Chemistry: molecular biology and microbiology – Apparatus – Including measuring or testing
Reexamination Certificate
1998-11-25
2001-06-26
Sisson, Bradley L. (Department: 1655)
Chemistry: molecular biology and microbiology
Apparatus
Including measuring or testing
C422S236000, C422S258000, C422S272000
Reexamination Certificate
active
06251660
ABSTRACT:
BACKGROUND OF THE INVENTION
The screening of a biological sample for contaminants plays a vital role especially in the area of clinical medicine . The potential contaminants include infectious bacteria, disease causing viruses and parasites that can seriously compromise the health of a mammal, and even lead to death. It is important to screen for such pathogens in order to prevent the transmission of such diseases as caused by these contaminants. For example, it is critical to evaluate blood that was obtained from a donor prior to a transfusion into a recipient. This evaluation consists of screening the blood for the presence of any pathogen. Typically, this evaluation is performed in a laboratory well equipped for such a task. However, in certain milieus, the presence of a sophisticated laboratory is not a realistic expectation.
The screening of a biological sample is not limited to examining whether or not the sample is contaminated. Screening a biological sample is often done diagnostically, looking for the presence, or absence, of certain indicating biomolecules. An example of this scenario is when the blood is analyzed for the presence of certain lactate dehydrogenase isozymes which are particular to the heart. If these isozymes are present in the blood, this is indicative of a myocardial infarction. Also, testing is conducted looking for the presence, or absence, of genetic markers whether as expressed proteins (for example, MHC antigens) or in the genome. Again, these types of tests are usually performed in technically sophisticated laboratories.
A need exists for the ability to conduct screening of biological samples in environments that are not generally associated with technically sophisticated laboratories.
SUMMARY OF THE INVENTION
The present invention pertains to novel devices and methods for screening a biological sample for the presence, or absence, of at least one target molecule. The presence of a predetermined target molecule can be used to indicate bacterial, viral, fungi and/or parasitic contamination of the sample. Additionally, the presence of a predetermined target molecule can also be used to indicate specific biomolecules in the sample which are endogenous to the host from which the sample was obtained.
This target molecule can be a nucleic acid, DNA or RNA (single or double stranded), polypeptide, protein, and combinations thereof. The invention encompasses the screening of one particular target molecule or a heterogenous group of target molecules present in the biological sample. The methods described herein provide for a relatively fast qualitative assay to determine the presence of contaminating organisms or endogenous biomolecules within a biological sample.
The present invention pertains to a devices that can be used for the analysis of molecules or substances present in biological material such as bodily fluids (e.g., blood, urine, saliva, cerebral spinal fluid, etc). The instant invention also pertains to apparatuses for operating the devices of the present invention, including those that cause motion of liquid reagents and perform detection of sample components. The invention also pertains to methods for using the devices and apparatuses of the instant invention for analysis of a biological sample. The devices of the present invention can be used in a variety of embodiments.
In one embodiment, the invention pertains to a device for testing a biological sample comprising a receptacle housing at least one reaction chamber comprising at least one compartment. More specifically, the test device comprises a receptacle which is attached to at least one sample collection unit housing bodily fluid. This bodily fluid serves as the biological sample which can undergo analysis for detecting the presence of at least one target molecule.
In one embodiment, the invention pertains to a breakable compartment. The barrier that partitions one compartment from the adjacent compartment can comprise breakable material. If the barrier is ruptured between two adjacent compartments, then the contents of each will be allowed to mix. The breakable barriers can be caused to break by applying an appropriate pressure against the barrier such that the breakable barrier rupture (for example, using an apparatus described herein). A physical object applied against the breakable barrier can cause it to rupture. An instrument with a sharp end which is applied against the breakable barrier can also cause it to rupture.
In one embodiment, the invention pertains to a device for testing a biological sample comprising a receptacle housing at least one reaction chamber comprising at least one compartment, wherein the compartment(s) comprises at least one bacterial vital staining reagent In this embodiment, the invention pertains to a device and method for testing a biological sample for the presence of bacteria. The bacterial cells of the biological sample are subjected to staining using vital bacterial stains that can detect a specific genius and/or species of bacteria.
In one embodiment, the invention pertains to a device and method for testing a biological sample comprising a receptacle housing at least one reaction chamber wherein said chamber comprises breakable compartments, wherein one compartment comprises at least one cell lysing reagent, another compartment comprises at least one reagent for the inactivation of amplification inhibitors, another compartment comprises at least one reagent for nucleic acid amplification and another compartment comprises at least one reagent for labeling at least one target molecule, wherein the labeled target molecule is subject to a method of detection.
In another embodiment, the invention pertains to a device for testing a biological sample comprising a receptacle housing at least one reaction chamber wherein said chamber comprises breakable compartments, wherein one compartment comprises at least one cell lysing reagent and another compartment comprising at least one reagent for labeling at least one target molecule, wherein the labeled target molecule is a polypeptide or protein subject to a method of detection. Typically, the method of detection is with a detectably-labeled antibody, or antibody fragment, that is specific for the target polypeptide or protein.
Thus, as a result of the work described herein, devices are now available for fast, efficient and easy to use methods of screening biological samples for the presence of pathogens or any other biomolecules.
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Adams Christopher P.
Boles T. Christian
Muir Andrew R.
Hamilton Brook Smith & Reynolds P.C.
Mosaic Technologies Inc.
Sisson Bradley L.
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