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

Test Kit - SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25) - Antibodies.com Test Procedure - SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25) - Antibodies.com Interpretation of Results - SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25) - Antibodies.com Sample Swab - SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25) - Antibodies.com
This product is discontinued

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (A254381) has been discontinued and is no longer available.

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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.
Sample Type
Oropharyngeal swabs, nasal swabs, and nasopharyngeal swabs.
Assay Time
10 minutes
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
Storage
Store at room temperature (2-30°C). Shelf life is 18 months.
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.
Disclaimer
This product is for research use only. It is not intended for diagnostic or therapeutic use.
Test Kit - SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25) - Antibodies.comEnlarge Image
Figure 1: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (A254381)

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
Test Procedure - SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25) - Antibodies.comEnlarge Image
Figure 2: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (A254381)

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

Before use, please read the instructions carefully and operate in strict accordance with the instructions.

Sample Requirements:

  • Oropharyngeal swab: The head of the patient is slightly tilted, with the mouth wide open, exposing the pharyngeal tonsils on both sides. Use the swab to gently wipe the tonsils on both sides at least 3 times, and then wipe the posterior pharyngeal wall up and down at least 3 times.
  • Nasal swab: Prior to collecting the nasal swab, the patient should be instructed to blow their nose. Carefully insert the swab into the nostril with the most secretion under visual inspection. Using gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab against the nasal wall several times and then remove it from the nostril.
  • Nasopharyngeal swab: Carefully insert the swab into the nostril with the most secretion under visual inspection. Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab several times then remove it from the nasopharynx (if there is a reflexive cough, stop for 1 minute).

Sample Preparation:

  • Remove the seal from a sample treatment solution tube.
  • Put the swab into the sampling tube, making sure the swab is submerged in the solution.
  • Rotate and squeeze the swab on the wall and bottom of the tube 10 times.
  • Squeeze the swab tip along the inner wall of the sample tube to keep as much solution in the tube as possible. Remove the swab.

It is recommended to perform the test immediately after sample collection and processing. If the test cannot be performed immediately, the processed samples can be stored at 2-8°C for 48hr.

Test Procedure:

  • Bring the pouch to room temperature before use.
  • Take out the cassette and put it on a horizontal table.
  • Add 3 drops of the processed sample vertically into the sample well and start the timer.
  • Observe the result after 10 minutes. The result is valid within 30 minutes. Results read after 30 minutes are invalid.
Interpretation of Results - SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25) - Antibodies.comEnlarge Image
Figure 3: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (A254381)

Interpretation of results for SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25).

Positive: Both the detection line (T line) and the quality control line (C line) are visible.

Negative: Only the quality control line (C line) is visible. The detection line (T line) does not appear.

Invalid: The quality control line (C line) does not appear, meaning the test is invalid and should be repeated with a new sample and a new test cassette.

Sample Swab - SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25) - Antibodies.comEnlarge Image
Figure 4: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (A254381)
Sample swab for SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CoV2Ag-25).
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