GG COVID-19 Products

  • ALL of Cellgenemedix’s COVID-19 products have been validated in multiple variants with clinical samples and commercial and verified commercial control materials.
  • GG COVID-19 variant PCR test and GG Good Agworks well on Omicron and Delta variant specimens (>100-500 specimens verified), as well as multiple other verified control materials.
  • Approved for use in Europe/Asia per CE/ISO and NOT AUTHORIZED OR CLEARED FOR USE IN THE USA
  • A real-time RT-PCR test intended for the qualitative detection of nucleic acid from COVID-19 (Brochure) approved by the Korean Export, USPTO, and European CE mark
  • Respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider or self collected nasal swabs (Good Ag Home COVID-19 Antigen Test)
  • Rapid and accurate identification of severe acute respiratory syndrome coronavirus 2 (COVID-19, COVID-19; SARS-CoV-2) with excellent adaptability to multiple clinical specimens and Real-Time PCR machines
  • GG COVID-19 I-plex Real-Time PCR: diagnosis of influenza virus-A(H1N1/H3N2)/B as well as COVID-19 (N).
  • GG SARS-CoV-2 Omicron & Delta RT-PCR test: screening and diagnostic test for SARS-CoV-2 and screening for Omicron/Omicron stealth and Delta at the same time in 1 tube
  • GG Pan-Res Virus DNA chip : detect and genotype respiratory viruses including different types of influenza viruses, respiratory syncytial viruses, adenoviruses, rhinoviruses, coronaviruses, and COVID-19.

Sample Quality

Variety of respiratory specimens such as nasopharyngeal, oropharyngeal, nasal swabs, bronchoalveolar lavage, tracheal aspirate, or sputum. Because the performance of this kit was proven on sputum specimnes, this kit can be applied in many clinical situations. Testing is limited to laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests. Refer to https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html for guidelines on specimen collection.

Manufacturing Capacities

The current manufacturing capabilities at GoodGene, InC include the ability to manufacture approximately 100,000 test products per week, however in the event of a surge in demand this could be increased to 200,000 test product per week within a 1 week time frame. All products can be delivered internationally within 3 to 10 business days depending on customs.

 

Individual info and quote

 

NameGoalMethodSpecificationsCertification
GG Covid-19 Good Ag Rapid testScreen at home and in clinic for Coronavirus Disease-19 (COVID-19)lateral flow assay with US-patented latex particles; rapid antigen testVisual inspectionCE mark achieved

ISO 13485 acquired

USPTO patent

GG Covid-19 Quadplex Real-Time PCRDetect COVID-19 with excellent accuaracy and specificity (~100%)Quadplex real time PCR assay, 1 tubeReprodudibility proven and Compatible with; Rotorgene-Q (Qiagen, Hilden, Germany), ABI 7500 (Applied Biosystems Inc., Foster City, CA) and CFX96 (Bio-Rad, Hercules, CA)CE mark achieved

ISO 13485 acquired

Korean Export permission acquired by Korean Ministry of Food and Drug Safety

USPTO patent

GG Covid-19 Omicron & Delta Real-Time PCRDetect presence of COVID-19 in addition to screening for Delta/OmicronQuadplex real time RT-PCR assay, 1 tube
GG COVID-19 VOC Real-Time PCRdiagnosis of COVID-19 (N) and its 8 variants.Quadplex real time RT-PCR assay, 2 tube
Pan-Res Virus DNA chipPan-respiratory Virus Detection DNA MicroarrayDetect entire virus which infect human respiratory tractChip scanner

(rental possible in

South Korea)

Clinical investigation status

USPTO patent

*For Investigational Use Only in the USA but available and approved for sale in Europe and Asia.
*The performance characteristics of this product have not been established in the USA.
*NOT AUTHORIZED OR CLEARED FOR USE IN THE USA

GG COVID-19 Real-Time QPlex PCR