WHO Information Note: NOVEL POINT-OF-CARE TOOLS FOR EARLY INFANT DIAGNOSIS OF HIV
October 12, 2018
Sufficient evidence has been generated on the performance of these assays in the intended field settings to support rapid national regulatory approval and initiation of scale-up. Performance was consistent between laboratory and field settings, and across countries. Further technical evaluations of these technologies are unlikely to add value, but may instead delay implementation and timely diagnoses of HIV-infected infants, a critical and vulnerable population. National regulatory agencies are encouraged to not delay adoption by conducting further evaluations, but instead adopt a rapid and streamlined registration and national approval process for immediate implementation.