This kit is used to qualitatively detect the novel coronaviruses (SARS-CoV-2) antigen in human nasal throat swabs, oral throat swabs, posterior oropharyngeal saliva, sputum and stool samples.
This kit is used for the qualitative detection of specific antigen against novel coronavirus (SARS-CoV-2) in human specimens (Nasal swabs, oropharyngeal swabs, lower respiratory tract samples).
Principle
This kit adopts colloidal gold-based flow-through, lateral-flow immunoassay and capture method to detect specific antigen against coronavirus in human specimens(Nasal swabs, oropharyngeal swabs.
This product is used for in vitro qualitative detection of SARS-CoV-2 antigen in human oropharyngeal swabs, nasal swabs and nasopharyngeal swabs. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of SARS-CoV-2 infection.
The current test kit is based on specific antibody antigen reaction and immunoassay technique. The test card contains a gold labeled novel
coronavirus N protein monoclonal antibody p re coated on the binding pad
and a paired novel coronavirus N protein monoclonal antibodies fixed in the
test line (T) and corresponding antibodies in the quality control line (C).
During the test, the N protein in the specimen binds to the gold-labeled nove lcoronavirus N protein antibody pre-coated on the binding pad, and the
conjugate moves upward under the capillary effect, and then is trapped by N
protein monoclonal antibody conjugate fixed in the Test Line (T). The higher
the N protein content in the specimen, the more conjugates are trapped, and
the darker the color of the Test Line (T). If there is no novel coronavirus in
the specimen or the virus content is below the detection limit, no colour
appears in the Test Line (T). A purple red band will app ear in the Control
Line (C) regardless of whether there is a virus in the specimen. The
purple red band that appears in the Control Line (C) is the criteria for
determining whether there is enough specimen and whether the
chromatography process is normal.
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-in serum, plasma or whole blood samples from patients suspected of COVID-19 infection by a healthcare provider.
A kit contains:
Package specifications: 25 tests/box
1) Getein SARS-CoV-2 antigen test card in a sealed pouch with desiccant
2) Sample extraction solution: 25 tubes/box
3) Sampling swab: 25 pieces/box
4) Disposable pipette: 25 pieces/box
5) User manual: 1 piece/box
1. Nasopharynx swab specimen, non-invasive
2. Very simple to use
3. Convenient, no devices required
4. Rapid, results within 20 minutes
5. Cost-efficient
6:Listed on German BfArm ,got approval by PEI
Clinical report from local CDC
Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is 99.68%.
