Human Influenza Virus a/B & Respiratory Syncytial Virus Nucleic Acid Multiplex Detection Kit

CAS-Envision Multiple Respiratory Pathogens RT-qPCR Detection Kit is a real-time reverse transcription polymerase chain reaction (RT-qPCR) test intended for the presumptive qualitative detection of nucleic acid from the SAR-CoV-2, Influenza A and Influenza B virus in upper respiratory specimens (such as Nasal swabs, nasopharyngeal swabs and sputum).
Results are the presumptive identification of the genomic RNA of SAR-CoV-2, Influenza A and lnfluenza B virus. The viral RNA is generally detective in upper. respiratory specimens during the early stage of infection.Positive results are indicativeof active infection with SAR-Cov-2, Influenza A or lnfluenza B, but not rule out bacterial infection or co-infection with other virus.
Negative results do not preclude SAR-CoV-2, Influenza A or Influenza B infection and should not be used as the sole basis for treatment or other patient management decisions.
The level of SAR-CoV-2, Influenza A and Influenza B that would be present in respiratory specimens from individuals with early infection is unknown. Therefore, negative results must be combined with clinical observations, patient history, and epidemiological information.

By real-time fluorescent PCR amplification technology, the kit uses fluorescent labeled probes and 
detects the fluorescent strength from the reporter during the amplification to monitor the PCR products quantity. Both detection probes and internal standard probes have fluorescent reporter and quencher. They are differentiated by labels with different colored fluorescent and detected independently at different wave lengths. When the probes are intact, the reporter is near the quencher, so it is inhibited. With PCR amplification, the probes hybrid with the targeted sequence and are degraded due to the 5'-3'exonuclease activity of the polymerase, and the fluorescent reporter and the quencher are separated, so the fluorescent signal can be detected. By presetting the cycle time, every effective cycle will lead to the increase of the fluorescent strength.

1. Accuracy: Conformity rate of 12 Negative Control: 100%; Conformity rate of 5 Positive Control: 100%.
2. Detection limitation: 500 copies /mL.
3. Inclusiveness: The LOD and repeatability of virus samples from different regions will not change.
4. Cross-Reactivity: This product will not cross react with positive samples of human coronavirus HKU1 OC43, NL63 and 229E, SAR coron, MERS corona-virus, H1N1 (new influenza A (H1N1) virus (2009), the seasonal H1N1) and H3N2, H5N1, H7N9, influenza B Yamagata, Victoria, respiratory syncytial virus type A, B, parainfluenza type 1, 2, 3, rhinovirus species A, B and C, adenovirus, 1, 2, 3, 4, 5, 7 and 55, enterovirus species A, B, C, D, Human pulmonary virus, partial pulmonary virus, EB virus, measles virus, human cytomegalo virus, rotavirus, norovirus, mumps virus, varicella-zoster virus and mycoplasma pneumoniae, chlamydia pneumoniae, legionella, bordetella pertussis, haemophilus influenzae, staphylococcus aureus, streptococcus pneumoniae, pyogenic streptococcus, klebsiella pneumoniae, mycobacterium tuberculosis, pyogenic streptococcus, candida albicans, candida glabrata, newborn Cryptococcus and human genome DNA.
5, Interfering Substances Studies: Endogenous substances such as blood and mucus that may be present in throat swabs and sputum samples do not interfere with the test results of the kit; exogenous substances such as phenylephrine, oxymetazoline, sodium chloride, and beclomethasone, flunisolide, budesonide, mometasone, fluticasone, histamine hydrochloride, alpha-interferon, zanamivir, ribavirin, oseltamivir, peramid Wei, lopinavir, ritonavir, arbidol, levofloxacin, azithromycin, ceftriaxone, meropenem, tobramycin did not interfere with the test results.
6. Precision: using precision reference CV1 and CV2 for within-batch and between-batch detection, the coefficient of variation (CV) of their Ct values is ≤ 5.0%.

Founded in 2018, CAS-Envision is a high-tech start-up company held by Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences.
CAS-Envision is committed to creating an operating system of semiconductor and biomedical interconnection, to provide unique one-stop technical solutions for lVD and biopharma.ceutical companies. The company has established three major business segments: One is POCT, including lmmunochromatography, molecular POCT, electrochemical detection). Second is ultra-sensitive detection, like digital PCR, single moleculeimmunity. Third is medical chips for brain-computer interface, sensor chip, medical SoC chip.