In March, GenMark received EUA for its ePlex SARS-CoV-2 Test. Respiratory Pathogen Panel. Multiplex molecular diagnostic solutions provider GenMark Diagnostics has secured CE mark approval for its ePlex respiratory pathogen panel 2 (RP2). The ePlex RP has received FDA clearance for nasopharyngeal swab (NPS) specimens collected in viral transport media. COVID-19. ;
The RP2 Panel provides results in less than two hours for more than 20 viruses and bacteria that cause common respiratory infections with similar symptoms, including COVID-19, flu, bronchitis, and the common cold. Clinical implications of rapid eplex® respiratory pathogen panel testing compared to laboratory-developed real-time PCR Anneloes L. van Rijn, Roel H.T. Due to the batch-wise testing, laboratory-developed real-time polymerase chain reaction (PCR) assays (LDT) often result in a time to result of one day.
10/01/2019: Under Article Text added the third bullet point verbiage “For dates of service on or after 10/1/2019, laboratories billing for services using GenMark” ePlex Respiratory Pathogen (RP) Panel should report 0115U. The ePlex RP2 Control M451 is composed of synthetic DNA and RNA specifically designed for and intended to be used solely with the ePlex RP2 Panel on the ePlex System. In March, GenMark received EUA for its ePlex SARS-CoV-2 Test. Read More.
The ePlex respiratory pathogen panel (RP panel) is a novel molecular biology-based assay, developed by GenMark Diagnostics, Inc. (Carlsbad, CA), to be performed within a single cartridge for the diagnosis of 25 respiratory pathogens (viral and bacterial). in Top News. GenMarkâs ePLex-BCID Gram-Positive panel detects 20 bacterial targets, and the Fungal Pathogen panel detects 13 yeast pathogens in one and a half hours. AB Molecular Ltd. Butyl Road, Botolph Claydon, Respiratory Pathogen Panel. AB Molecular is the exclusive distributor in the UK for GenMark Dx and has been established to promote their innovative ePlex technology.
The ePlex RP2 Panel is designed for use with the companyâs ePlex system, which has been cleared by the FDA for use with the ePlex Respiratory Pathogen (RP) Panel and Blood Culture Identification (BCID) Panels (Gram-positive, Gram-negative and Fungal pathogens). The QIAstat-Dx® RP assay detected 312 of the 338 respiratory targets (92%) that were detected by the ePlex® RPP assay. This assay does NOT detect SARS CoV-2 (novel coronavirus) or MERS. Multiplex molecular panels provide high sensitivity (few false negatives) and specificity (few false positives) for multiple pathogens in â¦ GenMarkâs ePlex Respiratory Pathogen Panel 2 (RP2) achieves CE mark.
The company said RP2 drove the majority of the placements and revenues in Q3. Respiratory Panel 2 (RP2)] 0115U Respiratory infectious agent detection by nucleic acid (DNA and RNA), 18 viral types and subtypes and 2 bacterial targets, amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected [USE FOR GenMark ePlex Respiratory Pathogen (RP) Panel] SARS-CoV-2 (2 assays) Seasonal coronavirus.
We are very pleased to announce the 510(k) clearance of ePlex and the Respiratory Pathogen Panel. The new RP2 panel includes SARS-CoV-2, the pathogen that causes COVID-19. If the tube system is used, ensure specimens are in leak-proof containers that are securely closed and double bagged. ORIGINAL ARTICLE Clinical implications of rapid ePlex® Respiratory Pathogen Panel testing compared to laboratory-developed real-time PCR Anneloes L. van Rijn1 & Roel H. T. Nijhuis1 & Vincent Bekker 2 & Geert H.