YY/T 1883-2023 in English

本文件规定了Rh血型C、c、E、e抗原检测卡（柱凝集法）的要求、试验方法、标签和使用说明书、包装、运输和贮存等。
本文件适用于以凝胶、玻璃微珠等材料进行填充的微柱，微柱中抗C、c、E、e为IgM类型的单克隆抗体，采用免疫血液学、颗粒过筛和离心技术三者结合的原理，进行定性检测的Rh血型系统中C、c、E、e四种抗原的检测试剂。
本文件不适用于血源筛查进行Rh血型C、c、E、e抗原检测的诊断试剂。

Scope

This document specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of Rh blood group C, c, E and e antigen detection cards (column agglutination method). This document is applicable to micro-columns filled with gel, glass beads and other materials. The anti-C, c, E, and e in the micro-columns are IgM type monoclonal antibodies. The three technologies of immunohematology, particle sieving and centrifugation are used. Based on the principle of combining the two, it is a detection reagent for the four antigens C, c, E, and e in the Rh blood group system for qualitative detection. This document does not apply to diagnostic reagents for blood source screening for Rh blood group C, c, E, and e antigen detection.