COVID-19 Real-Time PCR test CE

The COVID-19 Real-Time PCR Test is designed for specific and qualitative detection of the novel coronavirus SARS-CoV-2, responsible for COVID-19, in oropharyngeal swabs, nasopharyngeal swabs or sputum specimens as an aid in the diagnosis of COVID-19 infections, alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes. The product is intended for use by healthcare professionals specifically trained in nucleic acid amplification techniques and in vitro diagnostic procedures.

The COVID-19 Real-Time PCR Test comes in a ready-to-use format. All real-time PCR components, including DNA polymerase, reverse transcriptase, primers, probes, and dNTPs, are stabilized within each reaction well. In addition, an Internal Control (IC) is included within each well for monitoring PCR reaction inhibition.

  • CTK’s COVID-19 Real-Time PCR Test has 97.5% sensitivity, >99.9% specificity by utilizing multiplex PCR-fluorescent probe technology combined with fast, one-step RT-PCR technology.
  • With the designed dual-target gene detection primer-probe, the test is designed to work with open PCR systems, making CTK’s COVID-19 Real-Time PCR Test a practical solution for all varieties of laboratories.
  • Furthermore, CTK is working to submit its PCR test to the Foundation for Innovative New Diagnostics (FIND) in response to FIND’s expression of interest (EOI) for evaluating assays using its standardized, independent protocol. CTK is also participating in the WHO program “In-Vitro diagnostics for SARS-CoV-2 for emergency use listing”.
  1. Clinical Performance

Sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) for Aridia COVID-19 Real-Time PCR Test compared with Charité protocol are >99.9%.

  1. Analytical Specificity

The analytical specificity for Aridia COVID-19 Real-Time PCR Test was confirmed by testing a panel consisting of different microorganisms representing the most common respiratory pathogens. No cross-reactivity was detected between any of the microorganisms tested.

  • For use with nasal swab specimens, sputum specimens, etc.
  • Detects ORF1ab, nucleocapsid protein gene
  • Test packaging: 96 tests/kit
  • LOD: ≥10 RNA copies per reaction

Reagents and Materials provided:

  1. COVID-19 Real-Time PCR Test Strips (High Profile/Low Profile)
  2. COVID-19 Positive Control
  3. Negative Control
  4. PCR-Grade Water
  5. Resuspension Solution (for Reconstitution of the Stabilized Reaction Mix)
  6. Optical Caps
  7. Instructions for Use

Materials Required but not provided:

  1. Real-Time PCR thermocycler compatible with FAM, ROX and HEX channels (check “COMPATIBILITY of REAL-TIME PCR THERMOCYCLERS” section)
  2. RNA purification kit
  3. 5 mL centrifuge tubes
  4. Centrifuge for 1.5 mL tubes and PCR-well strips or 96-well plate (if available)
  5. Vortex
  6. Micropipettes (0.5-20 µL, 20-200 µL)
  7. Filter micropipette tips

Catalog #

Product

Quantity

Specimen

P0180

COVID-19 Real-Time PCR test

96/kit

S, P & WB

Compatible Tests

Catalog #

Product

Quantity

Specimen

R0180C

OnSite COVID-19 IgG/IgM Rapid Test

30/kit

S, P & WB

R0182C

OnSite COVID-19 Ag Rapid Test

20/kit

Swab

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FOR EXPORT ONLY