Chemistry: analytical and immunological testing – Clotting or clotting factor level tests
Patent
1987-03-16
1989-03-21
Richman, Barry S.
Chemistry: analytical and immunological testing
Clotting or clotting factor level tests
436 64, 435 13, 422 61, 422 73, G01N 3386
Patent
active
048142476
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates to a method of testing a hematologic fluid, and more particularly to a method of testing to determine the existence in the mammal of a pathological state or condition, to monitor a known pathological state existing in a mammal and a test kit therefor.
DESCRIPTION OF THE PRIOR ART
Common diagnostic tests performed on asymptomatic individuals during the course of their annual physical examiniation might include: complete blood count (CBC), blood chemistries (e.g. glucose or electrolyte levels) and urinalysis (test for glucose, ketones, etc.). Occasionally, these tests may detect a disease which was not obvious upon physical examination alone. These routine screening test would be useless in detecting at an early stage the disease states which kill and disable the great majority of individuals including cancer, rheumatic diseases, AIDS, heart disease, vascular disease, and others. Such disease states can in part be characterized by abnormalities in either the blood coagulation or immune response system, or both.
At present, the detection in a mammal of a pathological state or condition, e.g. cancer, AIDS, sepsis and the like is generally performed after the mammal has experienced some abnormal physical response, e.g. lack of energy, headaches, rectal bleeding, lumps, etc., or as preliminarily detected during an annual physical examination. Once evidencing such abnormal physical response, diagnostic procedures and/or other protocols are thereafter initiated and evaluated to qualify the pathological state as well as to quantify the extent of advancement of the pathological state or condition. Diagnostic procedures may involve X-rays, e.g. mammography for breast cancer, proctoscopy of the colon, etc.
Additionally, once a pathological state has been found to exist in the mammal and has been qualified as to the specific pathological state, there may be remedial procedures to reduce the impact of the pathologic state on the mammal, e.g. drug, radiation therapy, chemotherapy, and the like protocol, or alternately to eliminate the pathological state, e.g. by surgical procedure. In any event, the effectiveness of the remedial procedure is difficult to timely assess. For example, in the surgical removal of cancerous growth, only subsequent biopsies of proximate tissue may demonstrate total removal, and then, not necessarily on a 100 percent certain basis, let alone the possibility of metastasis.
Tests have been developed to determine the immune function of monocytes, neutrophils, lymphocytes, etc. wherein the individuality is isolated and tested for individual functionality by diverse methods. Such procedures are costly and time consuming and are not specific to a particular pathological state. Also, the results of individuality tests are difficult to interpret, let alone correlate. For example, although mammography may delineate the size, location, etc. of a lump in the breast in a female, the results will not always qualify whether the lump is cancerous or benign. Such pathological evaluation is effected by pathological observation of the actual cellular structure after biopsy or surgical removal of the lump.
Some of the above tests or procedures performed in a clinical laboratory are useful in the monitoring of certain diseases, e.g. liver enzymes for liver disease, blood urea nitrogen for kidney disease, T-cell function for immunological disorders, prothrombin and partial thromboplastin times for bleeding disorders, etc. However, such tests cannot determine either the effects of therapy on the coagulation changes in thrombotic diseases, or similar effects of therapy in cancer and other diseases which involve alterations in the immune response system.
OBJECTS OF THE INVENTION
An object of the present invention is to provide a method for determining whether a pathologic state or condition exists in a mammal.
A further object of the present invention is to provide a method for determining whether a pathological state or condition exists in mammal that may be perform
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Lazaro Eric J.
Spillert Charles R.
Suval William A.
Alfandary-Alexander Lyle
Richman Barry S.
University of Medicine and Dentistry of New Jersey
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