| SAMPLE TYPE | Bronchoalveolar Lavage | Nasopharyngeal Swab | Orofarengeal Swab | |
| TARGET | SARS-CoV-2 | Influenza A | Influenza B | RSV and/or Rhinovirus* |
| SENSITIVITY | 30 Copies/Reaction |
| Intended Use | Qualitative detection and discrimination of Coronavirus 2019 (COVID-19) SARS CoV-2, Influenza A, Influenza B, RSV and Rhinovirus viruses in patients with COVID-19, influenza or common cold like 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, 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, 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 |
| Specificity | 100.00% |
| Target Regions | N1 and N2 regions of nucleocapsid gene of SARS-CoV-2 virus, M2 gene of Influenza A virus, NS1 gene of Influenza B virus, G Protein of RSV 5’ UTR region of Rhinovirus 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. |
| Item | CoVIDenza Plus QLP 1.0 | CoVIDenza Plus QLP 1.0 |
| Cat. No. | M1370102-2 | M1370102-3 |
| Pack Size | 50 tests | 100 tests |
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