Lab COVID-19 Trust Score
- Has CE-IVD approval
- Has MFDS (Korea) approval
Key advantages of the Gencurix GenePro COVID-19 Detection Test
Target Genes(RdRp, E) Recommended by WHO
GenePro COVID-19 Detection Kit has been developed in accordance to the WHO guideline for ‘Laboratory testing of 2019 novel coronavirus (SARS-CoV-2).’
High target specificity & low false negative rate. Optimal primer and probe design facilitates minimal false positive and false negative results. RdRP and E gene have been designed to react in separate tubes, allowing the highest accuracy of the test results.
High performance enzyme
SuperScript III RT/Platinum Taq DNA polymerase’ provides the highest detection sensitivity and specificity with minimal sample required, avoiding false positive and false negative results.
RNA positive control
The test monitors the whole real-time RT-PCR process including reverse-transcription and amplification. DNA as a positive control can verify the amplification process of DNA, but cannot confirm the reverse-transcription process from RNA to DNA.
Developed in accordance with WHO guidelines for 2019 novel coronavirus (2019-nCOV) testing.
- RdRP gene: RNA-dependent RNA polymerase gene
- E gene: envelope protein gene
Sensitivity: for 1 cop/μL, the sensitivity rate is higher than 99%.
SuperScript III RT/Platinum Taq Mix.
<1.5 hrs after RNA extraction
Compatible PCR instruments
- BioRad CFX96
- Applied BioSystems ABI 7500
- ThermoFisher QuantStudio Dx Real-time PCR Instrument.
Positive, Not Detected or Inconclusive
Recommended RNA extraction kits for use with the Gencurix GenePro COVID-19 Detection Test
(Automated) RNA extraction kits by QIAGEN and Roche are recommended, as within WHO and CDC’s guidance. However, other Viral RNA Preparation Kits may be used as well.
The following respiratory tract specimens should be considered:
Upper respiratory tract – nasopharyngeal swab (NP) or oropharyngeal swab (OP):
- Use only synthetic fiber swabs with plastic shafts
- In case of oropharyngeal swab, insert swab into the posterior pharynx and tonsillar areas.
- In case of nasopharyngeal swab, insert the tubing into the nostril parallel to the palate
- Place swabs immediately into sterile tubes containing 2-3 ml of viral transport media.
- Have the patient rinse the mouth with water and then expectorate deep cough sputum directly into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container.
Lower respiratory tract – expectorated sputum:
Have the patient rinse the mouth with water and then expectorate deep cough sputum directly into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container.
- BioWorld (17 Mar 2020) – South Korea approves first four COVID-19 test kits under urgent-use license
- Korea Biomedical Review (11 Mar 2020) – Huons to market Gencurix’s COVID-19 detection kit