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Htay Htay Tin, Khin Yi Oo, Latt Latt Kyaw, Win Win Yee, Tin Tin Htay National Health Laboratory Myanmar National External Quality Assessment Scheme for HIV Antibody Testing in Myanmar

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Current situation of HIV epidemics in Myanmar HIV infection is one of the major infectious diseases National AIDS program prevent & control HIV Infection Myanmar has developed a multi-sectoral broad-based National Strategic HIV/AIDS Plan (NSP) 2011-2015 High priority is directed to reduce HIV related risk, vulnerability and impact among mobile populations in National Strategic Direction. HIV prevalence among 15-49 years age group has been gradually declining from 0.67% in 2007 to 0.47% in 2013 The HIV epidemics in Myanmar are largely concentrated among key populations with higher risk, particularly FSW, MSM, IDUs. 2

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Role of National Health Laboratory 1.To develop and implement the laboratory support services in line with the National Health Policy. 2.To function as the Central Reference Laboratory for Clinical and Public Health Services. 3.To promote and maintain Quality Assurance Scheme throughout the laboratory services. 4.To conduct applied research activities. 3 (Established in October 1963, formarly Pasteur Institut)

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Government laboratories in Myanmar, 2013 LevelTypeNo. of BedsQty Responsible person Central (NHL)Reference 1Director ( Labs ) Teaching Hosp.A300 & above11Prof. Path General Hosp.A20037SCS/CS Path. Specialist Hosp.A100-15030SCS/CS Path. District Hosp.B10052Lab officer / Med. Tech Township Hosp.C16-25-50344Grade I & II Station HospD16402Grade I Total877 4

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Many testing sites for HIV diagnosis -Blood safety in government hospitals labs - VCCT - PMCT in government hospitals labs, STD labs, NGOs and INGOs Need to assess the quality of HIV testing results

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HIV testing algorithm Strategy I Transfusion Safety Determine D(+) D(-) PositiveNegative Strategy II VCCT Positive D(+) U(+) Determine D(+) D(-) Negative UniGold D(+) U(-) Repeat D&U Positive D(+) U(+) D(+) U(-) D(-) U(-) Negative Indeterminate Strategy III PMTCT D(+) U(+) D(+) U(-) S(-) Risk Assessment Positive D(+) U(+) S(+) Determine D(+) D(-) Negative UniGold D(+) U(-) Repeat D&U D(+) U(+) D(+) U(-) D(-) U(-) Negative Indeterminate D(+) U(+) S(-) or D(+) U(-) S(+) StatPak

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History of NEQAS Establishment In 2004, Staff from NHL attended training course of EQA in Thailand for HIV testing In 2005, JICA Major Infectious Disease Control Project initiated support to strengthen the Blood safety program including screening of HIV With the funding from the MIDC Project, NHL established the National EQAS for HIV testing with 65 public laboratories in 2005 Participating labs increased annually and expansion of the scope from blood safety to entire HIV testing including VCCT & PMCT, 351 labs (2013) 7

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EQA Process 8 Provider (NHL) Training for new and low performance laboratories Participants Panel preparation and Distribution Panel testing and Reporting back to NHL -Preliminary reporting -Data collection/ Analysis -EQA report writing -Feedback to Participants -Self evaluation -Corrective action Supervisory visit and on-site training for low performance laboratories

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Objectives of NEQAS To assess and monitor the quality of HIV testing on a nationwide basis To identify the problems for corrective actions To improve and maintain the quality of HIV testing

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Methods Panel Sample preparation Convert plasma to serum using thrombin Add Proclin as a preservative Inactivate the HIV antibody positive sera (56 Cx 1 hour) Homogeneity are done ( Random testing of OD by ELISA on each panel ) Stability tests for any transportation effect

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Panel distribution and Analysis Distribute five samples per panel (including HIV antibody positive, weak positive & negative sera) twice a year Analyze the test results and send feedback report Panel 17 & Panel 18 were distributed & analyzed in 2013

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Corrective actions Refresher training On site testing assessment Monitoring and supervisory visits Future plan Private hospital laboratories to participate in this NEQAS program

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17 Training on EQAS for HIV testing

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18 Panel Samples Observation in site visits to NEQAS participated laboratory

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Running cost for NEQAS Activities Unit costQty /year Cost Preparation of panel samples (5 each) Posting cost (Panel samples) Communication cost (Follow up) Report publication Posting cost (Report) 6000 Ks/site 400 Ks /site 3000 Ks/site- air 200 Ks/site 400 Ks/copy 300 Ks/site 2222222222 12000 Ks 800 Ks 400 Ks 800 Ks 600 Ks Total estimated cost per year/site38000 Ks (USD 40) 19 Collecting registration fee from laboratories supported by INGOs (50 USD per year for 2 panels ) Refresher training (20 participants) estimated USD 3000 Supervisory visits

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Operational research for better practice and policy Findings from our Operational Research Myanmar has established a functioning External Quality Assurance System for HIV testing nationwide, but still needs continuous effort to maintain the system, especially for keeping high reporting rate. Systematic approach, commitment of responsible persons, continuous financial and technical support are key for the successful implementation of EQAS for HIV testing Experiences compiled in the National Guidelines, 2010 Expanding the program into other Laboratory Testing: Syphilis testing (New National Guidelines will be published soon)

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Acknowledgement We would like to thank DFAT for the Australia Fellowship Awards allowing us to attend International AIDS 2014 Conference National Reference Laboratory NRL, Australia for the continuous technical support to the improvement of quality in the labs To JICA (MIDC project) and WHO for their support to establish and sustain this NEQAS (HIV) program Last but not the least, to the participants of this NEQAS program for their active participation

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Thank you for your kind attention National Health Laboratory 22