AvidinAvidin
Influenza A/B + SARS-CoV-2 Quantification Kit
for CFX96, Quantstudio 5, ABI7500/7500 Fast, LightCycler® 96, Rotor-Gene™ 6000, Mic qPCR Cycler, 4-Channel
The Inf-Cov2Quant TM Influenza A / B + SARS-Cov-2 Quantification Kit is a multiplex molecular in vitro diagnostic kit capable of detecting and differentiating the presence of Influenza A and B viruses and novel coronavirus (SARS-CoV-2) RNA from the same upper or lower respiratory tract sample (such as nasopharyngeal, oropharyngeal, and nasal swabs, sputum, lower respiratory, bronchoalveolar lavage, and nasopharyngeal lavage fluids). This multi-diagnostic solution can quickly distinguish the two diseases, which are similar respiratory symptoms with a high transmission rate. The multiplex (tetraplex) quantitative diagnostic method, run in a single well, uses a one- step reverse transcription real-time polymerase chain reaction (RT-QPCR) protocol with high specificity and sensitivity.
The Inf-Cov2Quant TM Influenza A / B + SARS-Cov-2 Quantification Kit is a multiplex molecular in vitro diagnostic kit capable of detecting and differentiating the presence of Influenza A and B viruses and novel coronavirus (SARS-CoV-2) RNA from the same upper or lower respiratory tract sample (such as nasopharyngeal, oropharyngeal, and nasal swabs, sputum, lower respiratory, bronchoalveolar lavage, and nasopharyngeal lavage fluids). This multi-diagnostic solution can quickly distinguish the two diseases, which are similar respiratory symptoms with a high transmission rate. The multiplex (tetraplex) quantitative diagnostic method, run in a single well, uses a one- step reverse transcription real-time polymerase chain reaction (RT-QPCR) protocol with high specificity and sensitivity.
We also offer an easy solution and process for sample testing and therefore ensure full support throughout the whole process: from sample collection to diagnosis.
The assay is performed by real-time quantitative PCR (qPCR).
Analytical
Specificity
Analytical
Specificity
Serial dilution (350000; 70000; 14000; 2800; 560; 112; 40; 20; 10; 5; 4 copies/test) Influenza A (H1N1, H3N2 – WHO standard), Influenza B (B/VIC – WHO standard) and (800000; 160000; 32000; 6400; 1280; 256; 51; 10 copies/test) Sars-Cov-2 RNA sample (2 batches, 3 replicates) were tested.
Analytical Sensitivity:
Repeatability
Repeatability was confirmed with identical standard samples at different time points with different Lot and testers. Criteria of repeatability was CV < 20% of Ct Value.
The National Institute of Pharmacy and Nutrition hereby certifies, that on the basis of information provided, the medical device(s) names below and detailed in the attachment (if applicable), which is/are manufactured by the above economic operator, has/have been affixed with the CE mark under the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices and/or the Council Directive 93/42/EEC concerning medical devices (as amended) which was transposed into Hungarian national law (decree No. 8/2003. (III. 13) of the Ministry of Health, Social and Family Affairs on in vitro diagnostic medical devices and/or decree No. 4/2009 (III. 17) of the Ministry of Health on medical devices, as amended, may be freely sold in all member states of the European Economic Area (EEA) including Hungary.
