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Open Access Research

Utility of the point of care CD4 analyzer, PIMA, to enumerate CD4 counts in the field settings in India

Madhuri Thakar1*, Bharati Mahajan1, Nawaj Shaikh1, Salman Bagwan1, Suvarna Sane1, Sandhya Kabra2, Bharat Rewari2, Mohamad Shaukat2, Namita Singh3, Peter Trevor3 and Ramesh Paranjape1

Author Affiliations

1 Department of Immunology, National AIDS Research Institute, G-73, MIDC, Bhosari, Pune, 411 026, India

2 National AIDS Control Organization, New Delhi, India

3 Clinton Health Access Initiative, New Delhi, India

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AIDS Research and Therapy 2012, 9:26  doi:10.1186/1742-6405-9-26

Published: 21 September 2012

Abstract

Background

In resource limited settings non-availability of CD4 count facility at the site could adversely affect the ART roll out programme. Point of care CD4 enumerating equipments can make the CD4 count available at the site of care and improve the patients’ management considerably. This study is aimed at determining the utility of a Point of Care PIMA CD4 analyzer (Alere, Germany) in the field settings in India.

Method

The blood samples were collected from 1790 participants at 21 ART centers from different parts of the country and tested using PIMA and the reference methods (FACSCalibur, FACSCount and CyFlow SL3). The paired finger prick and venous blood samples from 175 participants were tested by the PIMA CD4 Analyzer and then by FACSCalibur.

Result

The CD4 counts obtained by PIMA CD4 analyzer showed excellent correlation with the counts obtained by the reference methods; for venous blood the Pearson’s r was 0.921, p < 0.001 and the relative bias was 0.2% (range: -42 to 42%) and for finger prick samples, the Pearson’s r was 0.856 and the relative bias was −9.1% (range: -46% to 27%). For CD4 ranges; <250, 251–350, 351–500 and >500 cells/mm3, the differences in the median CD4 counts obtained by the reference method and the PIMA analyzer were not significant (P > 0.05) and the relative bias were low (−7 to 5.1%). The Intermachine comparison showed variation within the acceptable limit of%CV of 10%.

Conclusion

In the field settings, the POC PIMA CD4 analyzer gave CD4 counts comparable to the reference methods for all CD4 ranges. The POC equipment could identify the patients eligible for ART in 91% cases. Adequate training is necessary for finger prick sample collection for optimum results. Decentralization of CD4 testing by making the CD4 counts available at primary health centers, especially in remote areas with minimum or no infrastructure would reduce the missed visits and improve adherence of the patients.

Keywords:
CD4+ T-cell count; HIV; Point-of-care; PIMA CD4 analyzer