Standard No.:	YY/T 1831-2021
English Name:	Treponema pallidum antibodies detection kit (immunochromatographic method)
Chinese Name:	梅毒螺旋体抗体检测试剂盒（免疫层析法）
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2021-12-06
Implemented on:	2023-5-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	120.0
Delivery:	via email in 1~3 business day

本标准规定了梅毒螺旋体抗体检测试剂盒（免疫层析法）的要求、试验方法、标识、标签和使用说明书、包装、运输和贮存。
本标准适用于通过免疫层析法为原理，对人血清、血浆或全血中的梅毒螺旋体抗体进行定性测定的胶体金法、乳胶法等梅毒螺旋体抗体检测试剂盒。