Performance Evaluation of the Alere PIMA CD4 Test for Monitoring HIV-Infected Individuals in Resource-Constrained Settings

Abstract

This new point-of-care product is a simple and reliable system and should contribute significantly to the simplification of performing CD4 testing and thus increase access for patients in resource-limited settings. The inability to obtain values for the frequency (%) of CD4+ T-lymphocyte count is one limitation of the PIMA system, the addition of which would be of value for clinical staging or monitoring in HIV-infected pediatric patients.

Evaluation of PIMA point-of-care CD4 testing in a large UK HIV service

“…These studies report an excellent correlation between the POCT and the laboratory test using flow cytometry with r values >0.95. Two of these studies also report a tendency for the POCT to under-read CD4 counts compared with laboratory testing, which was more marked at higher CD4 counts 5 7. We observed a greater difference between POCT and laboratory testing than previously reported which may be related to the higher CD4 counts in our patient cohort 4–7.…”

“…However, when compared with the laboratory CD4 test, the POCT results were generally somewhat lower. The under-reading of the test has previously been reported in other studies,5 7 8 although the majority of these studies were performed using venous blood rather than using capillary blood collected following a finger stick. These studies report an excellent correlation between the POCT and the laboratory test using flow cytometry with r values >0.95.…”

Evaluation of the Alere Pima™ for CD4+ T lymphocytes counts in HIV-positive outpatients in Southern Brazil

“…When there are acute symptoms, prompt evaluation of the patient's CD4 þ count is necessary to determine the appropriate clinical approach. 3,5,6 The Brazilian Public Health System offers laboratory monitoring of CD4 þ T cells and viral load to all HIV patients.…”

HIV point-of-care diagnostics: meeting the special needs of sub-Saharan Africa

“…A peer-reviewed assessment of the Poincare NOW revealed low sensitivity; 53% and 61% of adult patients at the 350 and 200 cells/μL thresholds, respectively, were misclassified [34,46]. The CD4 POC PIMA analyzer (Alere, Inc.) evaluated in South Africa and in Zimbabwe, however, performed well compared to the standard protocol [33,35].…”