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Gencurix GenePro COVID-19 Detection Test

Category

Test kits

Subcategory

PCR test

Manufacturer

Gencurix

Company origin

Korea

Certifications & Standards

CE (Europe), ISO 13485, MFDS (Korea)

Brief description

The Gencurix GenePro COVID-19 Detection Test is a RT-PCR kit for the detection of SARS-CoV-2 developed based on WHO interim guidelines. The test qualitatively detects the RdRP and E genes simultaneously.

Lab COVID-19 Trust Score

Trust score: 100%
Reviewer comment: CE-approved, high quality PCR test developed by established company.

Photos

Detailed information

Milestones

  • 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 accuracy

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.

Guidance

Developed in accordance with WHO guidelines for 2019 novel coronavirus (2019-nCOV) testing.

Target genes

  • RdRP gene: RNA-dependent RNA polymerase gene
  • E gene: envelope protein gene

Performance

Sensitivity: for 1 cop/μL, the sensitivity rate is higher than 99%.

RT-PCR enzyme

SuperScript III RT/Platinum Taq Mix.

Running time

<1.5 hrs after RNA extraction

Compatible PCR instruments

  • BioRad CFX96
  • Applied BioSystems ABI 7500
  • ThermoFisher QuantStudio Dx Real-time PCR Instrument.

Reporting outcomes

Positive, Not Detected or Inconclusive

Kit contents

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.

Specimens

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.

Test process

Cut-off

Test interpretation

Media coverage