Product Details

Specification

Product introduction

1. COVID-19 quick test kit(Colloidal Gold) is for professional in vitro diagnostic use, and should only be used for the qualitative detection of COVID-19 antigen.

2. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

3. The etiology of respiratory infection caused by microorganisms other than COVID-19 virus will not be established with this test. The COVID-19 antigen Rapid Test Device (Colloidal Gold) is capable of detecting both viable and non-viable COVID-19 particles. The performance of the COVID-19 quick test kit (Colloidal Gold) depends on antigen load and may not correlate with PCR performed on the same specimen.

4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at anytime rule out the presence of COVID-19 viral antigens in specimen, as they may be present below the minimum detection level of the test. As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

5. The validity of COVID-19 quick test kit (Colloidal Gold) has not been proven for identification or confirmation of PCR.

6. Inadequate or inappropriate specimen collection, storage, and transport may yield false negative test result.

7. Children tend to shed virus for longer periods of time than adults, which may result in differences in sensitivity between adults and children.

8. Positive and negative predictive values are highly dependent on prevalence. False positive test results are more likely during periods of low COVID activity when prevalence is moderate to low.

Advantages

-Easy operation

-Supports whole blood, serum and plasma tests

-Easy sample acquisition

Company profile

Lysun is a high-tech company founded in February 2018 with a team of engineers with strong research and development capabilities.The main team members have more than 20 years of experience in the IVD industry.

At present,we have obtained 7 national software copyrights,4 invention patents,1 utility model patent and 3 appearance patents.In January 2019,TUV SUD’s 13485 audit and CE audit were passed and CE audit were passed.

We are a petential company with versatility and all-round pride.It have grown rapidly and has become a leader in the field of POCT. Our mission is to provide people with the most convenient,accurate and affordable products to prevent diseases.

Certificate

http://www.lysunbio.com/