Evaluation of the VioOne HIV profile supplemental assay.

Autor:	Franz BJ; Department of Pathology and Laboratory Medicine, UNC-Chapel Hill School of Medicine , Chapel Hill, North Carolina, USA., Register H; Duke Human Vaccine Institute, Duke University Medical Center , Durham, North Carolina, USA., Sullivan V; Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention , Atlanta, Georgia, USA., Warber K; Clinical Reference Laboratory, Clinical Reference Laboratory Inc. , Lenexa, Kansas, USA., Granade TC; Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention , Atlanta, Georgia, USA., Cornaby C; Department of Pathology and Laboratory Medicine, UNC-Chapel Hill School of Medicine , Chapel Hill, North Carolina, USA., Magee ME; Clinical Reference Laboratory, Clinical Reference Laboratory Inc. , Lenexa, Kansas, USA., Denny TN; Duke Human Vaccine Institute, Duke University Medical Center , Durham, North Carolina, USA., Lockwood D; Avioq, Inc. , Research Triangle Park, North Carolina, USA., Schmitz JL; Department of Pathology and Laboratory Medicine, UNC-Chapel Hill School of Medicine , Chapel Hill, North Carolina, USA.
Jazyk:	angličtina
Zdroj:	Journal of clinical microbiology [J Clin Microbiol] 2024 Feb 14; Vol. 62 (2), pp. e0083623. Date of Electronic Publication: 2024 Jan 11.
DOI:	10.1128/jcm.00836-23
Abstrakt:	HIV is an ongoing global epidemic with estimates of more than a million new infections occurring annually. To combat viral spread, continuous innovations in areas including testing and treatment are necessary. In the United States, the Centers for Disease Control and Prevention recommend that laboratories follow an HIV testing algorithm that first uses a US Food and Drug Administration approved immunoassay to detect antibodies to HIV-1 or HIV-2 as well as HIV-1 p24 antigen in serum or plasma samples. An initially reactive specimen is tested by a supplemental assay for confirmation and to differentiate antibodies to HIV-1 or HIV-2. There are few Food and Drug Administration (FDA)-approved supplemental differentiation tests currently available. A multicenter investigation was conducted to determine the clinical performance for two independent versions of the Avioq VioOne HIV Profile Supplemental Assay (Avioq, Inc., Research Triangle Park, NC). The performance of both assay versions compared favorably with the performance parameters for the Geenius HIV 1/2 Supplemental Assay as published in that assay package insert (Bio-Rad Laboratories, Hercules, CA), the current gold standard for HIV supplemental testing. When comparing the two VioOne assays, version 2 (lacking HIV-2 p27 antibody detection) demonstrated improved reproducibility, specificity, and sensitivity as compared to its predecessor. IMPORTANCE We evaluated the reproducibility, sensitivity, and specificity data for two versions of the VioOne HIV Profile Supplemental Assay and compared these results back to similar results for the Geenius HIV 1/2 Supplemental Assay that are publicly available. Our study concluded that the VioOne HIV Profile Supplemental Assay compared favorably with the Geenius HIV 1/2 Supplemental Assay, thus providing an additional option for clinical laboratories to improve and expand their HIV testing capabilities. Competing Interests: Author Don Lockwood is an employee of Avioq, Inc. Avioq provided the reagents for this study.
Databáze:	MEDLINE
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