Technical Performance Evaluation of the MyT4 Point of Care Technology for CD4 T Cell EnumerationReportar como inadecuado

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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.


Over 250 HIV-positive patients were consecutively enrolled and their blood tested on the MyT4, BD FACSCalibur, and BD FACSCount.


Compared 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.


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.

Autor: Matilu Mwau , Silvia Kadima, Joy Mwende, Maureen Adhiambo, Catherine Akinyi, Marta Prescott, Judi Lusike, Jackson Hungu, Lara Voj



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