Could HIV-1 RNA Testing be an Option as the Second Step in the HIV Diagnostic Algorithm?

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  • Additional Information
    • Source:
      Publisher: J B Lippincott Country of Publication: United States NLM ID: 7705941 Publication Model: Print Cited Medium: Internet ISSN: 1537-4521 (Electronic) Linking ISSN: 01485717 NLM ISO Abbreviation: Sex Transm Dis Subsets: MEDLINE
    • Publication Information:
      Publication: Philadelphia Pa : J B Lippincott
      Original Publication: Philadelphia, Lippincott.
    • Subject Terms:
      HIV Antibodies/*blood ; HIV Infections/*blood ; HIV-1/*isolation & purification ; Nucleic Acid Amplification Techniques/*standards ; RNA, Viral/*blood ; Reagent Kits, Diagnostic/*standards ; Viral Load/*methods; Algorithms ; HIV Infections/diagnosis ; HIV Infections/drug therapy ; HIV-1/genetics ; Humans ; Polymerase Chain Reaction/methods ; RNA, Viral/genetics ; Reproducibility of Results ; Sensitivity and Specificity
    • Abstract:
      Background: There is benefit to early HIV-1 diagnosis and treatment, but there is no Food and Drug Administration-approved quantitative assay with a diagnostic claim. We compared the performance of the Hologic Aptima HIV-1 Quant (APT-Quant) and Aptima HIV-1 Qual (APT-Qual) assays for diagnostic use and the performance of a diagnostic algorithm consisting of Bio-Rad BioPlex 2200 HIV Ag-Ab assay (BPC) followed by APT-Quant (2-test) compared with BPC followed by Geenius HIV-1/2 supplemental assay (Geenius) with reflex to APT-Qual (3-test).
      Methods: Five hundred twenty-four plasma, which included 419 longitudinal specimens from HIV-1 seroconverters (78 were after initiating antiretroviral therapy [ART]) and 105 from ART-naive persons with established HIV-1 infections, were used to evaluate APT-Quant performance for diagnostic use. Specimens from 200 HIV-negative persons were used to measure specificity. For the algorithm comparison, BPC-reactive specimens were evaluated with the 2-test or 3-test algorithm. McNemar's test was used to compare performance.
      Results: The APT-Quant detected more samples early in infection compared with APT-Qual. The APT-Quant specificity was 99.8%. Before ART initiation, the algorithms performed similarly among samples from different stages of infection. After ART initiation, the 3-test algorithm performed significantly better (P = 0.0233).
      Conclusions: The APT-Quant has excellent performance for diagnostic use. The 2-test algorithm works well in ART-naive samples, but its performance decreases after the IgG response is elicited and with ART-induced suppressed viremia. Providing confirmation and viral load assay with 1 test result could be advantageous for patient care. However, additional factors and challenges associated with the implementation of this 2-test algorithm, such as cost, specimen type, and collection need further evaluation.
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    • Grant Information:
      CC999999 United States ImCDC Intramural CDC HHS
    • Accession Number:
      0 (HIV Antibodies)
      0 (RNA, Viral)
      0 (Reagent Kits, Diagnostic)
    • Publication Date:
      Date Created: 20200125 Date Completed: 20210406 Latest Revision: 20240524
    • Publication Date:
      20240524
    • Accession Number:
      PMC11111260
    • Accession Number:
      10.1097/OLQ.0000000000001137
    • Accession Number:
      31977972