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Failure of Test kits: E nsuring the quality of HIV testing in Malawi

Failure of Test kits: E nsuring the quality of HIV testing in Malawi. Geoff Chipungu MBBS DTM&H FCPath (SA) Micro US CDC Malawi Country office Laboratory Advisor. Malawi’s algorithm. Common Testing Issues [Elizabeth Marum , Hetal Patel]. Policy issues. Test kit specifications

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Failure of Test kits: E nsuring the quality of HIV testing in Malawi

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  1. Failure of Test kits:Ensuring the quality of HIV testing in Malawi Geoff ChipunguMBBS DTM&H FCPath (SA) Micro US CDC Malawi Country office Laboratory Advisor

  2. HTC in Malawi

  3. Malawi’s algorithm HTC Malawi

  4. Common Testing Issues[Elizabeth Marum, Hetal Patel]

  5. Policy issues Test kit specifications Time to read Storage Post-market evaluation Task shifting “Health Surveillance Assistants” (HSA) Other duties Sheer volume Option B+ “Batching” HTC Malawi

  6. Do we know how BIG the problem is? HTC Malawi • No • No systemic study as of yet • Some clues but hard to interpret and generalize

  7. ANC sentinel surveillance:?apples and oranges Extrapolate national: -/+9030 HTC Malawi

  8. HTC 2013 HTC Malawi

  9. The Blantyre patient • 45 years old • On ARVs nice July 2007, started as “Stage 3” • 2 VL done • LDL • Re-tested while being screened for “HART vs HEART” study • Awaiting a qualitative PCR and Western blot… HTC Malawi

  10. Implementing a Comprehensive Approach to Ensure Quality Consultative Meeting – Improving Access and Increasing Quality of HIV Testing in Africa

  11. Conclusion HTC Malawi In Malawi as in many countries, patient are started on ARVs based on 2 RTDs with no further confirmation There has been no systematic study but anecdotal evidence exists for false positives and false negatives EQA and mentorship needs to be intensified in Public health approach programs with task shifting

  12. Acknowledgements HTC Malawi • CDC • Abdoulaye Sarr, Beth Barr • Elizabeth Marum, Hetal Patel • College of Medicine • MLW • Liz Corbett, Augustine Choko, Noel Kayange • JHU • Mulinda Nyirenda, JohnstoneKumwenda, Newton Kumwenda • Ministry of Health • Ben Chilima, MabvutoChiwaula, Andreas Jahn

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