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CE Certificate Uncut Sheet Rapid Test IgG IgM Antibody Test

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Hangzhou Aichek Medical Technology Co.,Ltd

CE Certificate Uncut Sheet Rapid Test IgG IgM Antibody Test

Country/Region	china
City & Province	hangzhou zhejiang
Categories	Dyestuff Intermediates

Product Details

uncut sheet for COVID-19 IgGIgM Antibody Rapid Test Device CE certificate

For professional and in vitro diagnostic use only.

Product Name	Professional COVID-19 Antibody Rapid Test Device CE certificate
Formats	Strip(3mm)Device(4mm) uncut sheet
Place of Origen	China
Specimen	Blood
Read Time	5 minutes
Shelf life	2 years
Package	uncut sheet
Storage	2℃-30℃

[INTENDED USE]
The COVID-19 IgG/IgM Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with Novel coronavirus.

[PERFORMANCE CHARACTERISTICS]

Accuracy

If a person suffered the novel coronaviruses, there are several stages before recovery, like window period, early stage, initial stage, mid-term, and later period. The window period continues 14 days, 3-7days mostly, and no antibody produced at this time. Early stage is about 1-7 days after onset, and the IgM antibody appears, but the concentration is too low to be detected. Initial stage is about 8-14 days after onset, the

IgM antibody increases and the IgG antibody appears. Mid-term is about 15-39 days after onset, the IgM antibody decreases gradually and the IgG antibody peaks. The later period is about 1-2 months after onset, and IgM antibody could be detected hardly.

Also, everyone is different because of the difference of people’s immune response. For example, the antibody concentration of older people is higher than younger significantly, and the antibody levels in Asymptomatic infected human body are low

generally. A side-by-side comparison was conducted using the Novel coronavirus IgG/IgM Rapid Test and RT-PCR. 200 clinical specimens from Professional Point of Care site were evaluated, 57 were positive and 143 negative. In order to consider the difference of antibody production in people after infection as much as possible, we conducted 10 trails respectively. Base on the results from the clinical studies, the statistical analysis was made as follows:

COVID-19 IgM: the average sensitivity is 81.38% (95% CI: 70.18%~92.58%), the average specificity is 93.93% (95% CI: 88.23%~99.62%) and the total accuracy is 90.67% (95% CI: 87.07%~94.26%).

COVID-19 IgG: the average sensitivity is 92.50% (95% CI: 87.65%~97.35%), the average specificity is 95.53% (95% CI: 92.01%~99.06%) and the total accuracy is 94.67% (95% CI: 91.57%~97.77%).