
VIASURE Real Time PCR Detection Kits
Respiratory Virus Extended Mix – BD MAXTM System
Description
VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System is an automated RT-qPCR test designed for the simultaneous qualitative detection of RNA/DNA from SARS-CoV-2, Influenza A, Influenza B, RSV (types A and B), parainfluenza (types 1, 2, 3 and 4), human coronavirus (229E, NL63, HKU1 and OC43), metapneumovirus and adenovirus in nasopharyngeal swabs from patients suspected of respiratory infection by their healthcare professional (HCP).
This test is intended to be used as an aid in the diagnosis of infection with the above-mentioned microorganisms in combination with patient’s clinical signs and symptoms and/or epidemiological risk factors. Positive results are indicative of the nucleic acids (NA) target’s presence but do not preclude the presence of other pathogens not detected by the test. Negative results do not preclude the presence of the NA targets and should not be used as the sole basis for treatment, or other patient management decisions.
Specifications
Information
The assay uses the BD MAX™ System for automated extraction of RNA/DNA and subsequent RT-qPCR employing the reagents provided combined with universal reagents and disposables for the BD MAX™ System. RNA/DNA is extracted from samples. Complementary DNA (cDNA) is synthetized, and DNA/cDNA are amplified using RT-qPCR and detected using specific primers and fluorescent reporter dye probes for SARS-CoV-2, Influenza A, Influenza B, RSV (types A and B), parainfluenza (types 1, 2, 3 and 4), human coronavirus (229E, NL63, HKU1 and OC43), metapneumovirus and adenovirus.
The product is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures (including training on the Real Time PCR instrument (thermocycler) and nucleic acid extraction system).
Avaliable intructions for use:
VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAXTM System:
