METHODS FOR RAPID DISEASE SCREENING
First Claim
1. A method of screening for the necessity for further diagnosis of one or more diseases or conditions in a human subject, said method comprising:
- (a) obtaining a fluid sample from a human subject in need of screening for the necessity for further diagnosis of one or more diseases or conditions;
(b) determining the concentration of one or more analytes in said fluid sample;
(c) comparing each said concentration of said one or more analytes with independently selected screening criteria, wherein said independently selected screening criteria are adapted such that the sensitivity of a composite assay is at least 80%; and
(d) determining if said further diagnosis is required, thereby providing said screening for the necessity for further diagnosis of said one or more diseases or conditions in said human subject.
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Abstract
Methods are provided for screening for the necessity for further diagnosis of one or more diseases or conditions in a subject, which methods are based on the discovery that abnormal levels of selected analytes in a sample fluid from a subject can be correlated with specific diseases or conditions. Further provided are criteria, and methods for the determine thereof, for selected analytes with respect to selected diseases or conditions. Thus, a variety of diseases or conditions can be screened in a rapid, cost-effective composite assay. The methods are useful for screening of newborn humans for a variety of diseases and conditions, whereby additional diagnostic procedures need only be conducted for those diseases or conditions indicated by the methods of the invention.
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Citations
25 Claims
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1. A method of screening for the necessity for further diagnosis of one or more diseases or conditions in a human subject, said method comprising:
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(a) obtaining a fluid sample from a human subject in need of screening for the necessity for further diagnosis of one or more diseases or conditions; (b) determining the concentration of one or more analytes in said fluid sample; (c) comparing each said concentration of said one or more analytes with independently selected screening criteria, wherein said independently selected screening criteria are adapted such that the sensitivity of a composite assay is at least 80%; and (d) determining if said further diagnosis is required, thereby providing said screening for the necessity for further diagnosis of said one or more diseases or conditions in said human subject. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method for selecting independent screening criteria for a composite assay, said method comprising:
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(a) providing a first plurality of analyte concentrations obtained from fluid samples from a first group of subjects, said first group of subjects having no diagnosis for a first disease; (b) providing a second plurality of analyte concentrations obtained from fluid samples from a second group of subjects, said second group of subjects having a diagnosis for said first disease; (c) performing a principal component analysis of said first and second pluralities of said analyte concentrations, thereby providing an ordered list of principal components; and (d) selecting one or more analytes and associated criteria for a composite assay based on relative weights of said analytes in said ordered list of principal components, thereby providing independent screening criteria for a composite assay. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method for selecting a plurality of analytes and associated screening criteria suitable for a composite assay useful for the determination of the necessity for further diagnosis of a plurality of diseases or conditions in a human subject, said method comprising:
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(a) providing a first set of analytes and associated screening criteria adapted to evaluate the likelihood that a human subject is suffering from a first disease or condition; (b) providing a second set of analytes and associated screening criteria adapted to evaluate the likelihood that said human subject is suffering from a second disease or condition; and (c) selecting common analytes and associated screening criteria from said sets of analytes and associated screening criteria, thereby providing said analytes and associated screening criteria for said composite assay. - View Dependent Claims (25)
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Specification