VIASURE Real Time PCR Detection Kits
SARS-CoV-2 Variant – BD MAXTM System
VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for BD MAX™ System is an automated real-time RT-PCR test designed for the qualitative detection of HV 69/70 deletion, K417N mutation and K417T mutation in the S gene of SARS-CoV-2, associated to SARS-CoV-2 Alpha (lineage B.1.1.7), Beta (lineage B.1.351) and Gamma (linage P.1) variants, in nasopharyngeal and oropharyngeal swabs and saliva samples.
The assay is intended to be used with SARS-CoV-2 positive samples or, when the test is performed in conjunction with the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit for BD MAX™ System (Ref: 444215) with samples from patients suspected Coronavirus disease 2019 (COVID-19) by their healthcare professional (HCP).
This test is intended to be used as an aid to monitor the prevalence of variants that carry the HV 69/70 deletion, K417N or K417T mutations in the S gene and to assist in control measures. 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 specimens, and complementary DNA (cDNA) is synthetized and amplified using RT-PCR and detected using fluorescent reporter dye probes specific for HV 69/70 deletion, K417N or K417T mutations.
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 [1,6,7,8]. 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 [1,4]. 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 [1,4,6,9]. Less common symptoms are sore throat, nasal congestion, headache, diarrhea, nausea and vomiting [1,4]. 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 .
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CERTIFICATE OF ANALYSIS