Fluorion Covidenza kit has been developed for the detection and discrimination of SARS-CoV-2, Influenza A and Influenza B viruses from swab samples obtained from patients.
The positive control in the kit is synthetic DNA. It contains target regions of the N1, N2, M2, NS1 and RNAseP genes that are amplified only with the primer-probe sets included in this kit. The content of the positive control tube is not infectious.
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Fluorion Covidenza kit has been developed for the detection and discrimination of SARS-CoV-2, Influenza A and Influenza B viruses from swab samples obtained from patients.
The positive control in the kit is synthetic DNA. It contains target regions of the N1, N2, M2, NS1 and RNAseP genes that are amplified only with the primer-probe sets included in this kit. The content of the positive control tube is not infectious.
| SAMPLE TYPE | Bronchoalveolar Lavage | Nasopharyngeal Swab | Orofarengeal Swab |
| TARGET | SARS-CoV-2 | Influenza A | Influenza B |
| SENSITIVITY | 30 Copies/Reaction |
| Intended Use | Qualitative 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 |
| 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 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 QLP 1.0 æReal-Time PCR Kit CE-IVD | CoVIDenza QLP 1.0 Real-Time PCR Kit CE-IVD |
| Cat. No. | M1360102-2 | M1360102-3 |
| Pack Size | 50 tests | 100 tests |
Fluorion Covidenza +, developed for 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.)
| SAMPLE TYPE | Bronchoalveolar Lavage | Nasopharyngeal Swab | Orofarengeal Swab |
| TARGET | SARS-CoV-2 | Influenza A | Influenza B |
| SENSITIVITY | 30 Copies/Reaction |
| Intended Use | Qualitative 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 |
| 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 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 QLP 1.0 æReal-Time PCR Kit CE-IVD | CoVIDenza QLP 1.0 Real-Time PCR Kit CE-IVD |
| Cat. No. | M1360102-2 | M1360102-3 |
| Pack Size | 50 tests | 100 tests |
Highlights
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Professional’s opinion
Not every respiratory infection is Covid. The right diagnosis is the critical requirement for proper treatment. Evidence-based treatment based on PCR tests, is our most important tool against respiratory tract infectious diseases. Fast, Easy, Accessible.
Not every respiratory infection is Covid. The right diagnosis is the critical requirement for proper treatment. Evidence-based treatment based on PCR tests, is our most important tool against respiratory tract infectious diseases. Fast, Easy, Accessible.
Not every respiratory infection is Covid. The right diagnosis is the critical requirement for proper treatment. Evidence-based treatment based on PCR tests, is our most important tool against respiratory tract infectious diseases. Fast, Easy, Accessible.
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