SARS-CoV-2 & Influenza A/B Real-Time PCR Test CE

SARS-CoV-2 and Influenza cannot be differentiated based on symptoms alone, creating the need for a single test that can simultaneously differentiate between the respiratory diseases. The Aridia SARS-CoV-2 & Influenza A/B Real-Time PCR Test is designed for specific and qualitative detection and differentiation of the novel coronavirus SARS-CoV-2, Influenza A, and Influenza B in respiratory specimens, including oropharyngeal swabs, nasopharyngeal swabs and sputum, as an aid in the diagnosis of infections by SARS-CoV-2, Influenza A, or Influenza B viruses, 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

  • CTK’s Aridia SARS-CoV-2 & Influenza A/B Real-Time PCR Test detects and differentiates between SARS-CoV-2 (including currently circulating variants), Influenza A (H1N1, H3N2, and others) and Influenza B (Yamagata, Victoria).
  • CTK’s Aridia SARS-CoV-2 & Influenza A/B 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 in tubes with PCR Mix sufficient to perform 96 RT-PCR reactions per kit.
  • All components are stabilized in a lyophilized format to allow ambient shipment and storage (2-40°C)
  • The Aridia SARS-CoV-2 & Influenza A/B Real-Time PCR Test has a detection limit of ≤10 RNA copies per reaction for Influenza A, Influenza B and SARS-CoV-2.


 Aridia SARS-CoV-2 & Influenza A/B Real-Time PCR Test
MicroorganismPositive AgreementNegative AgreementOverall Agreement
Influenza A99.11% (95% Cl: 95.12-99.84%)100% (95% Cl: 97.02-100%)99.58% (95% Cl: 97.65-99.93%)
Influenza B97.22% (95% Cl: 85.83-99.51%)100% (95% Cl: 97.57-100%)99.47% (95% Cl: 97.08-99.91%)
SARS-CoV-2100% (95% Cl: 96.85-100%)100% (95% Cl: 95.72-100%)100% (95% Cl: 98.15-100%)

Reagents and Materials provided:

  1. SARS-CoV-2 & Influenza A/B PCR Mix (24 tests per vial) 4 vials, 1 per pouch
  2. SARS-CoV-2 & Influenza A/B Positive Control 1 vial in pouch
  3. SARS-CoV-2 & Influenza A/B Negative Control 1 vial in pouch
  4. PCR-Grade Water
  5. Instructions for Use

Materials Required but not provided:

  1. Real-Time PCR thermocycler compatible with FAM, ROX, HEX (JOE, VIC) and Cy5 channels
  2. RNA purification kit
  3. Sterile RNase-free 1.5 mL centrifuge tubes
  4. PCR tubes/strips/plate and optical caps/film
  5. Centrifuge for 1.5 mL tubes and PCR-well strips or 96-well plate (if available)
  6. Vortex
  7. Micropipettes (0.5-20 µL, 20-200 µL and 1000 µL)
  8. Filter micropipette tips
  9. Gloves and other recommended PPE


Instructions for Use

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