Abstract
ObjectiveTo estimate the proportion of invalid results generated by a CD4+ T-lymphocyte analyser used by Médecins Sans Frontières (MSF) in field projects and identify factors associated with invalid results.MethodsWe collated 25 616 CD4+ T-lymphocyte test results from 39 sites in nine countries for the years 2011 to 2013. Information about the setting, user, training, sampling technique and device repair history were obtained by questionnaire. The analyser performs a series of checks to ensure that all steps of the analysis are completed successfully; if not, an invalid result is reported. We calculated the proportion of invalid results by device and by operator. Regression analyses were used to investigate factors associated with invalid results.FindingsThere were 3354 invalid test results (13.1%) across 39 sites, for 58 Alere PimaTM devices and 180 operators. The median proportion of errors per device and operator was 12.7% (interquartile range, IQR: 10.3–19.9) and 12.1% (IQR: 7.1–19.2), respectively. The proportion of invalid results varied widely by country, setting, user and device. Errors were not associated with settings, user experience or the number of users per device. Tests performed on capillary blood samples were significantly less likely to generate errors compared to venous whole blood.ConclusionThe Alere Pima CD4+ analyser generated a high proportion of invalid test results, across different countries, settings and users. Most error codes could be attributed to the operator, but the exact causes proved difficult to identify. Invalid results need to be factored into the implementation and operational costs of routine CD4+ T-lymphocyte testing.
Highlights
The CD4+ T-lymphocyte count is the method recommended by the World Health Organization (WHO) to assess eligibility for antiretroviral treatment (ART).[1,2]
The CD4+ count guides the clinical management of people living with human immunodeficiency virus (HIV).[2]
WHO recommends testing of viral load to detect treatment failure, but the CD4+ count continues to be used for ART monitoring if viral load cannot be tested.[3]
Summary
The CD4+ T-lymphocyte count is the method recommended by the World Health Organization (WHO) to assess eligibility for antiretroviral treatment (ART).[1,2] The CD4+ count guides the clinical management of people living with human immunodeficiency virus (HIV).[2]. Increased availability of ART has driven the establishment of laboratories analysing CD4+ count, but access to CD4+ testing requires adequate laboratory capacity and the means to transport specimens.[6,7] Point-of-care CD4+ testing provides rapid results without the need to transport specimens and is considered an important tool to improve patient retention in care before treatment initiation.[8,9,10,11]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
