title: Sensitive detection of genetic variants of HIV-1 and HCV with an HIV-1/HCV assay based on transcription-mediated amplification.
abstract: This paper describes a comprehensive study of hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV-1) genotype sensitivity of the transcription-mediated amplification (TMA)-based HIV-1/HCV assay, developed and manufactured by Gen-Probe Incorporated (San Diego, CA) for screening human plasma specimens in blood bank settings. The TMA HIV-1/HCV assay is a qualitative, in vitro nucleic acid testing system used for initial screening. HIV-1 and HCV discriminatory assays are used to distinguish between HIV-1 and HCV infection or co-infection. In this study, multiple unique specimens representing HCV genotypes 1-6 were tested at various dilutions. The results show that the TMA HIV-1/HCV assay and the TMA HCV discriminatory assay have similar HCV genotype sensitivity, as both assays detected all six genotypes at 100 copies/ml and nearly all replicates tested at 30 copies/ml. Similarly, numerous unique specimens representing HIV-1 group M subtypes (A-G), HIV-1 group N, and group O specimens were tested at various dilutions. The TMA HIV-1/HCV assay and the TMA HIV-1 discriminatory assay were found to have similar HIV-1 subtype sensitivity; all variants at 100 copies/ml and nearly all at 30 copies/ml were detected. These results indicate that the TMA assays meet the sensitivity requirements for blood screening in blood banks worldwide.
authors.affiliation: Gen-Probe Incorporated, Research and Development, 10210 Genetic Center Drive, San Diego, CA 92121-4362, USA. jeffl@gen-probe.com
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Linnen
authors.forename: J Michael
authors.initials: JM
authors.lastname: Gilker
authors.forename: Alanna
authors.initials: A
authors.lastname: Menez
authors.forename: Alyshia
authors.initials: A
authors.lastname: Vaughn
authors.forename: Amy
authors.initials: A
authors.lastname: Broulik
authors.forename: Janel
authors.initials: J
authors.lastname: Dockter
authors.forename: Kristin
authors.initials: K
authors.lastname: Gillotte-Taylor
authors.forename: Kim
authors.initials: K
authors.lastname: Greenbaum
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Kolk
authors.forename: Larry T
authors.initials: LT
authors.lastname: Mimms
authors.forename: Cristina
authors.initials: C
authors.lastname: Giachetti
mesh_terms: D014644:Genetic Variation; D005838:Genotype; D015658:HIV Infections / Q000097:blood / Q000821:virology*; D015497:HIV-1 / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D006526:Hepatitis C / Q000097:blood / Q000821:virology*; D006801:Humans; D021141:Nucleic Acid Amplification Techniques; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014158:Transcription, Genetic
chemical_list: D011933:Reagent Kits, Diagnostic