Journal article
Clinical specificity and sensitivity of a blood screening assay for detection of HIV-1 and HCV RNA
Transfusion (Philadelphia, Pa.), Vol.42(7), pp.876-885
2002
DOI: 10.1046/j.1537-2995.2002.00130.x
PMID: 12375660
Abstract
BACKGROUND: An HIV‐1 and HCV NAT blood screening assay (Procleix HIV‐1/HCV, Gen‐Probe, Inc.) simultaneously detecting HIV‐1 and HCV RNA) has been implemented. Donor plasma samples reactive in the Procleix HIV‐1/HCV assay are tested with the HIV‐1 and HCV discriminatory assays to resolve whether HIV‐1 RNA, HCV RNA, or both are present.
STUDY DESIGN AND METHODS: To determine the specificity of the Procleix HIV‐1/HCV assay, data were analyzed for samples from 192,288 donations, tested in 16‐member pools. To determine sensitivity, data were analyzed for 2014 commercial samples known to contain HIV‐1, HCV, or both, as well as 10 HIV‐1 and 10 HCV commercial seroconversion panels.
RESULTS: The specificity of the Procleix HIV‐1/HCV assay was 99.7 percent. The HIV‐1 and HCV discriminatory assays showed similar specificity. The sensitivity of the Procleix HIV‐1/ HCV assay was 99.9, 99.6, and 100 percent, respectively, for samples containing HIV‐1, HCV, or both. The Procleix discriminatory assays were comparably sensitive. The Procleix discriminatory assays detected all tested samples of known HIV‐1 subtype or HCV genotype. Procleix HIV‐1/HCV testing of seroconversion panels showed that the median times to a positive reaction for HIV‐1 and HCV were reduced by 3 and 25 days, respectively, compared to serologic tests.
CONCLUSION: These studies support the use of the Procleix HIV‐1/HCV assay for routine blood donor screening.
Details
- Title: Subtitle
- Clinical specificity and sensitivity of a blood screening assay for detection of HIV-1 and HCV RNA
- Creators
- Janet VARGO - American Red Cross, Gaithersburg, Maryland, United StatesKatie SMITH - American Red Cross, Gaithersburg, Maryland, United StatesJ. Brooks JACKSON - American Red Cross, Gaithersburg, Maryland, United StatesWilliam RICHARDS - American Red Cross, Gaithersburg, Maryland, United StatesSusan STRAMER - American Red Cross, Gaithersburg, Maryland, United StatesLarry MIMMS - American Red Cross, Gaithersburg, Maryland, United StatesCaroline KNOTT - American Red Cross, Gaithersburg, Maryland, United StatesSongbai Wang - American Red Cross, Gaithersburg, Maryland, United StatesChyang Fang - American Red Cross, Gaithersburg, Maryland, United StatesSherrol MCDONOUGH - American Red Cross, Gaithersburg, Maryland, United StatesCristina GIACHETTI - American Red Cross, Gaithersburg, Maryland, United StatesSally CAGLIOTI - American Red Cross, Gaithersburg, Maryland, United StatesRichard GAMMON - American Red Cross, Gaithersburg, Maryland, United StatesDenise GILBERT - American Red Cross, Gaithersburg, Maryland, United States
- Resource Type
- Journal article
- Publication Details
- Transfusion (Philadelphia, Pa.), Vol.42(7), pp.876-885
- Publisher
- Blackwell Publishing; Oxford
- DOI
- 10.1046/j.1537-2995.2002.00130.x
- PMID
- 12375660
- ISSN
- 0041-1132
- eISSN
- 1537-2995
- Language
- English
- Date published
- 2002
- Academic Unit
- Pathology; VPMA - Administration
- Record Identifier
- 9984047660502771
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