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AIDS Res Hum Retroviruses. 2018 Dec 18. doi: 10.1089/AID.2018.0223. [Epub ahead of print]

Field performance of PIMA Point-of-Care Machine for CD4 Enumeration Under a Mobile HIV Counseling and Testing Program in Remote Fishing Communities of Lake Victoria, Uganda.

Author information

1
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; Anamuniina@iavi.or.ug.
2
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; flutwama@iavi.or.ug.
3
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; vbiribawa@iavi.or.ug.
4
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; dkizza@iavi.or.ug.
5
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; brianroyy@gmail.com.
6
UVRI-IAVI HIV Vaccine Program, Kampala, Uganda ; Pkato@iavi.or.ug.
7
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; jmpendo@iavi.or.ug.
8
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; ananvubya@iavi.or.ug.
9
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; jssempiira@gmail.com.
10
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; analutaaya@gmail.com.
11
UVRI-IAVI HIV Vaccine Program, Kampala, Uganda ; Assetaala@iavi.or.ug.
12
International Aids Vaccine Initiative, 20272, New York, New York, United States ; Swelsh@iavi.org.
13
International AIDS Vaccine Initiative , 50 Beale St, 13th Floor , CAPS/IAVI, Suite 13105 , San Francisco, California, United States , 94105 ; MPrice@iavi.org.
14
Makerere University College of Health Sciences, 58589, School of Public Health, Department of Epidemiology and Biostatistics, Kampala, Kampala, Uganda.
15
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; Nkiwanuka@gmail.com.
16
Makerere University College of Health Sciences, 58589, School of Biomedical Sciences, Department of Immunology and Molecular Biology, Kampala, Kampala, Uganda.
17
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda ; bbagaya@chs.mak.ac.ug.

Abstract

BACKGROUND:

Uganda is among the most HIV/AIDS afflicted countries, and many HIV infected persons live in remote areas with poor access to healthcare. The success of HIV care programs relies in part on patient monitoring using CD4 T cell counts. We conducted an evaluation of the point-of-care PIMA test using BD FACSCount as a gold standard.

METHODS:

151 participants were enrolled, provided venous blood and samples tested at the point of care with the Alere PIMATM CD4 Analyzer and the BD FACSCount in the UVRI-IAVI main laboratory. Correlation between the methods was assessed, as was the ability of the Pima Analyzer to predict values <200, <350, and ≥500 CD4 cells/mm3 when compared with BD FACSCount as the gold standard.

RESULTS:

A near perfect positive Pearson correlation coefficient (r=0.948; p<0.0001) between the two methods was observed. The Alere PIMATM Analyzer had a mean bias of -32.5 cells/mm3. The sensitivity and specificity, for PIMA to predict CD4 lymphocyte count less than 200 cells/mm3 were 71.4% and 100%, respectively; less than 350 cells/mm3 were 84.6% and 94.6%, respectively; and at CD4 count less than 500 cells/mm3 were 94.4% and 100%.

CONCLUSION:

The Alere PimaTM Analyzer provides reliable CD4 cell count measurement and is suitable for monitoring and screening eligible HIV patients in hard-to-reach settings. Key Words: CD4 count, point of care, HIV, Alere PimaTM Analyzer, FACSCount.

PMID:
30560683
DOI:
10.1089/AID.2018.0223

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