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Genesis KaiBiLi COVID-19 Antigen Rapid Test Device and COVID-19 IgG/IgM Rapid Test Device got FIND certification(CE-IVD).

COVID-19

Since the COVID-19 pandemic is a global crisis, tests with high sensitivity and specificity are crucial for the identification and management of COVID-19 patients. For now, Real-Time reverse transcription-polymerase chain reaction (RT- qPCR) is the current recommended laboratory method to diagnose SARS-CoV-2 acute infection, but several factors such as the requirement of special equipment and skilled staff limit the use of these time-consuming molecular techniques.

The COVID-19 Antigen&Antibody Rapid test kit is a valuable weapon in the SARS-CoV-2 mutations continues their spread.COVID-19 Antigen (Self-test) can Qualitative test, performed and results can be obtained in 15 minutes. With regular testing at home, you and your family can know your status so you can take action to help stop the spread of COVID-19. 

COVID-19 Antibody rapid test is a good way to find out if your vaccinations created antibodies to COVID-19 as expected. If not, you may still be at an increased risk of contracting COVID-19. It is also useful for someone who thinks they may have had COVID-19 and is at least 10 days post-infection. Different from Real-Time reverse transcription-polymerase chain reaction, the COVID-19 Antigen&Antibody Rapid test kit can be tested without instruments and can be used at home or for professional medical tests.

The KaiBiLi COVID-19 Antigen Rapid Test Device is an in vitro diagnostic test based on the principle of immunochromatography, which can quickly and easily qualitatively detect the 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swab or nasopharyngeal swab with high accuracy(the result is as follows).

 COVID-19-2

Different from antigen testing, the KaiBiLi COVID-19 IgG/IgM Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019- Novel Coronavirus in human whole blood, serum, or plasma specimen. It is only used as a supplementary detection indicator for new suspected cases of negative coronavirus nucleic acid detection or in conjunction with nucleic acid detection in the diagnosis of suspected cases. In terms of sensitivity and specificity of test results,For the IgG test, relative Sensitivity is 98.28% and Relative Specificity IS 97.01% .for IgM results, relative Sensitivity is 82.76% and relative Specificity is 98.51%.

It is worth mentioning that, the KaiBiLi COVID-19 IgG/IgM Rapid Test Device can not be used as a basis for the diagnosis and exclusion of pneumonitis infected by 2019-nCoV infection. It is not suitable for general population screening.


Post time: Aug-31-2021