InScience Antigen Rapid Test

Name

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

Description

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

Test type

Lateral flow (qualitative)

Test principle

This rapid SARS-CoV-2 (colloidal gold) antigen test kit 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 the SARS-CoV-2 antigens in the sample are bound by colloidal gold-labeled anti-SARS-CoV-2 monoclonal antibodies. These then migrate together to the test area as the capillary effect draws the liquid onto the nitrocellulose test strip.

A row of SARS-CoV-2 monoclonal antibodies are coated onto the strip in the test area (T line), and these also bind to antigens. The Antibody-Antigen-Antibody Colloidal Gold Sandwich results in a visible line on the T line if SARS-CoV-2 antigens are present in the sample. The quality control area (line C) is coated with goat anti-mouse antibodies that bind to colloidal gold-labeled antibodies, resulting in a visible Cline. If line C does not show any color, it indicates that the result is invalid and that this patient needs to be retested.

Components

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

  • 25 x test cassette.
  • 25 x swab
  • 25 x Sample Treatment Solution in Tube
  • 25 x tube cap

Detection type: Colorimetric

Example type: Oropharyngeal swabs, nasal swabs, and nasopharyngeal swabs.

Test time: 10 minutes

General notes

Clinical performance:

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

Cross-reactivity:

This SARS-CoV-2 antigen rapid test kit is not cross-reactive with samples of Staphylococcus aureus, Streptococcus pneumonia, Measles virus, Mumps virus, Adenovirus type 3, Mycoplasma pneumonia, Parainfluenza virus type 2, metapneumovirus, coronavirus OC43, coronavirus 229E, Bacillus parapertussis, influenza virus type B Victoria line, influenza virus type B line Y, influenza virus type A H1N1, influenza virus type A H3N2, avian influenza virus H7N9, virus H5N1 avian influenza, Epstein-Barr virus, enterovirus CA16, rhinovirus

Interfering substances:

This rapid SARS-CoV-2 antigen 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 in vitro clinical diagnostic only.
  • Please read the instructions carefully before testing and operate strictly according to the instructions.
  • Different lots of reagents and treatment solutions should not be mixed.
  • Specimen collection, storage, and testing must be in strict accordance with coronavirus-related technical testing guidelines and novel biosafety guidelines. The remaining sample removal solution, swabs, test cassettes, and all debris must be disposed of in accordance with the laboratory’s biosafety requirements.
  • It is recommended to treat the waste as infectious material, and to use ethyl ether, 75% ethanol, disinfectant containing chlorine, 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, it is valid within 1 hour after being opened, and the test cassette 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). Shelf life is 18 months.

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