Table 1.

Performance and features objectives for point-of-care (POC) nucleic acid amplification tests.

Criteria	Aim	Comments
Test Cost	$5–10 consumables per test	Disposable, single-use plastic cartridge, pre-loaded with reagents Compatible with injection molding,
Instrument Cost	<$500	Portable, handheld or desktop, providing temperature regulation, stable optical platform for cellphone or other detector, limited actuation; made with off-the-shelf components
Performance: Sensitivity, Limit of Detection (LOD); Specificity	Comparable to laboratory tests	e.g., HIV viral load testing LOD: 1–100 virons/mL plasma; Screening tests LOD: 1000 genome copies per sample. Sensitivity/Specificity (false negatives/ false positives): 98 to 99%.
Time for testing	30 to 60 min	Time spanning sample-in to report-out should be about 30 min, primarily due to time required for amplification of low-concentration target
Operator skill level	minimal, non-professional, semi-skilled	Training in less than 1 h. No pipetting, sample collection and loading raw sample into cartridge, no sample transfer after sample loading (e.g., no pre-sample processing with centrifuge), no addition of reagents at time of use.
Power	battery or chemical heating/cellphone	Ideally, should operate independent of grid electric power (Many resource-limited areas of the world do not have reliable electric power.)
Shelf life	test cartridge: 1 year @ 40 °C	No cold-chain, hermetically sealed cartridge can be stored in tropical climates for a year without refrigeration.