Sars-Cov-2 Antigen Rapid Test Kit

Sensitivity: 95.06% Specificity: 99.62%

Content of each kit: Test card (innovative and unique system), detailed instructions for use, sterile disposable swab, reactive solution for sample treatment, illustrative manual for use and operation.

General characteristics: CE self-diagnostic certification, holographic security label with individual code for authenticity verification, non-invasive, easy to use, no prescription required, rapid results in less than 15 minutes, high precision.

Sale restrictions: Exclusive sale to pharmacies, authorized companies, pharmaceutical distribution, socio-sanitary establishments, health establishments, occupational risk prevention, public organizations and health professionals.

Restricted sale to individuals. Sale subject to the provisions of Royal Decree 588/2021, of July 20, which modifies Royal Decree 1662/2000, of September 29, on medical devices for "in vitro" diagnosis, in order to regulate the sale to the public and the advertising of covid-19 self-diagnosis products. Sale subject in relation to tax matters to the provisions of Royal Legislative Decree 35/2020, of December 22, seventh final provision. Applicable tax rate of Value Added Tax to deliveries, imports and intra-community acquisitions of certain goods and provision of services necessary to combat the effects of SARS-CoV-2 as well as for the purposes of the special regime of the equivalence surcharge .

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.

The FlowFlex Rapid Antigen Test uses the latest patented technology to detect proteins in nasal samples, ensuring that it can detect all strains of the COVID-19 virus within just 15 minutes. Using a simple nasal swab with 2cm of the nose - it makes it extremely easy to personally administer an accurate lateral flow test without medical supervision.

Each individually packaged kit comes complete with:

1 x Test Cassette
1 x Extraction Buffer Tube with Reagent
1 x Disposable Swab
1 x Waste Bag
1 x Package Insert

Performance Efficacy:
Relative Sensitivity: 97.1% (83.8%-99.9%)*
Relative Specificity: 99.6% (97.7%-99.9%)*
Accuracy: 99.3% (97.5%-99.9%)*
*95% Confidence Intervals

The lab indicated that the recombinant protein of Indian mutant (B.1.617.2),
A.23.1(Unit Kingdom), AT.1 (Russia), B.1.1.7(Unit Kingdom), B.1.351 (South Africa),
B.1.616 (France), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil),
P.2 (Brazil) can be detected by Jinwofu SARS-CoV-2 Antigen Test Kit.
For the newly descovered mutant Omicron(B.1.1.529), we performed sequence
alignment analysis on its mutation sites, and found that all the mutation sites were
outside the epitope region recognized by the monoclonal antibody selected by our company.
By bioinformatics analysis, Jinwofu SARS-CoV-2 Antigen Test Kit can also effectively detect
mutant Omicron(B.1.1529)

PocRoc SARS-CoV-2 Antigen Rapid Test Kit (TRFIA) is intended for qualitative
detection of SARS-CoV-2 nucleocapsid antigen from NS specimen or VTM sample
without guanidine

-Target: nucleocapsid antigen
-Specimens: Nasal Swab (NS) /Oropharynge al Swab(OP) Virus Transport Medium (VTM)
- Time: Specimen lysis time: 1min; Detection Time: 15min
-Instrument: LTRIC-300,LTRIC-600,UV Flashlight
-Shelf Time: 18months
-LoD: Estimated 25 TCID50/Swab

SARS-CoV-2 Rapid Antigen Test kit
Colloidal Gold Method Medical
Simple Rapid
Convenient
Sensitivity : 98.4%
Specificity : 98.1%
Test Time : 10-15min

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Provide high-quality products at competitive prices
Product: SARS-CoV-2 Antigen Rapid Test Kit
Standard: CE, FDA certification
Packing quantity: 25tests/box
FOB: US$1.60/test