总胆红素测定试剂盒行业标准的建立和实验验证

Establishment and Experimental Verification of Industry Standard for Total Bilirubin Test Kit

目的建立总胆红素测定试剂盒(钒酸盐氧化法)行业标准,并进行实验验证。方法选择不同生产厂家钒酸盐氧化法的总胆红素测定试剂盒,按照行业标准规定,对线性范围、准确度、精密度、稳定性等项目进行验证。结果不同试剂盒的各项指标均符合拟定的行业标准。结论总胆红素测定试剂盒(钒酸盐氧化法)行业标准制定合理、可操作性强。该标准的制定有助于统一总胆红素测定试剂盒(钒酸盐氧化法)的质量标准,为其生产、检验及流通等领域的监管提供依据。

Objective To （vanadate oxidation method）. establish and verify the industry standard for total bilirubin test kit Methods Kits with vanadate oxidation of different factories were used. The standard was assessed by testing items of linearity, accuracy, precision and stability, etc. Results The kits met all requirements of the proposed industry standard. Conclusion The establishment of industry standard for total bilirubin test kit （vanadate oxidation method） was reasonable and operable, which will contribute to the standardization of the product quality and provide a basis for the regulation of production, inspection and distribution.