Currently Producible Products: Antibody-based Detection Type

Although antibody-based detection kits have not yet received permission from MFDS and KCDC in Korea, many experts are arguing that they should be permitted at this stage of COVID-19 spread. Antibody-based detection kits are quick and cheap, using samples from non-respiratory body fluids. Since these kits identify the antibodies, not genes, created against the viruses, they are conducive to tracking the virus’s path and understanding its epidemiology. Furthermore, the antibody-based detection kits may gain reliability along with the accumulation of relevant data. For these reasons, China started using antibody-based detection kits, and the U.S. is working on developing and conducting reliable antibody-based detection. Therefore, there is a chance that antibody-based detection kits would gain permission from MFDS and KCDC in the near future.

There are several domestic companies that produce antibody-based detection kits, and they have their unique features. The major companies include PCL, Sugentech, and SD Biosensor. The characteristics of their products are summarized in Table 3 and delineated below in detail.

Type Test Key characteristics
     
PCL COVID19 Ag Rapid FIA / COVID19 IgG/IgM Rapid Gold ▪ First developed using antibodies from China.
▪ Can make a diagnosis within 10 minutes with 85% accuracy
▪ Suitable for Point of Care testing.
▪ Produces both antigen-based and antibody-based detection kits.
– Antigen-based detection kit (COVID19 Ag Rapid FIA) requires POC FIA Analyzer, unlike its antibody-based detection kit (COVID19 IgG/IgM Rapid Gold) that does not require any extra testing equipment.
▪ Approved for clinical trials in Korea and received CE-IVD certification from the EU.
Sugentech SGTi-flex COVID-19 IgM/IgG ▪ Detects IgM, IgG, and IgM/IgG antibody.
▪ Accurate and easy to use – Results can be observed with the naked eye within 10 minutes. – Suitable for Point of Care testing.
▪ Uses either an IV blood sample or a droplet retrieved via finger-prick, including the patients without symptoms.
▪ Approved for clinical trials in Korea and received CE-IVD certification from the EU.
SD Biosensor STANDARD Q COVID-19 IgM/IgG Duo Test Kit ▪ Company that acquired the approval from MFDS and KCDC with its RT-PCR-based detection kit.
▪ Accurate and easy to use. – Results can be observed with the naked eye within 10 minutes. – Only 10µL of specimen (whole blood, serum, plasma) is required for testing. – Suitable for Point of Care testing since it does not require extra testing equipment.

Table. Characteristics of currently producible antibody-based detection kits

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