Table 4

Consensus operational characteristics for the typhoid target product profile

CharacteristicMinimum requirementOptimum requirementReferences
Kit configurationPackage of single kits sharing reagents (if required) and user manual. Instructions in English, French, Spanish and PortuguesePackage of single kits with individual reagents (if required) sharing user manual. Instructions in local languages28 38
Reagent preparationOne reagent preparation stepNone required28 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 instrumentNo equipment6 7
External maintenanceMinimal maintenance, simple to perform by non-laboratory personnelNo maintenance28
Calibration≤1 annual calibration, ideally autocalibration by operator or remotelyNo calibration28
Internal/ process controlIncluded in each assayIndustry standard
Batch/quality controlPositive and negative controls included in each kitIndustry standard
Power requirementsBattery or solar poweredNo power needed28
Water requirementNo external water required28
Waste disposalBiohazard waste, sharps disposalNo toxic waste requiring special disposal50
Bio-safetyBasic 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 worker6 7 23
Cost per testEnd-user cost <US$3.00End-user cost <US$1.007 28