Approved for use in Europe/Asia per CE/ISO and NOT AUTHORIZED OR CLEARED FOR USE IN THE USA
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Confirmatory Real-time reverse transcription polymerase chain reaction (rRT -PCR) test
Unparalleled linearity of 0.9929~0.9999 (Correlation coefficient; R2) in concentrations ranging from 10^2~7 copies/ul
Limit of Detection of 10~30 copies/uL even in sputum.
US patent filed/South Korea patent filed with original sequence for all molecular targets
European IVD-CE certification achieved (CMC/CE/2020/03072020.1)
ISO 13485 certified CGMP (Current Good Manufacturing Practice regulations) manufacturing process and quality management
New POC (Point of care) rapid antigen testing with unprecedented performance results
(Approved for use in Europe/Asia per CE/ISO and NOT AUTHORIZED OR CLEARED FOR USE IN THE USA)
GG COVID-19 Omicron/Delta PCR test kit
The GG COVID-19 variant RT-PCR kit enables multiplexing mutation hot spots in a singe tube to detect most (9) of the current COVID-19 variants of interest/concern including the “Delta variant” and “Omicron variant”.
GG COVID-19 variant RT-PCR kit is versatile, can be run on a variety of different PCR machines with a running time of ~2 hour (minus the nucleic acid extraction time) and LOD of ~10^1-2 cp/uL.
GG COVID-19 mutation kit may be used in the in vitro qualitative detection of COVID-19 virus variants from respiratory specimens and is the first PCR test that can differentiate Omicron variant from Delta variant versus non-Omicron, non-Delta Sars-CoV-2 (COVID-19) in a single tube.
Delta patients benefit most from the casirivimab and imdevimab (Regeneron) and Bamlanivimab(Eli Lily), while Omicron patients benefit from sotrovimab (VIR-7831(GlaxoSmithKline and Vir Biotechnology); GG COVID-19 mutation kit has the potential to guide therapy and be used in the triage of patients.
(Approved for use in Europe/Asia per CE/ISO and NOT AUTHORIZED OR CLEARED FOR USE IN THE USA)
Variety of molecular microbiology and cancer genetics products
Cellgenemedix Good Ag Rapid COVID-19 Antigen Test & GG COVID-19 Omicron/Delta PCR study for participation in research
Grant applications for underserved communities and countries
