REFERENCE PREPARATIONS IN THE STANDARDIZATION OF HIV-1 PCR - AN INTERNATIONAL COLLABORATIVE STUDY

Following the recent developments in diagnostic polymerase chain react ion (PCR) technology, we have assessed a set of HIV-1 DNA reference st andards using the first commercial diagnostic test kit for the detecti on for HIV-1 (Amplicor(TM), Roche) in an international collaborative s tudy. Nineteen laboratories in 11 countries analysed a set of ten (re- coded) HIV-1 DNA reference standards, whose performance had been valid ated in a previous collaborative study (Bootman and Kitchin, 1992). Re sults from the current study show that, using the diagnostic kit, 84% of laboratories (16/19) obtained correct diagnoses for all ten test sa mples. One additional laboratory failed only to detect the sample cont aining ten copies of target template. Test results from the remaining two laboratories were declared void in accordance with the Amplicor(TM ) quality control guidelines.