Validation of a Portable Instrument for Point-of-Care CD4 Testing

Lead Investigators: Connie Celum, Jared Baeten, Elly Katabira, Elioda Tumwesigye, Patrick Ndase

Primary Objective:

Accuracy of Daktari portable CD4 count system compared to flow cytometry.

Secondary Objectives:

Performance characteristics (e.g., ease of operation, throughput) of Daktari portable CD4 count system in facility-based care settings.

Study Design:

This is a diagnostic validation study, comparing a new diagnostic device to a reference standard. In this case, a novel, portable, battery-operated point-of-care CD4 counting system developed by Daktari Diagnostics will be compared to flow cytometry for accuracy and performance under typical operating conditions in research facilities in Kabwohe and Jinja, Uganda. The study will evaluate fingerstick CD4 counts on the portable system collected and run at local HIV facilities, and compare them to CD4 counts from venipuncture blood collected simultaneously and run on flow cytometers at local or remote laboratories.

Population:

HIV-infected men and women in Kabwohe and Jinja, Uganda.

Study Size:

N=150

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