br Background In resource limited countries many HIV

Background In resource-limited countries, many HIV patients currently do not have reliable access to essential diagnostic laboratory tests, including CD4, clinical chemistry, hematology, viral load, and diagnosis of common co-infections. CD4 T cell count monitoring remains an important surrogate marker for HIV disease to guide decisions for initiating and stopping prophylaxis for opportunistic infections and in clinical management of treated patients in areas where HIV viral load is not yet routinely available (Ford et al., 2017). CD4 testing is critical for identifying patients most in need of clinical care and antiretroviral therapy (Vojnov et al., 2016; Ford et al., 2017). While there is a progressive move away from CD4 cell count as the main way to determine eligibility for antiretroviral therapy (WHO, 2015), CD4 cell count testing still has an important role to play in baseline risk assessment, prioritizing patients when limited antiretroviral therapy drug supplies exist, and diagnosing treatment failure in settings where access to viral load monitoring is limited (Ford et al., 2015; Gilks et al., 2013). Furthermore, CD4 testing remains beneficial for HIV disease and opportunistic infection management of patients on antiretroviral therapy. Implementation of rapid, point-of-care (POC) CD4+ testing in HIV care and treatment settings has been shown to increase the number of patients who undergo and receive the results of CD4+ testing, and has the potential to improve retention between HIV diagnosis and antiretroviral treatment Bleomycin Sulfate (Desai et al., 2017; Peeling and Ford, 2017). Task-shifting to meet human resources for health needs is recommended by WHO (WHO, 2012). For example, trained lay providers have been delivering HIV testing services with rapid diagnosis test adequately for decades in many settings across sub-Saharan Africa (Flynn et al., 2017). Several CD4 enumeration technologies are available from highly automated laboratory instruments to simple sample-in-answer-out devices that can be deployed in small clinics. Recently, lay-counselors with basic training have been shown to use the Pima™ CD4 POC analyzer (Alere, Waltham, Massachusetts, USA) at a comparable performance level as laboratory-technicians in Kenya (Zeh et al., 2017). The recently developed Muse™ Auto CD4/CD4% Assay analyzer (Millipore-Sigma Corporation, Merck Life Sciences, KGaA, Darmstadt, Germany) is a reliable alternative flow cytometer for CD4 T lymphocyte enumeration to be used in routine immunological monitoring according to WHO recommendations for resource-constrained settings (Mossoro-Kpinde et al., 2016). Because CD4+ testing using the Muse™ Auto CD4/CD4% Assay analyzer is relatively easy to perform, the task of performing CD4+ tests in the HIV care and treatment setting could potentially be shifted from laboratory technicians to nurses or non-professional lay providers.
Material and methods
Results
Discussion The procedure was fast and needed only 30 min to be completed. The technique was found to be very easy to carry out and highly precise in terms of both repeatability and reproducibility, with intra- and inter- run variabilities <15% (Mossoro-Kpinde et al., 2016), considered as acceptable for clinical use (Peeling et al., 2015). Our observations illustrate that the precision (%CV < 15) of the test results obtained by trained lay providers were still within the acceptable limits. In addition to the technical feasibility of measuring CD4, Reversion mutation might have been important to compare the behavior of trained lay providers and technicians in the management of the basic troubleshooting that may affect the CD4 counting by the Muse™ Auto CD4/CD4% analyzer. The unique, patented micro-capillary flow cell technology used in the Muse™ Auto CD4/CD4% system eliminates the requirement for complicated sheath flow fluidics and enables absolute cell counts without the need for reference beads, making the system extremely compact, easy to maintain and simple to use. The Muse™ Auto CD4/CD4% system for CD4 T cell counting allows minimizing the sources of variations, is less expensive, small, simple to use and yet reproducible. Similarly, previous study has yet reported that the Pima™ CD4 POC analyzer (Alere) when operated by lay-counselors, constitutes a POC non-flow cytometry-based CD4 T cell counting device, which may be interchangeable with the existing conventional CD4 T cell enumeration platforms (Zeh et al., 2017). All these more affordable CD4 dedicated POC analyzers introduced into the market are thought to ensure decentralization of the HIV-monitoring services (Peeling et al., 2015; Pham et al., 2017). Indeed, POC CD4 T cell counting technologies reduce the time and increase patient retention along the testing and treatment cascade compared to conventional laboratory-based testing (Vojnov et al., 2016), which are therefore considered to be useful tools to perform CD4 T cell counting for expedite result delivery.