SG Biosciences has received approval from the Ministry of Food and Drug Safety for a respiratory virus multiplex diagnostic kit that can test for coronavirus disease (COVID-19), influenza A and B, and respiratory syncytial virus (RSV) in a single procedure.

SG Biosciences announced on the 12th that “InstaQ COV/Flu/RSV Ag Multi,” which uses quantum dots (QD), has obtained item approval as an in vitro diagnostic medical device. The dedicated reading device for checking test results, “InstaRead M,” has also completed registration with the Ministry of Food and Drug Safety.

This product is a professional point-of-care testing (POCT) device that simultaneously detects COVID-19, influenza A and B, and RSV with a single test. When a virus is detected during the testing process, the QD fluorescent marker emits light, and the dedicated reader interprets this signal to analyze the result. The company explained that this can reduce reading discrepancies that may occur with conventional methods that rely on visually checking the color of the test line.

QD is a nanomaterial that emits light at different wavelengths depending on particle size. Utilizing this property makes it possible to differentiate multiple targets in a single test. SG Biosciences stated that the product applies indium phosphide (InP)-based QD that does not use cadmium. The application of an environmentally friendly, non-toxic, cadmium (Cd)-free indium phosphide (InP)-based QD fluorescent marker is the first of its kind globally.

In clinical trials conducted at domestic university hospitals, COVID-19 sensitivity was confirmed at 93.5% and specificity at 100%. For influenza A, sensitivity was 95.8% and specificity 100%, while for type B the figures were 92.9% and 100%, respectively. RSV showed a sensitivity of 97.1% and a specificity of 99.8%.

SG Biosciences plans to launch InstaQ and InstaRead M in October. Starting with respiratory virus diagnostics, the company intends to expand its product portfolio to infectious diseases, hormones, and cancer markers, and to pursue overseas regulatory approvals as well.

Oh Se-moon, CEO of SG Biosciences, said, “This approval marks the beginning of commercialization of a QD-based multiplex diagnostic platform, beyond a single product launch,” adding, “Starting with respiratory diagnostics, we will expand our products into various diagnostic areas, including infectious diseases, hormones, and cancer markers.”

SG Biosciences is an in vitro diagnostics company established in 2007. It develops and manufactures immunodiagnostic products, including diagnostic kits for infectious diseases, and continues research, development, and commercialization activities related to in vitro diagnostics.

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