Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Patent
1992-11-12
1995-02-07
Saunders, David
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
435 72, 435 721, 435 723, 435 732, 435 74, 435 78, 435 794, 435 795, 435967, 435975, 436501, 436518, 436807, G01N 33543, G01N 33566, G01N 33569
Patent
active
053875036
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention relates to a method for determining the amount of a test analyte in a sample using internal calibration, as well as to a test kit for use in the method.
BACKGROUND OF THE INVENTION
Quantitative assays involving the binding of a given test analyte in a sample to a reagent present on a solid support make use of calibrators with which the samples tested in the assays are compared. In some assay systems, such as the radio-immunoassay (RIA) or enzyme-labelled immunosorbent assay (ELISA), where analyses of many samples are conducted simultaneously, it is ususal and convenient to include appropriate calibrators. However, when analyses are made of one sample at a time, which is typical of "doctor's office" assays, the inclusion of a set of calibrators for each sample will make the test more difficult and expensive to carry out. The results from the assays of such samples are therefore most often compared to the results obtained with a set of previously generated calibrators which is used over and over again.
Such externally calibrated assays cannot take account of variations in assay parameters such as incubation time, the temperature at which the assay is conducted, the liquid volumes of the sample and reagents and the concentration of reagents.
In an attempt to remedy the drawbacks inherent in using external calibration in an assay, EP 253 464 discloses a method of providing internal calibration in an assay in which a receptor for an analyte in a sample and a receptor for a conjugate of an analyte receptor with a label substance are immobilized in two separate areas on a solid support. The solid support is contacted with a sample containing the analyte to bind any analyte in the sample to the analyte receptor, after which the solid support is contacted with the conjugate which binds to the analyte in the sample as well as to the receptor for the conjugate.
Although the internal calibration provided in this assay takes several of the possible variations influencing signal development into account, the assay still has to be performed carefully with respect to the volume of the sample added, which means that the system remains relatively sensitive to outside influence. Thus, if a double volume of the sample is erroneously added, the concentration of analyte determined for the sample will be the double of the actual concentration.
The object of the present invention is to provide an assay method based on internal calibration for determining the concentration of a test analyte in a sample, which method does not show variations with respect to the above-mentioned critical parameter.
SUMMARY OF THE INVENTION
The present invention is based on the observation that assays for different analytes may be adjusted to progress in substantially the same manner, resulting in calibration curves for different assays which are comparable in that they tend to be parallel. This means that a calibration curve for one analyte assay may be used to calibrate another analyte assay provided that the conversion factor between the two calibration curves obtained in the two assays is known.
Accordingly, the present invention relates to a method of determining the amount of a test analyte in a sample, the method comprising calibrator analyte which is foreign to the sample in question, and which is so selected that its behaviour in an assay is comparable to that of the test analyte under the same assay conditions, which is bound, in a first discrete area, a reagent capable of selectively binding the test analyte and, in a second discrete area, a reagent capable of selectively binding the calibrator analyte, reagent capable of selectively binding the test analyte and a similarly labelled reagent capable of selectively binding the calibrator analyte, and levels of labelled reagent bound to the test and calibrator analytes, respectively.
In another aspect, the present invention relates to a test kit for determining the amount of a test analyte in a sample, comprising, in separate containers, sample i
REFERENCES:
patent: 4533629 (1985-08-01), Litman et al.
patent: 4540659 (1985-09-01), Litman et al.
patent: 4791056 (1988-12-01), Sizto et al.
patent: 4849338 (1989-07-01), Litman et al.
Oellerich et al., Scand. J. of Clin. & Lab. Invest. Supp. 193, vol. 49, pp. 62-71 (1989).
Litman et al., Clin. Chem., vol. 29, No. 9, pp. 1598-1603 (1983).
Anderson et al., Clin. Chem., vol. 32, No. 9, pp. 1692-1695 (1986).
Poulsen Fritz
Selmer Johan
Lambiris Elias J.
Novo Nordisk A S
Saunders David
Zelson Steve T.
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