Sars-Cov-2 Iggigm Rapid Test Kit

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.

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 .

BOSON RAPID SARS CoV-2 Antigen Test Card (Self Test) Manufactured by Xiamen Boson Biotech Co., Ltd. DHSC - UK Approved - 3rd Phase Approved. NASAL TEST CE & ISO Approved Full Home Test - Self Test Approval for UK and Europe Test Result in 15 Minutes. Sensitivity 97.70% Specificity 99.84% Accuracy 98.97% Layperson study statistics 99.84% of non-professionals carried out the test without requiring assistance 99.82% of different types of results were interpreted correctly Each Test have Unique Identifier Number - Easy to track Approved By - UK, Germany, France, Spain, Netherlands, Greece, Belgium, Italy, Portugal. 1 Test / Kit Catalog No.: 1N40C5-2 Kit Components: 1 Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 sterilized swab 1 extraction tube 1 sample extraction buffer IFU Tube holder on back of box Box / Carton Specifications : 1 Test / Kit Box size - 190*60*15 mm Carton size - 42*42*33 cm Carton gross weight - 9.9 kg 250 tests (boxes) / carton Euro 1.12