新冠检测 COVID-19

新冠试剂图.png

 

中华人民共和国商务部认可新冠防疫物资出口产品



灵敏度:96.04%    特异性:95.10%

Lab Test Result: Sensitivity: 96.04%; Specificity:95.10%;Accuracy:95.7%;Kappa Value:0.90


预期用途:Intended Use

本产品用于体外定性检测人体样本(血清、血浆、全血)中COVID-19新型冠状病毒IgM/IgG抗体,临床上主要用于新型冠状病毒感染的辅助诊断。仅用作对新型冠状病毒核酸检测阴性疑似病例的补充检测指标或疑似病例诊断中与核酸检测协同使用,不能作为新型冠状病毒感染的肺炎确诊和排除的唯- -依据,不适用于- -般人群筛查,仅限医疗机构使用。

This kit enables fast and easy screening tests for both symptomatic and asymptomatic carriers of the COVID-19 virus (named as SARS-CoV-2 or 2019-nCoV). It qualitatively tests the COVID-19 virus specific IgM and IgG antibodies in whole blood, serum, or plasma specimen. The results can be observed after 10 minutes with the naked eye.

 

储存条件及有效期:Storage and Validity

4~40℃避光干燥保存,有效期为18个月。

Keep this kit at 2-40, avoid direct sun light, and do not freeze! The kit is valid for 18 months from the date of manufacture (see label on strip pouch). The strip should be used up in 30 minutes after opening of the inner packaging.

 

规格:【Packing Specifications】

1人份/盒、25人份/盒、50人份/

1 test/kit、25 tests/kit、50 tests/kit.