Clinical Evaluation of PIMA Point-of-Care Assay for Evaluation of CD4 Cell Counts

1. CDR Jennifer Malia, DrPHU.S. Public Health Service CorpsMilitary HIV Research Program (MHRP)Walter Reed Army Institute of Research (WRAIR)July 31, 2014 Clinical Evaluation of PIMA Point-of-Care Assay for Evaluation of CD4 Cell Counts Malia JA1, Giese RJ 1, Manak M2, Bryant M3, Crawford K2, Lomabardi K2, Hale B4 and Peel SA 1 1Walter Reed Army Institute of Research, MHRP-WRAIR, Silver Spring, MD, 2Henry Jackson Foundation, MHRP- HJF, Silver Spring, MD, USA; USA; 3Howard University, Washington, DC, USA, 4DoD HIV/AIDS Prevention Program, San Diego, CA, USA

2. Clinical Evaluation of PIMA Point-of-Care Assay for Evaluation of CD4 Cell Counts • Background • CD4: • Key predictive marker of disease progression • WHO recommends initiation of therapy when CD4+ drop below 500 cells/ml • Standard: • Complex testing, time consuming, highly trained personnel & expensive. • Benefits of POC • Fully automated, rapid, minimum training, well suited for testing at remote sites • Materials and Methods • Prospective, random sampling • 210 Adults HIV+ across spectrum of CD4 levels • PIMA: • Disposable cartridge with sealed reagents • Reference lab & clinic by nurse • Evaluation: • PIMA Venous and Fingerstick vs. BD FACSCanto II • At critical low and mid levels of CD4

3. RESULTS Fig 2. Plot of CD4 counts as obtained by the Gold Standard FACS Canto vs that from PIMA Venous or PIMA Fingerstick. Fig 3. Bland-Altman analysis of Mean vs Difference in CD4 counts between the FACS Canto and PIMA Venous or PIMA Fingerstick.

4. CONCLUSION • Venous Blood samples; Coefficient of Correlation >85.9% • Fingerstick assay • excellent at low and high CD4+ ranges • less reliable at the critical mid- range. • Minimal space and resources. • Suitable for use in resource limited settings. We would like to acknowledge the Howard University General Clinical Research Center and their dedicated staff for their collaboration and efforts.

5. Thank You