Journal article
The contribution of assay variation and biological variation to the total variability of plasma HIV-1 RNA measurements. The Women Infant Transmission Study Clinics. Virology Quality Assurance Program
AIDS (London), Vol.13(16), pp.2269-2279
11/12/1999
DOI: 10.1097/00002030-199911120-00009
PMID: 10563712
Abstract
To assess the specific contributions of assay variation and biological variation to the total variation of plasma HIV-1 RNA measured by the Roche Monitor assay and the extent to which batch assays reduced both assay variability and total variability compared with real-time determinations.
A retrospective analysis of data obtained from three trials conducted by the Adult and Pediatric AIDS Clinical Trials Groups (ATCG), the Women and Infants Transmission Study (WITS) and the NIAID-sponsored Virology Quality Assurance Program.
Within-subject variation was assessed from stored, serially collected plasma samples from 663 subjects enrolled in the ACTG and WITS studies. Interassay and intra-assay variation were estimated from two of the clinical trials and 22 laboratories that participated in a quality assurance program and were used to estimate the effect of real-time testing on total variation.
The total variation (standard deviation) from a random effects model was 0.26 log10 RNA copies/ml. The estimated interassay variation was 0.08 log10 and intra-assay variation was 0.12 log10 RNA copies/ml. Biological variation accounted for 56-80% of total variation. The effect of real-time testing compared with batch testing was minimal.
Our estimates of total within-subject HIV-1 RNA variation support the current recommendation to obtain at least two specimens, preferably obtained less than 2 weeks apart, for viral RNA measurement before starting therapy. The major contribution of biological variation to the total variation supports the use of real-time HIV-1 RNA assays, provided that consistent specimen collection procedures are followed and acceptable assay proficiency is maintained.
Details
- Title: Subtitle
- The contribution of assay variation and biological variation to the total variability of plasma HIV-1 RNA measurements. The Women Infant Transmission Study Clinics. Virology Quality Assurance Program
- Creators
- Donald Brambilla - New England Research Institute, Watertown, MA 02472, USAPatricia S ReichelderferJames W BremerDavid E ShapiroRonald C HershowDavid A KatzensteinScott M HammerBrooks JacksonAnn C CollierRhoda S SperlingMary Glenn FowlerRobert W Coombs
- Resource Type
- Journal article
- Publication Details
- AIDS (London), Vol.13(16), pp.2269-2279
- Publisher
- England
- DOI
- 10.1097/00002030-199911120-00009
- PMID
- 10563712
- ISSN
- 0269-9370
- eISSN
- 1473-5571
- Grant note
- UO1-AI-4110 / NIAID NIH HHS N0-AI-35172 / NIAID NIH HHS AI-27664 / NIAID NIH HHS
- Language
- English
- Date published
- 11/12/1999
- Academic Unit
- Pathology; VPMA - Administration
- Record Identifier
- 9984047605802771
Metrics
13 Record Views