National Institute for Biological Standards and Control Assuring the quality of biological medicines NIBSC Multiplex Proficiency Panel - A multicentre study Clare Morris and David Padley Divisions of Retrovirology and Virology
Mar 31, 2015
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: