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

Details

• Alternative Title:
  Sex Transm Dis
• Personal Author:
  Masciotra, Silvina ; Luo, Wei ; Rossetti, Rebecca ; Smith, Tara ; Ethridge, Steven ; Delaney, Kevin P. ; Wesolowski, Laura G. ; Owen, S. Michele
• Description:
  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.
  
  
• Subjects:
  Algorithms HIV-1 HIV Antibodies HIV Infections Humans Nucleic Acid Amplification Techniques Polymerase Chain Reaction Reagent Kits, Diagnostic Reproducibility Of Results RNA, Viral Sensitivity And Specificity Viral Load

  More +
• Source:
  Sex Transm Dis. 47(5):S26-S31
• Pubmed ID:
  31977972
• Pubmed Central ID:
  PMC11111260
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  47
• Issue:
  5
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:154448bfc9ffb06bfed73dfdb919f725e2258e19285869d87bac820ef4b0c84c
• Download URL:
  https://stacks.cdc.gov/view/cdc/156935/cdc_156935_DS1.pdf
• File Type:
  [PDF - 119.04 KB ]