Chemistry: analytical and immunological testing – Optical result – With reagent in absorbent or bibulous substrate
Reexamination Certificate
1999-09-09
2002-04-30
Alexander, Lyle A. (Department: 1743)
Chemistry: analytical and immunological testing
Optical result
With reagent in absorbent or bibulous substrate
C436S164000, C422S051000, C422S067000, C422S105000
Reexamination Certificate
active
06379972
ABSTRACT:
THE TECHNICAL FIELD OF THE INVENTION
The present invention is related to a perforating analytical test device for hygienic and risk-free handling of hazardous samples comprising a test stick, which is placed in or can be placed into the device, which is capable of penetrating the sampling vessel or the stopper thereof without the need of opening the stopper of the sampling vessel.
THE BACKGROUND OF THE INVENTION
Some biological samples, especially those clinical samples which are taken for detection or diagnoses of infectious diseases are dangerous and unpleasant to handle. Fecal samples are not only unpleasant, but in addition to being inconvenient, the handling of the sample can be dangerous, particularly, if the sample contains pathogenic organisms, such as salmonella-, cholerae-, EHEC-bacteria, rotavirus or dysentery causing
Entamoeba histolytica.
In addition to fecal samples, many other types of samples originating from hospitals or medical centers constitute a health risks to those carrying out the test. Samples containing toxic or radioactive substances forms another group of hazardous samples.
Usually, when the test is carried out, the sample vessel or bottle is opened by removing the stopper in a place specially reserved for tests, which might constitute a contamination risk. Test sticks, such as those described in e.g. patent applications EP 284 232, EP 291 194, WO 94/15215 or some other of the multitude of test strip-, dipstick-variants developed during the past decades are then dipped into the sample solution and transferred to a test tube or some other vessel to develop the test results. The test stick is allowed to stand in said vessel until the result is detectable or can be made detectable, either visually or by some apparatus or device capable of reading or monitoring the result. Even if the test is performed with appropriate skill and the utmost care, a contamination risk always exists. When the stoppers of the sampling vessels are removed tiny drops of the sample solution might easily be splashed around and might contaminate the hands or clothes of those carrying out the test as well as the environment in which the test is carried out. When the test stick is transferred from the sampling vessel to the other vessel for developing, drops of the sample solution might drip down on the table or those performing the tests have to use some alternative means to avoid dripping. Consequently, a risk of contamination is always present and wastes, which have to be handled as hazardous waste products are produced. The equipments and means used as well as the environments have to be disinfected and sterilized when the test or tests have been completed.
Sampling rods or swabs or sampling devices which are brought into contact with a developing solution or reacting agents have been described for example in the following patent applications JP 08005627, WO 95/25948, WO 96/28715, GB 1587174. None of the described devices disclose a system wherein a hazardous sample is collected in a sampling vessel and the sampling vessel is transported to another laboratory sometimes even by air. In such cases the sampling vessel must be made of a strong and durable material to resist any accidents during transport. In the laboratory, the sample has generally been handled as described above, but it is not desirable that the person performing the test is exposed to open contact with the hazardous sample. The device of the present invention solves the problem by providing a combined perforating and analytical test device which is capable of perforating a strong and durable, even air-transportable sampling vessel without exposing the person performing the test to open contact with the sample.
SUMMARY OF THE INVENTION
Thus, the objective of the present invention is to provide a combined perforating analytical test device, which decreases the disadvantages connected with the hazardous systems of prior art and diminishes the risk of contamination caused by the removal of stoppers from the vessels and transfer of the test sticks from one vessel to another. At the same time the need of repeated and extensive disinfection measures is decreased and the perforating analytical test device can be destroyed using appropriate measure without exposing the person performing the test, at any time, to any contact with the sample. The purpose of the present invention is above all to protect those performing the test from unnecessary contamination risks and possible inconveniences caused by odors by providing a device, which is easy to handle and enables the test to be carried out without opening the sampling vessel and transferring the test stick to another vessel.
Further scope of the applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.
REFERENCES:
patent: 4912755 (1990-03-01), Blood et al.
patent: 5054499 (1991-10-01), Swierczek
patent: 86 05966 (1986-10-01), None
patent: 93 09431 (1993-05-01), None
patent: 96 01890 (1996-01-01), None
“CheckCup,” Applied Biotech, Inc. marketing brochure, No. 10-5100-A.
“StatusCup Plus,” LifeSign marketing brochure, May 11, 2001, Somerset, NJ.
Alexander Lyle A.
Birch & Stewart Kolasch & Birch, LLP
Oy Medix Biochemica AB
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