ViroKey Flu A/B & RSV RT-PCR Extension Kit

Primary DI

08885013953848

Basic UDI-DI Code

B-08885013953848

Reference

301074

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The ViroKeyTM Flu A/B & RSV RT-PCR Extension Kit (For use only with ViroKeyTM SARS- CoV-2 RT-PCR Test v2.0) is a triplex assay run in a separate well in conjunction with the ViroKeyTM SARS-CoV-2 RT-PCR Test v2.0, a dual-target assay run in its own well, which are real-time PCR based in vitro diagnostic tests. The tests used in combination are intended to use a single extraction of a sample via two (2) aliquots run in separate wells (as two (2) reactions) for the simultaneous qualitative detection of RNA from SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) in nasopharyngeal swabs and oropharyngeal swabs from patients with signs and symptoms of respiratory tract infections observed by their healthcare provider. Results are for the identification of SARS-CoV-2, Influenza A, Influenza B, and RSV RNA. The pathogens are generally detectable in upper and/or lower respiratory specimens during infection. Positive results are indicative of the presence of SARS-CoV-2, Influenza A, Influenza B, or RSV RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, Influenza A, Influenza B or RSV infection and should not be used as a sole basis for treatment or other patient management decisions. Mutations that arise within the highly conserved regions of the viral genome covered by both kits’ primers and / or probes may result in failure to detect the presence of the virus. Negative results must be combined with clinical observations, patient history, and epidemiological information.

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