SD Biosensor Standard Q COVID-19 IgM/IgG Duo Test Kit (ANTIBODY-BASED)

As explained above, SD Biosensor is a company that acquired the approval from MFDS and KCDC with its RT-PCR-based detection kit named Standard M nCoV RT Detection kit.

The company also developed an antibody-based detection kit named Standard Q COVID-19 IgM/IgG Duo Test Kit. Like other antibody-based detection kits made by PCL and Sugentech, SD Biosensor’s product can test for SARS-CoV-2 antibodies within 10 minutes.

Only 10µL of specimen (whole blood, serum, plasma) is required, which is suitable for Point of Care testing since it does not require extra testing equipment.

Figure 1. Image of SD Biosensor’s Standard Q COVID-19 IgM/IgG Duo Test Kit

Sugentech SGTi-flex COVID-19 IgM/IgG (ANTIBODY-BASED)

Sugentech is a company that develops in-vitro diagnostic systems and products.

It succeeded in developing rapid test kits for the COVID-19, detecting IgM, IgG, and IgM/IgG antibody. Both IgM and IgG are immunoglobulin antibodies that appear after COVID-19 infection.

IgM antibody is an indicator of current infection, and IgG antibody is an indicator of recent and past infection. Sugentech’s SGTi-flex COVID-19 IgM/IgG uses either an IV blood sample or a droplet retrieved via finger-prick, including the patients without symptoms. The company claims that its kits are accurate and easy to use, and results can be observed with the naked eye within 10 minutes.

It has been approved for clinical trials in Korea and also received CE-IVD certification from the EU. Figure 1 and Figure 2 are the image and procedures for testing with Sugentech’s SGTi-flex COVID-19 IgM/IgG.

Figure 1. Image of Sugentech’s SGTi-flex COVID-19 IgM/IgG

Figure 2. Procedures for testing with Sugentech’s SGTi-flex COVID-19 IgM/IgG

PCL (antibody-based)

PCL is a provider of in-vitro diagnostic products and developed a testing kit that can check nasal discharge for the presence of the virus. The kit was first developed using antibodies from China.

PCL claims that its antibody-based detection kit could make a diagnosis within 10 minutes with 85% accuracy. The testing can be done at home, just like a pregnancy test, which indicates that people could test themselves at home without suffering from the stigma and trauma of going to testing centers or clinics to have themselves checked. It also reduces the risk of exposure to other people.

PCL produces both antigen-based (COVID19 Ag Rapid FIA) and antibody-based (COVID19 IgG/IgM Rapid Gold) detection kits. COVID19 Ag Rapid FIA uses human oropharyngeal swabs and deep sputum samples, unlike COVID19 IgG/IgM Rapid Gold that uses fingertip blood samples.

Another difference between COVID19 Ag Rapid FIA and COVID19 IgG/IgM Rapid Gold is that COVID19 Ag Rapid FIA requires a POC FIA Analyzer as a test instrument, whereas COVID19 IgG/IgM Rapid Gold does not require a test instrument. PCL’s antibody-based detection kit has been approved for clinical trials in Korea and also received CE-IVD certification from the EU.

Figure 1 and Figure 2 are the image and procedures for testing with PCL’s COVID19 Ag Rapid FIA and COVID19 IgG/IgM Rapid Gold.

Figure 1. Image of PCL’s COVID19 Ag Rapid FIA and COVID19 IgG/IgM Rapid Gold

Figure 2. Procedures for testing with PCL’s COVID19 Ag Rapid FIA and COVID19 IgG/IgM Rapid Gold