Name

Covid-19 Antigen Rapid Test Kit (Colloidal Gold)

Description

Viral Antigen Rapid Test Kit for the detection of Covid-19 in human oropharyngeal, nasal and nasopharyngeal swabs. The test is a lateral flow assay with a colloidal gold indicator, which gives results in ten minutes.

Test type: Lateral flow (qualitative)

Test principle

This Covid-19 Antigen (Colloidal Gold) Rapid Test Kit uses the sandwich immunocapture method and colloidal gold immunochromatography to qualitatively determine the presence of Covid-19 antigens. During the test, the sample is dropped into the sample well and the Covid-19 antigens in the sample are bound by colloidal gold-labeled Covid-19 monoclonal antibodies. These then migrate together to the test area, as the capillary effect draws the liquid up the nitrocellulose test strip.

A row of Covid-19 monoclonal antibodies is coated on the strip in the test area (T line), and these also bind antigens. The antibody-antigen-antibody-colloidal gold sandwich results in a visible line on the T line if Covid-19 antigens are present in the specimen. The quality control area (C line) is covered with goat anti-mouse antibodies that bind to the colloidal gold-labeled antibodies, resulting in a visible Cline. If the C line shows no color, it indicates that the result is invalid and this patient should be retested.

Components

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

• 25 test cassettes.
• 25 swabs.
• 25 x sample treatment solution in tube
• 25 tube caps.

Detection type: colorimetric

Example type

Oropharyngeal swabs, nasal swabs, and nasopharyngeal swabs.

Test time: 10 minutes

Clinical performance:

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

Cross-reactivity:

This Covid-19Antigen Rapid Test Kit does not cross-react with samples of Staphylococcus aureus, Streptococcus pneumonia, Measles virus, Mumps virus, Adenovirus type 3, Mycoplasma pneumonia, Parainfluenza virus type 2, Metapneumovirus, OC43 coronavirus, 229E coronavirus, Bacillus parapertussis, Victoria line B influenza virus, Y line B influenza virus, H1N1 influenza A virus, H3N2 influenza A virus, H7N9 avian influenza virus, avian influenza virus H5N1, Epstein-Barr virus, CA16 enterovirus, rhinovirus.

Interfering substances:

This Covid-19 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, Peramivir, Lopinavir, Ritonavir, Arbidol, Levofloxacin, Azithromycin, Ceftriaxone, MeropeneM, Tobramycin.

Warnings:

• This kit is for clinical in vitro diagnostic use only.
• Please read the instructions carefully before testing and operate strictly according to the instructions.
• Different reagents and treatment solutions should not be mixed.
• Sample collection, storage, and testing must strictly adhere to new coronavirus-related technical testing guidelines and biosafety guidelines. The remaining sample waste solution, swabs, test cassettes, and all debris 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 cannot be reused.
• The test results in this kit are for clinical reference only. The diagnosis should be made after a thorough judgment of the patient’s clinical symptoms, signs, medical history, and other laboratory test results.

Storage

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

Disclaimer

This product is for research use only. Not intended for diagnostic use