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. Meggi 1, 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, 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
1 EDTA tube of 6 ml
500ul for microtube
Centrifugation with
Mini-centrifuge
50ul plasma to m-pima cartridge
DBS (routine)
Molecular Centralized lab of INS
Testing
Remaining blood
Centrifugation and processing

7. Patient Demographics Patient demographics n= 692 % Age (years) <19
n= 692 %
Age (years)
<19 27 4%
314
46%
164
24%
>35
167
Not available 20 3%
Median age (IQR) 29
Time on ART (months)
<1
123
18%
1 -- 6
104
15% 56 8%
≥12
386
56% 23
Median time on ART (IQR), years
1,64
ART regimen
AZT+3TC+LPVr 4 1%
AZT+3TC+NVP 7
TDF+3TC+EFV
675
98% 6

8. Sensitivity/Specificity/PPV/NPV mPima (Venous blood) vs Plasma CAPCTM
1000 threshold
POC viral load
<1000 cp/ml
≥ 1000 cp/ml
Valid result
Plasma
410 15
425
Conventional 13
248
261
423
263
686
95%
C.I
Measure
Estimate
Lower
Upper
Sensitivity
96,5%
94,2%
98,0%
Specificity
95,0%
91,6%
97,3%
Predictive value of a positive test
96,9%
94,8%
98,4%
Predictive value of a negative test
94,3%
90,8%
96,8%

9. Correlation of 0. 922 between Conventional Plasma vs
Correlation of between Conventional Plasma vs. POC viral load (venous)

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

11. 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

12. Capillary Blood was easy to collect and centrifuge

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

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

15. 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

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