TPP: For point-of-care CD4 tests to support the identification of individuals with advanced HIV disease

To measure CD4 T cells to support the identification of individuals older than five years with advanced HIV disease

Minimum/Acceptable: Easy to use and device-minimal test that can be used at the point-of-care (POC) for same-day identification of advanced HIV disease in people living with HIV. Preferred/Optimal/Ideal: Easy to use and device-minimal test that can be used at the point-of-care (POC) for same-day identification of advanced HIV disease in people living with HIV.

Minimum/Acceptable: Individuals > 5 years old newly diagnosed with HIV, returning to care, suspected of failing treatment, or suspected of advanced disease. Preferred/Optimal/Ideal: Individuals > 5 years old newly diagnosed with HIV, returning to care, suspected of failing treatment, or suspected of advanced disease.

Minimum/Acceptable: Finger-prick whole blood. <=100 microliters. Preferred/Optimal/Ideal: Finger-prick whole blood. <= 50 microliters.

Minimum/Acceptable: All levels including community-based testing, mobile testing, health centers, hospitals; centralized and decentralized; low- and high-volume settings. Preferred/Optimal/Ideal: All levels including community-based testing, mobile testing, health centers, hospitals; centralized and decentralized; low- and high-volume settings.

Clinical sensitivity:: Minimum/Acceptable: 80%. Preferred/Optimal/Ideal: 90%. Clinical specificity:: Minimum/Acceptable: 80%. Preferred/Optimal/Ideal: 90%. Time to results:: Minimum/Acceptable: < 40 minutes. Preferred/Optimal/Ideal: < 20 minutes.

Stability and storage:: Minimum/Acceptable: 12 months at 10–30°C; 50% humidity. Preferred/Optimal/Ideal: 18 months at 2–35°C; 80% humidity.

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