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

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.

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

Government laboratories in Myanmar, 2013 Level Type No. of Beds Qty Responsible person Central (NHL) Reference ー 1 Director ( Labs ) Teaching Hosp. A 300 & above 11 Prof. Path General Hosp. 200 37 SCS/CS Path. Specialist Hosp. 100-150 30 District Hosp. B 100 52 Lab officer / Med . Tech Township Hosp. C 16-25-50 344 Grade I & II Station Hosp D 16 402 Grade I Total 877

Need to assess the quality of HIV testing results 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

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

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)

Training for new and low performance laboratories EQA Process Provider (NHL) Participants Training for new and low performance laboratories 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

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

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

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

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

Training on EQAS for HIV testing

Panel Samples Observation in site visits to NEQAS participated laboratory

Running cost for NEQAS Activities Unit cost Qty/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 2 12000 Ks 800 Ks 400 Ks 600 Ks Total estimated cost per year/site 38000 Ks (USD 40) Refresher training (20 participants) estimated USD 3000 Supervisory visits ※Collecting registration fee from laboratories supported by INGOs (50 USD per year for 2 panels )

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 Expanding the program into other Laboratory Testing: Syphilis testing (New National Guidelines　will be published soon) Experiences compiled in the National Guidelines, 2010

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

Thank you for your kind attention National Health Laboratory