Table 4.

Consensus operational characteristics for the typhoid target product profile

Characteristic	Minimum requirement	Optimum requirement	References
Kit configuration	Package of single kits sharing reagents (if required) and user manual. Instructions in English, French, Spanish and Portuguese	Package of single kits with individual reagents (if required) sharing user manual. Instructions in local languages	28 38
Reagent preparation	One reagent preparation step	None required	28 39
Operating conditions	Between 5°C and 40°C ≤90% relative humidity	Between 5°C and 45°C ≤90% relative humidity	38
Transportation and storage stability	≥12 months at ≤35 °C and ≤70% relative humidity, no cold chain needed, ability to withstand transport stress (≤3 days at 60 °C)	≥24 months at ≤45 °C and ≤90% relative humidity, no cold chain needed, ability to withstand transport stress (≤3 days at 60 °C)	38
Equipment (instrumentation external to test)	Small, portable or handheld, battery-operated instrument	No equipment	6 7
External maintenance	Minimal maintenance, simple to perform by non-laboratory personnel	No maintenance	28
Calibration	≤1 annual calibration, ideally autocalibration by operator or remotely	No calibration	28
Internal/ process control	Included in each assay		Industry standard
Batch/quality control	Positive and negative controls included in each kit		Industry standard
Power requirements	Battery or solar powered	No power needed	28
Water requirement	No external water required		28
Waste disposal	Biohazard waste, sharps disposal	No toxic waste requiring special disposal	50
Bio-safety	Basic biosafety level 1, WHO Class B In-vitro diagnostic (moderate individual and low public health risk)	Basic biosafety level 1, WHO Class A In-vitro diagnostic (low individual and low public health risk).	50 51
Training requirements	≤0.5 days for lab technician	≤0.5 days for experienced health worker	6 7 23
Cost per test	End-user cost <US$3.00	End-user cost <US$1.00	7 28