Test strip, its production and use

Chemistry: analytical and immunological testing – Involving an insoluble carrier for immobilizing immunochemicals

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422 56, 422 57, 422 58, 435 4, 4352871, 4352872, 4352877, 4352879, 435805, 435810, 435970, 435971, 435973, 436169, 436510, 436514, 436528, 436531, 436805, 436810, G01N 33543, G01N 33558

Patent

active

057121702

DESCRIPTION:

BRIEF SUMMARY
The present invention concerns a test strip providing a rapid immunoassay which does not require separate reagents, apparatuses or devices. An assay may be performed simply by dipping a certain area of said test strip in a liquid sample and by observing a visible change in said strip taking place within a short space of time as a result of an immunological reaction. The present invention also concerns an advantageous industrial method for producing said test strip as well as its use in diagnostic and environmental analytical determinations.
Immunoassays are based on the use of antibodies. Antibodies comprise biologically provided reagents which bind to a desired analyte with great specificity. Immunoassays have been developed largely for clinical medicine wherein their sensitivity and specificity is of great value. There exist, however, good possibilities for immunoassays to serve also in environmental analysis by offering reliable assays for detecting pollutants in air, water and soil, for food quality control, etc.
The need for analysis of various environmental pollutants has increased in recent times. There is a need to find out the amount of pollutants, in order to assess whether the environment in question is potentially dangerous to men or animals. There is, for instance, a need to analyse whether the ground around service stations contains remnants of fuel containing various carcinogens; whether there are pathogenic bacteria in drinking water; whether there are carcinogenic remnants of pesticides in vegetables; whether there are remnants of chemicals preventing decomposition or slime formation in waste waters of wood industry, etc. When an environment has been found to be polluted, there is also a need to monitor the cleaning process by analysis. Further, new pollutions may be prevented by studying the dosage of toxic chemicals by analysis. In several fields there exists legislation on maximal concentrations of potentially harmful compounds, as well as various recommendations, which also requires reliable methods of analysis.
Since the compounds to be studied in the environment are so numerous, there is a great variation in the present methods of analysis. Bacteria are detected by microbiological cultivation and identification methods. For other pollutants traditional methods of analytical chemistry are used. Many carcinogenic compounds, for instance pesticides, are small molecules containing aromatic rings and these are well suited for gas chromatographic analysis. The analyses are often preceded by complex extraction processes. In some cases, determinations of bioassay type are in use (for instance, algal toxins are detected by studying the effect of a sample on mice).
Said analyses very often require complicated equipment and most analytical methods are badly suited to being performed in large series. This raises the costs of the determinations and prevents testing as many samples as actually needed. Only very few determinations of a general nature (such as the pH of water or a soil sample, or the detection of certain heavy metals) can be performed at the sampling site using rapid tests.
As examples of rapid tests which have long been used in clinical chemistry, tests for urinary pH, glucose and protein may be mentioned. The test means comprise strips that are dipped into a sample and interpreted according to color models on the package. Color changes are usually based on pH indicators or specific enzymatic reactions.
Immunochemical methodology was long considered to be expensive and complicated to perform, and it was used only for the most demanding determinations. During the last few years, however, rapid immunochemical tests have been developed for the needs of clinical chemistry. Said tests can be performed by an untrained person in a few minutes without any special equipment, the result being visually readable. This technique has been applied especially to pregnancy tests suitable for home use.
The most usual technical version of this kind of rapid test is disclosed in Patent publication GB

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