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Evaluation of the performance of the Cepheid Xpert HIV-1 Viral Load Assay for quantitative and diagnostic uses.
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.
Afiliación
  • Wesolowski L; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: lig7@cdc.gov.
  • Fowler W; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: William.fowler@fda.hhs.gov.
  • Luo W; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: wfl9@cdc.gov.
  • Sullivan V; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: vst5@cdc.gov.
  • Masciotra S; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: svm6@cdc.gov.
  • Smith T; Oak Ridge Institute for Science and Education at the Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: kra8@cdc.gov.
  • Rossetti R; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: nvp4@cdc.gov.
  • Delaney K; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: khd8@cdc.gov.
  • Oraka E; ICF at the Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: ght2@cdc.gov.
  • Chavez P; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: geo5@cdc.gov.
  • Ethridge S; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: sfe1@cdc.gov.
  • Switzer WM; Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: Switzerbis3@cdc.gov.
  • Owen SM; National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: smo2@cdc.gov.
J Clin Virol ; 122: 104214, 2020 01.
Article en En | MEDLINE | ID: mdl-31835210
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: ARN Viral / Infecciones por VIH / Carga Viral / Técnicas de Amplificación de Ácido Nucleico Tipo de estudio: Diagnostic_studies / Evaluation_studies / Prognostic_studies / Qualitative_research Límite: Humans Idioma: En Revista: J Clin Virol Asunto de la revista: VIROLOGIA Año: 2020 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: ARN Viral / Infecciones por VIH / Carga Viral / Técnicas de Amplificación de Ácido Nucleico Tipo de estudio: Diagnostic_studies / Evaluation_studies / Prognostic_studies / Qualitative_research Límite: Humans Idioma: En Revista: J Clin Virol Asunto de la revista: VIROLOGIA Año: 2020 Tipo del documento: Article Pais de publicación: Países Bajos