Longsee - COVID-19 Professional Rapid Test Kits

2019-nCoV Ag Rapid Test Kit (Immuno-chromatography)

Instructions for use

[INTENDED USE]

The rapid test in this kit is based on immuno-chromatography and is designed for the rapid qualitative determination of SARS-CoV-2 nucleocapsid antigen in nasal or throat swab specimens from individuals with suspected COVID-19 infection. The kit is intended for the rapid diagnosis of SARS-CoV-2 infections. 

For in vitro diagnostic use only. For professional use only

[SUMMARY]

The novel coronaviruses belong to the genus β. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, patients infected with the novel coronavirus are the main source of infection; asymptomatic infected persons can also be a source of infection. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations are fever, fatigue, and dry cough. In some cases, nasal congestion, runny nose, sore throat, myalgia, and diarrhea can also be observed.

[PRINCIPLE OF THE TEST]

This kit uses immuno-chromatography technology to detect the presence or absence of 2019-nCoV nucleocapsid proteins in swab specimens from patients with signs and symptoms of infection, where there is suspicion of 2019-nCoV by the double antibody sandwich method. When the concentration of 2019-nCoV antigens in specimens is higher or equal to the minimum detection limit, these antigens react separately with corresponding antibodies to form complexes, and the 2019-nCoV antibodies are coated in the detection area (T). These antigens are captured and a red reaction line is formed. The result is considered positive. Otherwise, the result formed in T without a red line is considered negative. Under normal test conditions, the quality control area (C) should be colored to indicate that the test is valid. 

[COMPONENTS]

[RESULT EVALUATION]

To read the test results, you just need to look at the observation window.

1. Positive: If two color bands are visible at the position of the quality control line (C-line) and the test line (T-line) in the result window, the test result is positive. The test result indicates the presence of 2019-nCoV antigens in the sample.

2. Negative: If a color band appears at the position of the quality control line (C-line) and no color band appears at the detection line (T-line) in the observation window, the test result is negative. The test result indicates that the sample is negative for 2019-nCoV antigens or the concentration is below the detection limit of the set.

3. Invalid: If no band appears at the position of the quality control line (C-line) and the test line (T-line) in the observation window, the test result is INVALID. The sample should be re-taken and the test repeated.

[LIMITATIONS]

1. This reagent is intended for in vitro diagnostics and professional use only.

2. This reagent is used for the qualitative detection of 2019-nCoV antigens in saliva and sputum samples, but cannot accurately determine the content of antigens in samples.

3. This kit has good analytical performance, but improper sample collection and storage can affect the accuracy of the results.

4. Test results are for reference only and not for final diagnosis, and should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of patients should be combined with their symptoms, signs, medical history, and other tests. A comprehensive consideration of laboratory examination and treatment response should be taken into account.

5. Due to the limitations of the methodology, experimenters should pay more attention to negative results, which must be combined with other test results to make a comprehensive assessment. It is recommended to use nucleic acid tests or methods for virus culture identification for verification and confirmation.

6. Analysis of the possibility of false-negative results:

1) Improper sample collection, transport and processing, as well as low virus titers in the sample, can lead to false-negative results.

2) Viral gene mutations can cause changes in antigenic determinants, resulting in false-negative results.

You can download this guide here.

How does Odem ensure high-quality at such a fair price?

The Better AG, founded in 2006 in Switzerland, has become the main supplier to thousands of companies in recent years.

The strategy:

• Purchasing in large volumes
• Tight quality control of goods
• Passing on the purchasing advantages to our customers

By offering the possibility to receive free samples, there are no risks to the customers.

What is the money-back guarantee?

If you are not satisfied with your purchase, you can return it within 14 days of receipt for a full refund.

What payment options are available?

We offer a convenient payment via invoice after receipt of goods to a German bank account.

Has the goods already been cleared by customs?

Yes, the goods have already been cleared by customs and will be delivered to you from our German warehouse. You will not incur any additional costs.