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

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The views expressed are those of the authors and should not be construed to represent the positions of the U.S. Army or the Department of Defense.

CDR Jennifer Malia, DrPHU.S. Public Health Service Corps

Military 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

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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

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RESULTSFig 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.

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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.

Thank You