This document describes key considerations for preparing for national implementation and scale-up of routine viral load (VL) monitoring. It outlines VL monitoring principles; implementation considerations; laboratory considerations (including referral network mapping, specimen transport, platform selection, point-of-care VL platforms, and laboratory quality management systems); and monitoring and evaluation.
Viral Load Testing: Laboratory Management
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ICAP, 2017.
Mwau M., et al. 2018. PLoS ONE 13(1): e0190659.
This article describes characteristics of 1,108,356 viral load (VL) tests assessed—including reason for testing, turnaround times, test results, treatment regimens, and socio-demographic information to assess VL program scale-up in Kenya.
Drain P.K. and Rousseau C. (2017). Curr Opin HIV AIDS. 2017 Mar; 12(2): 175–181. DOI: 10.1097/COH.0000000000000351.
This review highlights the obstacles for developing and implementing appropriate strategies for point-of-care (POC) HIV testing assays, including POC viral load testing, to improve clinical services for HIV-infected patients in resource-limited settings.
Association of Public Health Laboratories (APHL), 2017.
This brief highlights the viral load scale-up efforts of the Association of Public Health Laboratories (APHL) to implement quality testing services to monitor antiretroviral treatment effectiveness in Zimbabwe, Mozambique, Zambia, Ghana, and Kenya.
Médecins Sans Frontières (MSF), 2017.
This Excel sheet provides supplementary material for the MSF report, Putting HIV and HCV to the Test: A Product Guide for Point-of-Care (POC) CD4 Tests and Laboratory-based and POC HIV and HCV Viral Load Tests. It provides updated national recommendations on CD4 and viral load testing, across 55 low- and middle-income countries, sourced from the International Association of Providers of AIDS Care (IAPAC) database, and the extent of implementation. CD4 and viral load testing availability data was derived from Country Progress Reports (2014-2015), PEPFAR COPs, and the MSF Speed-up Scale-up Report, analysis was performed until mid-May 2017. It includes frequency of CD4 testing after ART initiation as well as national recommendations on use of viral load testing for ART monitoring and its availability.
ICAP—Columbia University, 2016.
The purpose of this document is to describe standard operating procedures for viral load (VL) monitoring, including the schedule for VL testing when used for routine monitoring of children, adolescents and adults on ART; interpretation of results; patient management; and specimen collection, preparation and transport. This template document to be adapted for use in various contexts and is one component of a VL monitoring toolkit, to be used in conjunction with ICAP’s VL Monitoring Flipchart and Enhanced Adherence Treatment Plan.
Kenya Ministry of Health, 2016.
This MOH Kenya package of forms and log books guides clinicians and laboratory staff through the process of tracking viral load samples and results and includes filling instructions.
Zeh C, et al. PLOS ONE 12(6): e0179316. https://doi.org/10.1371/journal.pone.0179316. (2017)
This study evaluated matched dried blood spots (DBS) and dried plasma spots (DPS) against plasma using the Abbott M 2000 and Roche Cobas Ampliprep/Cobas TaqMan (CAP/CTM) quantitative viral load (VL) assays in western Kenya. There was similar performance between matched DBS, DPS, and plasma using the Abbott test, and good correlation for matched DPS and plasma using the CAP/CTM test. The findings suggest that DBS and DPS may be reliably used as alternative specimens to plasma to measure HIV-1 VL using Abbott, and DPS may be reliably used with CAP/CTM in resource-limited settings.
Hamel DJ, et al. (2015). Afr J Lab Med. 2015; 4(1): 190. doi: 10.4102/ajlm.v4i1.190
This article provides an overview of methods for the development and support of a sustainable laboratory infrastructure, while simultaneously developing quality processes through a quality management system model and building upon the existing physical and human capital in a resource-limited setting such as Nigeria.
Minchella PA, et al. (2017). PLOS ONE 12(2): e0173009. doi.org/10.1371/journal.pone.0173009
This study analyzed VL testing data collected in Malawi January 2013–March 2016 for two outcomes: greater-than-median pretest phase turnaround time (TAT)—days elapsed from specimen collection to receipt at the laboratory—and greater-than-median test phase turnaround time—days from receipt to testing. Results included that the odds of longer pretest phase TAT were significantly higher for specimen collection districts without laboratories capable of conducting VL tests and longer test phase TAT was significantly associated with use of dried blood spots instead of plasma. The authors conclude that increasing efficiencies, improving quality management systems, and generally strengthening the VL spectrum should be considered essential components of controlling the HIV epidemic.