Key minimal and optimal operational characteristics for gonococcal infection test | ||
Minimal | Optimal | |
Specimen§ | Vaginal fluid in women and urine in men | Urine in men and women, vaginal, rectal and pharyngeal |
Steps performed by healthcare worker between specimen preparation and result | No more than three operator steps that are not timed nor labour intensive | One operator step (none of which has a timed interval), excluding waste disposal |
Training required | <90 min | 30 min |
Time to result | =60 min | =30 min |
Connectivity: device/reader | If combined with a reader, reader has integrated GPS module. | If combined with a reader, internally integrated GPS/GPRS module and conformity with HL-7 messaging standards |
Data export (for quality assurance): device/reader | If combined with a reader, full data export over mobile phone network |
|
Target price per test (excluding the cost of a device or reader)¶ | <US$5 | <US$1 |
*Should be guided by the knowledge of the local epidemics.
†Based on a sample size sufficient to achieve CIs of ±5% around a point estimate of sensitivity and specificity.
‡POCTs are only to provide a positive/negative result, other quantitative methods will be used for quantitation.
§Sensitivity and specificity for rectal and pharyngeal swabs are not yet determined.
¶It does not include the cost of device/reader in case the POCT is device based or/and requires a reader for the result.
FTP, File Transfer Protocol; GPRS, General Packet Radio Service; GPS, Global Positioning System; MSM, men who have sex with men; NG, Neisseria gonorrhoeae; POCT, point-of-care testing; SW, sex worker; TPP, target product profile.