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
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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