MLP - MultiPlex COVID-19/FLU/RSV Assay, 384 Well, 382 panels per plate

Product Description

The COVID-19/Flu/RSV Panel is a multiplex real-time reverse transcription polymerase chain reaction (rRT-PCR) assay for the qualitative identification of respiratory viral nucleic acids in multiple sample types.

This method a highly accurate, analytically sensitive, and is used for identification of disease-causing organisms by amplifying and detecting genetic material of target pathogens in samples.

This panel detects the following targets:

• SARS-CoV-2
• Influenza A including H1N1 and H3N1
• Influenza B (Victoria and Yamagata lineages)
• Respiratory syncytial virus A and B
• Ribonuclease P

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
	384-well PCR plate pre-loaded with the multiplex Simplicity Panel™ assays and positive control. Negative control assay is plated but negative control is user supplied.
	The Following is Supplied by the User: Materials
	Extracted Sample(s) qPCR optical film Sealer for optical film Negative Control
	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 Plate centrifuge Lab utility knife
	Instrumentation
	CFX384 Touch Real-Time PCR Detection System

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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.