Sars-Cov-2 Antigen Test Kit

Weight: 25.5g/ kit Packaging: 300kits/carton Weight of carton: 8.6kg/carton

SARS-CoV-2 Antigen Test Kit CRDLIGHT 25 pcs/ box 5 pcs/ box

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%.

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.

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 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