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National Institute for Biological Standards and ControlAssuring the quality of biological medicines
NIBSC Multiplex Proficiency Panel - A multicentre study
Clare Morris and David PadleyDivisions of Retrovirology and Virology
Panel History
• Panels produced for the UK National Blood Transfusion Authority.
• UK requirement to screen for HCV RNA in blood donations since 1999.
• Initially, annual HCV proficiency panels produced to monitor assay and operator performance across UK sites.
• In 2005 HIV-1 screening introduced in the one NBS site.• 1st HIV-1 RNA Proficiency panel produced in 2006.• Panels have consisted of dilutions of a single marker, up to
15 members/panel.
New multiplex approach
• Panel consisted of 15 coded samples.• Contained combinations of HIV, HCV, HBV.• One plasma negative was included.• 7 labs took part, 2 labs reported data using two systems.• Due to potential for confirmatory testing each lab was sent
4 panels.• Requested to test panel through routine algorithm.• 5 labs used commercial assays, 2 used in house assays
Biomerieux Amplicor Procliex Ultrio In house
1 1 3 2 2
Sample number Sample Concentration
1 HCV 100IU
2 HCV 50IU
3 HCV 10IU
4 HIV-1 200IU
5 HIV-1 100IU
6 HIV-1 50IU
7 Negative plasma 0
8 HIV-1, HCV, HBV 200IU, 100IU, 50IU
9 HIV-1, HCV, HBV 100IU, 50IU, 20IU
10 HCV + HIV 50IU + 200IU
11 HCV + HIV 20IU + 100IU
12 HCV + HBV 20IU + 100IU
13 HCV + HBV 50IU + 50IU
14 HIV + HBV 200IU + 100IU
15 HIV + HBV 100IU + 50IU
Panel Details
HIV-1 Results
Sample 1
HCV
2
HCV
3
HCV
4
HIV
5
HIV
6
HIV
7
NEG
8
HIV
HCVHBV
9
HIV
HCVHBV
10
HCV + HIV
11
HCV + HIV
12
HCV + HBV
13
HCV + HBV
14
HIV + HBV
15
HIV + HBV
LAB
1 - - - + + + - + + + + - - + +
2 Not tested for HIV
3 - - - + + + - + + + + - - + +
4a - - - + + + - + + + + - - + +
4b - - - + + + - + + + + - - + +
5 - - - + + + - + + + + - - + +
6 - - - + + + - + - + + - - + +
7a Reactive - Reactive
7b Reactive - Reactive
HCV Results
Sample 1
HCV
2
HCV
3
HCV
4
HIV
5
HIV
6
HIV
7
NEG
8
HIV
HCVHBV
9
HIV
HCVHBV
10
HCV + HIV
11
HCV + HIV
12
HCV + HBV
13
HCV + HBV
14
HIV + HBV
15
HIV + HBV
LAB
1 + + + - + + + + + +
2 + + + - + + + + - +
3 + + + - + + + + + +
4a + + + - + + + + + +
4b + + + - + + + + + +
5 + + + - + + + + + +
6 + + - - - + + + + +
7a Reactive - Reactive
7b Reactive - Reactive
HBV results
Sample 1
HCV
2
HCV
3
HCV
4
HIV
5
HIV
6
HIV
7
NEG
8
HIV
HCVHBV
9
HIV
HCVHBV
10
HCV + HIV
11
HCV + HIV
12
HCV + HBV
13
HCV + HBV
14
HIV + HBV
15
HIV + HBV
LAB
1 + + + + + +
2 Not tested for HBV
3 Not tested for HBV
4a Not tested for HBV
4b + + + + + +
5
6 + + + + + +
7a Reactive - Reactive
7b Reactive - Reactive
Conclusions
• HIV: One lab didn’t detect 100IU in triplex sample. All other labs detected HIV at all concentrations.
• HCV: Lab 2 failed to detect 20 IU sample. Lab 6 failed to detect 10 IU sample & 100 IU in a triplex sample.
• HBV: 3 data sets available. All HBV samples detected.
• 50 proficiency panels remaining, if you would like to receive one please E mail me at:
