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Papanicolau staining processRelated Patent Categories: Chemistry: Molecular Biology And Microbiology, Measuring Or Testing Process Involving Enzymes Or Micro-organisms; Composition Or Test Strip Therefore; Processes Of Forming Such Composition Or Test Strip, Involving Fixed Or Stabilized, Nonliving Microorganism, Cell, Or Tissue (e.g., Processes Of Staining, Stabilizing, Dehydrating, Etc.; Compositions Used Therefore, Etc.)Papanicolau staining process description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070003998, Papanicolau staining process. Brief Patent Description - Full Patent Description - Patent Application Claims
TECHNICAL FIELD [0001] This invention relates to methods, articles and compositions useful in staining biological samples. BACKGROUND OF THE INVENTION [0002] Medical diagnostic testing methods are critical screening tools for the early detection of pathological conditions. Early detection permits the identification of such conditions at a stage when successful treatment is more likely. Early treatment also frequently involves less damaging or less invasive treatment methods and decreases the impact on the patient. In addition to routine screening, diagnostic testing is also used in a variety of other applications, including biopsy analysis and monitoring the results of ongoing medical treatment. [0003] One particularly useful tool in diagnostic testing is the Papanicolaou staining process. This process was first developed for the staining of gynecological specimens, and has led to a dramatic decrease in the fatality rate from cervical cancer. Papanicolaou staining is now used in diagnosing a variety of pathological conditions from many different tissues and organs. [0004] However, Papanicolaou staining is subject to artifacts that can adversely affect the ability of a technologist or machine to successfully read a processed sample. These artifacts include spurious non-specific cytoplasmic staining, artifacts such as cytoplasmic cracking, cornflaking, smudged nuclear detail, hypochromatic staining and hyperchromatic staining. Such artifacts, at a minimum, reduce the fraction of the sample which can be evaluated, can produce false staining patterns that interfere with accurate diagnosis, and may render the sample unreadable. Difficulties in analyzing such samples leads to an increase in patient anxiety, rescreening costs, delays in diagnosis and, more importantly, potential misdiagnosis. [0005] There is a need in the art for improved procedures for staining diagnostic specimens, and for compositions and articles of manufacture useful in such methods. SUMMARY OF THE INVENTION [0006] An improved method for treating a biological sample with a Papanicolaou staining process is provided. The method comprises incorporating a detergent treatment into the staining process at any of various steps. The method has been found to advantageously reduce the number of artifacts produced during Papanicolaou staining. Also provided is a sample stained by such a process. BRIEF DESCRIPTION OF THE DRAWINGS [0007] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawings will be provided by the Patent and Trademark Office upon request and payment of the necessary fee. [0008] FIG. 1 shows a sample stained with a Papanicolaou staining process. DETAILED DESCRIPTION OF THE INVENTION [0009] The inventors have advantageously discovered that incorporation of a detergent treatment into a Papanicolaou staining procedure reduces the occurrence of artifacts to which the procedure is susceptible. Use of a detergent has been found to clear excess stain from the cytoplasm of cells stained by this procedure, allowing for increased contrast and improved ability to detect cellular, nuclear and chromatin morphology. Additionally, the removal of excess stain from the cytoplasm may lead to an increased ability to detect hyperchromasia associated with abnormality. [0010] The term "Papanicolaou staining process," "pap stain," "pap test" and the like refer to a modified or unmodified Papanicolaou staining procedure which differentially stains cell nuclei and cytoplasm in a sample, for example a sample obtained during a gynecological screening examination such as a pap smear. [0011] The test relies on the ability to distinguish the staining pattern, staining intensity and the size and shape of the nucleus and cytoplasm of different cell types within the sample. The Papanicolaou staining process advantageously provides dark stained nuclei and transparent cytoplasms, which is particularly useful in detecting abnormal cells within multi-layered samples provided by certain sampling techniques including pap smears. [0012] A usable test depends on the ability to read a significant percentage of cells in the sample, otherwise test accuracy may be comprised and samples may be rendered unusable, leading to additional rescreening costs and increased patient anxiety. [0013] Consequently, staining artifacts which reduce the ability to discern the true staining pattern of cells in a sample can dramatically impair the usefulness of a pap test. Artifacts can reduce the ability to differentiate between the staining pattern of the nucleus and the cytoplasm, can increase the percentage of cells or sample area which are unreadable, and can increase cytoplasmic staining thereby diminishing the transparency that is one of the primary advantages of the pap test, thus making it more difficult to distinguish abnormal cells within the sample. [0014] Before the present invention is described in further detail, it is to be understood that this invention is not limited to the particular methodology, solutions or apparatuses described, as such methods, solutions or apparatuses can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. [0015] Use of the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to "a sample" includes a plurality of samples, reference to "a detergent" includes a plurality of such detergents, reference to "a counterstain" includes a plurality of counterstains, and the like. Additionally, use of specific plural references, such as "two," "three," etc., read on larger numbers of the same subject unless the context clearly dictates otherwise. [0016] Terms such as "connected," "attached," and "linked" are used interchangeably herein and encompass direct as well as indirect connection, attachment, linkage or conjugation unless the context clearly dictates otherwise. Where a range of values is recited, it is to be understood that each intervening integer value, and each fraction thereof, between the recited upper and lower limits of that range is also specifically disclosed, along with each subrange between such values. The upper and lower limits of any range can independently be included in or excluded from the range, and each range where either, neither or both limits are included is also encompassed within the invention. Where a value being discussed has inherent limits, for example where a component can be present at a concentration of from 0 to 100%, or where the pH of an aqueous solution can range from 1 to 14, those inherent limits are specifically disclosed. Where a value is explicitly recited, it is to be understood that values which are about the same quantity or amount as the recited value are also within the scope of the invention, as are ranges based thereon. Where a combination is disclosed, each subcombination of the elements of that combination is also specifically disclosed and is within the scope of the invention. Conversely, where different elements or groups of elements are disclosed, combinations thereof are also disclosed. Where any element of an invention is disclosed as having a plurality of alternatives, examples of that invention in which each alternative is excluded singly or in any combination with the other alternatives are also hereby disclosed; more than one element of an invention can have such exclusions, and all combinations of elements having such exclusions are hereby disclosed. [0017] Unless defined otherwise or the context clearly dictates otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the invention, the preferred methods and materials are now described. [0018] All publications mentioned herein are hereby incorporated by reference for the purpose of disclosing and describing the particular materials and methodologies for which the reference was cited. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the invention is not entitled to antedate such disclosure by virtue of prior invention. [0019] The term "optional" or "optionally" means that the subsequently described event or circumstance may or may not occur, and includes instances where the event or circumstance occurs and instances in which it does not. Continue reading about Papanicolau staining process... 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