Sensitivity of the Procleix HIV-1/HCV Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA in a High-Risk Population

J. B Jackson; K Smith; C Knott; A Korpela; A Simmons; E Piwowar-Manning; S McDonough; L Mimms; J. M Vargo

doi:10.1128/JCM.40.7.2387-2391.2002

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Sensitivity of the Procleix HIV-1/HCV Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA in a High-Risk Population

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Sensitivity of the Procleix HIV-1/HCV Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA in a High-Risk Population

J. B Jackson, K Smith, C Knott, A Korpela, A Simmons, E Piwowar-Manning, S McDonough, L Mimms and J. M Vargo

Journal of clinical microbiology, Vol.40(7), pp.2387-2391

07/2002

DOI: 10.1128/JCM.40.7.2387-2391.2002

PMCID: PMC120572

PMID: 12089252

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Abstract

The Procleix HIV-1/HCV Assay is a high-throughput nucleic acid test for the simultaneous detection of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) RNA during blood donor screening. This study evaluated the clinical sensitivity of the Procleix assay and assessed the assay's ability to identify HIV-1- and HCV-infected individuals undetected by standard serologic tests. Plasma samples were obtained prospectively from 539 individuals at high risk for HIV-1 and HCV infection at seven clinics affiliated with Johns Hopkins University. Samples were tested in the Procleix HIV-1/HCV Assay and, if reactive, were then tested in the Procleix HIV-1 and HCV discriminatory assays to differentiate the source of viral RNA positivity. Of these 539 subjects, 287 (53.2%) tested reactive in the Procleix HIV-1/HCV Assay. In discriminatory assay testing, 12 of 287 subjects (4.2%) were reactive for HIV-1 RNA only, 260 (90.6%) were reactive for HCV RNA only, and 11 (3.8%) were coinfected with HIV-1 and HCV. The clinical sensitivity for samples tested neat was 100% for HIV-1 and 99.3% for HCV. Three subjects with Procleix HCV reactive/seronegative results seroconverted upon follow-up and were confirmed as Procleix HCV yield cases. The Procleix HIV-1/HCV Assay is a highly sensitive test that detects ongoing and early HIV-1 and HCV infection in a significant number of subjects at high risk for these diseases. Confirmation of Procleix yield cases upon follow-up demonstrated the ability of the Procleix HIV-1/HCV Assay to detect the presence of HIV-1 and HCV in blood earlier than standard serologic tests.

Virology

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Title: Subtitle: Sensitivity of the Procleix HIV-1/HCV Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA in a High-Risk Population
Creators: J. B Jackson - Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland
K Smith - Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland
C Knott - Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland
A Korpela - Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland
A Simmons - Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland
E Piwowar-Manning - Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland
S McDonough - Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland
L Mimms - Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland
J. M Vargo - Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland
Resource Type: Journal article
Publication Details: Journal of clinical microbiology, Vol.40(7), pp.2387-2391
DOI: 10.1128/JCM.40.7.2387-2391.2002
PMID: 12089252
PMCID: PMC120572
NLM abbreviation: J Clin Microbiol
ISSN: 0095-1137
eISSN: 1098-660X
Publisher: American Society for Microbiology
Language: English
Date published: 07/2002
Academic Unit: Pathology; VPMA - Administration
Record Identifier: 9984047614502771

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