Development of Internal Quality Control Material for ABO and Rhesus D Blood Grouping in Vietnam: A Preliminary Experimental Study

Abstract: BACKGROUND: ABO and Rhesus D (RhD) blood group systems are essential for transfusion safety. In Vietnam, the absence of domestically produced internal quality control (IQC) materials has resulted in reliance on costly and inconsistently supplied imported products or nonstandardized in-house controls. AIMS AND OBJECTIVES: To preliminarily assess the homogeneity, transport stability, and storage stability of the IQC material for ABO and RhD blood grouping. METHODOLOGY: An experimental study was conducted to produce eight IQC lots representing ABO and RhD blood group systems. A total of 272 samples were prepared. Homogeneity and stability were evaluated in accordance with ISO/IEC 17043:2023 and ISO 13528:2022 guidelines using column agglutination methods. The results were assessed using the predefined acceptance criteria and descriptive concordance analysis. RESULTS: Homogeneity testing demonstrated uniform serologic performance, with >95% of reactions exhibiting strong agglutination (≥3+) and 0% false positive results. All IQC lots (100%) met the predefined acceptance criteria and were classified as PASS. Transport stability at 2°C–8°C for 7 days showed complete retention of agglutination strength and specificity without hemolysis. Storage stability remained consistent for 6 weeks, with minor noninterpretive 4+ to 3+ shifts in <10% of samples. All stability assessments remained within acceptance limits. CONCLUSIONS: The IQC material for ABO and RhD blood grouping demonstrated satisfactory homogeneity and stability, meeting the ISO acceptance criteria. This supports the feasibility of domestic IQC production to improve quality assurance in transfusion laboratories in Vietnam. The findings should be interpreted in light of the limited sample size and study setting.