SAMPLE TYPEBronchoalveolar LavageNasopharyngeal SwabOrofarengeal Swab
TARGETSARS-CoV-2Influenza AInfluenza B
SENSITIVITY30 Copies/Reaction
  
Intended UseQualitative detection and discrimination of Coronavirus 2019 (COVID-19) SARS-CoV-2, Influenza A and Influenza B viruses in patients with COVID-19 or influenza-like clinical symptoms (e.g. fever, cough, shortness of breath), using lower respiratory tract (bronchoalveolar lavage (BAL), tracheal aspirate) and/or upper respiratory tract (nasopharyngeal and oropharyngeal fluids, nasal swab) samples.
Analitycal Specificity
(in vitro analysis)
DOES NOT cross-react with the below pathogens:
SARS-CoV, Adenovirus, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Candida albicans, RSV A, RSV B, Rhinovirus, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Hepatitis B, Hepatitis C, Hepatitis Delta, Human Immunodeficiency Virus, Cytomegalovirus, Epstein-Barr Virus, JCV, BKV, Human Papilloma Virus, Parvovirus, Herpes Simplex Virus, Mycobacterium tuberculosis, Aspergillus spp., Brucella abortus, Brucella melitensis, Brucella canis and Brucella suis, E.coli O157, Salmonella spp., Listeria monocytogenes
Analitycal Specificity
(in silico analysis)
DOES NOT cross-react with the below pathogens:
SARS-CoV, MERS-CoV, Human coronaviruses (HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1), Adenovirus, Influenza C, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parechovirus, Candida albicans, Corynebacterium diphtheriae, Legionella non-pneumophila, Bacillus anthracis, Moraxella catarrhalis, Neisseria elongata, Neisseria meningitides, RSV A, RSV B, Rhinovirus, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus salivarius, Leptospirosis, Chlamydia psittaci, Coxiella burnetii (Q- Fever), Staphylococcus epidermidis, Enterovirus, Haemophilus Influenzae, Mycobacterium tuberculosis, Bordetella parapertussis, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Hepatitis B, Hepatitis C, Hepatitis Delta, Human Immunodeficiency Virus, Cytomegalovirus, Epstein-Barr Virus, JCV, BKV, Human Papilloma Virus, Parvovirus, Herpes Simplex Virus, Mycobacterium tuberculosis, Aspergillus spp., Brucella abortus, Brucella melitensis, Brucella canis and Brucella suis, E.coli O157, Salmonella spp., Listeria monocytogenes
Specificity100.00%
Target RegionsN1 and N2 regions of nucleocapsid gene of SARS-CoV-2 virus, M2 gene of Influenza A virus, NS1 gene of Influenza B virus
Human RNaseP gene (internal control)
Reaction Duration~75 min. (may change depending on the Real-Time PCR instrument)
Storage Conditions• Products should be stored at -20°C or below.
• It is recommended not to freeze-thaw products more than three times. In cases where more freeze-thaw is required, solutions should be aliquoted and stored at -20°C or lower following the first thaw.
• Detection mixes are light-sensitive. Aliquoted reagents must be protected from light.
   
ItemCoVIDenza QLP 1.0 æReal-Time PCR Kit CE-IVDCoVIDenza QLP 1.0 Real-Time PCR Kit CE-IVD
Cat. No.M1360102-2 M1360102-3
Pack Size50 tests100 tests