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Evaluation of the VioOne HIV profile supplemental assay.

Publication ,  Journal Article
Franz, BJ; Register, H; Sullivan, V; Warber, K; Granade, TC; Cornaby, C; Magee, ME; Denny, TN; Lockwood, D; Schmitz, JL
Published in: J Clin Microbiol
February 14, 2024

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.

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Published In

J Clin Microbiol

DOI

EISSN

1098-660X

Publication Date

February 14, 2024

Volume

62

Issue

2

Start / End Page

e0083623

Location

United States

Related Subject Headings

  • United States
  • Sensitivity and Specificity
  • Reproducibility of Results
  • Microbiology
  • Humans
  • HIV-2
  • HIV-1
  • HIV Seropositivity
  • HIV Infections
  • HIV Core Protein p24
 

Citation

APA
Chicago
ICMJE
MLA
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Franz, B. J., Register, H., Sullivan, V., Warber, K., Granade, T. C., Cornaby, C., … Schmitz, J. L. (2024). Evaluation of the VioOne HIV profile supplemental assay. J Clin Microbiol, 62(2), e0083623. https://doi.org/10.1128/jcm.00836-23
Franz, Brian J., Heidi Register, Vickie Sullivan, Kimbrough Warber, Timothy C. Granade, Caleb Cornaby, Mark E. Magee, Thomas N. Denny, Don Lockwood, and John L. Schmitz. “Evaluation of the VioOne HIV profile supplemental assay.J Clin Microbiol 62, no. 2 (February 14, 2024): e0083623. https://doi.org/10.1128/jcm.00836-23.
Franz BJ, Register H, Sullivan V, Warber K, Granade TC, Cornaby C, et al. Evaluation of the VioOne HIV profile supplemental assay. J Clin Microbiol. 2024 Feb 14;62(2):e0083623.
Franz, Brian J., et al. “Evaluation of the VioOne HIV profile supplemental assay.J Clin Microbiol, vol. 62, no. 2, Feb. 2024, p. e0083623. Pubmed, doi:10.1128/jcm.00836-23.
Franz BJ, Register H, Sullivan V, Warber K, Granade TC, Cornaby C, Magee ME, Denny TN, Lockwood D, Schmitz JL. Evaluation of the VioOne HIV profile supplemental assay. J Clin Microbiol. 2024 Feb 14;62(2):e0083623.

Published In

J Clin Microbiol

DOI

EISSN

1098-660X

Publication Date

February 14, 2024

Volume

62

Issue

2

Start / End Page

e0083623

Location

United States

Related Subject Headings

  • United States
  • Sensitivity and Specificity
  • Reproducibility of Results
  • Microbiology
  • Humans
  • HIV-2
  • HIV-1
  • HIV Seropositivity
  • HIV Infections
  • HIV Core Protein p24