JinsLab Receives MFDS Approval for COVID-19 Rapid PCR Diagnostic Kit
[Asia Economy Reporter Lee Gwanju] JinsLab, a DNA diagnostic reagent specialist company and a subsidiary of GC (Green Cross Holdings), announced on the 16th that its rapid PCR diagnostic kit, ‘GCdia™ COVID-19 Fast Detection Kit,’ recently received official approval as a COVID-19 diagnostic reagent from the Ministry of Food and Drug Safety.
JinsLab’s product utilizes real-time gene amplification (RT-PCR) testing to confirm the presence of the COVID-19 virus (SARS-CoV-2) in nucleic acid (RNA) from specimens within approximately 30 minutes. The company explained that this shortens the PCR reaction time by 25-30% compared to previously approved products.
Additionally, the product has the advantage of being as fast as nucleic acid extraction speed, allowing analysis without time delays. Existing RT-PCR products generally require 3 to 4 times more PCR equipment than extraction equipment due to long reaction times, causing issues with cost and space.
The company stated that despite the reduced testing time, various performance tests confirmed that the product’s analytical sensitivity and clinical sensitivity are as high as those of existing PCR test products. A JinsLab representative said, “Our product can complement the limitations of both existing PCR tests and rapid antigen tests.”
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Founded in 2008, JinsLab is a DNA diagnostic specialist company with a product lineup capable of diagnosing COVID-19 as well as cervical cancer (HPV), hepatitis B (HBV), hepatitis C (HCV), pneumonia bacteria, Zika virus, sexually transmitted diseases (STD), tuberculosis, food poisoning, and prenatal Down syndrome.
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