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Journal of Clinical Microbiology, July 2002, p. 2387-2391, Vol. 40, No. 7
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.7.2387-2391.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

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,¹ K. Smith,² C. Knott,² A. Korpela,¹ A. Simmons,¹ E. Piwowar-Manning,¹ S. McDonough,² L. Mimms,² and J. M. Vargo^2*

Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland,¹ Gen-Probe Incorporated, San Diego, California²

Received 14 August 2001/ Returned for modification 11 November 2001/ Accepted 22 April 2002

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.

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* Corresponding author. Mailing address: Gen-Probe Incorporated, 10210 Genetic Center Dr., San Diego, CA 92121. Phone: (858) 410-8552. Fax: (858) 410-8622. E-mail: janetv{at}gen-probe.com.

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Journal of Clinical Microbiology, July 2002, p. 2387-2391, Vol. 40, No. 7
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.7.2387-2391.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

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