Key minimal and optimal operational characteristics for HPV DNA or RNA test
	Minimal	Optimal
Specimen	Provider-collected cervical specimen and self-collected cervicovaginal specimen (preferred because no need for speculum exam or clinic visit)	Provider-collected cervical specimen and self-collected cervicovaginal specimen (preferred because no need for speculum exam or clinic visit)
Steps performed by healthcare worker between specimen preparation and result	No more than three operator steps that are not timed nor labour intensive	Maximum 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
Regulatory requirements	Compliance with appropriate ISO standard
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	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$3	<US$1.5
Link to full target product profile—combined/mono-HPV DNA or RNA test

∗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.
‡Values are currently under revision.
§POCTs are only to provide a positive/negative result, other quantitative methods will be used for quantitation.
¶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; GSM, Global System for Mobile; HPV, human papillomavirus; ISO, International Organization for Standardization; POCT, point-of-care testing; TPP, target product profile.