{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,2]],"date-time":"2025-07-02T17:29:26Z","timestamp":1751477366984},"reference-count":11,"publisher":"American Society for Microbiology","issue":"7","license":[{"start":{"date-parts":[[2002,7,1]],"date-time":"2002-07-01T00:00:00Z","timestamp":1025481600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2002,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>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.<\/jats:p>","DOI":"10.1128\/jcm.40.7.2387-2391.2002","type":"journal-article","created":{"date-parts":[[2002,7,28]],"date-time":"2002-07-28T23:07:23Z","timestamp":1027897643000},"page":"2387-2391","update-policy":"http:\/\/dx.doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":19,"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"],"prefix":"10.1128","volume":"40","author":[{"given":"J. B.","family":"Jackson","sequence":"first","affiliation":[{"name":"Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Smith","sequence":"additional","affiliation":[{"name":"Gen-Probe Incorporated, San Diego, California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Knott","sequence":"additional","affiliation":[{"name":"Gen-Probe Incorporated, San Diego, California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Korpela","sequence":"additional","affiliation":[{"name":"Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Simmons","sequence":"additional","affiliation":[{"name":"Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E.","family":"Piwowar-Manning","sequence":"additional","affiliation":[{"name":"Department of Pathology, The John Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"McDonough","sequence":"additional","affiliation":[{"name":"Gen-Probe Incorporated, San Diego, California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Mimms","sequence":"additional","affiliation":[{"name":"Gen-Probe Incorporated, San Diego, California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. M.","family":"Vargo","sequence":"additional","affiliation":[{"name":"Gen-Probe Incorporated, San Diego, California"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/35.8.1588"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/174.1.26"},{"key":"e_1_3_2_4_2","unstructured":"Busch M. P. S. L. Stramer and S. H. Kleinman. 1997. Evolving applications of nucleic acid amplification assays for prevention of virus transmission by blood components and derivatives p. 123-176. In G. Garrity (ed.) Applications of molecular biology to blood transfusion medicine. American Association of Blood Banks Bethesda Md."},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(97)07361-3"},{"key":"e_1_3_2_6_2","doi-asserted-by":"crossref","unstructured":"Giachetti C. J. J. Linnen D. P. Kolk J. Dockter M. K. McCormick M. Ho-Sing-Loy M. Park K. Gillotte-Taylor L. Mimms and S. H. McDonough. 2002. Highly sensitive multiplex assay for the detection of human immunodeficiency virus type 1 and hepatitis C virus RNA. J. Clin. Microbiol. 40: 2408-2419.","DOI":"10.1128\/JCM.40.7.2408-2419.2002"},{"key":"e_1_3_2_7_2","unstructured":"Hirsch M. S. and J. Curran. 1996. Human immunodeficiency viruses p. 1953-1975. In B. N. Fields et al. (ed.) Fields virology 3rd ed. Lippincott-Raven Publishers Philadelphia Pa."},{"key":"e_1_3_2_8_2","unstructured":"Houghton M. 1996. Hepatitis C viruses p. 1035-1058. In B. N. Fields et al. (ed.) Fields virology 3rd ed. Lippincott-Raven Publishers Philadelphia Pa."},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1086\/313744"},{"key":"e_1_3_2_10_2","unstructured":"Kacian D. L. and T. J. Fultz. January 1996. Nucleic acid sequence amplification methods. U.S. patent 5 480 784."},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1021\/bi960085"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.284.2.198"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.40.7.2387-2391.2002","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.40.7.2387-2391.2002","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,5]],"date-time":"2022-03-05T01:47:31Z","timestamp":1646444851000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/JCM.40.7.2387-2391.2002"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2002,7]]},"references-count":11,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2002,7]]}},"alternative-id":["10.1128\/JCM.40.7.2387-2391.2002"],"URL":"https:\/\/doi.org\/10.1128\/jcm.40.7.2387-2391.2002","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2002,7]]},"assertion":[{"value":"2001-08-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2002-04-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2002-07-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}