Goal |
Quantification of HIV RNA viral load copies/ml |
Limit of detection |
200 HIV RNA viral load copies/ml |
Precision |
Less than 0.3 log10 HIV viral load copies/ml, as compared to reference gold standard test |
Time to results |
Less than 30 min total |
Throughput |
Minimum of 15 tests per 8-h workday |
Equipment |
Small, portable, and robust, with uninterrupted power supply for use in primary health care clinics at a wide range of temperatures |
Sample specimen |
Finger capillary whole blood (maximum, 200 μl) or heel stick for young children; dried blood spot would be acceptable |
Simple operation |
The device should be capable of being used by health care workers, including technicians, nurses, and physicians, after a minimal amount of training |
Quality control |
Internal full positive and full process negative controls to monitor individual test results |
Patient identification |
Results can be easily linked to a specific patient |
Data export for quality assurance |
Full data export over mobile phone network with computer or tablet interface |