- CTK’s SARS-CoV-2, Influenza A/B, & RSV A/B Real-Time PCR Test detects and differentiates between SARS-CoV-2 (including currently circulating variants), Influenza A/B (including Influenza lineages) and RSV A/B from a single sample.
- CTK’s Aridia SARS-CoV-2, Influenza A/B, & RSV 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).
SARS-CoV-2, Influenza A/B, & RSV A/B Real-Time PCR Test CE
SARS-CoV-2, Influenza, and RSV 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, & RSV A/B Real-Time PCR Test is designed for the specific and qualitative detection and differentiation of SARS-CoV-2, Influenza A/B, and RSV A/B in respiratory specimens, including nasopharyngeal swabs and oropharyngeal swabs, as an aid in the diagnosis of infections by SARS-CoV-2, Influenza A/B, and /or RSV A/B viruses, alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes. The product is intended for use by professionals trained in nucleic acid amplification techniques and in vitro diagnostic procedures.
- The Aridia SARS-CoV-2, Influenza A/B, & RSV A/B Real-Time PCR Test has a detection limit of ≤10 RNA copies per reaction for SARS-CoV-2, Influenza A, and RSV A/B, and 20 RNA copier per reaction for Influenza B.
|Aridia SARS-CoV-2, Influenza A/B, & RSV A/B Real-Time PCR Test|
|Microorganism||Positive Agreement||Negative Agreement||Overall Agreement|
|SARS-CoV-2||99.5% (95% CI: 97.3- 99.1%)||100% (95% Cl: 97.7-100%)||99.7% (95% Cl: 98.5-100%)|
|Influenza A/B||100.0% (95% CI: 94.2- 100.0%)||100.0% (95% CI: 98.8- 100.0%)||100.0% (95% CI: 99.0-100.0%)|
|RSV A/B||100% (95% Cl: 91.8-100%)||100% (95% Cl: 98.8-100%)||100% (95% Cl: 99.0-100%)|
Reagents and Materials provided:
- SARS-CoV-2, Influenza A/B, & RSV A/B PCR Mix (24 tests per vial) 4 vials, 1 per pouch
- SARS-CoV-2, Influenza A/B, & RSV A/B Positive Control 1 vial in pouch
- SARS-CoV-2, Influenza A/B, & RSV A/B Negative Control 1 vial in pouch
- PCR-Grade Water
- Instructions for Use
Materials Required but not provided:
- Real-Time PCR thermocycler compatible with FAM, ROX, HEX (JOE, VIC) and Cy5 channels
- RNA purification kit
- Sterile RNase-free 1.5 mL centrifuge tubes
- PCR tubes/strips/plate and optical caps/film
- Centrifuge for 1.5 mL tubes and PCR-well strips or 96-well plate (if available)
- Micropipettes (0.5-20 µL, 20-200 µL and 1000 µL)
- Filter micropipette tips
- Gloves and other recommended PPE
- Instructions for Use
- Product Flyer
|P0189||SARS-CoV-2 & Influenza A/B Real-Time PCR Test||96/Kit||Respiratory|
|P0180||COVID-19 Real-Time PCR Test||96/Kit||Respiratory|
|P0187||Influenza A/B & RSV Real-Time PCR Test||96/Kit||Respiratory|
|R0182C||COVID-19 Ag Rapid Test||20/Kit||Swab|
|R0187C||Influenza A/B Rapid Test||20/Kit||Swab|
|R0188C||COVID-19 + Influenza A/B Ag Rapid Test||15/Kit||Swab|
FOR EXPORT ONLY