SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (A254381)

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

Viral antigen rapid test kit for the detection of SARS-CoV-2 in human oropharyngeal, nasal, and nasopharyngeal swabs. The test is a lateral flow assay with a colloidal gold reporter, giving results in ten minutes.

Lateral Flow (Qualitative)

This SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) uses the sandwich immunocapture method and colloidal gold immunochromatography to qualitatively determine the presence of SARS-CoV-2 antigens. During the test, the sample is dropped into the sample well, and SARS-CoV-2 antigens in the sample are bound by colloidal gold-labeled monoclonal anti-SARS-CoV-2 antibodies. These then migrate together to the test area, as the capillary effect draws the fluid up the nitrocellulose test strip. A row of SARS-CoV-2 monoclonal antibodies are coated on the strip at the test area (T line), and these also bind the antigens. The antibody-antigen-antibody-colloidal gold sandwich results in a visible line at the T line, if the SARS-CoV-2 antigens are present in the sample. The quality control area (C line) is coated with goat anti-mouse antibodies that bind the colloidal gold-labeled antibodies, resulting in a visible C line. If the C line does not show any colour, it indicates that the result is invalid, and this patient needs to be tested again.

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) comes in packs of 25 tests and contains:

• 25 x Test Cassette.
• 25 x Swab
• 25 x Sample Treatment Solution in Tube
• 25 x Tube Cap

Colorimetric

Oropharyngeal swabs, nasal swabs, and nasopharyngeal swabs.

Clinical performance:

The performance of the kit was established using clinical samples, with kit results compared to nucleic acid test results. The kit showed sensitivity of 96.330% and specificity of 99.569%. In addition, separate oropharyngeal swabs, nasal swabs and nasopharyngeal swabs were collected from 50 patients and compared for homologous consistency. There was agreement in paired results (100% in all cases) from nasal swabs and oropharyngeal swabs, nasopharyngeal swabs and oropharyngeal swabs, and nasal swabs and nasopharyngeal swabs.

Cross-reactivity:

This SARS-CoV-2 antigen rapid test kit does not cross-react with samples of: Staphylococcus aureus, Streptococcus pneumoniae, measles virus, mumps virus, adenovirus type 3, Mycoplasma pneumoniae, parainfluenza virus type 2, metapneumovirus, coronavirus OC43, coronavirus 229E, Bacillus parapertussis , Type B influenza virus Victoria line, Type B influenza virus Y line, Type A influenza virus H1N1, Type A influenza virus H3N2, Avian influenza virus H7N9, Avian influenza virus H5N1, Epstein-Barr virus, Enterovirus CA16, Rhinovirus.

Interfering substances:

This SARS-CoV-2 antigen rapid test kit did not show false negative or false positive results when patients had been treated with: Histamine dihydrochloride, Zanamivir, Ribavirin, IFN-a, Oseltamivir, Paramivir, Lopinavir, Ritonavir, Arbidol, Levofloxacin, Azithromycin, Ceftriaxone, MeropeneM, Tobramycin.

Warnings:

• This kit is for clinical in vitro diagnosis only.
• Please read the instructions carefully before testing, and operate in strict accordance with the instructions.
• Different batches of reagents and treatment solutions should not be mixed.
• Sample collection, storage and testing should be in strict accordance with the novel Coronavirus related testing technical guides and biosafety guides. The remaining sample disposal solution, swabs, test cassettes and all wastes must be disposed of in accordance with laboratory biosafety requirements.
• It is recommended to treat the waste as infectious material, and use ethyl ether, 75% ethanol, chlorine-containing disinfectant, peracetic acid, chloroform and other solvents to soak the waste generated during the detection process, to inactivate the virus.
• The test cassette is ready to use, valid within 1 hour after opening, and the test cassette cannot be reused.
• The test results of this kit are for clinical reference only. Diagnosis should be made after comprehensive judgment of the clinical symptoms, signs, medical history and other laboratory examination results of the patient.

Store at room temperature (2-30°C). Shelf life is 18 months.

This product is for research use only. It is not intended for diagnostic or therapeutic use.