Mwau M., Kadima S., Mwende J., Adhiambo M., Akinyi C., Prescott M., Lusike J., Hungu J., Vojnov L.
Kenya Medical Research Institute, Nairobi, Kenya; Clinton Health Access Initiative, Nairobi, Kenya
Mwau, M., Kenya Medical Research Institute, Nairobi, Kenya; Kadima, S., Clinton Health Access Initiative, Nairobi, Kenya; Mwende, J., Kenya Medical Research Institute, Nairobi, Kenya; Adhiambo, M., Kenya Medical Research Institute, Nairobi, Kenya; Akinyi, C., Kenya Medical Research Institute, Nairobi, Kenya; Prescott, M., Clinton Health Access Initiative, Nairobi, Kenya; Lusike, J., Clinton Health Access Initiative, Nairobi, Kenya; Hungu, J., Clinton Health Access Initiative, Nairobi, Kenya; Vojnov, L., Clinton Health Access Initiative, Nairobi, Kenya
Objective: Though absolute CD4+ T cell enumeration is the primary gateway to antiretroviral therapy initiation for HIV-positive patients in all developing countries, patient access to this critical diagnostic test is relatively poor. We technically evaluated the performance of a newly developed point-of-care CD4+ T cell technology, the MyT4, compared with conventional CD4+ T cell testing technologies. Copyright:Design: Over 250 HIV-positive patients were consecutively enrolled and their blood tested on the MyT4, BD FACSCalibur, and BD FACSCount.Results: Compared with the BD FACSCount, the MyT4 had an r2 of 0.7269 and a mean bias of 223.37 cells/μl. Compared with the BD FACSCalibur, the MyT4 had an r2 of 0.5825 and a mean bias of 246.58 cells/μl. Kenya currently uses a CD4+ T cell test threshold of 350 cells/μl to determine patient eligibility for antiretroviral therapy. At this threshold, the MyT4 had a sensitivity of 95.3% (95% CI: 88.4-98.7%) and a specificity of 87.9% (95% CI: 82.3-92.3%) compared with the BD FACSCount and sensitivity and specificity of 88.2% (95% CI: 79.4-94.2%) and 84.2% (95% CI: 78.2-89.2%), respectively, compared with the BD FACSCalibur. Finally, the MyT4 had a coefficient of variation of 12.80% compared with 14.03% for the BD FACSCalibur.Conclusions: We conclude that the MyT4 performed well at the current 350 cells/μl ART initiation eligibility threshold when used by lower cadres of health care facility staff in rural clinics compared to conventional CD4+ T cell technologies. © 2014 Mwau et al.
adult; Article; blood analysis; CD4+ T lymphocyte; cell assay; controlled study; diagnostic accuracy; diagnostic test accuracy study; female; human; human cell; Human immunodeficiency virus infection; lymphocyte count; major clinical study; male; middle aged; nonhuman; outcome assessment; patient assessment; point of care testing; process development; sensitivity and specificity