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National Institute for Biological Standards and Control Assuring the quality of biological medicines NIBSC Multiplex Proficiency Panel - A multicentre.

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Presentation on theme: "National Institute for Biological Standards and Control Assuring the quality of biological medicines NIBSC Multiplex Proficiency Panel - A multicentre."— Presentation transcript:

1 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

2 Panel History Panels produced for the UK National Blood Transfusion Authority. UK requirement to screen for HCV RNA in blood donations since 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. 1 st HIV-1 RNA Proficiency panel produced in Panels have consisted of dilutions of a single marker, up to 15 members/panel.

3 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 BiomerieuxAmplicorProcliexUltrioIn house 11322

4 Sample numberSampleConcentration 1HCV100IU 2HCV50IU 3HCV10IU 4HIV-1200IU 5HIV-1100IU 6HIV-150IU 7Negative plasma0 8HIV-1, HCV, HBV200IU, 100IU, 50IU 9HIV-1, HCV, HBV100IU, 50IU, 20IU 10HCV + HIV50IU + 200IU 11HCV + HIV20IU + 100IU 12HCV + HBV20IU + 100IU 13HCV + HBV50IU + 50IU 14HIV + HBV200IU + 100IU 15HIV + HBV100IU + 50IU Panel Details

5 HIV-1 Results Sample 1 HCV 2 HCV 3 HCV 4 HIV 5 HIV 6 HIV 7 NEG 8 HIV HCV HBV 9 HIV HCV HBV 10 HCV + HIV 11 HCV + HIV 12 HCV + HBV 13 HCV + HBV 14 HIV + HBV 15 HIV + HBV LAB Not tested for HIV a b a Reactive - 7b Reactive -

6 HCV Results Sample 1 HCV 2 HCV 3 HCV 4 HIV 5 HIV 6 HIV 7 NEG 8 HIV HCV HBV 9 HIV HCV HBV 10 HCV + HIV 11 HCV + HIV 12 HCV + HBV 13 HCV + HBV 14 HIV + HBV 15 HIV + HBV LAB a b a Reactive - 7b Reactive -

7 HBV results Sample 1 HCV 2 HCV 3 HCV 4 HIV 5 HIV 6 HIV 7 NEG 8 HIV HCV HBV 9 HIV HCV HBV 10 HCV + HIV 11 HCV + HIV 12 HCV + HBV 13 HCV + HBV 14 HIV + HBV 15 HIV + HBV LAB Not tested for HBV 3 4a Not tested for HBV 4b a Reactive - 7b Reactive -

8 Conclusions HIV: One lab didnt 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:


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