Point-Of-Care Tests -- Target Product Profiles and Research Questions Table of contents 1. Gonococcal Infection Chlamydial Infection

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1 Point-Of-Care Tests -- Target Product Profiles and Research Questions Table of contents 1. Gonococcal Infection Chlamydial Infection Syphilis Infection Human Papillomavirus Trichomonas Vaginalis

2 AMR - antimicrobial resistance Ct - Chlamydia trachomatis DNA - deoxyribonucleic acid FSW - female sex worker FTP - File Transfer Protocol GPS - Global Positioning System GPRS - General Packet Radio Service HIV - human immunodeficiency virus HL7 - Health Level 7 HPV - human papillomavirus ICT - immunochromatographic test IFU - instructions for use IVD - in vitro diagnostic ISO - International Organization for Standardization LL - lower 95% confidence limit MSM - men who have sex with men MSW - male sex worker NAAT - nucleic acid-amplified tests Ng - Neisseria gonorrhoeae PMTCT - prevention of mother-to-child transmission RNA - ribonucleic acid POCT - point-of-care test QC - quality control RPR - rapid plasma reagin STI - sexually transmitted infection TP - Treponema pallidum TPP - target product profile TPPA - Treponema pallidum particle agglutination Tv - Trichomonas vaginalis UDS - Urethral Discharge Syndrome mrna - messenger RNA 2

3 1. Gonococcal Infection 1.1. Target Product Profile Combined/Mono Gonococcal Infection Test Goal of test To detect Ng Intended use and target patient 1 Surveillance/case management: sexually active population, including key populations (e.g. MSM, SW, STI-clinic/service attendees) Screening/regular testing: key populations Target use setting Results Equipment Target use(s) Reference technology Healthcare settings particularly at primary care level (level 1) or above Clear positive, negative or invalid result with minimal instructions for interpretation Single use, biodegradable or recyclable disposable diagnostic test preferred, reader optional (small, portable, tabletop or handheld, no electricity/power supply required) Gonorrhoea testing STI-patient Laboratory-based NAAT Performance Clinical sensitivity 2 90% (genital) 98% (genital) Clinical specificity 90% (genital) >98% (genital) Quantitation 3 Not applicable 1 Should be guided by the knowledge of the local epidemics 2 Based on a sample size sufficient to achieve confidence intervals of ±5% around a point estimate of sensitivity and specificity 3 POCTs are only to provide a positive/negative result, other quantitative methods will be used for quantitation 3

4 4

5 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR GONOCOCCAL INFECTION TEST Specimen 4 Vaginal fluid in women and urine in men Urine in men and women, vaginal, rectal and pharyngeal Specimen preparation Steps performed by healthcare worker between specimen preparation and result Additional consumables required but not provided within the test kit Cold chain sample processing; no more than one operator step No more than three operator steps that are not timed nor labour intensive None, except for specimen collection None required at any point Integrated One operator step (none of which has a timed interval), excluding waste disposal Test kit All materials required for test procedure, including devices, reagents or other consumables to diagnose one individual, included in packaged, self-contained kit (either packaged individually as one test per test kit or sufficient to perform the number of tests packaged in the test kit box e.g. 20, 50 or 100 tests) Test kit stability and storage conditions Six months, stable between 2-35 o C, 70% humidity, 3000m altitude 12 months, stable between 0-50 o C, 90% humidity, 3000m altitude Environmental tolerance of packaged test kit Transport stress (48 hours with fluctuations up to 50 C and down to 0 C) Tolerate exposures between 2 C and 45 C at an altitude up to 3000 metres, up to and including condensing humidity Operating conditions Operation between 15 C and 40 C at an altitude up to 2000 metres (between 10 C and 45 C at an altitude up to 3000 metres preferred) Extremely low relative humidity to condensing humidity Result interpretation in low light settings 4 Sensitivity and specificity for rectal and pharyngeal swabs is not yet determined 5

6 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR GONOCOCCAL INFECTION TEST Training required < 90 minutes 30 minutes Clean water None Time to result <=60 minutes <=30 minutes Duration of sample stability (time from specimen collection to insertion into test cartridge) 5 It is inherent to the definition of a POCT that specimen collection should be immediately followed by the the testing of the specimen Stability of valid result (read window) 6 At least 30 minutes (after which results may be false or invalid) Clear language in the IFU regarding test reading. 1 hour (after which results give invalid rather than false results) Clear language in the IFU regarding test reading. Safety precautions (bio-safety requirements) Closed, self-contained system; unprocessed sample transfer only; no open handling of biohazardous material Waste/disposal requirements Safe waste disposal Small environmental footprint; compostable plastics for test cartridges and other materials Internal QC - reagents Procedural (reagent-addition) control internalized in cartridge for each individual test run; positive control for internal QC available for purchase separately Procedural (specimen-addition) control internalized in cartridge for each individual test run; positive control for internal QC provided in each box of test kits Device control Indicator of instability or expiration Indicator of instability, expiration, inadequate sample and incorrect procedure and/or use but not as an additional component 5 Stability following the manufacturer's IFU 6 This requirement only applies to tests that require reading by a reader device 6

7 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR GONOCOCCAL INFECTION TEST Regulatory requirements Patient identification capability Result display; result interpretation Data acquisition and display: reader Compliance with appropriate ISO standard Yes simple, self-contained way to indicate a patient identifier Result can be read with the naked eye with minimal instructions for interpretation required by user, or with an integrated reader with an easy pictorial display: reactive, non-reactive, invalid for each test If combined with a reader, on-device visual read-out; able to add information (patient ID, operator ID, date, location, etc.); able to store patient results; able to print out results utilizing commoditized paper products (i.e. standard paper specifications and sizes) Connectivity: device/reader Data export (for quality assurance): device/reader If combined with a reader, reader has integrated GPS module If combined with a reader, full data export over mobile phone network If combined with a reader, internally integrated GPS/GPRS module and conformity with HL-7 messaging standards 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 utilize 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 HL7 standards, where appropriate; instrument tracks and transmits quality assurance data over time (e.g. identify shifts or trends) Target price per test (excluding the cost of a <US$5 <US$1 device or reader) 7 7 It does not include the cost of device/reader in case the POCT is device-based or/and requires a reader for the result 7

8 1.2. Research Question Review literature on AMR, resistance mutations and existing tests for ciprofloxacin and ofloxacin. Identify susceptible/resistant nucleic acid targets for recommended therapeutic agents. Investigate frequency of potential targets in different gonococcal genotypes and populations. 8

9 2. Chlamydial Infection 2.1. Target Product Profile Combined/Mono Chlamydial Infection Test Goal of test Intended use and target patient 8 To detect Ct Surveillance/case management: sexually active population, including key populations (e.g. MSM, SW, STI-clinic/service attendees) Screening/regular testing: under age of 25 years and key populations Target use setting Results Equipment Target use(s) Reference technology Healthcare settings particularly at primary care level (level 1) or above Clear positive, negative or invalid result with minimal instructions for interpretation Single use, biodegradable or recyclable disposable diagnostic test preferred, reader optional (small, portable, table-top or handheld, no electricity/power supply required) Testing STI patient Laboratory-based NAAT Performance Clinical sensitivity 9 >90% (LL > 90%) (genital) 100% (genital) Clinical specificity 98% (LL > 95%) (genital) 100% (genital) Quantitation 10 Not applicable 8 Should be guided by the knowledge of the local epidemics 9 Based on a sample size sufficient to achieve confidence intervals of ±5% around a point estimate of sensitivity and specificity 10 POCTs are only to provide a positive/negative result, other quantitative methods will be used for quantitation 9

10 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR CHLAMYDIAL INFECTION TEST Specimen 11 First-catch urine >= 2h since last void (all persons), healthcare worker collected vaginal swab Any urine (all persons), self-collected vaginal swab Specimen preparation sample processing; no more than one operator step Integrated Steps performed by healthcare worker between specimen preparation and result Additional consumables required but not provided within the test kit Cold chain No more than three operator steps that are not timed nor labour intensive None, except for specimen collection None required at any point One operator step (none of which has a timed interval), excluding waste disposal Test kit All materials required for test procedure, including devices, reagents or other consumables to diagnose one individual, included in packaged, self-contained kit (either packaged individually as one test per test kit or sufficient to perform the number of tests packaged in the test kit box e.g. 20, 50 or 100 tests) Test kit stability and storage conditions Six months, stable between 2-35 o C, 70% humidity, 3000m altitude 12 months, stable between 0-50 o C, 90% humidity, 3000m altitude Environmental tolerance of packaged test kit Transport stress (48 hours with fluctuations up to 50 C and down to 0 C) Tolerate exposures between 2 C and 45 C at an altitude up to 3000 metres, up to and including condensing humidity Operating conditions Operation between 15 C and 40 C at an altitude up to 2000 metres (between 10 C and 45 C at an altitude up to 3000 metres preferred) Extremely low relative humidity to condensing humidity Result interpretation in low light settings 11 Sensitivity and specificity for rectal and pharyngeal swabs is not yet determined 10

11 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR CHLAMYDIAL INFECTION TEST Training required < 90 minutes 30 minutes Clean water None Time to result <=60 minutes <=30 minutes Duration of sample stability (time from specimen collection to insertion into test cartridge) 12 It is inherent to the definition of a POCT that specimen collection should be immediately followed by the the testing of the specimen Stability of valid result (read window) 13 At least 30 minutes (after which results may be false or invalid) Clear language in the IFU regarding test reading. 1 hour (after which results give invalid rather than false results) Clear language in the IFU regarding test reading. Safety precautions (bio-safety requirements) Closed, self-contained system; unprocessed sample transfer only; no open handling of biohazardous material Waste/disposal requirements Safe disposal of all waste materials Small environmental footprint; compostable plastics for test cartridges and other materials Internal QC - reagents Procedural (reagent-addition) control internalized in cartridge for each individual test run; positive control for internal QC available for purchase separately Procedural (specimen-addition) control internalized in cartridge for each individual test run; positive control for internal QC provided in each box of test kits Device control Indicator of instability or expiration Indicator of instability, expiration, inadequate sample and incorrect procedure and/or use but not as an additional component 12 Stability following the manufacturer's IFU 13 This requirement only applies to tests that require reading by a reader device 11

12 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR CHLAMYDIAL INFECTION TEST Regulatory requirements Patient identification capability Result display; result interpretation Data acquisition and display: reader Compliance with appropriate ISO standard Yes simple, self-contained way to indicate a patient identifier Naked eyes, minimal instructions, integrated reader If combined with a reader, on-device visual read-out; able to add information (patient ID, operator ID, date, location, etc.); able to store patient results; able to print out results utilizing commoditized paper products (i.e. standard paper specifications and sizes) 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 utilize 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 HL7 standards, where appropriate; instrument tracks and transmits quality assurance data over time (e.g. identify shifts or trends) Target price per test (excluding the <US$5 <US$1 cost of a device or reader) It does not include the cost of device/reader in case the POCT is device-based or/and requires a reader for the result 12

13 2.2. Research Questions Why is sensitivity of ICTs so poor? Important to characterize the Ct antigen epitopes for detection by ICT POCTs. Can only detect > 10,000 bacterial load; but load in symptomatic and asymptomatic patients is actually much lower. Future of these tests? Test performance in pharyngeal and rectal swabs and on pooled specimens? Test impact on acceptability, feasibility, field performance, uptake, impact on prevalence in the community, impact on contact testing and treatment, increased uptake of testing for other STIs? Simple sample processing of rectal and pharyngeal swabs, and urine? Field testing of NAAT technologies further out in health system (e.g. level 1 or below, non-healthcare settings). Leverage NAAT technologies/platforms for STI testing/screening (e.g. emerging infectious diseases, EID, TB). 13

14 3. Syphilis Infection 3.1. Target Product Profile Combined/Mono Syphilis Infection Test Goal of test Intended use and target patient 15 Target use setting Results Equipment To detect TP-specific antibodies and non-tp-specific antibodies Surveillance/case management: sexually active population, including key populations (e.g. MSM, SW, STI-clinic/service attendees) Screening: pregnant women, key populations To detect TP-specific antibodies and non-tp-specific antibodies Clear reactive, non-reactive or invalid result with minimal instructions for interpretation Single use diagnostic test preferred, reader optional (small, portable, table-top or handheld, no electricity/power supply required) Target use(s) TP component Non-TP component Reference technology TPPA RPR Performance Clinical sensitivity 16 >80% >90% >95% of high titre (1 in 8) specimens >99% of high titre (1 in 8) specimens Clinical specificity >90% >95% >80% >95% Quantitation 17 Not applicable 15 Should be guided by the knowledge of the local epidemics 16 Based on a sample size sufficient to achieve confidence intervals of ±5% around a point estimate of sensitivity and specificity 17 POCTs are only to provide a positive/negative result, other quantitative methods will be used for quantitation 14

15 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR COMBINED TREPONEMAL (TP) AND NON-TREPONEMAL (NON-TP) POCT FOR SYPHILIS Specimen Finger prick capillary blood (maximum 50 µl) Finger prick capillary blood (maximum 20 µl) Specimen preparation Steps performed by healthcare worker between specimen preparation and result Additional consumables required but not provided within the test kit Cold chain sample processing; no more than one operator step No more than three operator steps that are not timed nor labour intensive None, other than for specimen collection None required at any point Integrated Max one operator step (none of which has a timed interval), excluding waste disposal Test kit All materials required for test procedure, including devices, reagents or other consumables to diagnose one individual, included in packaged, self-contained kit (either packaged individually as one test per test kit or sufficient to perform the number of tests packaged in the test kit box e.g. 20, 50 or 100 tests) Test kit stability and storage conditions Six months, stable between 2-35 o C, 70% humidity, 3000m altitude 12 months, stable between 0-50 o C, 90% humidity, 3000m altitude Environmental tolerance of packaged test kit Transport stress (48 hours with fluctuations up to 50 C and down to 0 C) Tolerate exposures between 2 C and 45 C at an altitude up to 3000 metres, up to and including condensing humidity Operating conditions Operation between 15 C and 40 C at an altitude up to 2000 metres (between 10 C and 45 C at an altitude up to 3000 metres preferred) Extremely low relative humidity to condensing humidity Result interpretation in low light settings Training required < 90 minutes 30 minutes Clean water None 15

16 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR COMBINED TREPONEMAL (TP) AND NON-TREPONEMAL (NON-TP) POCT FOR SYPHILIS Time to result <=60 minutes <=30 minutes Duration of sample stability (time from specimen collection to insertion into test cartridge) 18 It is inherent to the definition of a POCT that specimen collection should be immediately followed by the the testing of the specimen Stability of valid result (read window) 19 At least 30 minutes (after which results may be false or invalid) Clear language in the IFU regarding test reading 1 hour (after which results give invalid rather than false results) Clear language in the IFU regarding test reading. Safety precautions (bio-safety requirements) Closed, self-contained system; unprocessed sample transfer only; no open handling of biohazardous material Waste/disposal requirements Safe disposal of all waste materials Small environmental footprint; compostable plastics for test cartridges and other materials Internal QC - reagents Procedural (reagent-addition) control internalized in cartridge for each individual test run; positive control for internal QC available for purchase separately Procedural (specimen-addition) control internalized in cartridge for each individual test run; positive control for internal QC provided in each box of test kits Device control Indicator of instability or expiration Indicator of instability, expiration, inadequate sample and incorrect procedure and/or use but not as an additional component Regulatory requirements Patient identification capability Compliance with appropriate ISO standard Yes; simple, self-contained way to indicate a patient identifier 18 Stability following the manufacturer's IFU 19 This requirement only applies to tests that require reading by a reader device 16

17 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR COMBINED TREPONEMAL (TP) AND NON-TREPONEMAL (NON-TP) POCT FOR SYPHILIS Result display; result interpretation Data acquisition and display: reader Result can be read with the naked eye with minimal instructions for interpretation required by user, or with an integrated reader with an easy pictorial display: reactive, non-reactive, invalid for each test If combined with a reader, on-device visual read-out; able to add information (patient ID, operator ID, date, location, etc.); able to store patient results; able to print out results utilizing commoditized paper products (i.e. standard paper specifications and sizes) Connectivity: device/reader Data export (for quality assurance): device/reader If combined with a reader, reader has integrated GPS module If combined with a reader, full data export over mobile phone network If combined with a reader, internally integrated GPS/GPRS module and conformity with HL-7 messaging standards 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 utilize 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 HL7 standards, where appropriate; instrument tracks and transmits quality assurance data over time (e.g. identify shifts or trends) Target price per test (excluding the cost of a <US$3 <US$1.5 device or reader) It does not include the cost of device/reader in case the POCT is device-based or/and requires a reader for the result 17

18 3.2. Research Questions New markers for acute infection e.g. syphilis specific proteins or antigens or biomarkers in adults and infants? Reading of results: a better expression of quantification of the titres? The role of home-based testing for syphilis - is there a market? What is the optimal timing for detection of IgM in infants? 18

19 4. Human Papillomavirus Target Product Profile (TPP) Combined/Mono HPV Biomarker Test Goal of test Intended use and target patient 22 Target use setting Results Equipment To detect high-risk HPV (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) oncoprotein or correlated, related biomarker (e.g., quantitative mrna) in anal or cervical specimens Screening: High risk of being positive for high-risk HPV: HIV-positive women (cervical and anal), HIV-positive MSM (anal), HPVpositive women (general screening) To detect high-risk HPV (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) oncoprotein or correlated, related biomarker (e.g., quantitative mrna) in anal or cervical specimens Clear positive, negative or invalid result with minimal instructions for interpretation Single use, biodegradable or recyclable disposable diagnostic test preferred, reader optional (small, portable, tabletop or handheld, no electricity/power supply required) Target use(s) Reference technology Laboratory-based NAAT Performance Clinical sensitivity 23 70% >90% Clinical specificity 85% >90% Quantitation 24 Not applicable 21 The TPPs and research questions for HPV have been modified following further discussion with PAHO and NIH during a meeting in June Should be guided by the knowledge of the local epidemics 23 Based on a sample size sufficient to achieve confidence intervals of ±5% around a point estimate of sensitivity and specificity. 19

20 24 POCTs are only to provide a positive/negative result, other quantitative methods will be used for quantitation 20

21 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR HPV BIOMARKER TEST Specimen 25 Provider-collected cervical specimen and selfcollected 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) Specimen preparation Steps performed by healthcare worker between specimen preparation and result Additional consumables required but not provided within the test kit Cold chain sample processing; no more than one operator step No more than three operator steps that are not timed nor labour intensive None, other than for specimen collection None required at any point Integrated Max one operator step (none of which has a timed interval), excluding waste disposal Test kit All materials required for test procedure, including devices, reagents or other consumables to diagnose one individual, included in packaged, self-contained kit (either packaged individually as one test per test kit or sufficient to perform the number of tests packaged in the test kit box e.g. 20, 50 or 100 tests) Test kit stability and storage conditions Six months, stable between 2-35 o C, 70% humidity, 3000m altitude 12 months, stable between 0-50 o C, 90% humidity, 3000m altitude Environmental tolerance of packaged test kit Transport stress (48 hours with fluctuations up to 50 C and down to 0 C) Tolerate exposures between 2 C and 45 C at an altitude up to 3000 metres, up to and including condensing humidity 25 Sensitivity and specificity for rectal and pharyngeal swabs is not yet determined 21

22 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR HPV BIOMARKER TEST Operating conditions Operation between 15 C and 40 C at an altitude up to 2000 metres (between 10 C and 45 C at an altitude up to 3000 metres preferred) Extremely low relative humidity to condensing humidity Result interpretation in low light settings Training required < 90 minutes 30 minutes Clean water None (or self-contained in the kit) Time to result <=60 minutes <=30 minutes Duration of sample stability (time from specimen collection to insertion into test cartridge) 26 It is inherent to the definition of a POCT that specimen collection should be immediately followed by the the testing of the specimen Stability of valid result (read window) 27 At least 30 minutes (after which results may be false or invalid) Clear language in the IFU regarding test reading. 1 hour (after which results give invalid rather than false results) Clear language in the IFU regarding test reading. Safety precautions (bio-safety requirements) Closed, self-contained system; unprocessed sample transfer only; no open handling of biohazardous material Waste/disposal requirements Safe disposal of all waste materials Small environmental footprint; compostable plastics for test cartridges and other materials Internal QC - reagents Procedural (reagent-addition) control internalized in cartridge for each individual test run; positive control Procedural (specimen-addition) control internalized in cartridge for each individual test run; positive control for internal QC provided in each box of 26 Stability following the manufacturer's IFU 27 This requirement only applies to tests that require reading by a reader device 22

23 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR HPV BIOMARKER TEST for internal QC available for purchase separately test kits Device control Indicator of instability or expiration Indicator of instability, expiration, inadequate sample and incorrect procedure and/or use but not as an additional component Regulatory requirements Patient identification capability Result display; result interpretation Data acquisition and display: reader Compliance with appropriate ISO standard Yes; simple, self-contained way to indicate a patient identifier Result can be read with the naked eye with minimal instructions for interpretation required by user, or with an integrated reader with an easy pictorial display: reactive, non-reactive, invalid for each test If combined with a reader, on-device visual read-out; able to add information (patient ID, operator ID, date, location, etc.); able to store patient results; able to print out results utilizing commoditized paper products (i.e. standard paper specifications and sizes) Connectivity: device/reader Data export (for quality assurance): device/reader If combined with a reader, reader has integrated GPS module If combined with a reader, full data export over mobile phone network If combined with a reader, internally integrated GPS/GPRS module and conformity with HL-7 messaging standards 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 utilize 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 HL7 standards, where appropriate; instrument tracks and transmits quality assurance data over time (e.g. identify shifts or trends) 23

24 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR HPV BIOMARKER TEST Target price per test (excluding the <US$3 <US$1.5 cost of a device or reader) It does not include the cost of device/reader in case the POCT is device-based or/and requires a reader for the result 24

25 4.2. Target Product Profile Combined/Mono HPV DNA RNA Test Goal of test Intended use and target patient 29 Target use setting Results Equipment To detect of clinically relevant ( 1.0 pg/ml) high-risk HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) HPV DNA or RNA; correlated with CIN3+ Screening: Women aged years or HIV-positive women at any age To detect of clinically relevant ( 1.0 pg/ml) high-risk HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) HPV DNA or RNA; correlated with CIN3+ Clear positive, negative or invalid result with minimal instructions for interpretation Single use, biodegradable or recyclable disposable diagnostic test preferred, reader optional (small, portable, table-top or handheld, no electricity/power supply required) Target use(s) Reference technology Laboratory-based NAAT Performance Clinical sensitivity 30 85% 95% Clinical specificity * 31 Quantitation 32 Not applicable 29 Should be guided by the knowledge of the local epidemics 30 Based on a sample size sufficient to achieve confidence intervals of ±5% around a point estimate of sensitivity and specificity. 31 Values are currently under revision 32 POCTs are only to provide a positive/negative result, other quantitative methods will be used for quantitation 25

26 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR HPV DNA RNA TEST Specimen Specimen preparation Steps performed by healthcare worker between specimen preparation and result Additional consumables required but not provided within the test kit Cold chain Provider-collected cervical specimen and self-collected cervicovaginal specimen (preferred because no need for speculum exam or clinic visit) sample processing; no more than one operator step No more than three operator steps that are not timed nor labour intensive None, other than for specimen collection None required at any point Provider-collected cervical specimen and self-collected cervicovaginal specimen (preferred because no need for speculum exam or clinic visit) Integrated Max one operator step (none of which has a timed interval), excluding waste disposal Test Kit All materials required for test procedure, including devices, reagents or other consumables to diagnose one individual, included in packaged, self-contained kit (either packaged individually as one test per test kit or sufficient to perform the number of tests packaged in the test kit box e.g. 20, 50 or 100 tests) Test kit stability and storage conditions Six months, stable between 2-35 o C, 70% humidity, 3000m altitude 12 months, stable between 0-50 o C, 90% humidity, 3000m altitude Environmental tolerance of packaged test kit Transport stress (48 hours with fluctuations up to 50 C and down to 0 C) Tolerate exposures between 2 C and 45 C at an altitude up to 3000 metres, up to and including condensing humidity Operating conditions Operation between 15 C and 40 C at an altitude up to 2000 metres (between 10 C and 45 C at an altitude up to 3000 metres preferred) Extremely low relative humidity to condensing humidity Result interpretation in low light settings Training required < 90 minutes 30 minutes Clean water None Time to result <=60 minutes <=30 minutes 26

27 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR HPV DNA RNA TEST Duration of sample stability (time from specimen collection to insertion into test cartridge) 33 It is inherent to the definition of a POCT that specimen collection should be immediately followed by the the testing of the specimen Stability of valid result (read window) 34 At least 30 minutes (after which results may be false or invalid) Clear language in the IFU regarding test reading. 1 hour (after which results give invalid rather than false results) Clear language in the IFU regarding test reading. Safety precautions (bio-safety requirements) Closed, self-contained system; unprocessed sample transfer only; no open handling of biohazardous material Waste/disposal requirements Safe disposal of all waste materials Small environmental footprint; compostable plastics for test cartridges and other materials Internal QC - reagents Procedural (reagent-addition) control internalized in cartridge for each individual test run; positive control for internal QC available for purchase separately Procedural (specimen-addition) control internalized in cartridge for each individual test run; positive control for internal QC provided in each box of test kits Device control Indicator of instability or expiration Indicator of instability, expiration, inadequate sample and incorrect procedure and/or use but not as an additional component Regulatory requirements Patient identification capability Result display; result interpretation Data acquisition and display: reader Compliance with appropriate ISO standard Yes; simple, self-contained way to indicate a patient identifier Result can be read with the naked eye with minimal instructions for interpretation required by user, or with an integrated reader with an easy pictorial display: reactive, non-reactive, invalid for each test If combined with a reader, on-device visual read-out; able to add information (patient ID, operator ID, date, location, etc.); able to store patient results; able to print out results utilizing commoditized paper products (i.e. standard paper specifications and 33 Stability following the manufacturer's IFU 34 This requirement only applies to tests that require reading by a reader device 27

28 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR HPV DNA RNA TEST Connectivity: device/reader Data export (for quality assurance): device/reader sizes) If combined with a reader, reader has integrated GPS module If combined with a reader, full data export over mobile phone network If combined with a reader, internally integrated GPS/GPRS module and conformity with HL-7 messaging standards 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 utilize 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 HL7 standards, where appropriate; instrument tracks and transmits quality assurance data over time (e.g. identify shifts or trends) Target price per test (excluding the cost of a <US$3 <US$1.5 device or reader) Research Questions HPV Biomarker Test What is the optimal cut-off point for E7/E6 oncoprotein detection? Does quantitative mrna correlate with oncoprotein levels and therefore could be targeted (current assays that target mrna are qualitative and therefore have a clinical performance that resembles DNA detection)? Can detection of serum anti-e6/e7 antibodies be made sensitive enough to screen for CIN3+ and AIN3+. Current epidemiologic studies have relied primarily on ELISAbased technologies, which limit the lower bound of sensitivity due to small amounts of actual serum tested, poor kinetics, etc. Can a lateral flow or other configuration improve on the analytic sensitivity and therefore clinical sensitivity (for CIN3+)? 4.4. Research Questions HPV DNA RNA Test Is urine a viable specimen for DNA/qualitative RNA detection? Cheap, affordable, and safe media for specimen transport and storage for DNA, RNA, and protein targets. 35 It does not include the cost of device/reader in case the POCT is device-based or/and requires a reader for the result 28

29 29

30 5. Trichomonas Vaginalis 5.1. Target Product Profile Combined/Mono Trichomoniasis Test for Clinical Settings Goal of test Intended use and target patient 36 Target use setting Results Equipment To detect Tv Surveillance/case management: sexually active population, including key populations (e.g. FSW, STI-clinic/service attendees) Healthcare settings particularly at primary care level (level 1) or above Clear positive, negative or invalid result with minimal instructions for interpretation Single use, biodegradable or recyclable disposable diagnostic test preferred, reader optional (small, portable, table-top or handheld, no electricity/power supply required) Target use(s) Reference technology Testing STI patient Laboratory-based NAAT Performance Clinical sensitivity 37 85% (Clinician collected) 98% Clinical specificity 99% 100% Quantitation 38 Not applicable 36 Should be guided by the knowledge of the local epidemics 37 Based on a sample size sufficient to achieve confidence intervals of ±5% around a point estimate of sensitivity and specificity. 38 POCTs are only to provide a positive/negative result, other quantitative methods will be used for quantitation 30

31 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR TRICHOMONAS VAGINALIS TEST Specimen Vaginal swab Urine Specimen preparation sample processing; no more than one operator step Integrated Steps performed by healthcare worker between specimen preparation and result Additional consumables required but not provided within the test kit Cold chain No more than three operator steps that are not timed nor labour intensive None, other than for specimen collection Not required at any point Max one operator step (none of which has timed interval), excluding waste disposal Test kit All materials required for test procedure, including devices, reagents or other consumables to diagnose one individual, included in packaged, self-contained kit (either packaged individually as one test per test kit or sufficient to perform the number of tests packaged in the test kit box e.g. 20, 50 or 100 tests) Test kit stability and storage conditions Six months, stable between 2-35 o C, 70% humidity, 3000m altitude 12 months, stable between 0-50 o C, 90% humidity, 3000m altitude Environmental tolerance of packaged test kit Transport stress (48 hours with fluctuations up to 50 C and down to 0 C) Tolerate exposures between 2 C and 45 C at an altitude up to 3000 metres, up to and including condensing humidity Operating conditions Operation between 15 C and 40 C at an altitude up to 2000 metres (between 10 C and 45 C at an altitude up to 3000 metres preferred) Extremely low relative humidity to condensing humidity Result interpretation in low light settings Training required < 90 minutes 30 minutes Clean water None Time to result <=60 minutes <=30 minutes Duration of sample stability (time from specimen collection to insertion into test It is inherent to the definition of a POCT that specimen collection should be immediately followed by the the testing of the specimen 31

32 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR TRICHOMONAS VAGINALIS TEST cartridge) 39 Stability of valid result (read window) 40 At least 30 minutes (after which results may be false or invalid) Clear language in the IFU regarding test reading. 1 hour (after which results give invalid rather than false results) Clear language in the IFU regarding test reading. Safety precautions (bio-safety requirements) Closed self-contained system (optimal) unprocessed sample transfer only. Waste/disposal requirements Safe disposal of all waste material Small environmental footprint; compostable plastics for test cartridges and other materials Internal QC - reagents Procedural (reagent-addition) control internalized in cartridge for each individual test run; positive control for internal QC available for purchase separately Procedural (specimen-addition) control internalized in cartridge for each individual test run; positive control for internal QC provided in each box of test kits Device control Indicator of instability or expiration Indicator of instability, expiration, inadequate sample and incorrect procedure and/or use but not as an additional component Regulatory requirements Patient identification capability Result display; result interpretation Data acquisition and display: reader Compliance with appropriate ISO standards Yes simple, self-contained way to indicate a patient identifier Result can be read with the naked eye with minimal instructions for interpretation required by user, or with an integrated reader with an easy pictorial display: reactive, non-reactive, invalid for each test If combined with a reader, on-device visual read-out; able to add information (patient ID, operator ID, date, location, etc.); able to store patient results; able to print out results utilizing commoditized paper products (i.e. standard paper specifications and sizes) Connectivity: device/reader Not applicable Universal reader integrated (e.g. to GPS module) with local 39 Stability following the manufacturer's IFU 40 This requirement only applies to tests that require reading by a reader device 32

33 MINIMAL AND OPTIMAL OPERATIONAL CHARACTERISTICS FOR TRICHOMONAS VAGINALIS TEST Data export (for quality assurance): device/reader If combined with a reader, full data export over mobile phone network surveillance/sti programme initiatives 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 utilize 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 HL7 standards, where appropriate; instrument tracks and transmits quality assurance data over time (e.g. identify shifts or trends) Target price per test (excluding the cost of a Max US$5 per test Max US$1 per test device or reader) It does not include the cost of device/reader in case the POCT is device-based or/and requires a reader for the result 33

34 5.2. Research Questions Research to establish a rapid single Tv or multiple Tv/Ct/Ng, possibly HPV, test NAAT-based test. Multiplex NAAT for Tv in men with acute and recurrent UDS? Screening for key populations (asymptomatic), sex workers and HIV patients (female and male?), and pregnant women? Product development research for a universal reader. Benefit to diagnostic accuracy and cost-effectiveness of reader? Modelling of home-based testing to impact on the Tv prevalence in communities. Validation of home-based testing. Operation research around partner testing/notification with home-based testing (2 kits or 3 kits in a pack?) need for confirmatory testing? Benefit of putting condom(s) in the home-based tests? Acceptability of cost for home-based testing to different age groups? Psychological impact of home-based testing approach among users? Can home-based testing data be used for surveillance? Use of home-based testing within context of M-health? (follow-up, text messages, counselling, partner notification, attendance at clinics, link with hotline). 34

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