Key minimal and optimal operational characteristics for chlamydial infection test | ||
Minimal | Optimal | |
Specimen§ | First-catch urine =2 hours since last void (all persons), healthcare worker-collected vaginal swab | Any urine (all persons), self-collected vaginal swab |
Specimen preparation | Minimal sample processing; no more than one operator step | Integrated |
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 |
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 |
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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.
CT, Chlamydia trachomatis; FTP, File Transfer Protocol; GPRS, General Packet Radio Service; GPS, Global Positioning System; GSM, Global System for Mobile; MSM, men who have sex with men; POCT, point-of-care testing; SW, sex worker; TPP, target product profile.