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CE Certificate Uncut Sheet Rapid Test IgG IgM Antibody Test
CE Certificate Uncut Sheet Rapid Test IgG IgM Antibody Test
Specifications
Brand Name :
Aichek
Model Number :
COVID-19-G02001A
Certification :
CE
Place of Origin :
China
MOQ :
5000 Test
Price :
1 USD
Payment Terms :
T/T
Supply Ability :
negotiable
Packaging Details :
40box/carton
Storage :
2℃-30℃
Sample Type :
Blood
User :
Professionals
Accuracy :
94.67% (95% CI: 91.57%~97.77%).
Certificate :
CE ISO 13485
Key words :
Safe Reliable Economic
OEM :
OEM customized packing avaliable
Formats :
25T/box 1T/box
Description

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%).

Product tags

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CE Certificate Uncut Sheet Rapid Test IgG IgM Antibody Test

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Product Detail
Brand Name :
Aichek
Model Number :
COVID-19-G02001A
Certification :
CE
Place of Origin :
China
MOQ :
5000 Test
Price :
1 USD
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CE Certificate Uncut Sheet Rapid Test IgG IgM Antibody Test

Hangzhou Aichek Medical Technology Co.,Ltd

Active Member
4 Years
zhejiang, hangzhou
Since 2012
Business Type :
Manufacturer
Main Products :
COVID19 Rapid Test Kit, Antigen Rapid Test Kit, Antibody Rapid Test Kit
Total Annual :
500000-1000000
Employee Number :
150~200
Certification Level :
Active Member
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