscreen HIV-1 Ag EIA
NRL In-house HIV-1 WB
MMBS4320
Assay Interpretation
Assay Interpretation
Assay Interpretation
HIV Status
A
Negative
Negative
Negative
B
Negative
Negative
Negative
C
Negative
Negative
Negative
D
Reactive
Negative
E
Negative
Negative
F
Reactive
Negative
G
Negative
Negative
Negative
H
Negative
Negative
Negative
I
Reactive
Negative
J
Negative
Negative
Negative
K
Negative
Negative
Negative
L
Negative
Negative
Negative
M
Negative
Negative
Negative
N
Negative
Negative
Negative
O
Reactive
Negative
P
Negative
Negative
Negative
Q
Negative
Negative
Negative
R
Negative
Negative
Negative
S
Negative
Negative
Negative
T
Reactive
Negative
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Positive
Positive Negative
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Page 19 of 26
Table A16. Composition of Toxoplasma, Rubella and CMV Serology EQAS Panel ID 2014-04-16 Sample Identification by Program
Sample Origin
Sample Type
TORC435 A
Australian blood donor
Serum
B
Australian blood donor
Serum
C
Australian blood donor
Serum
D
The anti-T. gondii IgM negative serum was from an Australian blood donor
Recombinant Human Toxo p30 IgM diluted in anti-T. gondii IgM negative serum (~4.5 µg/mL)
E
The anti-Rubella IgM negative serum was from an Australian blood donor
Recombinant Human Rubella IgM diluted in anti-Rubella IgM negative serum (~1.5 µg/mL)
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A17. Characterisation of the samples that comprised Toxoplasma, Rubella and CMV Serology EQAS Panel ID 2014-04-16 when testing for Toxoplasma Serology Sample Identification by Program
DiaSorin LIAISON Toxo IgG II CLIA#
bioMerieux VIDAS TOXO IgM ELFA#
TORC435
Assay Interpretation
Assay Interpretation
Note:
#
A
Negative
Negative
B
Reactive
Negative
C
Negative
Negative
D
Reactive
Reactive
E
Negative
Negative
This testing was performed externally. All other testing was performed by NRL.
Table A18. Possible serology statuses for Toxoplasma, Rubella and CMV Serology EQAS Panel ID 2014-04-16 when testing for Toxoplasma Serology Sample Identification by Program
Toxoplasma Status (Anti-T. gondii total ± anti-T. gondii IgM)
Toxoplasma Status (Anti-T. gondii IgG only)
Toxoplasma Status (Anti-T. gondii IgM only)
TORC435
Assay Interpretation
Assay Interpretation
A
A
A, E
Assay Interpretation A, D
B
C, F
C
A, D
C
A
A, E
A, D
D
B, F
C
B
E
A
A, E
A, D
Note: A) No evidence of recent or past infection with Toxoplasma gondii; B) Evidence of recent infection with Toxoplasma gondii; C) Evidence of past exposure to Toxoplasma gondii; D) Past infection cannot be excluded (IgM only); E) Recent infection cannot be excluded (IgG only); F) Evidence of recent/past infection with CMV.
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Page 21 of 26
Table A19. Characterisation of the samples that comprised Toxoplasma, Rubella and CMV Serology EQAS Panel ID 2014-04-16 when testing for Rubella Serology Sample Identification by Program
bioMerieux VIDAS RUB IgG II ELFA
bioMerieux VIDAS RUB IgM ELFA
TORC435
Assay Interpretation
Assay Interpretation
A
Reactive
Negative
B
Negative
Negative
C
Reactive
Negative
D
Reactive
Negative
E
Reactive
Reactive
Table A20. Possible serology statuses for Toxoplasma, Rubella and CMV Serology EQAS Panel ID 2014-04-16 when testing for Rubella Serology Sample Identification by Program
Rubella Status (Anti-Rubella IgG only)
Rubella Status (Anti-Rubella IgM only)
TORC435
Assay Interpretation
A
C
Assay Interpretation A, D
B
A
A, D
C
C
A, D
D
C
A, D
E
C
B
Note: A) No evidence of recent or past infection with rubella virus; B) Evidence of recent infection with rubella virus; C) Evidence of past infection with and immunity to rubella virus; D) Past infection cannot be excluded (IgM only); E) Recent infection cannot be excluded (IgG only).
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Page 22 of 26
Table A21. Characterisation of the samples that comprised Toxoplasma, Rubella and CMV Serology EQAS Panel ID 2014-04-16 when testing for CMV Serology Sample Identification by Program
DiaSorin ETI-CYTOK-G PLUS EIA (Qualitative)
DiaSorin ETI-CYTOK-M reverse PLUS EIA
TORC435
Assay Interpretation
Assay Interpretation
A
Reactive
Negative
B
Reactive
Negative
C
Negative
Negative
D
Reactive
Negative
E
Negative
Negative
Table A22. Possible serology statuses for Toxoplasma, Rubella and CMV Serology EQAS Panel ID 2014-04-16 when testing for CMV Serology Sample Identification by Program
CMV Status (Anti-CMV total ± anti-CMV IgM)
CMV Status (Anti-CMV IgG only)
CMV Status (Anti-CMV IgM only)
TORC435
Assay Interpretation
Assay Interpretation
Assay Interpretation
A
C, F
C
A, D
B
C, F
C
A, D
C
A
A, E
A, D
D
C, F
C
A, D
E
A
A, E
A, D
Note: A) No evidence of recent or past infection with CMV; B) Evidence of recent infection with CMV; C) Evidence of past exposure to CMV; D) Past infection cannot be excluded (IgM only); E) Recent infection cannot be excluded (IgG only); F) Evidence of recent/past infection with CMV (Total only).
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
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Table A23. Characterisation of the samples that comprised Syphilis Serology EQAS Panel ID 2014-04-16 Sample Identification by Program
Sample Origin
Sample Type
TREP4310
TREP435
A
A
Western Pacific blood donors
Pooled plasma
B
B
Australian blood donor
C
C
D
Becton Dickinson BD Macro-Vue RPR Card Test Titre
Test Result
Assay Interpretation
DiaSorin Murex ICE* Syphilis EIA
Fujirebio SERODIA-TPPA
Assay Interpretation
Assay Interpretation
1:32
Reactive
Reactive
Reactive
Reactive
Plasma
Undiluted
Negative
Negative
Negative
Negative
Western Pacific blood donors
Pooled plasma
Undiluted
Negative
Negative
Reactive
Reactive
D
Australian blood donor
Plasma
Undiluted
Negative
Negative
Negative
Negative
E
E
Australian blood donor
Plasma
Undiluted
Negative
Negative
Negative
Negative
F
Not applicable
Southeast Asian blood donor
Plasma
Undiluted
Negative
Negative
Reactive
Reactive
Australian blood donor
Plasma
Undiluted
Negative
Negative
Negative
Negative
H
African blood donor
Plasma
1:4
Reactive
Reactive
Reactive
Reactive
I
Western Pacific blood donor
Plasma
1:64
Reactive
Reactive
Reactive
Reactive
J
Western Pacific blood donor
Plasma
Undiluted
Negative
Negative
Reactive
Reactive
G
NRL EQAS: Preliminary Report for Serology Panel ID 2014-04-16
Page 24 of 26
APPENDIX B Table B1. Troubleshooting common causes of outlying and/or aberrant results Type of error
Possible cause(s)
Sample mix-up
Two or more samples may have been interchanged, resulting in both outlying and aberrant results. Sample mix-up may occur during specimen reception or during testing.
Transcription
Common causes of transcription errors include: - Interchanging the results for two or more specimens; - Entering incorrect results; - Selecting the wrong assay or assay version in OASYS; - Entering values in the incorrect field (e.g. OD as S/Co); - Using a comma instead of a dot to denote a decimal point; - Selecting the incorrect assay interpretation. It is recommended that all results that are manually transcribed or entered via OASYS should be checked by a second individual in order to avoid such errors.
Inappropriate testing strategy followed
Testing negative samples in an immunoblot: Samples that are negative on screening should not be tested in an immunoblot as the samples may display non-specific reactivity and be reported indeterminate or falsely reactive unnecessarily. Only samples reactive on screening should be tested in an immunoblot. Failing to conduct neutralisation testing on samples showing reactivity on antigen tests: Participants that do not perform neutralisation testing may report It is recommended that neutralisation be falsely reactive test results. performed and reported on all samples screened reactive and results of other testing be reviewed to distinguish true from false reactivity. Using simple rapid HBsAg tests of inadequate sensitivity: Simple rapid HBsAg tests are often not as sensitive as EIA or instrument based tests. This can lead to falsely negative results in samples with low levels of HBsAg.
Aberrant serology status (This section applies to HEPM (HCV component), HIV and HTLV Serology EQAS only.
Incorrect data entry: When performing serological testing, participants use a variety of testing strategies that may involve testing with a combination of screening, supplemental and/or confirmatory assays. A final serology status (final interpretation) of “Positive”, “Negative” or “Inconclusive/Indeterminate” should only be assigned to a sample after consideration of all test results (screening, supplemental and confirmatory). Participants that test samples using only one assay should refer any reactive samples for further testing in order to distinguish true from false reactivity. When reporting a final interpretation in OASYS, a participant that would not report a status/final interpretation but would refer a sample for further testing should submit their results as: Serology Status Select Problem Code Refer for Further Testing
Do not select any option Would not report a status based on these results Yes
Otherwise, participants that would report a status/final interpretation should assign an appropriate status and select “No” for “Refer for Further Testing”.
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Table B1. Troubleshooting common causes of outlying and/or aberrant results (continued) Type of error
Possible cause(s)
Outlying and/or aberrant test results due to random error
Sporadic test results identified as outlying and/or aberrant can be classified as random events. Possible causes of random outlying and/or aberrant results include: - Insufficient mixing of sample, especially following freezing; - Poor pipetting; - Ineffective or inconsistent washing; - Transcription errors; - Sample mix-up; - Cross-contamination or carryover.
Outlying and/or aberrant test results due to systematic error
A series of test results identified as outlying and/or aberrant may be due to a systematic problem. Systematic problems may be due to: - Reagents contaminated, expired or subject to batch variation; - Instrument error or malfunction; - Insufficient washing; - Incorrect wavelength used to read the assay result; - Incubation time too long/short or temperature too high/low; - Insufficient mixing/centrifuging before testing; - Incorrect storage of test kits and/or reagents.
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