MLP - Extractionless COVID-19 Assay, 96 well, 94 panels per plate (Breakaway Plates)

Product Description

The COVID-19 panel is an in-vitro multiplex real-time reverse transcription polymerase chain reaction (rRT-PCR) assay for the identification of SARS-CoV-2 virus that is frequently found in the upper respiratory tract.

This method is highly accurate, extremely sensitive, and is used to identify the pathogen causing COVID-19 by amplifying and detecting genetic material (ribonucleic acid or RNA) of SARS-CoV-2.

The COVID-19 panel is capable of detecting SARS-CoV-2 N1 variants including Omicron sub-variants BA.4 and BA.5.

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 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.