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ISO13485 Swab One Step Rapid Test IVD Test Kit 99.05% Accuracy

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Contact name:Edward YU

Hangzhou Aichek Medical Technology Co.,Ltd

ISO13485 Swab One Step Rapid Test IVD Test Kit 99.05% Accuracy

Country/Region	china
City & Province	hangzhou zhejiang
Categories	Cotton Pad

Product Details

CE SARS-CoV-2 Professional Antigen Rapid Test Kit IVD Swab Type

Product Name	CE SARS-CoV-2 Professional Antigen Rapid Test Kit IVD Swab Type
Formats	Device(4mm)
Place of Origen	China
Specimen	Swab
Read Time	15 minutes
Shelf life	2 years
Package	25 device/box or 1Test/Box
Storage	2℃-30℃

Intend Use
The SARS-CoV-2 antigen rapid test kit is intended for professional detection sars-cov-2 antigen in infection human nasopharyngeal or oropharyngeal swab, the test provides preliminary test results. It's an aid inthe diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. To be attention the test result should no be used as the sole basis for diagnosis.

PRINCIPLE

The Device uses the principle of the double antibody sandwich method for detecting the nucleoprotein (N) of SARS-CoV-2. The marker is composed of the anti-N antibody 1 labeled with colored particles. When testing, the sample was added into the sample well and migrated to the absorbent pad by the capillary effect. If the virus exists, it will react with the marker and captured by the anti-N antibody 2 coated in the NC membrane. Then there is a colored line produced at the test area, indicating a positive result. If there is no virus in the sample, the colored line will not show at the test area and it means a negative result. Regardless of whether the virus contained in the sample, as a procedural control, a colored line will always appear at the control area, indicating that proper volume of specimen has been added and the correct test procedure is conducted.