Method for detection of a physiological abnormality

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving viable micro-organism

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055019617

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BRIEF SUMMARY
TECHNICAL FIELD

The present invention relates to an assay method for detecting a physiological abnormality such as hypertension in a human or animal, and to assays and kits for use in the method.
Hypertension is considered a major risk factor for heart disease. Untreated hypertension generally leads to irreversible damage to the heart and vasculature and undoubtedly shortens life. Cardiovascular problems associated with hypertension have decreased greatly during the last decade due to a combination of greater community awareness of the problem, early diagnosis by physical examination, and efficacious treatment of the condition once detected via the wide spectrum of antihypertensive medications currently on the market. In some cases hypertension can also be successfully contained by a combination of diet and lifestyle changes but the condition must be recognised and treated early if later deleterious effects are to be avoided. Nevertheless, the fact remains that hypertension is the commonest of the diseases affecting the heart and blood vessels.
Studies from the National Heart Foundation's Risk Factor Prevalence Study (1980) indicate that one in five men and one in six women in Australia have high blood pressure. By 50 years of age, 31% of men and 28% of women in Australia are hypertensive and by age 60 years this has increased to 47% and 39 % respectively. At present only about half of these persons are aware of their condition and only about one third are being successfully treated.
Most people suffering from the commonest variety of high blood pressure (essential hypertension which is of unknown aetiology), develop the disease in their thirties. However, during its early stages, it rarely produces symptoms. Unless a physical examination reveals that the blood pressure is high, a person may have the disease for many years without knowing. In general, they may be destined to develop hypertension at some time in the future due to their genetic predisposition. In terms of its inheritance, essential hypertension is understood to develop from a polygenic predisposition whose expression is enhanced by environmental mechanisms such as diet and whose outcome is fixed by inevitable structural changes due to the elevated blood pressure itself (Williams et at., 1990a,b).
The development of reliable detection techniques for the determination of physiological abnormalities such as the predisposition to hypertension is clearly of benefit in allowing early treatment. To date there is no satisfactory method to identify pre-hypertensive children; except perhaps, for the long-term procedure of blood pressure tracking. Standardised measurements of a child's blood pressure every two or three years during growth may show a consistently elevated pressure compared with other children of the same age, sex and body mass index and this will indicate a likelihood that the child will become a hypertensive adult. Blood pressure generally rises steadily with age and the blood pressure defined as mild hypertensive (95 mmHg diastolic and/or 150 mmHg systolic pressure) are rarely encountered in children. Nevertheless, the tendency to track in an upper or lower percentile rank is reasonably strong and is a good predictor of the adult ranking (Kneisley et at., 1990).
Clearly the development of a simple diagnostic test which is capable of detecting both the pre-hypertensive individual and those adults exhibiting labile blood pressure readings which make a definite diagnosis difficult, would herald a major breakthrough in early and definitive diagnosis and would allow for earlier treatment. Such a diagnostic test would be all the more acceptable if it had wide application such as in the testing of children of hypertensive parents. Furthermore, if the test is essentially non-invasive in its nature, it need not be confined to the above situations, but could be more wide reaching and applied to other "at-risk" groups in the community.


BACKGROUND ART

The most desirable form of test or predictive marker would be one which is indicative of som

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