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Neutralized Antibody Test Uncut Sheet For 2019-NCov Customized

Hangzhou Aichek Medical Technology Co.,Ltd
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Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China

Contact name:Edward YU

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Hangzhou Aichek Medical Technology Co.,Ltd

Neutralized Antibody Test Uncut Sheet For 2019-NCov Customized

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

uncut sheet for 2019-nCov neutralizing Antibody test

 

 

Product Name

uncut sheet for 2019-nCov neutralizing Antibody test

Formats

Strip(3mm)Device(4mm) uncut sheet

Place of Origen

China

Specimen

Blood

Read Time

15 minutes

Shelf life

2 years

Package

uncut sheet

Storage

2℃-30℃

For professional and in vitro diagnostic use only.

 

[INTENDED USE]

 

The product is suitable for qualitative detection of neutralizing antibodies (NAbs) against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the spike glycoprotein and the Angiotensin converting enzyme Ⅱ (ACE2) receptor. The device can be instrumental in vaccine and therapeutic development as it is suitable for all antibody isotypes. It may also help in current COVID-19 investigations of sero-prevalence, assessment of human immunity, longevity of protective immunity, efficacy of different vaccine candidates as well as tracking infection.

 

[PERFORMANCE CHARACTERISTICS]

 

Sensitivity

The sensitivity to S-mIgG1 neutralizing antibody can reach 2ug/mL.

Accuracy

A side-by-side comparison was conducted by the results of SARS-Cov-2 Neutralizing Antibody Test Device (Test Reagent) developed by Hangzhou Deangel Biological Engineering Co., Ltd. and cPassTM from Genscript CO., Ltd. 328 clinical specimens from Professional Point of Care site were evaluated, 105 were positive and others negative. Base on the results from the clinical studies, the statistical analysis was made as follows:

 

cPassTM

Total

Positive

Negative

Test

reagent

Positive

96

2

98

Negative

9

221

230

Total

105

223

328

 

For test reagent, the clinical sensitivity with the “Compared Reagent” was 91.4% (95% CI: 77.7%~100%), the clinical specificity was 99.1% (95% CI: 97.2%~100%), the coincidence rate was 96.6% (95% CI: 92.4%~100%).

 

uncut sheet

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