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Table 1 Table of studies included in review detailing information on study design, context, and measures of acceptability

From: Facilitators and barriers to point-of-care testing for sexually transmitted infections in low- and middle-income countries: a scoping review

Authors (year) STI Study design Country Setting Study population POCT used Sample used & collection method How integrated into care Acceptability (client testing uptake) Measures of feasibility
Antenatal care only
Watson-Jones et al. (2005) [23] TP Multi-study data synthesis Tanzania ANC (mixed urban/rural) Pregnant women RPR Venous blood Integrated into routine care Poor feasibility demonstrated
Many facilities were failing to implement syphilis screening effectively
During clinical observations of 342 ANC attenders across 9 sites, only 39% were either tested for syphilis or booked for testing
Only 970/2256 eligible ANC attenders (43%) over 4 months were documented as receiving an RPR test. Of 144 (15%) who were RPR-positive, only 88 (61%) were treated and 53 (37%) had a sexual contact who attended the clinic for treatment
Only 10% of 110 interviewed staff who were consulting with patients and likely to assess prenatal clients had received training in performing the RPR test
Ansbro et al. (2015) [24] TP Qualitative Zambia ANC (mixed urban/rural) HCWs (ANC) SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care 93.8% (15/16) of pilot HCWs and 62.5% (15/24) of rollout HCWs thought patients were accepting of the RST Most HCWs agreed RSTs were successfully integrated into facility PMTCT services (16/16 pilot, 23/24 rollout HCWs)
Dassah et al. (2015) [25] TP Interrupted time series (before-after) Ghana ANC (mixed urban/rural) Pregnant women Fingerprick blood Integrated into routine care Almost all health facilities that were previously not screening pregnant women for syphilis had absolute increases in AST uptake, following the rollout
However, all other facilities bar one that performed AST in 2009 had an absolute reduction in AST uptake in 2010
AST uptake of 50.0% and 33.6% in 2009 and 2010, respectively, thus leading to a much larger decrease (16.4%) in estimates of uptake following POCT rollout
Vani et al. (2015) [26] TP Qualitative India ANC (mixed urban/rural) Key stakeholders at facility, state, and district level Integrated into routine care HCWs reported that POCT would be feasible if finger prick
Maddox et al. (2017) [27] TP Qualitative Malawi ANC (mixed urban/rural) HCWs, laboratorians, Ministry of Health leaders and partner agency representatives Chembio Dual Path Platform HIV-Syphilis Assay
Alere Determine Syphilis TP*
Fingerprick blood Stakeholders viewed the dual RDT as a feasible alternative to the standard tests for use in the ANC setting, although some concerns over the complexity of the dual test
Dassah et al. (2018) [28] TP Qualitative Ghana ANC (mixed urban/rural) HCWs Alere Determine Rapid Syphilis TP Fingerprick blood Integrated into routine care Decentralisation of syphilis testing and provision of free syphilis testing and treatment appeared successful
The main successes of the rollout programme were reported to be easy integration of syphilis screening into ANC services and its decentralisation to most public health facilities
Kanyangarara et al. (2018) [29] TP Secondary data analysis DRC, Kenya, Malawi, Tanzania, Uganda, Zimbabwe, Benin, Burkina Faso, Mauritania, Senegal, Sierra Leone, Togo ANC (mixed urban/rural) Health facilities offering ANC Integrated into routine care Diagnostic capacity for syphilis at health facilities offering ANC varied across countries, ranging from 3% in Burkina Faso to 92% in Zimbabwe
One in twelve women received ANC at a facility ready to provide syphilis detection and treatment during the first 3 months of pregnancy
One in ten women received ANC during the first 3 months of pregnancy at a facility ready to provide syphilis screening
Olugbenga et al. (2018) [30] TP Field evaluation Nigeria ANC (mixed urban/rural) Pregnant women SD BIOLINE HIV/Syphilis Duo Fingerprick blood Standalone project. POCT results determine treatment 99.9% preferred dual RDT compared to single tests for HIV and syphilis Clinic staff rated the dual RDT with an overall feasibility score 12.3/16 [Clarity of kit instruction = 2.39/3; Ease of use = 2.41/3; Ease of interpretation of results = 2.27/3; Rapidity of test results = 1.91/2; Hands-on time 1.356; Training time required = 1.95/3]
Garcia et al. (2007) [31] TP Implementation Study Bolivia ANC (mixed urban/rural) Pregnant women Abbott Determine Rapid Syphilis TP Fingerprick blood Standalone project. POCT results determine treatment Study participants reported that they found the test highly acceptable 577/11618 (5.0%) tested positive by syphilis RDT test
93.2% (538/577) received at least a single dose of penicillin, and 81.5% (n = 470) received all three recommended doses
Bolivian health policy directly influenced by study—The Ministry of Health added syphilis screening with RDTs to the national maternal health guidelines
Severe et al. (2013) [32] TP Time-series implementation study Haiti ANC (mixed urban/rural) Pregnant women SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care Pre-POCT: 91.5% (31,810/34,776)
Post-POCT: 95.9% (15,373/16,025)
Post-QI intervention: 96.8%
(15,916/16,435)
High rates of testing across all time periods
Syphilis treatment only increased from 70.3 to 74.7% after the introduction of rapid tests (p = 0.28), but it improved significantly from 70.2 to 84.3% (p < 0.001) after the systems strengthening QI intervention
Bonawitz et al. (2015) [33] TP Quasi-experimental evaluation Zambia ANC (mixed urban/rural) Pregnant women SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care Baseline: 10.3% screened for syphilis by RPR testing
Midline: 67.5% screened (p < 0.001)
Endline 56.3% screened (p < 0.001)
Dassah et al. (2015) [34] TP Case control Ghana ANC (mixed urban/rural) Pregnant women Integrated into routine care
Bocoum et al. (2017) [35] TP Mixed methods evaluation Burkino Faso ANC (mixed urban/rural) Pregnant women Alere Determine Syphilis TP Fingerprick blood Integrated into routine care Good acceptability. Few refusals recorded Only 39% of eligible pregnant women underwent screening, likely due to stock outs
HCWs reported that the test was easy to use given its similarity to pre-existing HIV tests
Wang et al. (2018) [36] TP Implementation study China ANC (mixed urban/rural) Pregnant women Dual HIV/Syphilis RDT—type not specified Fingerprick or venous blood Standalone project. POCT results required confirmation 97.8% (1787/1828) Feasible. Among 1787 pregnant women who received RDT tests, 98.3% (1757/1787) participants were given their test result the same day
Among 1757 pregnant women received RDT testing results, 54.9% (965/1757) receiving their RDT results within 30 min, 20.7% (364/1757) received results within 30–60 min and 428 (24.4%) received results longer than 1 h later
Strasser et al. (2012) [37] TP Pre-post interventional study Uganda, Zambia ANC/PMTCT (mixed urban/rural) Pregnant women and their male partners SD BIOLINE Syphilis 3.0 Fingerprick or venous blood Integrated into routine care Zambia
Baseline: 79.9% (12,761/15,967)
Intervention: 95.6% (11,460/11,985)
Uganda
Baseline: 1.7%
Intervention: 90.3% (13,131/14,540)
RST testing was easily incorporated into services with no negative effects noted on other services
Zambia:
Baseline—51.1% (267/523) syphilis-positive women treated. Intervention—95.2% (1000/1050) treated [958 on same day]
Uganda:
Intervention—5.3% (690/13,131) were positive and 103.6% (715/690) treated [Women who tested syphilis-negative but whose partner tested positive were treated, resulting in over 100% of positive cases in women treated, 708 of 715 (99.0%) of those treated received on same day
No adverse effects noted on other services, and significant increases noted in percentages of pregnant women testing for HIV and receiving antiretroviral prophylaxis
Mabey et al. (2012) [38] TP Multi-country implementation study Tanzania, Uganda, Zambia, China, Peru, Brazil ANC (mixed urban/rural), community-based screening (in Amazon) Pregnant women & sexually active population (in Amazon) Brazil/Peru/Tanzania/Uganda/Zambia: SD Bioline Syphilis 3.0
China: Wantai anti-TP Antibody Rapid Test
Fingerprick blood Integrated into routine care 78.1% (150,068/192,140) screened The proportion of ANC attenders screened for syphilis increased to > 90%, and the proportion of pregnant women with syphilis who were treated the same day exceeded 90% in all countries
In Brazil, HCWs in remote communities succeeded in screening 55% of the sexually active population for syphilis, exceeding the 30–40% target originally set
All six countries changed their policy to recommend the use of rapid tests to provide a STAT service
Wilkinson & Sach (1998) [39] TP Intervention study South Africa ANC (mobile clinics/rural) Pregnant women RPR Venous blood Integrated into routine care 100% (398/398) Following introduction of on-site testing, 51 of 68 women (75%) with a positive RPR test received all three doses of penicillin, compared with 22 of 45 women (49%) when testing was done in the laboratory (p = 0.004)
The mean number of penicillin doses received by RPR positive women increased from 1.9 to 2.6 (p = 0.0003)
Far fewer women received no or only one penicillin dose (8/68, 11.7%) when testing was done on-site than when it was laboratory-based (13/45, 28.9%; p = 0.02)
With on-site testing all women received at least one penicillin dose, whereas with laboratory testing 10 (22.2%) did not receive any treatment (p = 0.0001)
Smith et al. (2015) [40] TP Implementation study Guatemala ANC (rural outreach service) Pregnant women SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care 50.3% (901/1793) Antenatal care coverage in public healthcare services increased from 73.7 to 99.6% before and after introduction of the outreach screening program
Syphilis screening increased from 49.6 to 50.3% (p = 0.87)
Syphilis prevalence = 8/901 (0.89%). All syphilis cases were confirmed, treated, and their partners notified
Myer et al. (2003) [41] TP Cluster RCT South Africa ANC (rural) Pregnant women RPR Venous blood Standalone project. POCT results determine treatment Mixed feasibility—No significant difference in outcomes between intervention and control clinics
Nurses at busy intervention clinics frequently had difficulty in conducting the on-site test, informing women of their infection, and initiating treatment. Supply chain issues for testing materials
On-site results available for 94.9% (4754/5011) eligible women
The average time from the first antenatal visit to the completion of syphilis treatment was 16 days shorter for women attending intervention clinics compared to those attending control clinics (95% CI 11–21, p < 0.001)
Similar proportions received no treatment (20% v 19%) and adequate treatment (64% v 69%)
3.3% of pregnancies resulted in perinatal death among women attending intervention clinics, compared with 5.1% among women attending control clinics (p = 0.31)
Bronzan et al. (2007) [42] TP Non-randomised trial South Africa ANC (rural) Pregnant women RPR
Abbott Determine Rapid Syphilis TP
Fingerprick blood for ICS. Venous blood for on-site RPR Standalone project but well integrated into care. POCT results determine treatment Feasible. Significantly more women received at least one dose of penicillin at the intervention clinics with onsite testing
Intervention clinics: 89.4% (93/104) of eligible women received at least one dose of penicillin
The onsite RDT resulted in the greatest percentage of pregnant women correctly diagnosed and treated for active syphilis
Fleming et al. (2013) [43] TP Mixed methods Kenya ANC (rural) Pregnant women Fingerprick blood Integrated into routine care Pre-intervention: 18% (179/1586)
Post-intervention: 70% (1123/1614)
Evaluation suggests RDTs are feasible for use in ANC services at low-level, rural facilities
Pre-intervention: 18% (279/1586) tested
During intervention: 70% (1123/1614) tested
Increase in syphilis testing statistically significant at every facility
At the three dispensaries, testing increased from 0 to 79% of attendees
Baker et al. (2015) [44] TP Mixed methods Tanzania, Uganda ANC (rural) Mothers in villages and healthcare key informants Integrated into routine care Tanzania: effective coverage of syphilis screening estimated at 15% (213/1422)
Uganda: effective coverage of syphilis screening estimated at 3% (88/2933)
Baker et al. (2015) [45] TP Cross-sectional Tanzania ANC (rural) Women and ANC HCWs Integrated into routine care Estimated effective coverage of syphilis screening in Tandahimba was 12% despite near universal accessibility coverage
25% in Tandahimba and 26% in Newala received a syphilis test during ANC
De Schacht et al. (2015) [46] TP Quasi-experimental operational research study Mozambique ANC (rural) Pregnant women, HCWs SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care Baseline coverage of syphilis screening: 80.8% (95%CI 65.3–96.2)
After introduction of POC testing: 87.0% (95%CI 76.4–97.7); p = 0.282
Variable effect of introduction of POCTs across different facilities:
Moamba and Marracuene: Significantly increased
Macia: Inititally low, and remained unchanged
Magude: Significantly decreased
No difference in time from first ANC visit to syphilis screening—same-day testing performed both before and after introduction of POC testing
Nnko et al. (2016) [47] TP Qualitative Tanzania ANC (rural) Pregnant women SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care 100% (7954/7954) Pre-implementation, 62% (31/50) of health facilities had the capacity to screen syphilis using RPR, however, only 22.6% (7/31) did screening
Introduction of RDT doubled the number of women who attended the ANC clinics, and significantly increased the number of women who tested for syphilis at the clinics (17.9% (636/3561) vs 100% (7954/7954), p < 0.01)
Proportion of pregnant women who were found with syphilis and offered treatment increased significantly (46.3% (50/108) vs 94.8% (862/909), p < 0.01)
90.1% (5719/6345) of the positive cases from September 2009 to October 2010 were tested and treated on the same day
Kuupiel et al. (2019) [48] TP Cross-sectional Ghana ANC (rural)—PHC clinics HCWs from PHC offering ANC Integrated into routine care
Young et al. (2018) [49] TP Implementation Study Kenya ANC (rural)—dispensaries Pregnant women SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care Pre-POCT: 4.3% (23/529)
Implementation: 97.6% (572/586)
Syphilis testing proportions increased from 4.3 to 97.6%
HIV testing rates remained over 90% in all facilities before and during integrated POCT period
Pre-intervention: No syphilis infections detected (0/529)
During intervention: 18 syphilis infections detected (prevalence = 3.1%)
Over 95% of participants received all four tests (HIV, syphilis, malaria, anaemia)
Young et al. (2019) [50] TP Qualitative Kenya ANC (rural)—dispensaries HCWs and pregnant women SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care Improved client acceptability to POCT
Pai et al. (2012) [51] TP Cross-sectional India ANC (rural)—tertiary care teaching hospital Pregnant women Inverness Medical Determine Rapid Syphilis TP Fingerprick blood Standalone project. POCT results required confirmation 96.0% (1002/1066) of consented women completed testing strategy Baseline: 8.98% (n = 90) women reported being screened for all three infections in their current pregnancy
Intervention: 96% of women screened
Bique Osman et al. (2000) [52] TP Cluster non-randomised trial Mozambique ANC (suburban) Pregnant women RPR Venous blood Standalone project. POCT results determine treatment “Very few women declined to participate” Feasible use of RPR in clinics—5.8% false negative and 12.8% false positive compared to lab
Munkhuu et al. (2009) [53] TP Feasibility study Mongolia ANC (urban) Pregnant women, HCWs SD Bioline Syphilis 3.0 Fingerprick blood Standalone project. POCT results determine treatment 100% (246/246) Feasible
Munkhuu et al. (2009) [54] TP Cluster RCT Mongolia ANC (urban) Pregnant women SD Bioline Syphilis 3.0 Fingerprick blood Standalone project. POCT results determine treatment POCT: 99% (3849/3850)
Control: 79.6% (3065/3850)
Feasible and more effective for the prevention of congenital syphilis
1st ANC visit: Control—79.6% tested. Intervention—Over 99% tested (p < 0.001)
3rd trimester: Control—62.1% tested. Intervention—99.7% tested (p < 0.001)
Intervention: 73 (1.9%) and 20 (0.5%) cases of syphilis detected
Control: 27(0.9%) and 2 (0.08%) cases detected
Treatment: Control—89.6% (26/29) of detected cases treated. Intervention—98.9% (92/93) of detected cases treated (p = 0.02)
Congenital syphilis: Control—15/3552 deliveries. Intervention—1/3632 deliveries (93.5% reduction, p = 0.002)
Gaitan-Duarte et al. (2016) [55] TP Cluster RCT Colombia ANC (urban) Pregnant women Arm A: SD Bioline Syphilis 3.0 & SD Bioline HIV 3.0
Arm B: SD Bioline HIV/Syphilis Duo
Fingerprick blood Standalone project. POCT results determine treatment Single tests: 99.8%
Dual test: 99.6%
In comparison to the baseline period, syphilis testing showed an increase of 9.7% in Arm A (single HIV and syphilis RDTs) and of 6.6% in Arm B (dual HIV/syphilis RDT)
Same day treatment: Single tests—69% (20/29). Dual tests—80% (16/20)
Treatment at any time: Single tests—82.8% (24/29). Dual tests—100% (20/20)
Berrueta et al. (2017) [56] TP Cross-sectional DRC, Zambia ANC (urban) Pregnant women DRC: Alere Determine syphilis TP
Zambia: SD Bioline Syphilis 3.0, RPR, or both
Fingerprick blood Integrated into routine care Overall:
DRC: 59.7% (2479/4153) Zambia: 27.8% (5025/18066)
When clinics had screening resources: DRC: 92.8% (2469/2660) Zambia: 52.0% (4761/9155)
Supplies available for screening on 78 days out of 122 in Kinshasa, and 69 days out of 129 in Lusaka
Kinshasa: 59.7% (n = 2479) screened overall. 92.8% screened when test supplies available
Lusaka: 27.8% (n = 5025) screened overall. 52.0% screened when tests supplies available
Nkamba et al. (2017) [57] TP Qualitative DRC, Zambia ANC (urban) Pregnant women, clinic administrators, and HCWs DRC: Alere Determine syphilis TP
Zambia: SD Bioline Syphilis 3.0
Fingerprick blood Standalone project. POCT results determine treatment Testing and treatment at first ANC visit acceptable to both providers and patients
Althabe et al. (2019) [58] TP Cluster RCT DRC, Zambia ANC (urban) Pregnant women DRC: Alere Determine Syphilis TP test
Zambia: SD Bioline Syphilis 3.0
Fingerprick blood Integrated into routine care Intervention: 99.9%
Control: 93.8%
Behavioural components implemented with a compliance rate between 88 and 100% what was planned
No stockouts of supplies for screening or treatment
Kasaro et al. (2019) [59] TP Field evaluation Zambia ANC (urban) Pregnant women SD BIOLINE HIV/Syphilis Duo Test
Chembio Dual Path Platform HIV-Syphilis Assay
Fingerprick blood Standalone project. No discussion of treatment 99.7% preferred the dual test over single tests Both dual RDTs received high and similar feasibility scores from staff
Tinajeros et al. (2017) [60] TP Mixed methods Bolivia ANC (urban) HCWs
Clinical records of pregnant women
Garcia et al. (2013) [61] TP Feasibility study Peru ANC (urban/peri-urban) Pregnant women SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care Screening coverage: 94.8% (and remained above 92% after end of implementation period) Feasible and improved several aspects of the health system
Treatment coverage 91.6%
Bocoum et al. (2015) [62] TP Field evaluation Burkino Faso ANC—Maternity ward at an urban PHC HCWs working in the maternity ward at an urban PHC centre 1. Accu-Tell Rapid Anti-TP
2. Alere Determine syphilis TP
3. Cypress Diagnostics Syphilis quick test
4. SD Bioline Syphilis 3.0
Fingerprick blood Standalone project. POCT results required confirmation
Pant Pai et al. (2019) [63] TP
TV
Cross-sectional India ANC (rural outreach service) Pregnant women OSOM Rapid Trichomonas Test MedMira Multiplo Rapid TP/HIV antibody test Fingerprick blood & vaginal swab Standalone project. POCT results required confirmation 100% (510/510) consented to testing
92% (453/491) rated testing with high satisfaction
Baseline laboratory screening rates: 42% for syphilis (214/510); 0.4% for TV (2/510)
Intervention: 100% of consenting participants screened at point-of-care
Gadoth et al. (2020) [64] CT,
NG
TV
Cross-sectional Field evaluation DRC ANC (mixed urban/rural) Pregnant women Xpert CT/NG
Xpert TV
Clinician-collected cervical swabs Standalone project. POCT results determine treatment 99% (366/371) 9 had invalid CT/NG tests with 3 invalid TV tests
97% of positive tests were subsequently treated
Badman et al. (2016) [65] CT
NG
TV
Descriptive feasibility study Papua New Guinea ANC (urban) Pregnant women Xpert CT/NG
Xpert TV
Self-collected vaginal swabs Standalone project. POCT results determine treatment Nearly all women who attended ANC requested to participate. 100% completion of study procedures amongst those enrolled 56% (125/222) of those who attended clinic enrolled due to limited testing facilities (one single, four-module, GeneXpert machine) combined with 20–15 new visits on a single day per week
All women received their test results the same day
All women with positive results had received their treatment within 1 week
Wynn (2017) [66] CT
NG
TV
Cross-sectional Botswana ANC (urban) Pregnant women Xpert CT/NG
Xpert TV
Self-collected vaginal swabs Standalone project. POCT results determine treatment 85.8% (400/466) enrolled 99% of participants received results either in person (61%) on the same day as testing or by phone (39%) within a week
Of 54 women with positive results: 40 received results and treated on the same day in person (74.1%), 8 received results on the same day via phone (14.8%), 5 women received delayed results and 1 woman did not receive results
Overall, 52 (96%) were treated, and 77% were treated on the same day
Wynn et al. (2016) [67] CT
NG
TV
Prospective cohort Botswana ANC (urban) Pregnant women Xpert CT/NG
Xpert TV
Self-collected vaginal swabs Standalone project. POCT results determine treatment 89% (200/225) Feasible. 100% of consenting women successfully tested for CT, NG, and TV, and given their results
One sample re-tested as temperature of the Xpert machine was above the threshold
72% (n = 143) received their results in person on the day of testing
29% (n = 57) contacted by telephone, on the same day, after leaving the clinic as could not wait for their STI results
100% of women who tested positive for an STI were successfully treated, most immediately (80%)
Morikawa et al. (2018) [68] CT
NG
TV
Field evaluation South Africa ANC for women living with HIV—PHC clinics (urban/peri-urban) Pregnant women living with HIV Xpert CT/NG
Xpert TV
Self-collected vaginal swabs Integrated into routine care 97.3% (430/442) 91.9% (159/173) of those with a positive STI test result received same-day results and treatment
100% of women with an STI were treated within 7 days
Both antenatal care & non-antenatal settings
Bristow et al. (2017) [69] TP Conjoint analysis Haiti Health centres offering STI/HIV testing and ANC Men and women seeking STI/HIV testing or ANC at health centres
Laksanasopin et al. (2015) [70] TP Field evaluation Rwanda PMTCT clinics or VCT centres (3 urban community-level health centres) PMTCT or VCT clinic attendees Smartphone dongle with a triplexed immunoassay (HIV antibody, treponemal and non-treponemal antibodies for syphilis) Fingerprick blood Standalone project. No discussion of treatment 97% of patients preferred the dongle compared to laboratory-based tests HCWs reported good feasibility
Fehler & Ballard (1998) [71] TP Cross-sectional pilot South Africa STD clinic (urban) & PHC clinic providing ANC (informal settlement) Pregnant women & symptomatic STI clinic attendees RPR Venous blood Integrated into routine care Feasible
Before on-site screening: 73% (29/40) of reactive RPR tests at STD clinic and 50% (10/20) at ANC clinic treated for syphilis. Presumed that all those with positive RPR on-site received treatment although not explicitly stated
Withers et al. (2019) [72] TP Field evaluation Vietnam STI clinic (for MSM) and ANC MSM and pregnant women SD BIOLINE HIV/Syphilis Duo Fingerprick blood Standalone project. POCT results required confirmation
Flores et al. (2015) [73] TP Quasi-experimental time-series study Peru Reference hospital (peri-urban) Hospital users seeking HIV/TP testing or pregnant women seeking ANC SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care 52% clients completely satisfied and 48% satisfied with point-of-care testing Baseline period: 61.0% of pregnant women tested for syphilis received timely results (within 45 min). Clients that did not receive their results within the 45-min norm, obtained their results after a minimum of 24 h, and often following days and weeks
Intervention period: 100% of pregnant women other key populations received timely results with POCTs
Marks et al. (2018) [74] TP &
Yaws
Qualitative Solomon Islands Outpatient and ANC departments of a district hospital and four rural health clinics HCWs and clinic patients Chembio Dual Path Platform Syphilis Screen and Confirm test kit Fingerprick blood Integrated into routine care
Non-antenatal settings
Gupte et al. (2011) [75] TP Cross-sectional India Fixed, satellite and mobile clinics offering services for sex workers Sex workers (female, male and transgender) Qualpro Syphicheck-WB Fingerprick blood Standalone project. POCT results required confirmation 63.1% (19,809/31,395) Introduction of rapid test improved feasibility of providing syphilis testing in all clinical settings, including mobile venues. Among the 19,809 SWs who accepted rapid syphilis testing, 598 tested positive (3.0% prevalence of lifetime syphilis infection). Among those screened with a positive rapid test, two-thirds accepted a confirmatory RPR test, with a reactivity rate of 85.3% (any titer) and 40.5% for active syphilis (RPR titer >/= 1:8)
Chen et al. (2012) [76] TP Cross-sectional China FSW outreach services at sex work venues FSW Wantai anti-TP Antibody Rapid Test Fingerprick blood Integrated into existing FSW outreach services—Clients referred to clinics for further diagnosis/treatment 95.0% (2670/2812) Feasible to integrate into FSW outreach services
RDT results: 182/2670 (6.8%) had a positive result
136/182 (74.7%) of FSW with positive results were willing to attend a clinic for further confirmatory testing and treatment
Campos et al. (2006) [77] TP Field evaluation Peru Mobile outreach to commercial sex venues FSW Alere Determine syphilis TP Fingerprick blood Standalone project. POCT results determine treatment 97.4% (3586/3682) 0.3% invalid test rate. 87% POCT positives subsequently went onto get treatment and 64% completed the three-dose regimen. Relatively easy to use operationally and to incorporate into existing services
Parthasarathy et al. (2013) [78] TP Retrospective analysis India STI clinic FSW, MSM, IVDU Immunochromatographic strip test & RPR Fingerprick blood Integrated into STI programme Avahan experience demonstrated that syphilis screening could be effectively integrated into a large-scale HIV prevention programme
The proportion of RDT used for screening increased from 7.4% in 2007 to 77.0% (p < 0.001) in 2009, replacing RPR as the predominant screening test. During the same period, the syphilis screening rates among clinic attendees increased from 9.0 to 21.6% (p < 0.001)
Mishra et al. (2010) [79] TP Field evaluation India STI clinic (fixed and mobile site camps) FSW Qualpro Syphicheck-WB Fingerprick blood Integrated into syphilis screening programme POC overall:
33.4% (1627/4871)
POC, first-time attendees:
26.9% (1117/4157)
Standard protocol, first-time attendees:
18.9% (1017/5391)
Treatment completion: Off-site RPR = 44.8%. POC screening = 68.3% (p = 0.003)
POC—97.5% (115/118) of FSWs who tested positive received same-day treatment
This corresponding to at least one dose of treatment in 68.3% of women with active syphilis, as determined by the reference laboratory
Sabido et al. (2009) [80] TP Field evaluation Brazil STI clinic (urban) STI clinic attendees including FSW, male clients of FSW, and other patients living or working in Manaus harbour area. HCWs and laboratory technicians Omega Diagnostics VisiTect Syphilis Fingerprick blood Standalone project. POCT results determine treatment 52% of respondents stated that they would choose the conventional test over POCT Operationally appropriate. Results of the time-flow analysis conducted among 84 patients showed that, excluding time spent receiving treatment for 7 (8.3%) patients, average time spent at the clinic was 51 min (SD 32)
Bristow et al. (2018) [81] TP Conjoint analysis Peru STI clinic (urban) and a gay men’s community health centre MSM, TGW
Benzaken et al. (2008) [82] TP Field evaluation Brazil STI clinic (urban) & outreach clinic offering services near red-light district STI clinic attendees including male and female sex workers and sex worker clients Omega Diagnostics VisiTect Syphilis Fingerprick blood Standalone project. POCT results determine treatment Reported as largely acceptable
Bien et al. (2015) [83] TP Qualitative China Urban community-based locations: (1) A local VCT site, (2) A local community-based organisation with ties to MSM community MSM
Lipsitz et al. (2014) [84] TP Cross-sectional Peru Mobile testing unit (outreach) MSM, TGW (although open to all visitors) Inverness Medical Determine Rapid Syphilis TP Fingerprick blood Standalone project. POCT results required confirmation. (Positive results referred)
Allan-Blitz et al. (2019) [85] TP Cross-sectional Peru Outreach to MSM/TGW venues MSM, TGW SD BIOLINE HIV/Syphilis Duo Fingerprick blood Standalone project. POCT results required confirmation 303/585 (51.8%)
Pinto et al. (2014) [86] TP Cross-sectional Brazil Social support services (including shelters, hostels, homes and temporary charitable housings) Homeless population with assisted social services Omega Diagnostics VisiTect Syphilis Fingerprick blood Standalone project. POCT results determine treatment 86.6% (1405/2110) All individuals with a positive RDT result agreed to start treatment right away, and, through the guidance of the multidisciplinary team, they were referred to health units to complete the treatment and for monitoring of the cure process
Hall et al. (2020) [87] TP Mixed methods Macao, China Community-based NGO study field site Female Filipino migrant domestic workers ABON Syphilis Ultra Rapid Test Device Fingerprick blood Standalone project. POCT results required confirmation (positive results referred) 85.3% (1164/1363)
Benzaken et al. (2007) [88] TP Field evaluation Brazil STI clinic (urban) Patients self-presenting to a STI clinic 1. Qualpro Syphicheck-WB
2. SD Bioline Syphilis 3.0
3. Abbott Determine Rapid Syphilis TP
4. Omega Diagnostics VisiTect Syphilis
Venous blood Standalone project. POCT results required confirmation High reproducibility between clinic and lab teams (kappa > 0.9 across all test scenarios)
Gallo Vaulet et al. (2018) [89] TP Field evaluation Argentina STI clinic (urban) Patients self-presenting to a STI clinic (50.2% MSM) Alere Determine syphilis TP Fingerprick blood Integrated into routine care 31.1% (587/1887)
Ribeiro et al. (2015) [90] TP Cross-sectional Brazil Home Residents in urban area of Amazonas state SD Bioline Syphilis 3.0 Fingerprick blood Standalone project. POCT results required confirmation 85.6% (1501/1752) Eleven HCW evaluated four sample tubes for HIV and four DTS for syphilis. Of those, three (27.3%) interpreted at least one test result incorrectly for syphilis
Overall, 40/44 (90.9%) of the syphilis readings on dried test spots were correct
3 syphilis dried test spots (6.8%) were falsely reported as negatives
Nurses reported all the incorrect syphilis readings (as opposed to nurse practitioners)
Mark et al. (2017) [91] TP Observational cohort study Kenya Home Male partners of pregnant women SD Bioline Syphilis 3.0 Fingerprick blood Standalone project. POCT results determine treatment During partner’s pregnancy: 93% (74/80) 6 months post-partum: 98% (226/230) Feasible and no effect on HIV testing
96% (151/158) accepted HIV testing prior to syphilis test introduction
95% (70/74) accepted HIV testing when both HIV and syphilis testing were offered
Ruffinen et al. (2015) [92] TP Implementation study Brazil PHC HCWs involved in POC testing SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care HCWs reported that the acceptance of rapid testing was excellent or good at all ten polo bases 3 months after the introduction, 25.9% (6473/25,322) screened in Alto Solimões DSEI (11 polo bases)
Syphilis prevalence = 2.5% (165/6473)
86.7% of all syphilis-positive individuals started treatment following the rapid test and that all were referred for confirmatory testing. Failure to immediately treat syphilis-positive individuals was primarily caused by a lack of benzathine benzylpenicillin at four of the ten polo bases
Mashamba-Thompson et al. (2018) [93] TP Cross-sectional South Africa Rural PHC PHC HCWs (operations managers, PHC specialist nurses, staff nurses) Integrated into routine care Only 0.5% of rural PHCs have currently accessible, available and in use syphilis tests
Smit et al. (2013) [94] TP Cross-sectional Tanzania Demographic surveillance study Participants of community-based study (representative of population) SD Bioline Syphilis 3.0 Fingerprick blood Integrated into larger demographic surveillance study
West et al. (2002) [95] TP Cross-sectional The Gambia Rural community—field laboratory set up in 20 villages for a reproductive health survey Women of reproductive age aged 15–54 RPR
Quorum Diagnostics RST
Venous blood Standalone project. No discussion of treatment 97.7% (1295/1325) RPR tested in the field (field screening in these 30 women not carried out owing to logistical difficulties, either generator or equipment failure or lack of consumables in the field laboratory)
Parkes-Ratanshi et al. (2019) [96] TP E-mail survey Uganda Mixed public/private sector facilities HCWs
Verwijs et al. (2019) [97] CT
NG
TV
TP
Cross-sectional Rwanda Research clinic Women aged 18 years or older at risk of acquiring STIs Xpert CT/NG
OSOM Rapid Trichomonas Test
Alere Determine syphilis TP
Clinician-collected cervical swabs, Fingerprick blood Standalone project. POCT results determine treatment. WISH algorithms used to determine who screened 100% (705/705) of enrolled participants accepted STI testing. 15.3% rejected HIV testing. 86.9% (344/396) chose to wait for the results. 100% clients who completed a satisfaction survey liked all testing procedures Staff and participants considered point-of-care testing feasible and acceptable with tests easy to perform and interpret
Prevalences: CT = 8.5% (60/705). NG = 7·1% (50/705). TV = 16.1% (111/690)
WISH algorithms: CT sensitivity 71·7%, specificity 100%, NG sensitivity 76·0%, specificity 100%, and TV sensitivity 68·5%, specificity 97·4%
Garrett et al. (2018) [98] CT
NG
TV
Prospective cohort pilot study South Africa Large urban public healthcare clinic HIV negative women presenting for STI care Xpert CT/NG
OSOM Rapid Trichomonas Test
Clinician-collected blind vaginal swabs Standalone project. POCT results determine treatment 23.6% (63/267) were diagnosed with at least one of CT/NG/TV
Stime et al. (2018) [99] CT
NG
TV
Mixed methods (time in motion study, qualitative) South Africa Large urban public healthcare clinic STI clinic attendees Xpert CT/NG
OSOM Rapid Trichomonas Test
Clinician-collected blind vaginal swabs Standalone project. POCT results determine treatment Syndromic management (n = 39): mean total visit duration = 2:05 and the mean clinical appointment duration was seven minutes
STI POCT (n = 9): mean total visit duration = 4:26. Mean additional visit time of 2:49 of which the longest step was running the GeneXpert samples (2:12). While the clinical visit accounted for 64% of the total time, much of this time was spent waiting for results
Staff in favour of expanding POCT
Badman et al. (2019) [100] CT
NG
Diagnostic evaluation Papua New Guinea Survey (urban) FSW, MSM, TGW Xpert CT/NG Self-collected anorectal swabs Standalone project. POCT results determine treatment 99.95% (2134/2135) 98% (2095/2134) valid test results—144 (6.7%) invalid at first test, of which 105 (72.9%) generated a valid test on repeating testing
Jones et al. (2007) [101] TV RCT South Africa Home Women aged 14–25 XenoStrip TV test# Self-collected vaginal swabs Standalone project. POCT results determine treatment 97% of women at the 6-week interview who successfully self-sampled reported that they would self-sample in the future 87% (146/168) test kits were received at the clinic from women who reported mailing them
96% contained the self-collected swab for PCR testing, 79% contained the used TV test strip, and 77% the self-administered questionnaire
Most women reported that self-sampling was easy or very easy, but more women in the clinic group reported this than women in the home group. 95% of these women reported being able to read the results, and 92% of the recorded results matched the reading by clinic staff. Almost all clinic women (98%) who came for their appointment were rated as finding it easy or very easy to perform the rapid test on their own. All women who tested positive were treated in both groups
Lippman et al. (2007) [102] TV RCT Brazil Home Women aged 18–40 years recruited from the general clinic population and from the clinic catchment area XenoStrip TV test Self-collected vaginal swabs Standalone project. POCT results required confirmation 96% (n = 787) were comfortable collecting their own vaginal sample and found self-collection easy Overall, home-based testing was feasible: 94% of home group participants were able to complete collection and self-testing at home on their first attempt
80% of women in the home group returned samples to the study clinic within 2 weeks of enrolment compared with 76% of women presenting for screening in the clinic group (one-sided p = 0.06)
Following a reminder phone call or letter for non-responders at 2 weeks, a slightly higher proportion of home group participants responded before the 6-week follow-up visit (93%—381/410) as compared with clinic group response (89% (359/403) (one-sided p = 0.03)
Benzaken et al. (2006) [103] NG Field evaluation Brazil STI clinic (urban) Women with vaginal discharge or referred by a partner with urethral discharge NGThermo Biostar Clinician-collected cervical swabs Standalone project. No discussion of treatment Three of the four staff members were able to obtain results within 30 min of receiving the specimen
Yin et al. (2006) [104] CT Field evaluation China STI clinics, female re-education centres and sex entertainment venues (urban) Women at risk of chlamydia infection Clearview Chlamydia MF Clinician collected vaginal and cervical swabs Standalone project. No discussion of treatment Excellent agreements between the results read by two independent staff for either vaginal or cervical specimens in different study sites (k statistics 0.94–1.00 vaginal specimens and 0.96–1.00 for cervical specimens; all p values were < 0.001)
  1. ANC antenatal care; CT Chlamydia trachomatis; DRC Democratic Republic of the Congo; FSW female sex worker; HCW Healthcare worker; IVDU intravenous drug user; MSM men who have sex with men; NG Neisseria gonorrhoeae; NGO Non-governmental Organisation; PHC primary healthcare; POCT point-of-care test; RCT randomised controlled trial; RPR rapid plasma reagin; SD standard diagnostics (company); STI sexually transmitted infection; TGW transgender women; TV Trichomonas vaginalis; TP Treponema pallidum; VCT voluntary counselling and testing
  2. *Alere, formerly known as Inverness Medical Innovations, Inc, until 2010, acquired the Determine line of rapid tests from Abbott laboratories in 2005. Alere was subsequently acquired by Abbott in 2017
  3. #The Xenostrip TV test was acquired by Genzyme and sold under the brand OSOM. Sekisui acquired Genzyme’s diagnostics products business in 2011, and continues to sell the test as the OSOM Trichomonas rapid test