Coronavirus disease 2019 (COVID-19) is a new disease, caused by a novel coronavirus (SARS-CoV-2) that has not previously been seen in humans. It is a respiratory illness that can spread from person to person. The rapid diagnosis of COVID-19 is critical for the prevention and control of this pandemic.

Antigen and antibody tests are highly accurate, easy to perform, and require minimal education for users. As a reference standard method, RT-PCR has been performed to make a definitive diagnosis of COVID-19 infection. However, even PCR may result in high false negative results and requires long turn-around-time.

Antigen testing can be a "breakthrough" innovation to help screen more people for viruses. It detects the presence of viral proteins, which enables the identification of acute or early infection.

Antibody status can be used to aid the clinical diagnosis of suspected cases that present 7 days or more after the start of symptoms. IgM is an early phase immunoglobulin that will develop first during acute infection. IgG is largely responsible for long-term immunity after infection. All patients will develop IgM and IgG by day 14.

ü  NowCheck COVID-19 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of specific SARS-CoV-2 antigens present in the human nasopharynx.

• - In a retrospective, multi-center, randomized, and single-blinded study, the NowCheck COVID-19 Ag Test showed 88.68% sensitivity (47/53) and 98.25% specificity (112/114) compared to PCR assays.
•      - No cross-reaction with potential cross-reactive substances except SARS-coronavirus.
•      - No interference with Endogenous/Exogenous interfering substances such as anti-viral drugs, antibiotics, or anti-inflammatory medications.

ü  NowCheck COVID-19 IgM/IgG Test is a rapid chromatographic immunoassay for the qualitative detection of specific antibodies to SARS-CoV-2 present in human serum, plasma, or whole blood.

•  - In a retrospective, multi-center, randomized, and single-blinded study, the NowCheck COVID-19 IgM/IgG Test showed 96.77% sensitivity (30/31) and 98.65% specificity (73/74), compared to PCR assays.
•  - Additional quality control for NowCheck COVID-19 Ag and IgM/IgG Tests are available to be purchased as optional contents.

For those who are interested in NowCheck COVID-19 Tests, please contact your local distributor or mail to [bionote@bionote.co.kr].