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

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 of lymphocytes (CD4%).

Results: In Phase-I, 179/217 samples yielded reportable results with Presto™ using venous blood filled cartridges. Compared to predicate, a mean bias of 40.4±45.8 (LOA of -49.2 to 130.2) and %similarity (%CV) of 106.1%±7.75 (7.3%) was noted for CD4 absolute counts. In Phase-2 field study, 118/135 capillary-bled Presto™ samples resulted CD4 parameters. Compared to predicate, a mean bias of 50.2±92.8 (LOA of -131.7 to 232) with %similarity (%CV) 105%±10.8 (10.3%), and 2.87±2.7 (LOA of -8.2 to 2.5) with similarity of 94.7±6.5% (6.83%) noted for absolute CD4 and CD4% respectively. No significant clinical differences were indicated for either parameter using two sampling methods.

Conclusion: The Presto™ produced remarkable precision to predicate methods, irrespective of venous or capillary blood sampling. A consistent, clinically insignificant over-estimation (5-7%) of counts against PLG/CD4 and equivalency to FACSCount™ was noted. Further field studies are awaited to confirm longer-term use.