An assessment of chromosomal alterations detected by fluorescence in situ hybridisation in pancreatobiliary tract malignancy

Abstract Background Using fluorescence in situ hybridisation (FISH) to detect any gain of chromosomes 3, 7, or 17 and loss of the 9p21 locus has been proven to be sensitive in the diagnosis of pancreatobiliary tumors. However, both genetic and environmental factors contribute to the pathogenesis of pancreatobiliary tumors. Therefore, it is unknown whether this method is suitable for Chinese patients with pancreatobiliary tumors. This study aims to compare the sensitivity, specificity, predictive values and accuracy of cytology, ERCP/MRCP and FISH based on Chinese patients with pancreatobiliary tumors,and to analyze differences between brushing-based and formalin-fixed paraffin-embedded (FFPE)-based FISH. Methods A total of 66 brush cytology specimens obtained during ERCP were detected by FISH and cytology test respectively to compare the sensitivity, specificity, predictive values and accuracy. Besides, FFPE-based FISH was performed on 46 corresponding paraffin sections of pancreatobiliary tumors obtained by surgical resection. Results Our findings demonstrate that FISH greatly improves diagnostic sensitivity and negative predictive value compared to ERCP/MRCP and cytology without much reduction in specificity and positive predictive value. However, our results also indicate that FFPE-based FISH could not effectively identify the false-negative of brushing-based FISH. Conclusions We believe that FISH can effectively distinguish true positive and false positive results of cytological or radiological suspicions of malignancy. However, FFPE-based FISH still does not precisely recognize the false-negative of brushing-based FISH. Both cytology-based and PPFE-based FISH had limitation in some specimens.

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Correlation of Immunohistochemistry and Fluorescence in Situ Hybridization for HER-2 Assessment in Breast Cancer Patients: Single Centre Experience

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2018.124 ◽

2018 ◽

Vol 6 (4) ◽

pp. 593-599 ◽

Cited By ~ 2

Author(s):

Magdalena Bogdanovska-Todorovska ◽

Slavica Kostadinova-Kunovska ◽

Rubens Jovanovik ◽

Blagica Krsteska ◽

Goran Kondov ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Patients ◽

In Situ Hybridisation ◽

False Negative ◽

High Sensitivity ◽

High Specificity ◽

Fluorescence In Situ Hybridisation ◽

Breast Cancer Patients ◽

Her 2

BACKGROUND: Accurate assessment of HER-2 is imperative in selecting patients for targeted therapy. Most commonly used test methods for HER-2 are immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH). We evaluated the concordance between FISH and IHC for HER-2 in breast cancer samples using Food and Drug Administration approved tests.MATERIAL AND METHODS: Archived paraffin tissue blocks from 73 breast cancer patients were used. HER-2 immunostaining was performed using Ventana anti–HER-2 monoclonal antibody. The FISH assay was performed using PathVysion™ HER-2 DNA Probe Kit.RESULTS: Of the 73 cases 68.5% were IHC 0/1+, 15.07% were IHC 2+ and 16.44% were IHC 3+. Successful hybridisation was achieved in 72 cases. HER-2 FISH amplification was determined in 16.67% cases. Ten IHC 3+ and two IHC 2+ cases were FISH positive. Two of the IHC 3+ cases were FISH negative. Concordance rate was 100%, 18.18% and 83.33% for IHC 0/1+, 2+ and 3+ group, respectively. Total concordance was 84.72%, kappa 0.598 (p < 0.0001). The sensitivity of IHC in detecting IHC 2+ and IHC 3+ cases was 16.7% and 83.3%, and the specificity was 85% and 96.67%, respectively.CONCLUSION: The consistency between the methods was highest for IHC negative and lowest for IHC equivocal cases. The immunohistochemistry showed high sensitivity for IHC 2+/3+ cases and high specificity for IHC 3+ cases. Our results support the view that false-positive rather than false-negative IHC results are a problem with HER-2/IHC testing, and that IHC should be used as an initial screening test, but IHC 2+/ 3+ results should be confirmed by FISH.

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The Human Epidermal Growth Factor Receptor 2 Screening Tests for Breast Cancer Suggested by the New Updated Recommendation of the American Society of Clinical Oncology/College of American Pathologists Will Involve a Rise of the In-Situ Hybridization Tests for the European Laboratories of Pathology

ISRN Oncology ◽

10.1155/2014/793695 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Christian Garbar ◽

Aude-Marie Savoye ◽

Corinne Mascaux ◽

Eva Brabencova ◽

Hervé Curé

Keyword(s):

Breast Cancer ◽

In Situ Hybridisation ◽

False Negative ◽

Growth Factor Receptor ◽

Screening Tests ◽

Fluorescence In Situ Hybridisation ◽

Her2 Positive ◽

Epidermal Growth ◽

American Society

Aims. The differences between the 2007 and the 2013 ASCO/CAP HER2 guidelines have been compared. We also discussed the potential consequences in our pathological practice. Material and Methodology. 189 HER2 fluorescence in situ hybridisation (FISH) tests were performed from 1016 preliminary HER2 immunohistochemical tests (IHC). All cases were reviewed and reclassed following the 2007 and 2013 ASCO/CAP recommendations. Results. The 2013 version decreased false-negative IHC (3/118 versus 1/54, P=ns) and created more 2+ IHC (40/186 versus 89/186, P=0.001) or more 3+ IHC (9/186 versus 39/186, P=0.001). One false-positive IHC was described for the 2013 version (0/9 versus 1/39, P=ns). Equivocal FISH was reduced (8/186 versus 2/186, P=ns). An estimation based on our data for 1000 patients showed a rise of our FISH tests for the control of 2+ IHC (180 tests for the 2007 version versus 274 tests for the 2013 version or FISH work overflow is +52%) and for the control of 2+/3+ IHC (300 for the 2007 version versus 475 for the 2013 version or FISH work overflow is +58%). Conclusions. The new 2013 ASCO/CAP guidelines have detected more HER2 positive cases but have increased the number of FISH tests.

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Comparison of Pathvysion and Poseidon HER2 FISH assays in measuring HER2 amplification in breast cancer: a validation study

Journal of Clinical Pathology ◽

10.1136/jcp.2009.066852 ◽

2009 ◽

Vol 63 (4) ◽

pp. 341-346 ◽

Cited By ~ 6

Author(s):

Monika Francz ◽

Kristof Egervari ◽

Laszlo Kardos ◽

Judit Toth ◽

Zoltan Nemes ◽

...

Keyword(s):

Breast Cancer ◽

Validation Study ◽

Predictive Value ◽

In Situ Hybridisation ◽

Correlation Coefficients ◽

Fluorescence In Situ Hybridisation ◽

Her2 Gene ◽

Perfect Agreement ◽

Diagnostic Facility

AimsThe current study was done as a validation study prior to setting up a clinical HER2 testing service using the new commercial Poseidon HER2 fluorescence in situ hybridisation (FISH) assay. However, it was felt that the experience of the authors of this study may be of interest to other laboratories when considering setting up a HER2 diagnostic facility.Methods122 patients who had been diagnosed with invasive breast cancer were selected. Immunolabelling with HercepTest, PathVysion and Poseidon FISH assays were carried out using tissue microarray blocks.ResultsConcordance correlation coefficients showed near perfect agreement in average HER2 and centromere specific signal counts per cell and in the HER2/CEP17 ratios between the PathVysion and the Poseidon FISH assays. In addition, the κ measure showed perfect agreement (κ 0.9441, p<0.0001), and if only 2+ cases were considered there was substantial agreement (κ 0.7671, p=0.0006), between the two assays. The sensitivity and the specificity of the Poseidon FISH kit were calculated to be 95.2% and 100%, respectively, whereas the positive predictive value (PPV) and negative predictive value (NPV) were 100% and 99%, respectively. With regard to the ability to presume HER2 polysomy, the Poseidon FISH kit had a sensitivity of 93.3% and a specificity of 99.1%, with PPV and NPV of 93.3% and 99.1%, respectively, as assessed with PathVysion classification as the reference.ConclusionsStatistical analysis confirmed that the two FISH assays are comparable in terms of detection of HER2 gene amplification. Proceeding from these findings, the genetic diagnoses obtained with the Poseidon kit can be considered to be as valuable as the results from the Food and Drug Administration approved PathVysion assay, and its utilisation in routine HER2 diagnostics is proposed.

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Comparison of Auramine Phenol and ZN Staining in Diagnosis of Pulmonary Tuberculosis with GeneXpert MTB/RIF as Gold Standard

Journal of Islamabad Medical & Dental College ◽

10.35787/jimdc.v9i3.435 ◽

2020 ◽

Vol 9 (3) ◽

pp. 190-194

Author(s):

Naureen Saeed ◽

Fatima-tuz-zuhra ◽

Nadeem Ikram ◽

Farhana Shaukat ◽

Fareeha Sardar

Keyword(s):

Pulmonary Tuberculosis ◽

Positive Predictive Value ◽

Predictive Value ◽

Gold Standard ◽

Sputum Sample ◽

False Negative ◽

Smear Microscopy ◽

Predictive Values ◽

Pulmonary Tb ◽

Sensitivity Specificity

Background: Pakistan faces an immense burden of pulmonary tuberculosis (TB) due to large number of cases and limited resources. Despite the recent advancement in the diagnostic techniques for pulmonary TB, smear microscopy is still a useful technique for the diagnosis of this disease. This study was conducted in order to compare the diagnostic value of Auramine stain with the conventional Ziehl-Neelsen (ZN) stain on the sputum smear for the diagnosis of pulmonary TB, keeping GeneXpert MTB/RIF as the gold standard. Method: This cross-sectional study was conducted on 356 suspected patients of pulmonary TB referred to the Pathology laboratory from TB ward and OPD of District Head Quarter (DHQ) teaching hospital Rawalpindi, Pakistan. Sputum specimen were collected and two smears were prepared from each sputum sample on which Auramine phenol and Ziehl-Neelsen staining were carried out as per WHO recommendations. All these samples were further tested using Gene Xpert MTB/RIF technique. The sensitivity, specificity, Positive predictive value (PPV) and Negative predictive values (NPV) of ZN and Auramine stain were calculated and compared with GeneXpert MTB/RIF technique. Results: Out of the total 356 samples, 64(18%) were positive and 291(82%) were negative by GeneXpert which was taken as the gold standard. On comparison with GeneXpert, percentage of true positive was greater in case of Auramine than ZN stained samples (16.29% versus 12.92%), while the percentage of false positive was same for both staining techniques (0.28%). There were lesser false negative cases observed in samples stained by Auramine as compared to the ones stained by ZN (1.68% versus 5.05%). The sensitivity, specificity, positive predictive value and negative predictive values were 97.87%, 94.17%, 71.88 and 99.66%, respectively for the ZN staining and 98.31%, 97.98%, 90.63% and 99.66% respectively, for the Auramine phenol staining. Conclusion: Smear microscopy using Auramine phenol stain is a useful technique for the diagnosis of pulmonary TB. The Auramine phenol staining with fluorescent microscopy is found to be superior to ZN staining because of higher sensitivity and specificity. Keywords: Auramine phenol, Fluorescence microscopy, GeneXpert, Mycobacterium tuberculosis, Ziehl-Neelsen

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Characterization of Focal Liver Lesions using CEUS and MRI with Liver-Specific Contrast Media: Experience of a Single Radiologic Center

Ultraschall in der Medizin - European Journal of Ultrasound ◽

10.1055/s-0043-105264 ◽

2017 ◽

Vol 38 (06) ◽

pp. 619-625 ◽

Cited By ~ 19

Author(s):

Lukas Beyer ◽

Florian Wassermann ◽

Benedikt Pregler ◽

Katharina Michalik ◽

Janine Rennert ◽

...

Keyword(s):

Contrast Media ◽

Predictive Value ◽

False Negative ◽

Focal Liver Lesions ◽

Liver Lesions ◽

Predictive Values ◽

Negative Results ◽

False Negative Results ◽

Sensitivity Specificity

Abstract Aim The purpose of this study was to compare contrast-enhanced ultrasound (CEUS), magnetic resonance imaging (MRI) using liver-specific contrast agent and a combination of both for the characterization of focal liver lesions (FLL). Methods 83 patients with both benign and malignant liver lesions were examined using CEUS and MRI after the intravenous administration of liver-specific contrast media. All patients had inconclusive results from prior imaging examinations. Histopathological specimens could be obtained in 53 patients. Ultrasound was performed using a multi-frequency curved probe (1 – 6 MHz) after the injection of 1 – 2.4 ml ultrasound contrast media. The sensitivity, specificity, positive predictive value and negative predictive value of CEUS, MRI and a combination of both (CEUS + MRI) were compared. Results The sensitivity, specificity, positive and negative predictive values regarding lesion classification were 90.9 %, 70.6 %, 92.3 % and 66.6 %, respectively, for CEUS; 90.9 %, 82.4 %, 95.2 % and 70.0 %, respectively, for MRI; and 96.9 %, 70.6 %, 92.7 % and 85.7 % respectively, for CEUS + MRI. There were no statistically significant differences. 6 malignant lesions were missed using CEUS or MRI alone (false negatives). The use of both modalities combined reduced the false-negative results to 2. Conclusion CEUS and MRI with liver-specific contrast media are very reliable and of equal informative value in the characterization of focal liver lesions. The number of false-negative results can be decreased using a combination of the two methods.

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Fluorescence in situ hybridisation analysis of bone marrow trephine biopsy specimens; an additional tool in the diagnostic armoury

Journal of Clinical Pathology ◽

10.1136/jclinpath-2012-201131 ◽

2012 ◽

Vol 66 (1) ◽

pp. 54-57 ◽

Cited By ~ 11

Author(s):

Michael J Neat ◽

Mufaddal T Moonim ◽

Robert G Dunn ◽

Helen Geoghegan ◽

Nicola J Foot

Keyword(s):

In Situ Hybridisation ◽

Fish Analysis ◽

Fluorescence In Situ Hybridisation ◽

Trephine Biopsy ◽

Additional Tool ◽

Bone Marrow Trephine Biopsy ◽

Biopsy Specimens ◽

Wide Range ◽

Formalin Fixed Paraffin Embedded

Fluorescence in situ hybridisation (FISH) analysis is now widely employed in the diagnosis and risk stratification of a wide range of malignant diseases. While this technique is used successfully with formalin-fixed paraffin-embedded (FFPE) sections from numerous tissue types, FISH analysis of FFPE tissue sections from trephine biopsy specimens has been less widely reported, possibly due to technical limitations relating to the decalcification protocols employed. During the last 4 years FISH analysis has been carried out successfully in 42 out of 55 (76%) consecutive trephine biopsy specimens received as part of the standard diagnostic service at our institution. Samples decalcified using EDTA-based protocols were analysed successfully in 31/31 cases (100%), whereas only 11/24 samples (46%) decalcified using formic acid-based protocols were successful. In our experience, FISH analysis of trephine biopsy specimens is a highly reproducible technique and a very useful adjunctive tool in the diagnostic armoury; however, its use in a standard diagnostic setting relies on the use of EDTA-based decalcification protocols.

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Diagnostic value of self-report compared with Beck Depression Inventory (BDI-II) in screening of depression

10.1101/2020.04.29.20085852 ◽

2020 ◽

Author(s):

Mehran zarghami ◽

Fatemeh Taghizadeh ◽

Mahmood mousazadeh

Keyword(s):

Positive Predictive Value ◽

Beck Depression Inventory ◽

Predictive Value ◽

Total Population ◽

False Negative ◽

Diagnostic Value ◽

Self Report ◽

Case Group ◽

Predictive Values ◽

Sensitivity Specificity

AbstractBackgroundDepression is a common cause of mortality and morbidity worldwide. To detect depression, we compared Beck Depression Inventory scoring as a valid tool with participants self-reporting depression.MethodologyThis cross-sectional study aimed to explore the diagnostic values of self-reporting in patients’ with depression comparing to Beck Depression Inventory scoring in Mazandaran Persian cohort study, with a total of 1300 samples. The sample size was determined to include 155 participants through the census method. In order to increase the test power, 310 healthy participants were included in the study through random selection. In order to evaluate the diagnostic value of self-reporting, BDI-II was completed by blind interviewing to the case group as well as to another group who reported that they were not depressed, as control.ResultsSensitivity, specificity, accuracy, false positive, false negative, positive and negative predictive values of self-reporting was calculated 58.4%, 79.1%,73.4%, 20.8%, 41.6%, 51.8%, and 83.2% for the total population respectively, as well as, sensitivity, specificity, accuracy, positive and negative predictive values of self-report in males were 83.3%, 77.2%, 77.1%, 43.8% and 95.6% and 53.7%, 78.1%, 71.2%, 49.2%, and 81.1% for females, respectively.ConclusionThe positive predictive value and sensitivity of self-reporting are insufficient in total population and females, and therefore self-reporting cannot detect depressed patients, but regarding to its average positive predictive value, perhaps, it can be used to identify non-depressant individuals.

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Pre-Procedural Surveillance Testing for SARS-CoV-2 in an Asymptomatic Population Shows Low Rates of Positivity

10.1101/2020.05.08.20078592 ◽

2020 ◽

Author(s):

James A Mays ◽

Alexander L Greninger ◽

Keith R Jerome ◽

John B Lynch ◽

Patrick C Mathias

Keyword(s):

Positive Predictive Value ◽

Beck Depression Inventory ◽

Predictive Value ◽

Total Population ◽

False Negative ◽

Self Report ◽

Case Group ◽

Cross Sectional ◽

Predictive Values ◽

Sensitivity Specificity

Background: Depression is a common cause of mortality and morbidity worldwide. To detect depression, we compared Beck Depression Inventory scoring as a valid tool with participants self-reporting depression.Methodology: This cross-sectional study aimed to explore the diagnostic values of self-reporting in patients' with depression comparing to Beck Depression Inventory scoring in Mazandaran Persian cohort study, with a total of 1300 samples. The sample size was determined to include 155 participants through the census method. In order to increase the test power, 310 healthy participants were included in the study through random selection. In order to evaluate the diagnostic value of self-reporting, BDI-II was completed by blind interviewing to the case group as well as to another group who reported that they were not depressed, as control.Results: sensitivity, specificity, accuracy, false positive, false negative, positive and negative predictive values of self-reporting was calculated 58.4%, 79.1%,73.4%, 20.8%, 41.6%, 51.8%, and 83.2% for the total population respectively, as well as, sensitivity, specificity, accuracy, positive and negative predictive values of self-report in males were 83.3%, 77.2%, 77.1%, 43.8% and 95.6% and 53.7%, 78.1%, 71.2%, 49.2%, and 81.1% for females, respectively.Conclusion: The positive predictive value and sensitivity of self-reporting are insufficient in total population and females, and therefore self-reporting cannot detect depressed patients, but regarding to its average positive predictive value, perhaps, it can be used to identify non-depressant individuals.

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