Life Technologies Corporation

Erhard Schoenbrunner

Jerry Boonyaratanakornkit

Sven-Erik Behrens

Mona Shahbazian

Aron Lau

Marc Balcer

This specification relates to Formalin-fixed embedded quality control material for use for validation, verification, and to run controls for molecular assays. The quality control material can be used for a variety of tissues and for a variety of molecular assays. The quality control material can be used in commercial labs for validation and limit-of-detection analyses.

Method of preparing quality control material for FFPE

Systems and methods are used to generate a protocol for an assay. At least one performance characteristic parameter of an assay and at least one standardized protocol for each assay of a plurality of assays and assay types are stored. A performance characteristic parameter selection and an assay selection are received from a client device of a laboratory. One or more performance characteristic parameters and a standardized protocol are retrieved from the database device. The client device is sent the one or more performance characteristic parameters and one or more study variable values. One or more amendments to the one or more performance characteristic parameters and one or more study variable values are received from the client device. A protocol for the assay is generated based on the one or more amendments.

Systems and methods for laboratory assay validation or verification

The invention relates to the field of nucleic acid amplification, particularly to quality control materials for use in viral RNA assays. It specifically relates to the construction of a recombinantby the identification of a region in the 3'NTR of the viral RNA genome where additional sequence elements can be stably inserted. Chimericwith sequence insertions in the 3&#x2032; nontranslated region (3&#x2032;NTR) of the viral RNA genome were stable in replication and capable of forming infectious, RNase resistant virus particles. This chimericwith a 3&#x2032;NTR insertion can be utilized as a quality control material in analytical assays for RNA targets, including external, internal controls, quantitative standards in PCR and NAT nucleic acid assays.

[object Object]

The construction of a chimeric Pestivirus by the identification of selected regions in the 3'NTR of the viral RNA genome is described where additional RNA sequences can be stably inserted. These sequence insertions in the viral RNA genome were stable in replication and capable of forming infectious, RNase resistant virus particles. This chimeric Pestivirus with a 3&#x2032;NTR insertion can be utilized as a quality control material in analytical assays for RNA targets, including external, internal controls, quantitative standards in PCR and NAT nucleic acid assays.

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Moraga, CA, United States of America

Erhard Schoenbrunner