UnScience Antigen Single Test – Apple Scientific Inc.

Name

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

Description

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.

Assay Type

Lateral Flow (Qualitative)

Principle of Assay

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.

Components

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

Detection Type

Colorimetric

Sample Type

Oropharyngeal swabs, nasal swabs, and nasopharyngeal swabs.

Assay Time

10 minutes

General description

There are five immunoglobulin classes in humans. Out of these, immunoglobulin M (IgM) is a high molecular weight protein that has five or six subunits. IgM monomers are made of two heavy chains and two light chains connected by a disulfide bond. Human serum shows low concentration of IgM monomers. It has a high carbohydrate content of about 12%. It is the first immunoglobulin produced by neonates.
IgM antibodies are present as pentamers in the serum and are produced in response to antigens.
IgM from human serum is purified from normal human serum by precipitation and gel filtration techniques. The immunoglobulin is determined to be atleast 95% pure by HPLC procedures.

Application

Purified human IgM may be used as a reference antigen, standard, blocking agent, or coating protein in a variety of immunoassays including ELISA, dot immunobinding, Western immunoblotting, immunodiffusion, and immunoelectrophoresis. Other applications include starting materials for the preparation of immunogens and solid phase immunoadsorbents. IgM from human serum was used as standard in ELISA (100 μg/ml) and dot blot assay. Antibody concentration range of 200 μg/ml to 1 mg/ml was used in IgM binding assays.
IgM from human serum has been used

in ELISA inhibition assay
in immunoblotting
as MW (molecular weight) standards
in IgM binding assay
to confirm the depletion of immunoglobulins

Packaging

10 mg in serum bottle

1, 5 mg in glass bottle

Biochem/physiol Actions

Immunoglobulin M (IgM) acts as an antigen specific part of the B cell antigen receptor on the surface of B lymphocytes that are not stimulated, in its monomeric form. Polymeric IgM molecules also serve as important activators of the classical complement cascade. IgM is essential in agglutination and cytolytic reactions.

Physical form

Solution in 0.05 M Tris-HCl, 0.2 M sodium chloride, pH 8.0, containing 15 mM sodium azide.

Storage and Stability

Store at 2-8 °C. If slight turbidity occurs upon prolonged storage, clarify the solution by centrifugation before use.

Disclaimer

Unless otherwise stated in our catalog or other company documentation accompanying the product(s), our products are intended for research use only and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to humans or animals.

General Notes

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.

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25)