scholarly journals Histopathologic Review of Previously Negative Prostatic Core Needle Biopsies following a New Diagnosis of Adenocarcinoma of the Prostate by Core Needle Biopsies: Implications for Quality Assurance Programs

2008 ◽  
Vol 1 ◽  
pp. CPath.S581
Author(s):  
Jay Patel ◽  
Lester J. Layfield
Keyword(s):  
Quality Assurance ◽  
Core Biopsy ◽  
False Negative ◽  
False Negative Rate ◽  
Intraepithelial Neoplasia ◽  
Surgical Pathology ◽  
Core Needle ◽  
Prostate Needle Biopsy ◽  
Negative Results ◽  
New Diagnosis

Programs for quality assurance are increasingly important in surgical pathology. Many quality assurance (QA) techniques for surgical pathology were adopted from procedures introduced in cytopathology. Surgical pathology specimens have diminished in size such that the majority of diagnostic biopsies of prostatic lesions are now core needle biopsies. These specimens raise issues similar to those of cytology specimens, including concerns regarding adequacy and the representative nature of the biopsy. Due to sample size, some neoplasms may not be diagnosed on initial biopsy, raising concerns regarding false negative results. Cytopathologists have instituted QA procedures including review of all previously negative slides received within five years prior to the new diagnosis of high grade squamous intraepithelial lesion or gynecologic malignancy. No such requirement exists in surgical pathology for review of core biopsies. The Department of Pathology at the University of Utah instituted a QA policy requiring review of prior negative prostatic needle biopsies following a new diagnosis of prostatic adenocarcinoma. We reviewed five years of QA records of prostate needle biopsy review. During this time, nine hundred and fifty-eight core biopsy sets were performed. Two hundred and ninety-five of these contained at least one biopsy with a diagnosis of adenocarcinoma. Two hundred and eight patients had a prior set of prostatic needle biopsies with a diagnosis of adenocarcinoma. The remaining 87 had prior biopsies with either a diagnosis of prostatic intraepithelial neoplasia (23), small atypical acinar proliferation (21) or no evidence of malignancy (43). QA review of these 87 cases revealed two biopsies which revealed foci of adenocarcinoma. Both had been initially diagnosed as no evidence of malignancy. The false negative rate for core biopsy was 0.68%. In an additional twenty-one cases, microscopic foci of atypical small acinar proliferations were found in core biopsies antedating the positive core biopsy (7.1%).

scholarly journals Pooling of Upper Respiratory Specimens Using a SARS-CoV-2 Real-time RT-PCR Assay Authorized for Emergency Use in Low-Prevalence Populations for High-Throughput Testing

2020 ◽  
Vol 7 (11) ◽  
Author(s):  
Gwynngelle A Borillo ◽  
Ron M Kagan ◽  
Russell E Baumann ◽  
Boris M Fainstein ◽  
Lamela Umaru ◽  
...  
Keyword(s):  
Real Time ◽  
False Negative ◽  
False Negative Rate ◽  
Nucleic Acid Amplification ◽  
Rt Pcr ◽  
Pooled Testing ◽  
Negative Results ◽  
Single Positive ◽  
Upper Respiratory ◽  
Respiratory Specimens

Abstract Background Nucleic acid amplification testing is a critical tool for addressing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Specimen pooling can increase throughput and conserve testing resources but requires validation to ensure that reduced sensitivity does not increase the false-negative rate. We evaluated the performance of a real-time reverse transcription polymerase chain reaction (RT-PCR) test authorized by the US Food and Drug Administration (FDA) for emergency use for pooled testing of upper respiratory specimens. Methods Positive specimens were selected from 3 prevalence groups, 1%–3%, >3%–6%, and >6%–10%. Positive percent agreement (PPA) was assessed by pooling single-positive specimens with 3 negative specimens; performance was assessed using Passing-Bablok regression. Additionally, we assessed the distributions of RT-PCR cycle threshold (Ct) values for 3091 positive specimens. Results PPA was 100% for the 101 pooled specimens. There was a linear relationship between Ct values for pooled and single-tested specimens (r = 0.96–0.99; slope ≈ 1). The mean pooled Ct shifts at 40 cycles were 2.38 and 1.90, respectively, for the N1 and N3 targets. The median Cts for 3091 positive specimens were 25.9 (N1) and 24.7 (N3). The percentage of positive specimens with Cts between 40 and the shifted Ct was 1.42% (N1) and 0.0% (N3). Conclusions Pooled and individual testing of specimens positive for SARS-CoV-2 demonstrated 100% agreement, which demonstrates the viability of pooled specimens for SARS-COV-2 testing using a dual-target RT-PCR system. Pooled specimen testing can help increase testing capacity for SARS-CoV-2 with a low risk of false-negative results.

scholarly journals Evaluation of risk factors for false-negative results with an antigen-specific peripheral blood-based quantitative T cell assay (T-SPOT®.TB) in the diagnosis of active tuberculosis: A large-scale retrospective study in China

2018 ◽  
Vol 46 (5) ◽  
pp. 1815-1825 ◽  
Author(s):  
Chi Yang ◽  
Shaojun Zhang ◽  
Lan Yao ◽  
Lin Fan
Keyword(s):  
Risk Factors ◽  
Retrospective Study ◽  
Respiratory Diseases ◽  
False Negative ◽  
False Negative Rate ◽  
Active Tuberculosis ◽  
Pulmonary Tb ◽  
Negative Results ◽  
False Negative Results ◽  
Negative Sputum

Objective To investigate the diagnostic efficacy of an interferon-γ release assay, T-SPOT®. TB, for diagnosing active tuberculosis (TB) and to identify risk factors for false-negative results. Methods This retrospective study enrolled consecutive patients with active TB and with non-TB respiratory diseases to evaluate the risk factors for false-negative results when using the T-SPOT®. TB assay for the diagnosis of active TB. Patients with active TB were categorized as having confirmed pulmonary TB, clinically diagnosed pulmonary TB or extrapulmonary TB (EPTB). Results This study analysed 4964 consecutive patients; 2425 with active TB and 2539 with non-TB respiratory diseases. Multivariate logistic regression analyses identified the following five factors that were all associated with an increased false-negative rate with the T-SPOT®. TB assay: increased age (odds ratio [OR] 1.018; 95% confidence interval [CI] 1.013, 1.024); decreased CD8+ count (OR 0.307; 95% CI 0.117, 0.803); negative sputum acid-fast bacilli (AFB) smear staining (OR 1.821; 95% CI 1.338, 2.477); negative mycobacterial cultures (OR 1.379; 95% CI 1.043, 1.824); and absence of EPTB (OR 1.291; 95% CI 1.026, 1.623). Conclusions Increased age, decreased CD8+ count, negative sputum AFB smear results, negative sputum mycobacterial cultures and absence of EPTB might lead to an increased false-negative rate when using the T-SPOT®. TB assay.

scholarly journals Clinical study on primary screening of oral cancer and precancerous lesions by oral cytology

2020 ◽  
Author(s):  
Shintaro Sukegawa ◽  
Sawako Ono ◽  
Keisuke Nakano ◽  
Kiyofumi Takabatake ◽  
Hotaka Kawai ◽  
...  
Keyword(s):  
Conventional Method ◽  
False Positive ◽  
Precancerous Lesions ◽  
False Positive Rate ◽  
False Negative ◽  
False Negative Rate ◽  
Intraepithelial Neoplasia ◽  
Low Grade ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion

Abstract Background This study was conducted to compare histological diagnostic accuracy between conventional method and liquid-based cytology (LBC) method and to clarify the effectiveness of cytology. Methods Histological diagnoses of 251 cases were classified as negative (no malignancy lesion, inflammation, and mild/moderate dysplasia) and positive [oral intraepithelial neoplasia/carcinoma in situ (OIN/CIS) and squamous cell carcinoma (SCC)]. Cytological diagnoses were classified as negative for intraepithelial lesion or malignancy (NILM), oral low-grade squamous intraepithelial lesion (OLSIL), oral high-grade squamous intraepithelial lesion (OHSIL), or SCC. Cytological diagnostic results were compared with histology results. Results Of NILM cytology cases, the most frequent case was negative [LBC n = 50 (90.9%), conventional n = 22 (95.7%)]. Among OLSIL cytodiagnoses, the most common was negative (LBC n = 34; 75.6%, conventional n = 14; 70.0%). Among OHSIL cytodiagnoses (LBC n = 51, conventional n = 23), SCC was the most frequent (LBC n = 31; 60.8%, conventional n = 7; 30.4%). Negative cases were common (LBC n = 13; 25.5%, conventional n = 14; 60.9%). Among SCC cytodiagnoses SCC was the most common (LBC n = 16; 88.9%, conventional n = 14; 87.5%). Regarding the diagnostic results of cytology, assuming HSIL and SCC as cytologically positive, the LBC method/conventional method showed a sensitivity of 79.4%/76.7%, specificity of 85.1%/69.2%, false positive rate of 14.9%/30.7%, and false negative rate of 20.6%/23.3%. Conclusions LBC method was superior to conventional method in cytodiagnosis. It was especially superior for LSIL and HSIL. Because of the false positive and false negative cytodiagnoses, it is necessary to make a comprehensive diagnosis considering the clinical findings.

scholarly journals Avoiding COVID-19 Hospital Outbreaks: RT-PCR Swab and Clinical Assessment

2021 ◽  
Author(s):  
Luca Allievi ◽  
Amedeo Bongarzoni ◽  
Guido Tassinario ◽  
Stefano Carugo
Keyword(s):  
Clinical Assessment ◽  
False Negative ◽  
False Negative Rate ◽  
High Specificity ◽  
Diagnostic Process ◽  
Rt Pcr ◽  
Negative Results ◽  
High False Negative Rate ◽  
Degree Of Confidence ◽  
Low Sensitivity

Nasopharyngeal RT-PCR swab test for COVID-19 diagnosis has a high specificity but also a low sensitivity. The high false-negative rate and the overconfidence in negative results sometimes lead to hospital outbreaks. Therefore, we recommend always integrating the clinical assessment in the diagnostic process, mostly after the test, to determine what degree of confidence can be attributed to a negative result.

High False-Negative Rate of HER2 Quantitative Reverse Transcription Polymerase Chain Reaction of the Oncotype DX Test: An Independent Quality Assurance Study

2011 ◽  
Vol 29 (32) ◽  
pp. 4279-4285 ◽  
Author(s):  
David J. Dabbs ◽  
Molly E. Klein ◽  
Syed K. Mohsin ◽  
Raymond R. Tubbs ◽  
Yongli Shuai ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Quality Assurance ◽  
Reverse Transcription ◽  
False Negative ◽  
False Negative Rate ◽  
Oncotype Dx ◽  
Rt Pcr ◽  
Chain Reaction ◽  
Negative Rate ◽  
Polymerase Chain

Purpose HER2 (ERBB2) status is an important prognostic and predictive marker in breast carcinoma. In recent years, Genomic Health (GHI), purveyors of the Oncotype DX test, has been separately reporting HER2 by reverse transcription polymerase chain reaction (RT-PCR) to oncologists. Because of the lack of independent evaluation, this quality assurance study was undertaken to define the concordance rate between immunohistochemistry (IHC)/fluorescent in situ hybridization (FISH) and GHI RT-PCR HER2 assay. Methods All patients at three participating laboratories (Magee-Womens Hospital [Pittsburgh, PA], Cleveland Clinic [Cleveland, OH], and Riverside Methodist Hospital [Columbus, OH]) with available HER2 RT-PCR results from GHI were included in this study. All IHC-positive and equivocal patient cases were further evaluated and classified by FISH at respective laboratories. Results Of the total 843 patient cases, 784 (93%) were classified as negative, 36 (4%) as positive, and 23 (3%) as equivocal at the three institutions using IHC/FISH. Of the 784 negative patient cases, 779 (99%) were also classified as negative by GHI RT-PCR assay. However, all 23 equivocal patient cases were reported as negative by GHI. Of the 36 positive cases, only 10 (28%; 95% CI, 14% to 45%) were reported as positive, 12 (33%) as equivocal, and 14 (39%) as negative. Conclusion There was an unacceptable false-negative rate for HER2 status with GHI HER2 assay in this independent study. This could create confusion in the decision-making process for targeted treatment and potentially lead to mismanagement of patients with breast cancer if only GHI HER2 information is used.

scholarly journals Effect of omeprazole, rabeprazole, and rebamipide on the accuracy of urea breath test in patients with Helicobacter pylori infection

2010 ◽  
Vol 4 (2) ◽  
pp. 337-342
Author(s):  
Duangporn Thong-Ngam ◽  
Maneerat Chayanupatkul ◽  
Thirada Thongbai
Keyword(s):  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Breath Test ◽  
False Negative ◽  
False Negative Rate ◽  
Urea Breath Test ◽  
Once Daily ◽  
Negative Results ◽  
Negative Rate ◽  
H Pylori

Abstract Background: The urea breath test (UBT) has been widely used for H. pylori eradication after treatment. The breath test could be adversely affected by various factors including proton pump inhibitors (PPIs) that are also used in the therapy for H. pylori infection. Objective: Determine the effect of omeprazole, rabeprazole and the mucoprotective agent rebamipide, on the UBT. Methods: Fifty-six patients with dyspepsia and positive for H. pylori by rapid urease test were enrolled. They were classified into three groups: Group 1 (n=25) received omeprazole 20 mg once daily, group 2 (n=13) received rabeprazole 20 mg once daily, and group 3 (n=18) received rebamipide 100 mg three times a day. All patients received a 14-day course of their medications. UBT was performed on day 0 as a baseline and on day 14 in all patients. In patient with negative results of UBT on day 14, the UBT was performed in consecutive week until the test became positive. Results: Fifty-six patients (20 men and 36 women) participated in the study. Their mean age was 46.77±14.3 years. False negative rate after 14-day treatment in omeprazole, rabeprazole and rebamipide group were 20.0%, 30.8%, and 0% respectively. There was a significant difference between 13C level in patients with negative and positive UBT results (2.7±0.7 vs.22.9±3.7/mL, p=0.025). The reversal of false negative to true positive tests occurred within two weeks after discontinuation of omeprazole and rabeprazole. Conclusion: Proton pump inhibitors had an effect on the accuracy of H. pylori detection using UBT. Rabeprazole revealed a higher false negative rate in the UBT than omeprazole. The mucoprotective drug, rebamipide, did not influence negative results in the UBT.

Re-Evaluate the Value of Frozen Sections in Diagnoses of Breast Malignancies that Failed to be Diagnosed by Core Needle Biopsy: A Chinese Retrospective Analysis of Clinical Practice

2021 ◽  
Author(s):  
Jialei Xue ◽  
Jianwei Li ◽  
Yue Gong ◽  
Qiuxia Cui ◽  
Li Dai ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Core Needle Biopsy ◽  
Needle Biopsy ◽  
Frozen Section ◽  
False Negative ◽  
False Negative Rate ◽  
Frozen Sections ◽  
Core Needle ◽  
Negative Rate ◽  
Breast Malignancies

Abstract Objective: The value of frozen sections in diagnoses of breast malignancies that failed to be diagnosed by core needle biopsy (CNB) is indeterminate. To re-evaluate and improve the utility of frozen section on this kind of breast malignancy, we conducted a retrospective data analysis and constructed a prediction model.Method: We reviewed data of breast cancer patients that failed to be diagnosed by CNB (CNB-undiagnosable) in Fudan University Shanghai Cancer Center (FUSCC) from May 1, 2006 to December 31, 2019. Clinical characteristics of patients were collected. the correlation between clinical features and false negative rate (FNR) of frozen sections was explored with logistic regression analysis, after which a nomogram was constructed to predict the probability of false negative.Result: The diagnostic sensitivity of frozen section on CNB-undiagnosable breast cancer was 67.18%, and the FNR was 32.82%. In multivariate analysis, papillary lesion (OR, 4.251; 95% CI, 2.804-6.492; P<0.0001) and sclerosing adenosis (OR, 3.727; 95% CI, 1.897-7.376; P= 0.0001) on CNB were risk factors of false negative, while clustered microcalcifications on mammography (OR, 0.345; 95% CI, 0.216-0.543; P < 0.0001) and ultrasonic BI-RADS category 4C-5 (OR, 0.250; 95% CI, 0.081-0.777; P = 0.0157) were favorable factors of true positive. The false negative rate of frozen section could be controlled at about 10% by the prediction of nomogram. Conclusion: Frozen sections are valuable in the diagnosis of CNB-undiagnosable breast cancers. It is recommended to implement the intraoperative frozen sections for high-risk breast lesions with a low probability of false negative indicated by prediction, so as to minimize the occurrence of unnecessary re-operation.

scholarly journals Expression Profile of p53 and p21 in Large Bowel Mucosa as Biomarkers of Inflammatory-Related Carcinogenesis in Ulcerative Colitis

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Cristiana Popp ◽  
Luciana Nichita ◽  
Theodor Voiosu ◽  
Alexandra Bastian ◽  
Mirela Cioplea ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Epithelial Cells ◽  
False Negative ◽  
Intraepithelial Neoplasia ◽  
Architectural Distortion ◽  
P53 Overexpression ◽  
Negative Results ◽  
False Negative Results ◽  
One Year ◽  
Tissue Biomarker

Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease that slightly increases the risk of colorectal cancer in patients with long-standing extended disease. Overexpression of p53 and p21 in colonic epithelia is usually detected in UC patients when no dysplasia is histologically seen and it is used by pathologists as a discriminator between regenerative changes and intraepithelial neoplasia, as well as a tissue biomarker useful to predict the risk of evolution toward malignancy. We present a one-year prospective observational study including a cohort of 45 patients with UC; p53 and p21 were evaluated in epithelial cells. p53 was positive in 74 samples revealed in 5% to 90% of epithelial cells, while 63 biopsies had strong positivity for p21 in 5% to 50% of epithelial cells. Architectural distortion was significantly correlated with p53 overexpression in epithelial cells. Thus, we consider that architectural distortion is a good substitute for p53 and p21 expression. We recommend use of p53 as the most valuable tissue biomarker in surveillance of UC patients, identifying the patients with higher risk for dysplasia. Association of p21 is also recommended for a better quantification of risk and for diminishing the false-negative results.

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