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Dual Diagnostic Technologies

Learn about the effective case management of sexually transmitted infections (STIs) with dual diagnostic technologies. This research program aims to improve control and prevention, decrease spread, and provide targeted counseling and education on STIs and HIV.

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Dual Diagnostic Technologies

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  1. Dual Diagnostic Technologies UZ-UCSF COLLABORATIVE RESEARCH PROGRAMME ANNUAL RESEARCH DAY 17 APRIL 2015 Dr Evaristo Marowa Dermato-Venereologist

  2. Approach to STI Case Management • STIs are common and serious especially to women and neonates • Effective case management is a cornerstone of control • Given at “point of first contact” it: • Decreases spread and prevents complications • Targets STI/HIV counselling and education to a receptive audience

  3. STI – Syndromic Case Management REQUIREMENTS • Adequate medical history • Good sexual history • Complete STI clinical examination • Management guidelines • Good supply of effective medicines

  4. Symptom + sign Particularly vaginal discharge or GUD Risk assessment Incorporate rapid diagnostic test Decision Action Condom use Partner notification Other action 2nd Generation Syndromic Diagnosis Approach

  5. Decision flowchart for introducing a new diagnostic test Is testing currently available or possible at the facility? No Yes Access, coverage and quality? Good Poor Can current system be fixed? No Yes • Maintain current system • Ensure continued/improved quality control programme • Introduce new diagnostic test(s)

  6. Current Rapid Tests for Syphilis(Equivalent to TPHA) Negative Positive C T Invalid C T S S S • Procedure: • Use dropper provided, dispense 1 drop of serum/whole blood to sample well S • 2. Add 2 drops of diluent buffer to sample well S • 3. Read results at 15 minutes C T

  7. Bioline Treponemal Point-of-care (POC) Test

  8. Chembio Syphilis POC Test Procedure 12345678 12345678 12345678 2. Add 2 drops of buffer to the sample+buffer well. 3. Add five drops of buffer to the buffer well when the colored lines disappear. 1. Add 5 l of serum/blood to the sample+buffer well. 4. Read the results at 15 minutes Negative result: one line or Positive result: two lines 12345678 12345678

  9. Ideal, conventional diagnostic algorithm for the diagnosis of active syphilis – RPR+TPHA Serum RPR -ve +ve Treponemal test No treatment necessary -ve +ve Confirmed syphilis TREAT Figure 12

  10. Span ‘Signal Spirolipin’ Flow-through Syphilis Dual Test Platform Control Spot Cardiolipin Antigen Spot (RPR equivalent) Treponemal Antigen Spot (TPHA equivalent) Patient Name or Number

  11. Step 1 Step 2 Step 3 Addition of wash buffer Addition of serum Addition of wash buffer Step 4 Step 5 Addition of conjugate Addition of wash buffer

  12. ONLY THE NON-SPECIFIC CARDIOLIPIN TEST REACTIVE NON –REACTIVE TESTS CONFIRMED REACTIVE TEST ONLY THE TREPONEMAL TEST REACTIVE Rapid Simultaneous Detection of Reagin and Treponemal Antibodies Using the ‘Signal Spirolipin’ Flow-through Test

  13. Field testing by CDC-USA in Madagascar(Courtesy Prof Ron Ballard)

  14. Chembio Dual Cardiolipin / Treponemal Test

  15. Syphilis testing and treatment algorithm with dual diagnostic test Whole Blood sample Dual (combined) rapid syphilis diagnostic test Tp +ve, NTp +ve Tp +ve, NTp -ve Tp –ve, NTp +ve Tp –ve, NTp -ve Active infection. Initiate treatment Past/early syphilis Retest in 4-6 weeks to confirm Biological false +ve, no treatment Uninfected, no treatment Tp = Treponemal result Ntp = Non=treponemal result

  16. The Future: Dual testing for HIV and syphilis

  17. The future multiplex technology for diagnosis of urethral discharge • Amplified nucleic acid based testing - for N. gonorrhoeae - for C. trachomatis - for M. genitalium - ? for U. urealyticum - for T. vaginalis

  18. The future multiplex technology for diagnosis of vaginal discharge syndrome • Amplified nucleic acid based testing - for T. vaginalis - for N. gonorrhoeae - for C. trachomatis - for M. genitalium

  19. Criteria for choice of tests for purposes of procuremet • Cost • Test Performance • Stability • Need for additional supplies, e.g. micropipette • Format: dipstick vs cassette • Training required • Ease of interpretation of results • Regulatory approval in country accuracyreproducibility

  20. Quality Assurance • Quality control of tests (QC) • Rapid tests have no internal QC • Need to monitor transport and storage conditions (temperature and humidity) • Temperature spiking in transit • Storage at central stores • Storage at health-care facilities at all levels • Quality of testing – EQA (proficiency) • Quality system throughout health-care infrastructure • National reference labs, regional, district, health centre

  21. The Future Goal • The development of integrated diagnostic platforms that are rapid, easy to use, sensitive and specific to detect multiple targets for diagnosis of infectious diseases • oral rapid tests to screen for HIV/syphilis, other viral STIs • Determination of antimicrobial resistance • For monitoring treatment and prevention • For use in peripheral point-of-care settings • Access ensured in low resource settings

  22. Tatenda Thank you Merci

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