VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit for BD MAX™ System is an automated real-time RT-PCR test designed for the qualitative detection of RNA from the SARS-CoV-2 in respiratory samples from individuals suspected of COVID-19 by their healthcare provider.
This test is intended to be used as an aid in the identification of the presence of the SARS-CoV-2 viral RNA. The assay uses the BD MAX™ System for automated extraction of RNA
and subsequent real-time RT-PCR employing the reagents provided combined with universal reagents and disposables for the BD MAX™ System.
RNA is extracted from respiratory specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for SARS-CoV-2.
Coronavirus are enveloped non-segmented positive-sense RNA viruses and belong to Coronaviridae family.
There are six coronavirus species known to cause human diseases. Four viruses (229E, OC43, NL63 and HKU1) cause common cold symptoms and the other two (severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV)) are zoonotic and producing more severe complications. SARS-CoV and MERS-CoV have caused more than 10,000 cumulative cases in the past two decades, with mortality rates of 34% MERS-CoV and 10% SARS-CoV.
In December 2019, some people that worked at or lived around the Huanan seafood market in Wuhan, Hubei Province, China, have presented pneumonia of unknown cause. Deep sequencing analysis of the respiratory samples indicated a novel coronavirus, which was named firstly 2019 novel coronavirus (2019-nCoV) and lately SARS-CoV-2.
Human-to-human transmission of the SARS-CoV-2 has been confirmed, even in the incubation period without symptoms, and the virus causes severe respiratory illness like those SARS-CoV produced. Although the pneumonia is the principal illness associated, a few patients have developed severe pneumonia, pulmonary edema, acute respiratory distress syndrome, or multiple organ failure and death. Centers of Disease Control and Prevention (CDC) believes that symptoms of SARS-CoV-2 may appear in as few as 2 days or as long as 14 days after exposure, being the most common fever or chills, cough, fatigue, anorexia, myalgia and dyspnea. Less common symptoms are sore throat, nasal congestion, headache, diarrhea, nausea and vomiting. Loss of smell (anosmia) or loss of taste (ageusia) preceding the onset of respiratory symptoms has also been reported. Older adults and people who have severe underlying medical conditions like heart or lung disease or diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness.
Diagnosis of SARS-CoV-2 is performed detecting conventional causes of pneumonia early and detected by next generation sequencing or real-time RT-PCR methods. Several assays that detect the SARS-CoV-2 have been are currently available, such as China CDC (gene targets, ORF1ab and N), Charité – Germany (gene targets, RdRP and E) or US CDC (two targets in N gene).
CDC recommends upper respiratory tract specimens (nasopharyngeal (NP) and oropharyngeal (OP) swabs, nasal mid-turbinate swab, nasal swab, nasopharyngeal wash/aspirate or nasal wash/aspirate (NW) specimens collected mainly by a healthcare provider) and/or lower respiratory specimens (sputum, endotracheal aspirate, or bronchoalveolar lavage in patients with more severe respiratory disease) for the identification of SARS-CoV-2. In addition, other clinical specimens as blood, urine and stool may be collected to monitor the presence of the virus.
CERTIFICATE OF ANALYSIS