ISO13485 Swab One Step Rapid Test IVD Test Kit 99.05% Accuracy
Brand Name:Aichek
Certification:CE
Model Number:COVID-19-G02001A
Minimum Order Quantity:5000 Test
Payment Terms:T/T
Place of Origin:China
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Location:
Hangzhou Zhejiang China
Address:
3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
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within 41 hours
Product Details
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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.
ISO13485 Swab One Step Rapid Test IVD Test Kit 99.05% Accuracy
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