We are proud to announce the launching of DV105 Trans SARS-CoV-2, Influenza A/B and Respiratory Syncytial Virus Assay!
Why detect ARS-CoV-2, Influenza A/B and Respiratory Syncytial Virus?
While the global spreading of COVID-19 is posing a major public health threat, the common seasonal respiratory infections still continue to circulate. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), influenza A, influenza B, and respiratory syncytial virus (RSV) cause acute respiratory infections with similar clinical manifestations. The infection management and treatment strategies, however, differ depending on the pathogen. Rapid identification of the virus that is causing the infection is important to ensure correct measures for infection control and treatment.
What is Trans SARS-CoV-2, Influenza A/B and Respiratory Syncytial Virus Assay?
The kit is designed for detecting SARS-CoV-2, Influenza A Virus, Influenza B Virus and Respiratory Syncytial virus RNA in specimens using multiplex real time RT-PCR technology with primers and probes targeting the conserved regions of ORF1ab genes of SARS-CoV-2, MP gene of Influenza A virus, NEP gene of Influenza B virus and M gene of Respiratory Syncytial virus.
Simultaneously, this kit contains an endogenous control (The internal control RNase-P gene is detected by VIC channel) to monitor the process of specimen collection, nucleic acid extraction and PCR and reduce false negative results.
Kit Contents
Component Name | Main Constituents | Specifications (48 tests) | Specifications (200 tests) |
PCR Reaction Mix | Reaction buffer, dNTPs, etc. | 600 μL×1 tube | 1250 μL×2 tubes |
PCR Enzyme Mix | Reverse transcriptase, RNase inhibitor, Taq DNA polymerase, uracil-DNA glycosylase | 48 μL×1 tube | 200 μL×1 tube |
PCR Primer / Probe Mix | Primers and probes for SARS-CoV-2, Influenza A Virus, Influenza B Virus, Respiratory Syncytial virus and the internal control-RNase P gene | 312 μL×1 tube | 1300 μL×1 tube |
Positive Control | In vitro transcribed RNA for SARS-CoV-2, Influenza A Virus, Influenza B Virus, Respiratory Syncytial virus and the internal control-RNase P gene | 50 μL×1 tube | 200 μL×1 tube |
Negative Control | RNase-free Water | 50 μL×1 tube | 200 μL×1 tube |
Product Information
Minimum Detection Limit | 500 copies/mL |
Accuracy | Positive Detection Rate | 100% |
Negative Detection Rate for Negative Control | 100% |
Analytical Specificity | The kit was evaluated for cross-reactivity with four influenza A virus (H1N1, H3N2, H5N1, H7N9) , two influenza B virus (Yamagata, Victoria), Adenoviruses, seven Human coronavirus(SARS-CoV-2, HCoV-HKU1, HCoV-229E, HCoV-OC43, HCoV-NL63, MERS-COV and SARS-COV), Respiratory Syncytial virus (A/B strain), Cytomegalovirus, Enterovirus virus (EV71,CA16), Human parainfluenza virus, Measles virus, human metapneumovirus, Mumps virus, Respiratory syncytial virus, rhinovirus, Bacillus pertussis, Chlamydia pneumoniae, Corynebacterium, Escherichia coli, Haemophilus influenzae, Lactobacillus, Catamola, Non-toxic Mycobacterium tuberculosis, Mycoplasma pneumoniae, Neisseria meningitidis, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus saliva and human genome. The results indicated that the influenza A virus (H1N1, H3N2, H5N1, H7N9) was tested as positive of influenza A/B , the influenza B (Yamagata, Victoria) was tested as positive of influenza A/B , the SARS-CoV-2 was tested as positive of SARS-CoV-2, respiratory syncytial virus (A/B strain) was tested as positive of respiratory syncytial virus, and others were tested as negative. The reference standards with and without mucin were both found positive. The negative samples were tested as negative. |
Precision | Negative detection rate of the negative samples | 100% |
positive detection rate of the strong positive samples | 100% |
positive detection rate of the limited positive samples | ≥95% |
Specimen Types | nasal swab specimens |
Storage | -20±5°C away from light for 12 months |
Shipping | Dry ice (-20°C) |
Features
● 4 tests in 1 setup: SARS-CoV-2, Influenza A virus, Influenza B virus and Respiratory Syncytial virus
● UDG and dUTP minimize carry-over contamination.
● High sensitivity.
● Suitable for the currently widely used fluorescence PCR instrument.
● CE marked.
The product has the Declaration of Conformity in vitro diagnostic medical devices Directive (98/79/EC) IVDD of EU. It indicates that our products meet the requirements of the relevant EU directives, has completed the registration with the EU competent authorities, and meet the access conditions for the EU market.
