Respiratory Virus Mix I – BD MAX^TM System

Description

VIASURE Respiratory Virus Mix I Real Time PCR Detection Kit for BD MAX™ System is designed for the qualitative detection of RNA from SARS-CoV-2, Influenza B, Influenza A and RSV (types A and B) in nasopharyngeal swabs.

The detection is done in one step real-time RT-PCR format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction tube.

The isolated RNA target is transcribed generating complementary DNA by reverse transcriptase, which is followed by the amplification of a conserved region of N and ORF1ab genes of SARS-CoV-2, M1 gene of Influenza B, M1 gene of Influenza A and N gene of RSV (types A and B) using specific primers and a fluorescent-labelled probe.

Specifications

Method

Real Time PCR

Specimen Type

Respiratory

Storage up to

(From production) 2 years

Storage temperature

(Also transport) Room temperature

Information

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.

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.

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 and other respiratory viruses, such as Influenza and RSV.

Diagnosis can be problematic, as a wide range of pathogens can cause acute respiratory infections presenting with similar clinical syndromes. Real-time PCR assays have been shown to be a sensitive and specific diagnostic tool for the detection of SARS-CoV-2, Flu A, Flu B and RSV viruses.