1. PERFOMANCE CHARACTERISTICS AND COST BENEFIT OF THE SD BIOLINE HIV/SYPHILIS DUO TEST KIT IN ZIMBABWE
Mtapuri-Zinyowera S, Gumbo P, Munemo E, Ncube G, Machiha A, Mangwanya D, Simbi R, Maeka K, Mugabe M, Mupandasekwa S, Sakubani T.
ZIMA CONGRESS – Aug 2015
VICTORIA FALLS

2. MANDATES OF THE NMRL
To carryout evaluations and validations of new diagnostic technologies – rapid tests, POC technologies or conventional machines.
Run disease surveillances – influence policy change
Do diagnostic tests that are routinely carried out in the clinical labs.
Outbreak response.
Trainings
Quality assurance – QASI, DTS
Support programs.

3. BACKGROUND
MTCT of syphilis and HIV can result in severe adverse pregnancy outcomes and serious illness in infants, including miscarriage, stillbirth, preterm delivery, congenital syphilis, and pediatric HIV infection.
Syphilis and HIV testing of all pregnant women is recommended to prevent MTCT of these infections.
Both the WHO and the Pan American Health Organization have set a goal of elimination of MTCT by 2015.
To accomplish this goal, countries must achieve near-
universal testing and treatment of pregnant women.

4. SD BIOLINE HIV/SYPHILIS DUO
Study design
This was a crossectional comparison of two testing strategies, i.e. use of a combined HIV and syphilis test at a clinic comparing with laboratory enzyme immune assays as gold standards.
Study sites
The study sites in the Southern region were Mbare poly clinic, Budiriro poly clinic and Harare Hospital ANC department. In the Northern region the sites were Mpilo Central Hospital, Khami Clinic, Luveve clinic, Thorngrove Hospital, Mzilikazi clinic, Dulumadzimu clinic and Beitbridge Hospital.
Testing laboratory was the National Microbiology Reference Laboratory.
Inclusion and exclusion criteria
The inclusion criteria was ANC pregnant women who would have consented to be in the study. The exclusion criteria was pregnant women that were critically ill, patients unable or unwilling to provide informed consent or unsuitable
specimens with volumes inadequate for testing.

5. Objectives
1. To assess the operational characteristics of rapid test, including the ease of use, technical complexity and inter-reader variability. 2. To determine the laboratory-based performance of dual HIV/syphilis rapid diagnostic test (RDT) compared to reference assays. 3. To analyze the cost benefit of the use of a single combined HIV and syphilis test kit compared to using separate HIV and syphilis test kits.

6. METHODOLOGY – OPERATIONAL CHARACTERITICS
241 Pregnant mothers were recruited after informed consent.
Normal rapid HIV testing was done using the country’s algorithm and results given back.
Another was then done using the SD Duo.

7. METHODOLOGY-LAB BASED PERFOMANCE
Specimens were collected from 321 mothers attending 3 clinics in Harare after informed consent – Mbare polyclinic, Budiriro polyclinic and Harare Hospital ANC.
Normal rapid tests were carried out using the normal algorithm then SD Bioline Duo.
Specimens were then tested in the laboratory using EIA assays with the gold standards for HIV being Anilabs (Labsystems Diagnostics Oy, Finland), Vironostika HIV ag/ab (Biomerieux, France) confirming with HIV Blot 2.2 westernblot kit (MP Diagnostics, Singapore).
The reference tests for syphilis were the RPR kit (Lab 21
Health Care Ltd, UK) TPHA kit (AMS, UK).

8. RESULTS :- INTER-READER VARIABILITY
SD color scale
1% ~ 11% : Weak positive
14% ~ 26% : Medium positive
More than 29%: Strong positive
A total of 241 patients were tested for both HIV and Syphilis in the Matebeland region whereby 63(26%) were HIV positive and 30(12.4%) were RPR positive. In terms of inter reader variability the reader results fell within the same category of positivity according to the SD Bioline grading kit and there was no reader variability as no results among all readers overlapped to the next category of the grades.

9. HIV RESULTS HIV ELISA(GOLD STANDARD) SD BIOLINE HIV/Syphilis
Duo (HIV testing)
POSITIVE
NEGATIVE
TOTAL 37
284
321

10. SYPHILIS RESULTS SYPHILIS (GOLD STANDARD) SD BIOLINE HIV/Syphilis
Duo (HIV testing)
POSITIVE
NEGATIVE
TOTAL 3
290
291
294

11. COST BENEFIT
In 2014 the PMTCT programme tested 390,311 pregnant women for HIV and were also tested for syphilis calculations for cost benefit were then done.
Cost /test :-
HIV test is US$1.00
syphilis test is US$0.75
SD Bioline Duo is $1.50.

12. COST BENEFIT Cost benefit of the Duo test is reduced by 14%
Saved US$
Distribution and storage costs of the SD Bioline Duo test kit is reduced by half as compared to the current scenario whereby two
kits are used as compared to one kit which tests 2 diseases.
TEST/cost per test
NUMBER TESTED
TOTAL COST (US$)
SD DUO
HIV/US$1.00
309311
SYPHILIS/US$0.75
Grand Total
618622

13. USER FEEDBACK QUESTIONNAIRE
18 nurses involved in study – 10 responded.
8 (80%) indicated that test was easy to carry out with 2 (20%) said that they had difficult with the colour scale grading system.
70% indicated that it was time saving though challenges would be there if the patient needed only one test.
100% all agreed :-
The instructions on the kit were clear.
The job aid was essential
It was better to use the Duo kit as compared to the separate kits.

14. CONCLUSION
The use of a combined HIV and syphilis point of care (POC) test allows reduced testing and time in running different assays and the test is also cost effective.

15. THANK-YOU