- ALL of Cellgenemedix’s COVID-19 products have been validated in multiple variants with clinical samples and verified commercial controls.
- Good Ag antigen test and PCR test work well on both Omicron and Delta variant specimens (>100-500 specimens verified) as well as multiple other variantas and validated commercial controls.
- Approved for use in Europe/Asia per CE/ISO (Inquire per email to see CE certificate)
- NOT AUTHORIZED OR CLEARED FOR USE IN THE USA (ISO certified)
The “Good Ag COVID-19 Antigen test (GG-CAG-01/02/03)” is a lateral flow assay for home use (OTC) and professionals (POC) for rapid antigen testing of COVID-19 which can detect as little as 0.1-0.01ng/ml N (Nucleocapsid) antigen of SARS-Cov-2 in nasal/nasopharyngeal/oral/ oropharyngeal swab/sputum/saliva specimens with higher analytical sensitivity than most if not all the commercially available antigen kits (LOD 10-20 time lower). It shows higher clinical performance (sensitivity 85-95% and specificity 100% in reference to real time PCR assay) that allows home testing to detect SARS-Cov-2 within 15-20 minutes without need of additional instrument.
Please refer to Sample collection guide for specific instructions on how to collect the samples. The Good Ag COVID-19 Antigen test is special in that it targets conserved (non-mutated to date, especially both in Delta and Omicron) areas of the NP (nucleoprotein) of the SARS-CoV-2 genome. It uses USPTO-/international patented technology to detect these areas of COVID-19 antigen, thus creating strong, reliable results even in people with mutant strains of coronavirus.
The Good Ag COVID-19 Antigen test was demonstrated at near patient or Point of Care (POC) testing that non-laboratory personnel can perform the test accurately in the intended use environment. In addition, the robust use of the Good Ag COVID-19 Antigen test for self-administered (OTC) or Point of Care (POC) testing was demonstrated by clinical studies.
- Higher analytical sensitivity than other commercial antigen kits (LOD 10-20 time lower)
- Higher clinical performance (sensitivity 85-95% and specificity >95% in reference to real time PCR assay)
- Both batch / individual test available (GG-CAG-01 and 03: batch of 25/GG CAG-02: 1)
- Allow home testing to detect SARS-Cov-2 within 20 minutes without need of additional instrument
- One of the best tools to screen/diagnose COV-19 in the public (Home test, Point of care test)
- Cost effective
For investigational use only: please contact the Technical Support at +1-832-468-6985 (Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or cellgenemedix@cellgenemedix.com (24/7 available) before testing patient specimens.
Attached below is the IFU for Good Ag COVID-19 rapid test.
Instructions for Use
NOT AUTHORIZED OR CLEARED FOR USE IN THE USA; For investigational use only.
CE + ISO approved for clinical use in Europe and Asia
| Test Principle | Latex based lateral flow assay |
|---|---|
| Targets | N (Nucleoprotein) antigen of SARS-Cov-2 |
| Number of Tests | 10T I Kit (GG-CAP-01) 25T I Kit (GG-CAP-02) 50T I Kit (GG-CAP-03) 2 T I Kit (GG-HAP-01) |
| Time to Result | 1.5 hr ~ 2 hr |
| Specimen Type | sputum, nasopharyngeal or oropharyngeal swabs, nasal swabs |
| Instrument Required | None; PPE for professional use Good Ag test |
| Kit Storage | 2-30 °C, avoid direct sunlight |
| Performance in analytical and clinical studies | LOD 10-20 time lower; sensitivity 85-95% and specificity 100% in reference to real time PCR assay in patient samples collected within 6 days of symptom onset |
| Purpose | detect as little as 0.01ng/ml N (Nucleoprotein) antigen of SARS-Cov-2 in nasal(GG HAG-01/02; home use)/nasopharyngeal or oropharyngeal or nasal swab (GG CAG-01/02/03; professional use) specimens |
