Sars-Cov-2 Antigen Rapid Test Kit

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%.

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 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

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

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)

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

The product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled SARS-CoV-2 recombinant protein, mouse-anti human IgG antibody immobilized in G test area, mouse-anti human IgM antibody immobilized in M test area and the corresponding antibody in quality control area (C).
During the test, when the SARS-CoV-2 IgM antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgM antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgM antibody immobilized in M test area subsequently and this produces a purple-red band appears in the M test area. When the SARS-CoV-2 IgG antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgG antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. Theconjugates migrate upward through capillary effect and would be captured by mouse-anti human IgG antibody immobilized in G test area subsequently and this produces a purple-red band appears in the G test area. If it is a negative sample, there is not a purple-red band appeared in the M and G test area. Regardless of the presence or absence of the SARS-CoV-2 antibody in the sample, a purple-red band will appear in the quality control area (C). The purple-red band in the quality control area (C) is a criterion for judging whether there is enough sample and whether the chromatography process is normal. It also serves as the internal control standard for reagents.