Respiratory Pathogen Panel

Yes. The BioCode^® RPP testing assay is FDA 510(k) cleared in the United States and can be tested in parallel with other FDA-cleared BioCode^® assays. This FDA clearance certifies that this assay is substantially equivalent to a device that has been cleared by the FDA and is currently in commercial distribution.

The BioCode^® Respiratory Pathogen Panel test has a data masking option enabling select target reporting based on a clinician’s order. The pathogen targets can be masked and unmasked to cover specific targets. This option means the laboratory is not testing for targets the clinician does not suspect, reducing the chance of reimbursement and liability challenges with insurance, enabling custom reporting, and offering flexibility for changing laboratory demands.

Barcoded Magnetic Bead technology is a patented technology of Applied BioCode Inc. This technology is designed for multiplex detection of nucleic acids and proteins, such as antigens and antibodies. These microparticles are combined with digital barcodes for multiplex immunoassays and molecular detection. A semiconductor fabrication process produces the barcode magnetic beads, enabling the scanning and identification of 4,096 barcodes.

The following extraction systems are compatible with the BioCode^® Respiratory Pathogen Panel Test:

• NUCLISENS^® easyMag^®: The NUCLISENS easyMAG is an automated system for total nucleic acid extraction from biological samples. This system supports RNA and DNA extraction and molecular diagnostics testing.
• MagNA Pure 96: The MagNA Pure 96 System is an automated nucleic acid purification system for molecular diagnostics. It can process up to 96 samples in an hour.
• KingFisher™ Flex: Thermo Scientific KingFisher Flex is an automated extraction and purification system for proteins, cells, RNA, and DNA. The medium- to high-throughput extraction analyzes 24 or 96 samples per run.

Yes, the BioCode^® Respiratory Pathogen Panel Test can detect co-infections. The assay can detect 17 microbial pathogens in a single reaction, including:

• Viruses: Influenza A; Parainfluenza 1, 2, 3, and 4; rhinovirus/enterovirus; adenovirus; Influenza B; respiratory syncytial virus A/B; coronavirus; Human Metapneumovirus A/B
• Bacteria: Mycoplasma pneumoniae, Chlamydia pneumoniae, Bordetella pertussis