REPORT ON AN INTERNATIONAL COLLABORATIVE STUDY TO ESTABLISH A REPLACEMENT WHO INTERNATIONAL STANDARD FOR HIV-1 RNA NAT ASSAYS

1. Summary Stocks of the 1 st International Standard for HIV-1 RNA are running low and it has recently been shown that the standard contains HBV DNA, making it less suitable for use with multiplex assays that detect multiple markers. Another candidate standard that was evaluated in the original collaborative study and shown to perform well has been re-evaluated to establish whether it would be a suitable replacement for the current international standard. Eight laboratories from six different countries participated in a collaborative study to evaluate a replacement for the 1 st International Standard for HIV-1 RNA for use in nucleic acid-based techniques (NAT). A total of eight different NATs were used, five in a quantitative format, three qualitative and five commercial assays were used.