Rapid Point-of-Care Tests for STIs: needs, progress, challenges
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1 Rapid Point-of-Care Tests for STIs: needs, progress, challenges Ranmini Kularatne Centre for HIV and STIs National Institute for Communicable Diseases National Health Laboratory Service South Africa Nov 2017
2 Overview Characteristics of an ideal POCT Needs: Asymptomatic STIs STIs in priority/ key populations Extragenital infections Progress: Available assays Assays in the pipeline Challenges: Technical aspects & training requirements Performance characteristics in the field EQA/ PTS Impact on treatment? Strategic implementation
3 WHO Criteria for POCT: ASSURED A - Affordable S - Sensitive S - Specific U - User-friendly R - Rapid & Robust E - Equipment-free D - Deliverable to end-users
4 STI POCTs: Needs
5
6
7 Distribution of VDS aetiologies by age category 70,0% 60,0% 50,0% 40,0% 30,0% 20,0% 10,0% AnySTI NG CT TV MG BV only CA only BV/CA with no STI 0,0% ,0% Aetiological surveillance of Sexually Transmitted Infection Syndromes: NICD GERMS-SA
8
9 Factors associated with asymptomatic STI STI diagnosis in past year 3.00 ( ) Sex under influence of drugs in past 6 months 2.12 ( ) Sex with internet-sought partner in past year 1.98 ( ) Sex at sex-on-site venue in past year 1.92 ( )
10 Surveillance for STIs among FSW in Hillbrow, Jhb Black V et al. Presented at 2015 World STI & HIV Congress, Brisbane 268 FSW; consistent condom use in 33% Self-reported mean number of sex partners = 125 (8-440); equivalent to 33, 500 sex acts per month for 268 FSW
11 Pregnancy: 206/470 (43.8%) symptomatic for STI Post-delivery: 26/216 (12%) symptomatic for STI
12 Commercially available STI POCTs
13 Cepheid GeneXpert CT/NG
14 Unemo et al. Lancet Infect Dis 2017
15 Unemo et al. Lancet Infect Dis 2017
16 OSOM Trichomonas test: Sekisui Diagnostics
17 Unemo et al. Lancet Infect Dis 2017
18
19 WHO recommended process for implementing syphilis POCTs
20 SA Epidemiology: RPR Seropositivity among ante-natal care attendees Source: Department of Health Annual HIV & Syphilis Antenatal Survey
21 Types of rapid syphilis POCTs Treponemal Treponemal/ Non-Treponemal
22 33 studies: 19 (58%) evaluated POCT using whole blood STI Clinic patients; female sex workers; antenatal clinic attendees; blood bank Treponema pallidum specific reference standard used on serum Sample Determine TP (Abbott Diagnostics, UK) SD Bioline (Standard Diagnostics, Korea) SyphiCheck WB (QualPro Diagnostics, India) VisiTect (Omega Diagnostics, UK) Sensitivity (95% CrI) Specificit y (95% CrI) Sensitivity (95% CrI) Specificity (95% CrI) Sensitivity (95% CrI) Specificity (95% CrI) Sensitivity (95% CrI) Specificity (95% CrI Serum 90% (80.4, 95.2) 94.1% (89.3, 97.7) 87.1% (75.7, 94.5) 95.8% (89.9, 99.5) 74.5% (56.8, 88.4) 99.1% (96.4, 100) 85.1% (72.8, 92.6) 96.5% (91.9, 99.3) Whole blood 86.3% (77.3, 91.7) 95.8% (92.4, 97.7) 84.5% (78.8, 92.6) 97.9% (92.5, 99.3) 74.5% (63.9, 82.1) 99.6% ( ) 74.3% (53.6, 83.7) 99.4% (98.2, 99.9) CrI = Credible Interval
23 Clinic v laboratory performance of syphilis POCTs: Ante-natal Care Test TPPA Positive RPR (> 1:8) & TPPA positive Sensitivity Specificity Sensitivity Specificity Rural district in Northern Tanzania Prevalence of active syphilis is 2.3% POCT Whole blood positive EIA Plasma 59.6% 99.4% 82% 100% 95.2% 97.7% 100% 100% 1 district hospital; rest were community health centres/ rural dispensaries. POCT (SD Bioline) would result in a higher proportion of pregnant women with active syphilis receiving treatment c/t standard testing (82% v 16%).
24 Cost-effectiveness of Syphilis POCTs Decision-analytic model for 43 sub-saharan African countries Use of rapid POCTs for antenatal syphilis screening is highly cost-effective in SSA: reduction in DALYs per health care dollar spent higher in countries with high prevalence rates. Stillbirths averted Neonatal deaths averted Cases of congenital syphilis averted DALYs averted Increase in direct medical cost Cost/ DALY averted 95% CI SA ,028 $ 920,106 $ 31 (12-170) Probability screening is costeffective Prevalence Target rate 99.8% 0.008%
25 POCT assays in the pipeline
26 Next-generation technologies: microfluidics and nanotechnologies 1. Sample preparation Microfluidic sample processing: micro or nanoparticles (magnetic) complexed with antibodies to bind target analyte 2. Target detection a) Optical: fluorescence, absorbance, chemiluminescence b) Non-optical: electrical sensing, elctrochemical
27 Unemo et al. Lancet Infect Dis 2017
28 Atlas Genetics io Platform (Atlas Genetics) Electrochemical detection of target Organisms lysed, DNA extracted & purified PCR amplification of target sequence produces SS DNA Target hybridized to electrochemically labelled probe. Exonuclease enzyme digests complex, releasing electrochemical label detected. All processes in 1 cartridge; < 30 mins; one cartridge can process up to 24 tests CT; CT/NG; CT/NG/TV; MG CT assay (CE marked): Sens = 95.5% Spec 96.8%
29 GeneXpert Omni (Cepheid) Highly portable: height 23cm; weight 1kg Battery-operated: 4hrs of operation; supplemental re-chargeable battery (12 hrs) Wireless and web-enabled Dedicated mobile device to control each test module; single system module stores >20,000 results Cost = US$ 2,895 Full Xpert menu available 2018
30 Unemo et al. Lancet Infect Dis 2017
31 STI POCTs: challenges
32 Interpreting results of syphilis POCTs Reading of results Time to reading of results Chembio DPP: read result mins after addition of buffer; DO NOT read result after 20 mins from addition of buffer to well 1. VisiTect Syphilis: negative results must be confirmed only at the end of 30 minutes.
33 Impact of rapid syphilis tests on screening and treatment at ante-natal care facilities Rural district in Zambia: 18 healthcare facilities Improved syphilis testing uptake in first 6 months Endline test period: frequent stock-outs of RST kits; lack of sustained on-site supervision Lack of impact of increased screening on treatment
34 Sexually Transm Dis 2013; 40 (11): Systematic review of 2,379 maternity clinic records at 6 public clinics in Northern Cape and Gauteng Only 41% tested for HIV and 71% tested for syphilis at first pregnancy visit Women tested for syphilis were almost 4 times more likely to have had no HIV test (OR 3.9, 95% CI = ) 243 had reactive HIV tests: only 104 (43%) had documented sdnvp treatment before delivery 98 with reactive syphilis: 73% received one penicillin injection, only 36% received all 3 injections Only 47% began treatment within 2 weeks of test Lack of functional integration of care at facility level
35 WHO Criteria for POCT: ASSURED A S S U R E D Cost-effective, integration into HCT, PreEP, PMTCT Field evaluation studies: whole blood, non-invasive specimens Dual TP/ NTP rapid tests can reduce over-treatment Training: technical aspects, results interpretation, ongoing EQA/ PTS, timeous results delivery & action Adequate sample collection, stock management Treatment availability, patient education
36 Where would rapid STI POCTs be most useful? 1. Targeted screening for asymptomatic STIs in priority and high-risk populations Include screening for extra-genital infections 2. Screening for syphilis at ante-natal care facilities Remote rural sites with limited access to laboratory facilities Late-bookers Low patient return rates 3. Early warning surveillance for drug-resistant Neisseria gonorrhoeae infection: aetiological testing of treatment failure cases 4. Screening for asymptomatic STIs in pregnant females 5. Identifying STIs in symptomatic VDS patients
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