2019-nCoV Ag Test
(Latex Chromatography Assay)

Key features and details:

2019-nCoV Ag Test (Latex Chromatography Assay) is a rapid immunoassay designed for qualitatively detecting SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens. It aids in diagnosing COVID-19 infections.

Packaging Size:

5 Tests

SKU:

03COTA0005

Product Description:

2019-nCoV Ag Test (Latex Chromatography Assay) is a lateral flow chromatographic immunoassay designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens. This test is intended for use as a self-test by individuals aged 18 years or older or by an adult for testing individuals under 18 years. The test uses monoclonal antibodies specific to the nucleocapsid protein of SARS-CoV-2. The specimen is applied to the test device, where the antigens, if present, form immune complexes with the monoclonal antibodies. These complexes migrate to the test zone and are captured by another set of monoclonal antibodies, forming a visible colored line. The control line (C) ensures the test is performed correctly.

Specifications:

SKU:

Disease Screened:

COVID-19

Analyte / Target:

SARS-CoV-2 Nucleocapsid Protein Antigen

Packaging Size

5 Tests

Sample Type:

Anterior Nasal Swab

Diagnostic Platforms:

Rapid Test

Diagnostic Solutions:

Infectious Disease

Species Reactivity:

Human

03COTA0005

This kit is for in vitro diagnosis use only. The test results are for clinical reference only and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infection.
The desiccant in the pouch is only used for product storage, not for other purposes.
Do not use a damaged test kit. Do not reuse the test kit.
Do not use kits or reagents after the expiration dates shown on the labels.
Do not open any package until you are ready to begin your test.
Use the test within 60 minutes after unsealing the foil pouch.
Read results within 15~30 minutes.
This test should be performed at 15 to 30℃. If stored refrigerated, ensure that the pouch and extraction diluent are brought to operating temperature before performing testing.
Testing the specimen immediately after collection is preferred, and it should not be repeatedly frozen and thawed.
Use the collectors and diluent provided by this reagent to collect specimens. Do not mix different batches of the test device and diluent.
Inadequate or inappropriate specimen collection is likely to yield false test results.
Do not perform the test in direct sunlight.
Keep out of reach of children. The test contains small parts that may present a choking hazard.
During use, avoid contact with the extraction diluent. If it accidentally splashes into the eyes or touches the skin or mucous membrane, rinse with plenty of water as soon as possible. If irritation is found, please contact your doctor.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
Disinfection and disposal of all potentially contagious materials must be in accordance with local, state, and federal guidelines.

The kit detects both viable and nonviable SARS-CoV-2 viral antigens and may yield a positive result without living microorganisms.
A negative test result may occur if the antigen level in the specimen is below the test's detection limit.
Failure of the user to follow the test procedure correctly may adversely affect the test performance and/or invalidate the test result.
False positive results may occur, particularly in individuals without COVID-19 symptoms and/or those living in areas with low numbers of COVID-19 infections and without known exposure to COVID-19.
Positive test results do not exclude co-infection with other pathogens.
Negative test results do not indicate the presence/absence of other viral or bacterial pathogens.
A negative result does not rule out infection by the SARS-CoV-2 virus, particularly in people who have come into contact with the virus. Follow-up tests with molecular diagnostics should be scheduled to rule out infection in these people. Persons who show symptoms of the disease but have a negative result until infection is ruled out should follow country-specific restrictions. If the test result is negative, yet clinical symptoms persist, it is advised.

Sohrabi C, Alsafi Z, O'Neill N, et al. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020,76:71-76.
Chang, C.-k., Hou, M.-H., Chang, C.-F., Hsiao, C.-D., & Huang, T.-h. J. A. R. (2014). The SARS coronavirus nucleocapsid protein forms and functions. 103, 39-50.
The Impetus of COVID-19 in Multiple Organ Affliction apart from Respiratory Infection: Pathogenesis, Diagnostic Measures and Current Treatment Strategy.Baby, Devan, Nair et al.Infect Disord Drug Targets (2020).

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Purchase Information:

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