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 swabAny urine (all persons), self-collected vaginal swab
Specimen preparationMinimal sample processing; no more than one operator stepIntegrated
Steps performed by healthcare worker between specimen preparation and resultNo more than three operator steps that are not timed nor labour intensiveOne operator step (none of which has a timed interval), excluding waste disposal
Time to result=60 min=30 min
Connectivity: device/readerIf 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/readerIf combined with a reader, full data export over mobile phone network
  • If combined with a reader, full data export over mobile phone network (data transmission can automatically select between GPRS or more advanced networks and GSM, based on available coverage).

  • GPRS should be able to use the internet FTP to transmit data: data transfer should be initiated every 6–12 hours automatically by the reader; data can be exported in a format compatible with HL-7 standards, where appropriate; instrument tracks and transmits quality assurance data over time (eg, identify shifts or trends).

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.