Results from 8 years of the proficiency testing program for diagnosis of hemoglobinopathies under the prevention and control program of thalassemia in Thailand

Abstract

Introduction Hemoglobin (Hb) analysis is a key testing for diagnosis of hemoglobinopathies. Accurate analysis, interpretation of results, and genetic risk assessment are important. We report on 8 years of the proficiency testing (PT) program for hemoglobinopathies in Thailand. Methods Laboratory participants were required to test two simulated PT items in each cycle using capillary electrophoresis, one was a husband and another was his pregnant wife. Related hematological parameters were provided. The participants also provide interpretation and evaluate the risk of having three severe thalassemia diseases in an expected fetus. Three cycles were operated per year in accordance with the ISO17043 and ISO13528 guidelines. A total of 84 laboratories throughout Thailand were participated. Results A total of 24 PT cycles were performed during 2012‐2019. Most participants had Excellent performance for the PT items with normal, β‐thalassemia trait, hemoglobin E trait, hemoglobin E trait with α‐thalassemia, and Hb H disease. However, when the PT items with homozygous Hb E and Hb E‐β‐thalassemia were tested, an increase in a Needs improvement performance was noted. From 24 PT cycles, the performance with Excellent, Good, Fair, and Needs improvement was ranging from 10.5%‐95.8%, 0%‐11.3%, 0%‐77.2%, and 2.3%‐37.0%, respectively. Conclusion Most participants have proven their performance to be reliable and demonstrated their abilities to provide interpretation and genetic risk assessment on most of the PT items. For complex thalassemia however, a need to improve the interpretation and risk assessment skills is required which is essential for effective prevention and control of severe thalassemia diseases in Thailand.

Generation of a single‐tube quality control material for hemoglobin and DNA analyses of hemoglobinopathies

“…For this purpose, each laboratory requires the appropriate performance of internal and external quality control and participation in the PT program. We have reported the results of the PT programs for initial screening and Hb analysis in Thailand 7,8,17 …”

“…We have reported the results of the PT programs for initial screening and Hb analysis in Thailand. 7,8,17 No PT program for DNA analysis of hemoglobinopathies has been established in Thailand. Due to the lack of appropriate PT items, most of these PT programs have been operated separately.…”

“…Each participant reported the results of the Hb variant and DNA analyses into the provided form. The form was sent back to us within the specified period as described previously 7,17 …”