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

Introduction: Hemoglobinopathies are major public health problems worldwide. Accurate laboratory diagnosis of the carrier is essential, which includes initial screening, Hb analysis, and DNA analysis. For the first time, we have developed a single‐tube quality control (QC) sample for these laboratory tests. Methods: The QC sample was made from a lyophilized mixture of the stabilized hemolysate with carbon monoxide saturation and the white blood cells of known thalassemia mutations. Homogeneity and stability were examined by Hb and DNA analyses on day 0 and every month for 12 months, at room temperature, 4°C, and −20°C. A preliminary proficiency testing (PT) program for hemoglobinopathies using this single QC material was developed. Results: Hemoglobin (Hb) and DNA analyses of a single‐tube QC sample demonstrated satisfactory results of Hb analysis for at least five months and DNA analysis for at least one year of storage at −20°C. The results obtained from a preliminary PT program on five expert laboratories confirmed that a single tube QC sample prepared could be used as a PT item with various Hb and DNA analyses methods. Conclusion: A single lyophilized control sample has been generated for use in hemoglobinopathies' internal and external quality control program. Unlike other available control materials, which are used for individual testing, a single‐tube QC sample generated can be used to control the pre‐analytical and analytical processes of both Hb and DNA analyses and is suitable for use in the PT program of hemoglobinopathies. [ABSTRACT FROM AUTHOR]