title: Options to Expand HIV Viral Load Testing in South Africa: Evaluation of the GeneXpert® HIV-1 Viral Load Assay.
abstract: BACKGROUND
  Expansion of HIV viral load (VL) testing services are required to meet increased targets for monitoring patients on antiretroviral treatment. South Africa currently tests >4million VLs per annum in 16 highly centralised, automated high-throughput laboratories. The Xpert HIV-1 VL assay (Cepheid) was evaluated against in-country predicates, the Roche Cobas Taqmanv2 and Abbott HIV-1RT, to investigate options for expanding VL testing using GeneXpert's random access, polyvalent capabilities and already established footprint in South Africa with the Xpert MTB/RIF assay (207 sites). Additionally, the performance of Xpert HIV-1VL on alternative, off-label specimen types, Dried Blood Spots (DBS) and whole blood, was investigated.
  
  
  METHODS
  Precision, accuracy (agreement) and clinical misclassification (1000cp/ml) of Xpert HIV-1VL plasma was compared to Taqmanv2 (n = 155) and Abbott HIV-1 RT (n = 145). Misclassification of Xpert HIV-1VL was further tested on DBS (n = 145) and whole blood (n = 147).
  
  
  RESULTS
  Xpert HIV-1VL demonstrated 100% concordance with predicate platforms on a standardised frozen, plasma panel (n = 42) and low overall percentage similarity CV of 1.5% and 0.9% compared to Taqmanv2 and Abbott HIV-1 RT, respectively. On paired plasma clinical specimens, Xpert HIV-1VL had low bias (SD 0.32-0.37logcp/ml) and 3% misclassification at the 1000cp/ml threshold compared to Taqmanv2 (fresh) and Abbott HIV-1 RT (frozen), respectively. Xpert HIV-1VL on whole blood and DBS increased misclassification (upward) by up to 14% with increased invalid rate. All specimen testing was easy to perform and compatible with concurrent Xpert MTB/RIF Tuberculosis testing on the same instrument.
  
  
  CONCLUSIONS
  The Xpert HIV-1VL on plasma can be used interchangeably with existing predicate platforms in South Africa. Whole blood and DBS testing requires further investigation, but polyvalency of the GeneXpert offers a solution to extending VL testing services.
authors.affiliation: Department of Haematology and Molecular Medicine, School of Pathology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.|National Priority Program of the National Health Laboratory Services, Johannesburg, South Africa.
authors.forename: Natasha
authors.initials: N
authors.lastname: Gous
authors.affiliation: Department of Haematology and Molecular Medicine, School of Pathology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
authors.forename: Lesley
authors.initials: L
authors.lastname: Scott
authors.affiliation: National Priority Program of the National Health Laboratory Services, Johannesburg, South Africa.
authors.forename: Leigh
authors.initials: L
authors.lastname: Berrie
authors.affiliation: Department of Haematology and Molecular Medicine, School of Pathology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.|National Priority Program of the National Health Laboratory Services, Johannesburg, South Africa.
authors.forename: Wendy
authors.initials: W
authors.lastname: Stevens
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology; D015497:HIV-1; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012367:RNA, Viral / Q000032:analysis / Q000097:blood*; D012680:Sensitivity and Specificity; D013019:South Africa / Q000453:epidemiology; D013048:Specimen Handling / Q000379:methods; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral