Method for correcting for blood volume in a serum analyte...

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or...

Reexamination Certificate

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Details

C435S011000, C435S023000, C435S040500, C435S283100, C435S805000, C436S015000

Reexamination Certificate

active

06187531

ABSTRACT:

FIELD OF THE INVENTION
The present invention is directed generally to the field of blood analyte assay systems in which a hematocrit is used to calculate the serum concentration of the analyte, and more particularly relates to a method for quantifying the amount of cholesterol in dried blood samples.
BACKGROUND OF THE INVENTION
Methods for determining the concentration of serum constituents are indispensable for the diagnosis and treatment of clinical conditions. The volume of plasma must be known when quantitating the concentration of a serum constituent. The volume of red blood cells present in blood (hematocrit) in universally proportional to the volume of plasma. The hematocrit, however, varies significantly from person to person posing a problem when analyzing whole blood for plasma (serum) chemistries. The present invention describes an unexpected way of overcoming this difficulty. It is widely recognized that in otherwise healthy individuals, hematocrit is directly proportional to total hemoglobin. Hemoglobin determinations are more consistent and accurate than hematocrit determinations. Thus the present invention permits the measurement accurate calculation of the concentration of the serum constituent being measured from a dried blood sample.
Another object of the invention is to provide an assay for blood analytes such as cholesterol and prostate specific antigen (PSA) which obviates the need for a hematocrit determination.
These and other objects of the invention would be apparent in light of the detailed description below.
SUMMARY OF THE INVENTION
The present invention relates to a method for determining plasma volume from dried blood samples where the dried blood sample is eluted and the cholesterol and hemoglobin levels are measured. It has been discovered that the hematocrit correction in measuring serum constitutent concentrations in fresh blood samples can be achieved from measuring hemoglobin from the dried blood sample and applying a correction factor based on the hemoglobin level. A blood collection and drying device and preferred materials on which blood is dried is described.
These and other features and advantages of the present invention may be better understood by considering the following detailed description of certain preferred embodiments of the invention. In the course of this description, reference will be made to the attached drawings.


REFERENCES:
patent: 5122451 (1992-06-01), Tanaka et al.
patent: 5788942 (1998-08-01), Kitani et al.
patent: 6040135 (2000-03-01), Tyrrell

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