Ideal product attributes for POC HIV viral load test

DomainOptimal criteria
GoalQuantification of HIV RNA viral load copies/ml
Limit of detection200 HIV RNA viral load copies/ml
PrecisionLess than 0.3 log10 HIV viral load copies/ml, as compared to reference gold standard test
Time to resultsLess than 30 min total
ThroughputMinimum of 15 tests per 8-h workday
EquipmentSmall, portable, and robust, with uninterrupted power supply for use in primary health care clinics at a wide range of temperatures
Sample specimenFinger capillary whole blood (maximum, 200 μl) or heel stick for young children; dried blood spot would be acceptable
Simple operationThe device should be capable of being used by health care workers, including technicians, nurses, and physicians, after a minimal amount of training
Quality controlInternal full positive and full process negative controls to monitor individual test results
Patient identificationResults can be easily linked to a specific patient
Data export for quality assuranceFull data export over mobile phone network with computer or tablet interface