Technical Performance Evaluation of the MyT4 Point of Care Technology for CD4+ T Cell Enumeration |
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Authors: | Matilu Mwau Silvia Kadima Joy Mwende Maureen Adhiambo Catherine Akinyi Marta Prescott Judi Lusike Jackson Hungu Lara Vojnov |
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Institution: | 1. Kenya Medical Research Institute, Nairobi, Kenya.; 2. Clinton Health Access Initiative, Nairobi, Kenya.; CEA, France, |
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Abstract: | ObjectiveThough 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.DesignOver 250 HIV-positive patients were consecutively enrolled and their blood tested on the MyT4, BD FACSCalibur, and BD FACSCount.ResultsCompared with the BD FACSCount, the MyT4 had an r2 of 0.7269 and a mean bias of −23.37 cells/µl. Compared with the BD FACSCalibur, the MyT4 had an r2 of 0.5825 and a mean bias of −46.58 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.ConclusionsWe 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. |
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