The panel has been validated for nasopharyngeal swabs, oropharyngeal swabs and saliva samples
FluoroType SARS-CoV-2/Flu/RSV Test Kit. (Credit: Business Wire.)
Bruker has introduced its FluoroType SARS-CoV-2/Flu/RSV winter four-plex PCR panel for simultaneous detection of the SARS-CoV-2 virus, both influenza A and B viruses, along with the respiratory syncytial virus (RSV).
The firm said that the winter season requires the differentiation of multiple viruses in a single assay, to facilitate the diagnosis and patient management.
Its FluoroType SARS-CoV-2/Flu/RSV panel is a CE-IVD labelled that has been validated for nasopharyngeal swabs, oropharyngeal swabs and saliva samples.
Bruker Daltonics microbiology and diagnostics executive vice president Wolfgang Pusch said: “We appreciate the positive customer feedback on the performance of our new FluoroType SARS-CoV-2/Flu/RSV panel.
“Compared to PCR assays that detect only the SARS-CoV-2 virus, our winter four-plex panel offers added value in a cost-effective workflow. Our clinical laboratory customers now also have the option of offering the saliva workflow for patient convenience, faster time-to-result, and reduced resource requirements without RNA extraction.”
FluoroType SARS-CoV-2/Flu/RSV panel works on FluoroCycler XT real-time PCR system
The FluoroType SARS-CoV-2/Flu/RSV panel is intended for use with Bruker´s FluoroCycler XT real-time PCR system, or with other common real-time thermocyclers.
The test kit contains reagents required to generate up to 96 PCR result panels in less than two hours from the extraction of nucleic acid.
It been evaluated for the sensitivity and specificity using 112 nasopharyngeal or oropharyngeal swabs, and showed 100% outcomes for all the four viruses with reduced detection limitations.
Also, the winter four-plex panel has been validated with an RNA extraction-free protocol on 60 saliva samples, which demonstrated 100% sensitivity and 97.5% specificity.
The company said that the sensitivity and specificity of the test may not be achieved 100% all the time in large scale patient sampling and diagnostic use, but swab and saliva PCR protocols may provide most sensitive assays.
Furthermore, the company has validated the test for use on Bruker´s GenoXtract (GXT) automated nucleic acid extraction devices with associated Bruker RNA extraction kits, and for Qiagen extraction chemistry, along with the saliva workflow without RNA extraction.