J Virol Methods. 1999 Mar;78(1-2):21-34. Unique Identifier : AIDSLINE
An international collaborative study to assess inter-laboratory
variation in the sensitivity of gene amplification assays for the
detection of HIV-1 RNA sequences was conducted using a panel of eight
duplicate dilutions of an HIV-1 genotype B clinical isolate and negative
control samples. Twenty-five laboratories participated in the study and
used a variety of in-house assays and commercial assay systems. With few
exceptions, the assays were more sensitive than a p24 antigen assay.
Overall, the PCR-based Amplicor Monitor assay was the most sensitive and
gave the highest mean copy number for any one sample. Some of the
in-house assays gave results comparable with the Monitor assay whilst
the NASBA and bDNA assays appeared to be less sensitive. As a result of
this study, an HIV-1 Working Reagent for the standardisation of nucleic
acid amplification assays was developed and assessed in a subsequent
study. Similar differences in sensitivity between the different assay
systems was observed. The discrepancies in viral copy number obtained
using the Working Reagent highlights the need for an International
Standard against which all Working Reagents may be calibrated.
JOURNAL ARTICLE Adult DNA, Complementary DNA, Viral/ANALYSIS Gene
Amplification/*METHODS Human HIV Core Protein p24/ANALYSIS HIV
Infections/*VIROLOGY HIV-1/GENETICS/*ISOLATION & PURIF International
Cooperation Laboratories/*STANDARDS Male Polymerase Chain
Reaction/*STANDARDS Reproducibility of Results RNA,
Viral/*ANALYSIS/GENETICS Sensitivity and Specificity Support, Non-U.S.