Technical Performance Evaluation of the MyT4 Point of Care Technology for CD4 T Cell EnumerationReport as inadecuate




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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.

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 −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.

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.



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

Source: http://plos.srce.hr/



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