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Performance of mPima for quantification of HIV Viral load for pregnant and post-partum woman in primary health care clinics in Mozambique. Team:

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  1. Performance of mPima for quantification of HIV Viral load for pregnant and post-partum woman in primary health care clinics in Mozambique Team: B. Meggi1, A. Zitha1 , C. Mudenyanga2, A. Vubil1 , D. Mutsaka2 , C. Nhachigule1 , T. Bollinger 2, N.Mabunda1 , O. Loquiha2 , T.F. Peter2 , I.V. Jani1 1Instituto Nacional da Saúde, Maputo, Mozambique 2Clinton Health Access Initiative, Maputo, Mozambique

  2. Background • 8 conventional laboratories serve the whole country needs for viral load with long TAT. • Logistics of sample transportation are a bottleneck to achieving optimal results TAT. • Point-of-care (POC) test for CD4 and EID have shown positive impact in patient important outcomes. • POC for viral load (POCVL) would significantly improve management of HIV+ patients

  3. m-PIMA HIV-1/2 VL Test • Instrument: Scaled up for EID testing at 130 health facilities. • Investigational use only cartridge : Quantitative HIV-1/2 viral load (VL) • Requires 50µl of plasma sample • Test result in less than 70 min • Kit’s volumetric transfer tool simplifies sampling

  4. Methods • Cross-sectional study in 2 PHCC in Maputo City • Sample size: 699 (Women PMTCT cascade) • 233 patients for each VL interval (< 1000 cps/ml, 1000-10000 cps/ml, >10000 cps/ml) • 1 microtube 0,5mL venous blood mini-centrifuged (not provided by the manufacturer) for POCVL testing • 6 ml EDTA tube- Plasma conventional testing (CAPCTM Roche) • 1 DBS card (routine VL in Mozambique)

  5. Study Sample Flowchart

  6. Patient Demographics

  7. Sensitivity/Specificity/PPV/NPV mPima (Venous blood) vs Plasma CAPCTM

  8. Correlation of 0.922 between Conventional Plasma vs. POC viral load (venous)

  9. BIAS of 0.202 log cp/ml between conventional vs POC Viral Load (venous)

  10. Sub study-Capillary Blood • H Polana Caniço and CS 1 de Maio. • Sample size: 93 pregnant woman • Capillary Blood=> advantage • 5-6 drops of capillary blood=> microtube=>Centrifuged=> plasma transferred to mPima • 6 ml EDTA of venous blood => Microtube=> mPima

  11. Capillary Blood was easy to collect and centrifuge

  12. Correlation of 0.983 between Venous blood vs Capillary Blood POC viral load

  13. BIAS of 0.021 log cps/ml between POCVL for Venous and Capillary Blood

  14. Conclusion • The mPima POC Viral load can be operated by nurses and implemented in routine primary health care services. • The use of a mini-centrifuge is a feasible approach to obtain plasma for POC VL testing. • The use of capillary blood could simply the collection in clinical environment. • The mPima presents an opportunity to increase device utilization through VL/EID integration

  15. Acknowledgments • Study participants • Implementing partner: Clinton Health Access Initiative • Staff at all study sites and laboratories • Funders: • UNITAID • UNICEF • Government of Flanders

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