title: 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.
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.
authors.affiliation: Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland, USA.
authors.forename: J B
authors.initials: JB
authors.lastname: Jackson
authors.forename: K
authors.initials: K
authors.lastname: Smith
authors.forename: C
authors.initials: C
authors.lastname: Knott
authors.forename: A
authors.initials: A
authors.lastname: Korpela
authors.forename: A
authors.initials: A
authors.lastname: Simmons
authors.forename: E
authors.initials: E
authors.lastname: Piwowar-Manning
authors.forename: S
authors.initials: S
authors.lastname: McDonough
authors.forename: L
authors.initials: L
authors.lastname: Mimms
authors.forename: J M
authors.initials: JM
authors.lastname: Vargo
mesh_terms: D015492:AIDS Serodiagnosis; D000293:Adolescent; D000328:Adult; D000368:Aged; D001782:Blood Donors; D005260:Female; D015658:HIV Infections / Q000175:diagnosis; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods / Q000706:statistics & numerical data; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis* / Q000097:blood / Q000235:genetics; D012307:Risk Factors; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods* / Q000706:statistics & numerical data
chemical_list: D012367:RNA, Viral