1. www.ias2011.org Evaluation of point of care CD4 Testing in Ethiopia Belete Tegbaru National HIV Laboratory The Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia 6 th IAS Conference July 17-20, Rome Italy

2. www.ias2011.org Presentation outline Background Problems & questions Objective Plan of the evaluation Methodology Results Summary Expected Benefits of POC instruments Anticipated Challenges for implementation

3. www.ias2011.org 233,361 Sites giving ART Currently on ART As of end of March 2011 HIV testing sites 2,309 Total Tested (2010/11) 6,592,896 [+ve, 80,318 (1.2%)] Sites giving CD4 testing service 698 1.108 Hospitals 2.590 HCs 138 All Hospitals In Ethiopia (80 Million Population):

4. www.ias2011.org Absence of on time CD4 count results (centralized and referred) Service Lost follow-up Cold chain system Cost Problems & questions Distance to sites -TAT for results, HIV-DR? transport,storage & power interruption Expertise, maintenance, training, referral linkage

5. www.ias2011.org Objective To evaluate a point-of-care technology (PIMA TM ) at different level for CD4 testing sites Pima TM CD4 + T cell Technology - against standard CD4 instruments To see the feasibility: of PIMA for CD4 testing To see how far Pima TM CD4 + T cell Technology could help the facilities to reach their patients on time

6. www.ias2011.org Handy & can be charged for those without electricity Reagent at room temperature Can be done from finger prick

7. www.ias2011.org Plan of the evaluation With standard Machines at central & Hospital lab (N=2 sites, 300 samples) At Health center level; referred samples (n=7 sites, 750 samples) + Finger prick samples ( 300 samples) Finger Prick samples (n=10 sites, 500 samples) Phase-III Phase-II Phase-I

8. www.ias2011.org Methodology Evaluate against standard machines (FACSCalibur and FACSCount) Intra-test, inter-test, inter-instrument, interpersonal variations were determined Referred samples for FACSCount to referral sites and PIMA on site results were compared Operational parameters (failure rate, rate of additional devices for planning and training were evaluated)

9. www.ias2011.org Results FACSCaliburFACSCountPIMA Total Samples316 Total tested303297306 Mean CD4 (cells/  l) 314.9 [290.6-339.3] 323.3 [298.8-347.8] 317.3 [293.2-341.3] Range9-9974-10393-970 Failure rate No result obtained 5(1.7%)11 (3.7%)8 (2.6%) Total cartidgesDamagedRetesting PIMA-Lab33312 (3.6%)15 (4.9%) PIMA –HCs1402(1.4%)15(10.7%) Lab: 27(8.1%, 5.4-11.1) Site level: 17(10.7%,7.2-18.7] for planning 9.4% extra devices

10. www.ias2011.org PIMA versus FACSCaliburFACSCount PIMA Bias (Mean) 2.3 cells/  l-6.0cells/  l LOA (cells/  l) [-106.1 to +110.7][-102.4 to + 90.4] Similarity (%)103.2%, CV=15.5%100.9%, CV=14.4% CorrelationsR=0.960, p<0.001R= 0.990, p<0.001 FACSCaliburFACSCount

11. www.ias2011.org Closeness of values

12. www.ias2011.org ParametersAt our Lab evaluation (n=306) Site in AA (n=141) Within town PIMA Mean 317.3 331  191 FACSCount mean 323.3 349  206 Diff -6.0 -18 Similarity (%) 100.9 98  10.6 Time to referral center and distance 5-10 min 10-15 Km, 20-30 Min Period of referral NA 1x/week TAT of results NA 3-4 days PIMA versus FACSCount at health centers before and after referral

13. www.ias2011.org FACSCaliburFACSCount Phase-I (Lab based) Total 9.2%8.4% Downward 5.7%6.1% Up-ward 17.3%14.1% Phase-II (Clinic based, N=140, Addis Ababa) Total 1.4% Downward 0.93% Up-ward 3.1% PIMA Misclassification rate Taking 200 cells/µl as a cutoff

14. www.ias2011.org Variability studies

15. www.ias2011.org Sample Vial-A Vial-B TECH-A TECH-B PIMA-1PIMA-2PIMA-1 TECH-A PIMA-1 TECH-A Day-1 Day-2 <200: 103 cells/µl >200: 510 cells/µl Each test= 10x

16. www.ias2011.org Sample Vial-A Vial-B TECH-A TECH-B PIMA-1PIMA-2PIMA-1 TECH-A PIMA-1 Inter machine variation Day-1

17. www.ias2011.org Sample Vial-A Vial-B TECH-A TECH-B PIMA-1PIMA-2PIMA-1 TECH-A PIMA-1 Inter technician variation Day-1

18. www.ias2011.org Sample Vial-A Vial-B TECH-A TECH-B PIMA-1 TECH-A PIMA-1 Inter-assay variation Day-1

19. www.ias2011.org Sample Vial-A Vial-B TECH-A TECH-B PIMA-1 TECH-A PIMA-1 Intra-assay variation Day-1

20. www.ias2011.org Sample Vial-A Vial-B TECH-A TECH-B PIMA-1PIMA-2PIMA-1 TECH-A PIMA-1 Day-2: Daily variation Day-1

21. www.ias2011.org Parameters CD4 (cells/µl) <200= 103 cells/µl >200= 510 cells/µl WHO (CV%) PIMA Sample (n=10 times) Inter-Machine ≤200<15%9.2% >200<10%5.2% Intra assay ≤200<15%13.1% >200<10%6.4% Inter assay ≤200<15%10.7% >200<10%3.2% Inter personnel ≤20010.7% >2002.1% Daily variation (after 16-17 hrs test) <200 (109.6 cells), P= 0.10 10.7% >200 (542.1 cells), p=0.52 2.1%

22. www.ias2011.org Meaning of Pont-of-care In phase-II: 4 HCs tested 255 patients by both PIMA and FACSCount Results obtained by FACSCount after referral Total testedResults returned Lost or no result & need re-draw blood FACSCount 25523312 (4.7%)** PIMA 2552532(0.7%)* **- drawing of blood for 2 nd time due to lost results * Reading failure

23. www.ias2011.org Expected Benefits of POC instruments

24. www.ias2011.org Patient Program Laboratory Expansion of sites Reduce the cost of referral Reduce the cost of cold chain Serve the patient on site Reduce lost follow-up Limited training required Storage (room temp. and space) Sample collection (easy and safe) Can be done at lower level Get service on site Initiate ART on time No cost for transport & others Follow their status at any time Increase quality of life

25. www.ias2011.org Anticipated Challenges for implementation Supply of reagents and machines Vs expansion –Mechanism to solve – connectivity and planning Maintenance Vs expansion –Preventive maintenance free- –Technical service replacement strategy CD4% for pediatric cases –development

26. www.ias2011.org Summary 1.Good agreement with standard machines with low bias and good percentage of similarity 2.On Planning: a total of 9.4% extra devices required at lab & site level 3.Failure rate on testing= 8/306= 2.6% at lab level 4.Gives extra advantage – No need to re-draw blood - point-of-care ~5% of the cases 5.Power interruption was not a problem at site level 6.The intra-, inter-tests are within WHO recommendations for ≤200 and >200 cells/  l CD4 Tests

27. www.ias2011.org Collaborating Individuals Dr. Tsehaynesh MeseleEHNRI Dr. Almaz AbebeEHNRI Mr. Dereje TeshomeEHNRI Mr. Ermias HailuEHNRI Mr. Feyissa ChallaEHNRI Mr Habteyes HailuEHNRI Mrs. Yodit AlemayehuEHNRI Katherine Theiss-Nyland CHAI Dr. Peter TrevorCHAI

28. www.ias2011.org Ethiopian Health and Nutrition Research Institute –Organize and lead the evaluation CHAI: Financial, material and technical support Alere: Training of laboratory personnel at the National HIV laboratory

29. www.ias2011.org THANK YOU!