Evaluation of a new solid-phase ABO and RhD blood grouping kit.

Abstract

Objectives: Rapid and accurate identification of blood groups is the foundation of emergency blood support. We performed a complete assessment of a new solid-phase kit for ABO forward grouping and RhD grouping (ABD Kit, InTec Products, Xiamen, China) on the analytical performance, which was compared with those of traditional methods.

Methods: We analysed 1260 clinical samples using the ABD Kit, including weakly agglutinated samples of A, B and D antigen, and compared the test results with those via Gel card, test tube and slide methods. We also validated the results of typing blood samples containing weak antigens using first-generation gene sequencing.

Results: The ABO forward group and RhD group of 1260 samples was determined using ABD Kit, revealing that the inter-batch repeatability rate of the kit was 100%. The results of the kit were compared with those of the gel card method, revealing that the detection accuracy of the kit was also 100%, which was confirmed by comparing the detection of weak antigen samples with the results of first-generation gene sequencing. The accuracy of the test tube agglutination method was 100%. In contrast, the accuracy of the slide agglutination method was low, especially in the detection of weak A blood antigens (agglutination strength 1+), weak B blood antigens (agglutination strength 1+) and weak D blood antigens (agglutination strength 1+ or 2+).

Conclusions: The ABD Kit (InTec Products, Xiamen, China) showed high sensitivity, reproducibility and specificity, indicative of excellent analytical performance. It is a reliable, practical and promising solution for rapid and accurate identification of blood types.