Evaluation of the Performance of the Cepheid Xpert HIV‐1 Viral Load Assay for Quantitative and Diagnostic Uses

Details

• Alternative Title:
  J Clin Virol
• Personal Author:
  Wesolowski, Laura ; Fowler, William ; Luo, Wei ; Sullivan, Vickie ; Masciotra, Silvina ; Smith, Tara ; Rossetti, Rebecca ; Delaney, Kevin ; Oraka, Emeka ; Chavez, Pollyanna ; Ethridge, Steven ; Switzer, William M. ; Owen, S. Michele
  More +
• Description:
  Background ; Cepheid’s Xpert HIV‐1 Viral Load (Xpert VL), a simplified, automated, single-use quantitative assay used with the GeneXpert System, is not FDA-approved. ; Objectives ; Using stored plasma, we conducted a study to assess the ability of Xpert VL to quantify viral load relative to the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 (Cobas VL) and to examine the use of the Xpert VL as a qualitative diagnostic test. ; Study Design ; Following HIV-1 viral stock dilutions, we conducted a probit analysis to identify the concentration where 95% of specimens had quantified VLs. We also examined Xpert and Cobas log VL correlation in linearity panels; compared the proportion of 220 seroconverter specimens with virus detected using McNemar’s test; and tested specimens from persons with untreated, established HIV-1 infection (n=149) and uninfected persons (n=497). Furthermore, we examined Xpert VL as a qualitative test in seroconverter specimens with early (n=20) and later (n=68) acute infections. ; Results ; At 1.80 log10 copies/mL, 95% of specimens had quantifiable virus using Xpert VL. Xpert and Cobas VLs were highly correlated (R2=0.994). The proportion of seroconverter specimens with virus detected using Cobas and with Xpert VL was not statistically different (p=0.0578). Xpert VL detected 97.9% of established infections, and specificity was 99.80% (95% CI 98.87%−99.99%). Xpert VL detected 90% and 98.5% of early and later acute infections, respectively. ; Conclusions ; If approved, Xpert VL could allow U.S. laboratories that cannot bring on large, complex testing platforms to conduct HIV monitoring. An approval for diagnostic use may provide timely identification of HIV infections.
• Subjects:
  • Automation, Laboratory
  • HIV Infections
  • HIV-1
  • Humans
  • Nucleic Acid Amplification Techniques
  • RNA, Viral
  • Sensitivity and Specificity
  • Specimen Handling
  • Viral Load
• Keywords:
  • HIV-1
  • nucleic acid test
  • viral load
  • diagnostic
• Source:
  J Clin Virol. 122:104214
• Pubmed ID:
  31835210
• Pubmed Central ID:
  PMC11089535
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  122
• Download URL:
  https://stacks.cdc.gov/view/cdc/156350/cdc_156350_DS1.pdf
• File Type:
  [PDF - 739.42 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:1e21c626bd6cd54e522e2e9a26d93d10cd9f094fa3b3fce5cb4f94d5d03044ce