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Evaluation of point of care CD4 Testing in Ethiopia

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. Presentation outline. Background Problems & questions Objective

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Evaluation of point of care CD4 Testing in Ethiopia

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

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

  3. As of end of March 2011 In Ethiopia (80 Million Population): 233,361 HIV testing sites 2,309 6,592,896 [+ve, 80,318 (1.2%)] Total Tested (2010/11) • 698 • 108 Hospitals • 590 HCs Sites giving ART Sites giving CD4 testing service • 138 • All Hospitals Currently on ART

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

  5. Objective To evaluate a point-of-care technology (PIMATM) at different level for CD4 testing sites • PimaTM CD4 + T cell Technology - against standard CD4 instruments • To see the feasibility: of PIMA for CD4 testing • To see how far PimaTMCD4 + T cell Technology could help the facilities to reach their patients on time

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

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

  8. 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. Results Lab: 27(8.1%, 5.4-11.1) Site level: 17(10.7%,7.2-18.7] for planning 9.4% extra devices

  10. PIMA versus FACSCalibur FACSCount

  11. Closeness of values

  12. PIMA versus FACSCount at health centers before and after referral

  13. PIMA Misclassification rate Taking 200 cells/µl as a cutoff

  14. Variability studies

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

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

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

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

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

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

  21. Meaning of Pont-of-care • In phase-II: 4 HCs tested 255 patients by both PIMA and FACSCount **- drawing of blood for 2nd time due to lost results * Reading failure

  22. Expected Benefits of POC instruments

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

  24. 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

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

  26. Collaborating Individuals • Dr. TsehayneshMesele EHNRI • Dr. Almaz Abebe EHNRI • Mr. Dereje Teshome EHNRI • Mr. ErmiasHailu EHNRI • Mr. FeyissaChalla EHNRI • MrHabteyesHailu EHNRI • Mrs. Yodit Alemayehu EHNRI • Katherine Theiss-Nyland CHAI • Dr. Peter Trevor CHAI

  27. 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

  28. THANK YOU!

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