Options to Expand HIV Viral Load Testing in South Africa: Evaluation of the GeneXpert® HIV-1 Viral Load Assay
Autor: | Lesley Scott, Natasha Gous, Leigh Berrie, Wendy Stevens |
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Rok vydání: | 2016 |
Předmět: |
0301 basic medicine
Male RNA viruses Physiology Human immunodeficiency virus (HIV) lcsh:Medicine HIV Infections medicine.disease_cause Pathology and Laboratory Medicine Geographical locations South Africa 0302 clinical medicine Immunodeficiency Viruses Antiretroviral Therapy Highly Active Medicine and Health Sciences Medicine Mass Screening Public and Occupational Health 030212 general & internal medicine Dried blood lcsh:Science Whole blood Multidisciplinary GeneXpert MTB/RIF Hematology Middle Aged Viral Load Vaccination and Immunization Body Fluids Blood Molecular Diagnostic Techniques Medical Microbiology Viral Pathogens Viruses RNA Viral Female Anatomy Pathogens Viral load Research Article Adult 030106 microbiology Immunology Antiretroviral Therapy Research and Analysis Methods Sensitivity and Specificity Microbiology Blood Plasma Specimen Handling 03 medical and health sciences Antiviral Therapy Virology Retroviruses Antiretroviral treatment Humans Microbial Pathogens Mass screening business.industry lcsh:R Lentivirus Organisms Biology and Life Sciences HIV Antiretroviral therapy Specimen Preparation and Treatment Africa HIV-1 lcsh:Q Preventive Medicine People and places business Viral Transmission and Infection |
Zdroj: | PLoS ONE PLoS ONE, Vol 11, Iss 12, p e0168244 (2016) |
ISSN: | 1932-6203 |
Popis: | 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. Method 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. Conclusion 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. |
Databáze: | OpenAIRE |
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