Specification

Product introduction

The COVID-19 quick test kit (Colloidal Gold) is a rapid visual immunoassay for the qualitative, presumptive detection of COVID-19 antigens from oropharyngeal swabs and nasopharyngeal swab specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute COVID-19 virus infection.

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

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

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

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.

Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative test results are not intended to rule in other non-SARS viral or bacterial infections.

Negative results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed.

If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required.

Advantages

Advantages of COVID-19 quick test kit：

-Easy operation

-Multiple specifications are available

-Easy sample acquisition

Company profile

Hangzhou Lysun Biotechnology Co., Ltd. was established in 2018 and is located in the beautiful city of Hangzhou Binjiang High-tech Zone. It is a biomedical high-tech enterprise specializing in the research and development, production and sales of in vitro diagnostic reagents and supporting instruments.As a professional POCT product manufacturer and service provider, Lysun focuses on the development, design and manufacture of diagnostic reagents and supporting POCT instruments in the fields of self-test, clinical biochemistry, and immunology. The core members of the company have rich experience in the IVD industry, and more than 50% have a master's degree or above. The company adheres to the concept of "quality first, customer first, honesty and people-oriented", establishes and implements a standardized and rigorous R&D management process and a stable and efficient quality management system. The company has passed the EN ISO 13485:2016 quality management system certification and passed CE product certification of TUV South Germany.Since its establishment, Lysun has obtained nearly 20 various patents and copyrights, and has various honors and qualifications such as provincial technology-based small and medium-sized enterprises and the Young Eagle Project. The company adheres to the talent concept of making the best use of their talents and making their employees the business owners. "The foundation of the great cause, the fate will last forever", Lysun will continue to focus on the in vitro diagnostic reagent industry and become a professional manufacturer of medical diagnostic products.

Certificate

http://www.lysunbio.com/