Reference preparations in the standardisation of HIV-1 PCR--an international collaborative study.
Following the recent developments in diagnostic polymerase chain reaction (PCR) technology, we have assessed a set of HIV-1 DNA reference standards using the first commercial diagnostic test kit for the detection of HIV-1 (Amplicor, Roche) in an international collaborative study. Nineteen laboratories in 11 countries analysed a set of ten (re-coded) HIV-1 DNA reference standards, whose performance had been validated in a previous collaborative study (Bootman and Kitchin, 1992). Results from the current study show that, using the diagnostic kit, 84% of laboratories (16/19) obtained correct diagnoses for all ten test samples. One additional laboratory failed only to detect the sample containing ten copies of target template. Test results from the remaining two laboratories were declared void in accordance with the Amplicor quality control guidelines.
Bootman
J S
JS
PCR Reference Centre, AIDS Collaborating Centre, NIBSC, Potters Bar, Herts, UK.
Kitchin
P A
PA
D004279:DNA, Viral / Q000235:genetics / Q000592:standards; D005188:False Negative Reactions; D005189:False Positive Reactions; D015658:HIV Infections / Q000175:diagnosis; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D007391:International Cooperation; D016133:Polymerase Chain Reaction / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data
D004279:DNA, Viral