Assessment of staining quality
AssigneeVisiopharm A/S
InventorsMichael Grunkin, Johan Doré Hansen
Life of this patent
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Abstract
The quality of staining histological specimens has an impact on the histological assessment of the specimen. One of the causes for variability in the accuracy is the variations in the staining of the specimens to be tested in the working laboratories. The present invention provides a method for assessing the staining quality in a working laboratory and providing a quantitative quality measure for the staining quality. Thereby, it is possible for each working laboratory to evaluate their staining quality and to get feedback of how to improve the quality. The invention further relates to a system and a software program for carrying out the method.
Claims26
An automated or semi-automated method for assessing the quality of staining of a specimen containing cells in a standardized laboratory using a digital image analysis system comprising a computer processor, the staining being a staining specific for a marker in the specimen, the method comprising the steps of:
- a) providing a plurality of specimens of the same type, the specimens containing cells;
- b) staining the marker in at least one of the specimens according to a predetermined staining protocol by the standardized laboratory thereby obtaining a reference specimen(s);
- c) digitally imaging each of the reference specimen(s);
- d) forwarding at least an unstained one of the specimens to a working laboratory to be stained according to the predetermined staining protocol in order to obtain a control specimen(s);
- e) digitally imaging each of the control specimen(s) and receiving at the standardized laboratory from the working laboratory the digital image of each of the control specimen(s) or receiving at the standardized laboratory from the working laboratory the control specimen(s) and digitally imaging each of the control specimen(s);
- f) deriving by the digital image analysis system for each of the reference specimen(s) from the image of each reference specimen a quality parameter relating to the staining, wherein the quality parameter is selected from the group consisting of connectivity, mitose index, number of cells, number of positive and negative nuclei, Allred-score, H-Score, area of positive and negative nuclei, D-score, and Nottingham index using an image analysis method that provides a quantitative readout of the marker on a given digital image;
- g) calculating a reference level as a mean, trimmed mean, median or mode of the quality parameter(s) of all of the reference specimen(s), the reference level representing a central tendency of the marker for a given reference specimen;
- h) deriving by the digital image analysis system for one of the control specimen(s) the quality parameter from the image of the control specimen using the image analysis method;
- and
- i) obtaining a deviation of the quality parameter of the control specimen by comparing the quality parameter of the control specimen to be assessed with the reference level, wherein the deviation of the quality parameter can be used as a quantitative measure for the quality of staining of the control specimen in the working laboratory to correct their staining procedure thereby improving their staining quality.
An automated or semi-automated method for assessing the quality of staining of a specimen containing cells in a working laboratory using a digital image analysis system comprising a computer processor, the staining being a staining specific for a marker in the specimen, the method comprising the steps of:
- a) providing a plurality of specimens of the same type, said specimens containing cells;
- b) staining the marker in each of the plurality of said specimens in one of participating working labs according to a predetermined staining protocol thereby obtaining control specimens;
- c) digitally imaging each stained specimen;
- d) validating staining of the plurality of said specimen by:
- assessing quality of the staining and assigning each of the assessed specimen a grade;
- and
- selecting the assessed control specimens receiving a grade higher than a certain grade as reference specimens;
- e) deriving by the digital image analysis system for each of the reference specimens from the image of each reference specimen a quality parameter relating to the staining, wherein the quality parameter is selected from the group consisting of connectivity, mitose index, number of cells, number of positive and negative nuclei, Allred-score, H-Score, area of positive and negative nuclei, D-score, and Nottingham index using an image analysis method that provides a quantitative readout of the marker on a given digital image;
- f) calculating a reference level as a mean, trimmed mean, median or mode of the quality parameters of all the reference specimens, the reference level representing a central tendency of the marker for a given reference specimen;
- g) deriving by the digital image analysis system for one of the control specimens the quality parameter from the image of the control specimen using the image analysis method;
- and
- h) obtaining a deviation of the quality parameter of the control specimen by comparing the quality parameter of the control specimen to be assessed with the reference level, wherein the deviation of the quality parameter can be used as a quantitative measure for the quality of staining of the control specimen in the working laboratory to correct their staining procedure thereby improving their staining quality.
Dependencies are inferred from the claim text.