Abstract
Expanding access to HIV viral load testing is essential to improving the care and treatment of people living with HIV/AIDS and ending the AIDS epidemic. Though significant investments have been made in the past five years, many high burden, low resource countries continue to have viral load access rates below 50%. Plasma preparation tubes (PPTs) can simplify storage, transport, and preparation of plasma used for viral load testing. A systematic review was conducted to evaluate the accuracy of plasma preparation tubes for HIV viral load testing. Study results regarding the accuracy of PPT viral load measurements across various storage and transportation conditions were examined. The quality of evidence was evaluated using GRADE and QUADAS-2 criteria. The review identified 16 studies using PPTs with data from 6,141 individuals from 1995 to 2014. Overall the quality of evidence was rated as moderate, with unclear applicability for studies evaluating viral load assays that are no longer commercially available. Significantly elevated viral load results (>0.3 log copies/ml difference) have been observed with PPTs; however, when manufacturer handling instructions are followed, when plasma is aliquoted into a secondary tube, or when PPTs are centrifuged prior to testing, PPT results only differed from standard EDTA plasma testing using commercially available viral load assays by a range on average of -0.03 to +0.08 log copies/ml across studies. Although spuriously elevated viral load results have been observed with PPTs, following proper sample handing techniques have been shown to provide accurate results. PPTs, therefore, provide a high quality alternative specimen type for countries seeking solutions to infrastructure and specimen transportation challenges in an effort to scale-up viral load testing and achieve 90-90-90 targets.
Highlights
Viral load testing is the preferred method for monitoring individuals on HIV antiretroviral treatment [1]
The quality of studies included in the systematic review was moderate overall
preparation tubes (PPTs) have been shown to provide equivalent viral load results to plasma from standard EDTA tubes if proper handling of PPTs is followed according to the guidance from independently published studies included in this review as well as manufacturer instructions [31,32]
Summary
Viral load testing is the preferred method for monitoring individuals on HIV antiretroviral treatment [1]. The primary and preferred sample type for viral load testing is plasma [3], which is prepared from whole blood collected via venipuncture. Whole blood in EDTA tubes, must be transported and centrifuged into plasma within 6–24 hours of sample collection, depending on the manufacturer [4]. This can be restrictive for many countries and health care facilities. Dried blood spots, which can be prepared from fingerstick whole blood, provide an alternative method for sample collection; limited progress has been made in ensuring the quality of using dried blood spots for HIV viral load testing through international regulatory approvals [7]. Countries have sought alternative specimen types and/or technologies to further support and expand viral load testing access
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