Table 3

Test performance characteristics for a typhoid diagnostic target product profile

CharacteristicMinimum requirementOptimum requirementReferences
Sample typeVenous bloodCapillary blood or less invasive sample type (eg, saliva), excluding stool and urine12 28
Sample collectionTransfer and quantification device included in the testIndustry standard
Sample volume/ sample transfer device≤1 mL venous blood≤100 µL capillary blood47
Additional sample preparation2 sample processing stepsNone requiredMay need to separate serum from whole blood before applying to RDT
Ease of use≤5 steps, of which≤2 are timed≤3 steps, of which≤1 is timed6
Total hands-on time≤5 min≤1 min7 28
Time to result≤2 hours≤15 min28 34
Read out of resultsBinary results6
In use stabilityResults stable ≥15 minResults stable ≥1 hour28
Data output and connectivityNo wireless connectivity requiredWireless connectivity used to transfer data48
Data interpretationReadout easily interpretable by non-laboratory personnelNo data interpretation required7
Analyte typeAny acceptable analyte, or combination of analytes, that can meet sensitivity and specificity thresholds7
Analytical sensitivity/ limit of detectionLimit of detection should be such that it allows clinically relevant performance as defined below7
Diagnostic sensitivity*≥90%≥95%22 23 35–37
Diagnostic specificity≥95%≥98%22 23 35–37
ReproducibilityKappa ≥0.9 between different operators and laboratories/locations49

  • *Consensus not reached among survey respondents.