Calibration of HCV working reagents for NAT assays against the HCV international standard. The Collaborative Study Group.
OBJECTIVE
Five HCV RNA reference reagents, the Paul Ehrlich Institut (PEI) reference 75, the National Institute for Biological Standards and Control (NIBSC) reagent 96/586, the Central Laboratory of the Netherlands Red Cross Blood Transfusion Service (CLB) Pelispy HCV RNA run control S2001, the Istituto Superiore di Sanità (ISS) reagent 0498 and the CBER panel member No. 1, were calibrated against the WHO International Standard, 96/790.


METHODS
The reference materials were calibrated in a collaborative study organised by NIBSC. Nineteen laboratories, using a range of qualitative and quantitative assays returned results.


RESULTS
The concentrations of the reagents were: 25,000 IU/ml for the PEI material, 710 IU/ml for the NIBSC material 96/586, 1,000 IU/ml for the CLB material, 1,700 IU/ml for the ISS material 0498 and 250 IU/ml for the CBER panel member No. 1.


CONCLUSIONS
The calibration of these five reference reagents for HCV RNA nucleic acid amplification technology (NAT) assays enables them to be used for standardisation and validation of assays. Such calibrants are essential for meeting the requirements of the European Medicinal Evaluation Agency (EMEA) for the testing of plasma pools and donations for HCV RNA for the release of blood products and the PEI requirements for the release testing of erythrocyte and thrombocyte concentrates.
Saldanha
J
J
Division of Virology, National Institute for Biological Standards and Control, South Mimms, UK. jsaldanha@nibsc.ac.uk
Heath
A
A
Lelie
N
N
Pisani
G
G
Nübling
M
M
Yu
M
M
D002138:Calibration; D016001:Confidence Intervals; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006801:Humans; D007202:Indicators and Reagents / Q000592:standards*; D016133:Polymerase Chain Reaction / Q000379:methods / Q000592:standards*; D012367:RNA, Viral / Q000097:blood*; D012015:Reference Standards; D012680:Sensitivity and Specificity; D014944:World Health Organization
D007202:Indicators and Reagents; D012367:RNA, Viral