Title: Methods for threshold determination in multiplexed assays

Abstract

Methods for determination of threshold values of signatures comprised in an assay are described. Each signature enables detection of a target. The methods determine a probability density function of negative samples and a corresponding false positive rate curve. A false positive criterion is established and a threshold for that signature is determined as a point at which the false positive rate curve intersects the false positive criterion. A method for quantitative analysis and interpretation of assay results together with a method for determination of a desired limit of detection of a signature in an assay are also described.

Inventors:

Tammero, Lance F. Bentley; Dzenitis, John M; Hindson, Benjamin J

Issue Date:

2014-06-24

Research Org.:

Univ. of California, Berkeley, CA (United States)

Sponsoring Org.:

USDOE

OSTI Identifier:

1134715

Patent Number(s):

8762068

Application Number:

12/607,956

Assignee:

Lawrence Livermore National Security, LLC (Livermore, CA)

Patent Classifications (CPCs):

C - CHEMISTRY C12 - BIOCHEMISTRY C12Q - MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS

G - PHYSICS G01 - MEASURING G01N - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES

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C - CHEMISTRY C12 - BIOCHEMISTRY C12Q - MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS

C12Q1/6813 - Hybridisation assays
C12Q1/6851 - Quantitative amplification
C12Q1/6888 - for detection or identification of organisms
C12Q2537/143 - Multiplexing, i.e. use of multiple primers or probes in a single reaction, usually for simultaneously analyse of multiple analysis
C12Q2537/165 - Mathematical modelling, e.g. logarithm, ratio
C12Q2545/101 - with an internal standard/control
C12Q2545/114 - involving a quantitation step

G - PHYSICS G01 - MEASURING G01N - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES

G01N33/53 - Immunoassay
G01N33/569 - for microorganisms, e.g. protozoa, bacteria, viruses
G01N35/00613 - {Quality control}
G01N35/00693 - {Calibration}

G - PHYSICS G16 - INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS G16B - BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY

G16B25/00 - ICT specially adapted for hybridisation
G16B40/00 - ICT specially adapted for biostatistics
G16B40/10 - Signal processing, e.g. from mass spectrometry [MS] or from PCR

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DOE Contract Number:  

W-7405-ENG-48

Resource Type:

Patent

Resource Relation:

Patent File Date: 2009 Oct 28

Country of Publication:

United States

Language:

English

Subject:

47 OTHER INSTRUMENTATION