MLP - Multiplex Respiratory Panel 29 targets including ABX Resistance and COVID-19 Assay, 96 well, 3 panels per plate (Breakaway Plates)

Product Description

The COVID-19 Respiratory Plus Panel is an in-vitro multiplex real-time reverse transcription polymerase chain reaction (rRT-PCR) assay for the qualitative identification of nucleic acids from organisms frequently found in the respiratory tract. This method a highly accurate, analytically sensitive, and is used to identify organisms by amplifying and detecting genetic material of pathogens in samples. The panel will aid in the research of causative agents of respiratory tract infections and their prevalence. 

The target organisms included in the panel are as follows: Adenovirus, Bocavirus, Coronavirus (229E, HKU1, NL63, OC43), Epstein–Barr virus, Enterovirus, Human Metapneumovirus (HMPV A&B), Influenza A&B, Parainfluenza (types 1-4), Rhinovirus, Respiratory syncytial virus, SARS-CoV-2 (COVID-19), Acinetobacter baumannii, Bordetella pertussis, Chlamydophila pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella pneumoniae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, and Streptococcus pyogenes (Group A Strep). The panel also detects mecA, which is a gene responsible for Methicillin/Oxacillin resistance.

Usage Information

	Reagent Storage and Use Guidelines
	Store all reagents at -25°C to -15°C Do not freeze-thaw plates more than 3 times.
	The Following is Included in the Kit
	96-well PCR plate pre-loaded with the COVID-19 Respiratory Microbiota assays and positive and negative controls.
	The Following is Supplied by the User: Materials
	Extracted Sample(s) qPCR optical film Sealer for optical film
	Equipment
	Manual defrost -20°C freezer Laminar Flow or PCR Dead Air Box for general plate setup. Do not use Laminar Flow for infectious samples Pipettes and appropriate filtered pipette tips Plate Vortex [recommend Vortex Genie 2 (Model G560) with the 3-inch platform and rubber cover] Plate centrifuge Lab utility knife
	Instrumentation
	CFX96 Touch Real-Time PCR Detection System (or equivalent)

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Limitations of Use
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.