Performance Evaluation of the Becton Dickinson FACSPresto™ Near-Patient CD4 Instrument in a Laboratory and Typical Field Clinic Setting in South Africa.

ABSTRACT:

Background

The BD-FACSPresto™ CD4 is a new, point-of-care (POC) instrument utilising finger-stick capillary blood sampling. This study evaluated its performance against predicate CD4 testing in South Africa.

Methods

Phase-I testing: HIV+ patient samples (n = 214) were analysed on the Presto™ under ideal laboratory conditions using venous blood. During Phase-II, 135 patients were capillary-bled for CD4 testing on FACSPresto™, performed according to manufacturer instruction. Comparative statistical analyses against predicate PLG/CD4 method and industry standards were done using GraphPad Prism 6. It included Bland-Altman with 95% limits of agreement (LOA) and percentage similarity with coefficient of variation (%CV) analyses for absolute CD4 count (cells/μl) and CD4 percentage

SUBMITTER: Coetzee LM 

PROVIDER: S-EPMC4880207 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature