Value of Electrical Impedance Scanning (EIS) in the Evaluation of BI-RADS™ III/IV/V-Lesions

Two hundred and fifty-six (256) patients (72% preoperative, 28% pre-Mammotome) were prospectively examined with EIS using the TS 2000 (TransScan Research and Development Center, Israel; temporarily distributed by Siemens, Erlangen) with the “LOS”-software (level of suspicion). All exams were performed with the targeted scan probe, the observer knowing all clinical and imaging facts. The area of the lesions was examined with EIS at least with 5 single scans. The evaluation included a scaling of lesions from 1 (surely benign) up to 5 (highly suggestive for malignancy) as well as the additional notification of spots. Results of EIS were based upon the automatic scaling which is provided by the software and were compared with mammography and histology. Furthermore the influence of the histology, size of lesions, and presence/absence of spots on the EIS results were analyzed. Histology revealed benign results in 138 lesions and malignant results in 118 lesions (DCIS=61, ID-Ca=51, IL-Ca=5, mucinous Ca=1). Mammography as expected yielded high values with 91% sensitivity and 62% specificity. Overall sensitivity of EIS was 75.4%, specificity 42.03%, negative predictive value 66.7% and positive predictive value 52.7% (89 TP, 58 TN, 80 FP, 29 FN). EIS was false negative in 20 ID-Ca, 3 IL-Ca, 1 IDL-Ca, 4 DCIS, and 1 mucinous carcinoma. Sensitivity and specificity of EIS did not differ for the different histological differentiations neither for the degree of invasion. Also the additional notification of “spots” didn't show a correlation to malignancy. There were significant differences of the sensitivity of EIS regarding the tumor size. While EIS correctly diagnosed 85% of lesions <10 mm in size, only 64% of lesions >10 mm were detected. Most frequent lesion types for false positives were mastopathy (55/80 FP) and fibroadenoma (21/80 FP). Patient acceptance of EIS was perfect and there were no drop outs because of movement artifacts. In conclusion the “LOS”-software clearly improved the clinical performance of the TS 2000 as compared to the initial software. The high sensitivity of EIS in small cancers which was found in our study may indicate an advantage of this method. However, the overall sensitivity and specificity with this setup of EIS is still far too low. Further improvements especially including the measurement of higher frequencies should be realized.

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Sensitivity and Specificity of Gene Xpert in the Diagnosis of Spinal Tuberculosis: A Prospective Controlled Clinical Study

Global Spine Journal ◽

10.1177/2192568219858310 ◽

2019 ◽

Vol 10 (5) ◽

pp. 553-558

Author(s):

Anil M. Solanki ◽

Saumyajit Basu ◽

Amitava Biswas ◽

Subhendu Roy ◽

Aditya Banta

Keyword(s):

Positive Predictive Value ◽

Negative Predictive Value ◽

Sensitivity And Specificity ◽

Predictive Value ◽

Spinal Tuberculosis ◽

False Negative ◽

High Sensitivity ◽

Control Group ◽

Surgical Biopsy ◽

True Negative

Study Design: Prospective matched cohort study Objective: To evaluate the sensitivity and specificity of Gene Xpert in the diagnosis of spinal tuberculosis. Methods: From January 2016 to August 2018, Gene Xpert results were prospectively studied in 68 patients of clinicoradiologically suspected spinal tuberculosis (STB) and a control group (CG) of 92 patients, all of whom underwent computed tomography–guided/C-arm-guided/open surgical biopsy. Sensitivity, specificity, positive predictive value, and negative predictive value are obtained using standard equations. Results: Out of 68 cases of STB, Gene Xpert was positive in 62 (true positive: 62/68) and negative in 6 (false negative: 6/68). Gene Xpert was negative for all 92 cases of CG (true negative: 92/92, false positive 0/92). Thus, in our series, sensitivity of Gene Xpert is 91.18%, specificity is 100%, positive predictive value is 100%, and negative predictive value is 93.88%. Out of all cases of STB, 62/68 (91.18%) were Gene Xpert positive, but only 35/64 (54.69%) was acid-fast bacilli (AFB) culture positive and 53/60(88.33%) was histopathologically conclusive of TB. Also, Gene Xpert was positive in 7/7 (100%) cases of STB in which histopathology were inconclusive and 25/29 (86.21%) cases of STB in which AFB culture was negative. Conclusion: In STB, Gene Xpert clearly outperforms AFB culture and histopathology due to its high sensitivity and specificity apart from being rapid in diagnosis. Hence it is justified to diagnose spinal tuberculosis by Gene Xpert though histopathology is confirmative and AFB culture remains the gold standard.

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Designing and Interpreting COVID-19 Diagnostics: Mathematics, Visual Logistics, and Low Prevalence

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2020-0443-sa ◽

2020 ◽

Author(s):

Gerald J. Kost

Keyword(s):

Sensitivity And Specificity ◽

Predictive Value ◽

Clinical Performance ◽

Geometric Mean ◽

High Sensitivity ◽

False Positives ◽

Predictive Values ◽

Minimum Requirements ◽

Sensitivity Specificity ◽

Low Prevalence

ABSTRACT Context. Coronavirus infectious disease-19 (COVID-19) diagnostics require understanding of how predictive values depend on sensitivity, specificity, and especially, low prevalence. Clear expectations, high sensitivity and specificity, and manufacturer disclosure will facilitate excellence of tests. Objectives. To derive mathematical equations for designing and interpreting COVID-19 tests, assess Food and Drug Administration (FDA) Emergency Use Authorization and Health Canada minimum requirements, establish sensitivity and specificity tiers, and enhance clinical performance in low prevalence settings. Design. PubMed and other sources generated articles on COVID-19 testing and prevalence. EndNote X9.1 consolidated references. Mathematica and open access software helped prove equations, perform recursive calculations, graph multivariate relationships, and visualize patterns, including a new relationship, predictive value geometric mean-squared. Results. Derived equations were used to illustrate shortcomings of COVID-19 diagnostics in low prevalence. Visual logistics helped establish sensitivity/specificity tiers. FDA/Canada's 90% sensitivity, 95% specificity minimum requirements generate excessive false positives at low prevalence. False positives exceed true positives at <5.3% prevalence, or if sensitivity is improved to 100% and specificity to 98%, at <2% prevalence. Recursive testing improves predictive value. Three tiers emerged from these results. With 100% sensitivity, physicians can select desired predictive values, then input local prevalence, to determine suitable specificity. Conclusions. Understanding low prevalence impact will help healthcare providers meet COVID-19 needs for effective testing. Laypersons should receive clinical performance disclosure when submitting specimens. Home testing needs to meet the same high standards as other tests. In the long run, it will be more cost-effective to improve COVID-19 POC tests rather than repeat testing multiple times.

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Pearls and Pitfalls of Interpretation in CT Colonography

Canadian Association of Radiologists Journal ◽

10.1177/0846537119892881 ◽

2020 ◽

Vol 71 (2) ◽

pp. 140-148

Author(s):

Michael Schonberger ◽

Philippe Lefere ◽

Abraham H. Dachman

Keyword(s):

Computed Tomography ◽

Sensitivity And Specificity ◽

False Positive ◽

Ct Colonography ◽

False Negative ◽

High Sensitivity ◽

Negative Results ◽

False Negative Results ◽

The Common

The accuracy of computed tomography (CT) colonography (CTC) requires that the radiologist be well trained in the recognition of pitfalls of interpretation. In order to achieve a high sensitivity and specificity, the interpreting radiologist must be well versed in the causes of both false-positive and false-negative results. In this article, we review the common and uncommon pitfalls of interpretation in CTC.

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SAT-422 Evaluation of the Siemens Thyroid Stimulating Immunoglobulin (TSI) Assay for Diagnosis and Prognosis of Graves’ Disease

Journal of the Endocrine Society ◽

10.1210/jendso/bvaa046.387 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

Author(s):

Heather Paul ◽

Nadia Moledina ◽

Jason Robinson ◽

Alex Chin ◽

Gregory A Kline ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Predictive Value ◽

False Negative ◽

Thyroid Stimulating Hormone ◽

Clinical Findings ◽

Graves Disease ◽

Sample Collection ◽

Primary Analysis ◽

Sensitivity Specificity ◽

Stimulating Hormone

Abstract Background: Hyperthyroidism due to Graves’ disease (GD) is an autoimmune condition caused by thyroid stimulating hormone receptor (TSHR) autoantibodies. Autoantibodies to the TSHR can stimulate or block thyroid hormone production, therefore testing specifically for stimulating antibodies would be beneficial for diagnosis of GD. Objectives: The primary objective of the first phase of this trial is to assess the diagnostic capability of the Siemens Thyroid Stimulating Immunoglobulin (TSI) immunoassay in diagnosing GD and to compare it with the Roche TSH Receptor Antibody (TRAb) assay. Design and Methods: Two hundred patients with suspected GD are being enrolled in this single-center multiphase prospective cohort study. Consenting patients undergo biochemical testing including thyroid stimulating hormone (TSH), free T3 (FT3) and T4 (FT4), TRAb and TSI measurements. GD diagnosis was confirmed by endocrinologists that were blinded to TSI results. Results: To date, 85 patients were included in the analysis, of which 66 were diagnosed with GD. For the primary analysis, all patients taking anti-thyroid drugs (ATD) at time of sample collection (n=14) were removed. The respective sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) for TSI was 98, 84, 94 and 94%, which were comparable to those generated by TRAb (98, 95, 95, and 98%). In patients with clinical findings of GD (ie. orbitopathy or goiter, n=33), both the TSI and TRAb assays had identical sensitivity and specificity at 96% and 80% respectively. In patients without orbitopathy or goiter (n=38), the TSI assay had perfect sensitivity and excellent specificity of 100% and 86% respectively (TRAb had 100% sensitivity and specificity). Sensitivity, specificity, NPV, and PPV were slightly lower for both TSI and TRAb in patients treated with ATDs compared to patients without treatment (TSI: 85, 84, 62, 95%; TRAb: 91, 95, 75, 98%). Of ten patients with GD and false negative TSI results, nine were on ATDs. Of this subset, four patients had discordant results between TSI (negative) and TRAb (positive). Notably, one of these patients had normalization of their FT3 and FT4 on the day of sample collection. Discussion and Conclusion: Based on our preliminary results, TSI is an excellent marker for diagnosing GD, particularly in untreated GD patients. The performance of the TSI assay has been comparable to the TRAb assay and correlates well with clinical findings. Discordant false negative results were only seen in patients on ATD. One potential explanation is that the TSI assay is detecting a decrease in stimulating autoantibodies when there is normalization of FT3 and FT4. Importantly, all discordant samples will be tested by a TSI bioassay to confirm diagnosis. Further patient enrollment is occurring, and prognostic assessment of these assays will soon be possible.

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Standardization and characterization of antigens for the diagnosis of aspergillosis

Canadian Journal of Microbiology ◽

10.1139/w2012-013 ◽

2012 ◽

Vol 58 (4) ◽

pp. 455-462 ◽

Cited By ~ 4

Author(s):

Cheila Denise Ottonelli Stopiglia ◽

Alicia Arechavala ◽

Mariana Carissimi ◽

Julia Medeiros Sorrentino ◽

Valério Rodrigues Aquino ◽

...

Keyword(s):

Mass Spectrometry ◽

Aspergillus Niger ◽

Sensitivity And Specificity ◽

Predictive Value ◽

High Sensitivity ◽

Antigenic Activity ◽

Sds Page ◽

Mascot Search Engine ◽

Commercial Kit

The aim of this study was to develop and characterize antigens for the diagnosis of aspergillosis. Nine strains of Aspergillus species Aspergillus fumigatus , Aspergillus flavus , and Aspergillus niger were grown in Sabouraud and Smith broth to produce exoantigens. The antigens were tested by immunodiffusion against sera from patients with aspergillosis and other systemic mycoses. The protein fraction of the antigens was detected by SDS–PAGE; Western blot and representative bands were assessed by mass spectrometry coupled to a nano Acquity UltraPerformance LC and analyzed by the Mascot search engine. Concurrently, all sera were tested with Platelia Aspergillus EIA. The most reactive antigens to sera from patients infected by A. fumigatus were produced by A. fumigatus MG2 Sabouraud and pooled A. fumigatus Sabouraud samples, both with a sensitivity of 93% and specificity of 100% and 97%, respectively. Aspergillus niger and A. flavus antigens were reactive against A. niger and A. flavus sera, each one with a sensitivity and specificity of 100%. Two proteins, probably responsible for antigenic activity, β-glucosidase in A. fumigatus and α-amylase in A. niger were attained. The commercial kit had a specificity of 22%, sensitivity of 100%, positive predictive value of 48%, and negative predictive value of 100%. The antigens produced showed high sensitivity and specificity and can be exploited for diagnostics of aspergilloma.

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Diagnosis of prion diseases by RT-QuIC results in improved surveillance

Neurology ◽

10.1212/wnl.0000000000010086 ◽

2020 ◽

Vol 95 (8) ◽

pp. e1017-e1026 ◽

Cited By ~ 4

Author(s):

Daniel D. Rhoads ◽

Aleksandra Wrona ◽

Aaron Foutz ◽

Janis Blevins ◽

Kathleen Glisic ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Prion Disease ◽

Disease Surveillance ◽

Prion Diseases ◽

False Negative ◽

High Sensitivity ◽

Disease Type ◽

Diagnostic Sensitivity ◽

Class Iii ◽

The Impact

ObjectiveTo present the National Prion Disease Pathology Surveillance Center's (NPDPSC’s) experience using CSF real-time quaking-induced conversion (RT-QuIC) as a diagnostic test, to examine factors associated with false-negative RT-QuIC results, and to investigate the impact of RT-QuICs on prion disease surveillance.MethodsBetween May 2015 and April 2018, the NPDPSC received 10,498 CSF specimens that were included in the study. Sensitivity and specificity analyses were performed on 567 autopsy-verified cases. Prion disease type, demographic characteristics, specimen color, and time variables were examined for association with RT-QuIC results. The effect of including positive RT-QuIC cases in prion disease surveillance was examined.ResultsThe diagnostic sensitivity and specificity of RT-QuIC across all prion diseases were 90.3% and 98.5%, respectively. Diagnostic sensitivity was lower for fatal familial insomnia, Gerstmann-Sträussler-Scheinker disease, sporadic fatal insomnia, variably protease sensitive prionopathy, and the VV1 and MM2 subtypes of sporadic Creutzfeldt-Jakob disease. Individuals with prion disease and negative RT-QuIC results were younger and had lower tau levels and nonelevated 14-3-3 levels compared to RT-QuIC–positive cases. Sensitivity was high throughout the disease course. Some cases that initially tested RT-QuIC negative had a subsequent specimen test positive. Including positive RT-QuIC cases in surveillance statistics increased laboratory-based case ascertainment of prion disease by 90% over autopsy alone.ConclusionsRT-QuIC has high sensitivity and specificity for diagnosing prion diseases. Sensitivity limitations are associated with prion disease type, age, and related CSF diagnostic results. RT-QuIC greatly improves laboratory-based prion disease ascertainment for surveillance purposes.Classification of evidenceThis study provides Class III evidence that second-generation RT-QuIC identifies prion disease with a sensitivity of 90.3% and specificity of 98.5% among patients being screened for these diseases due to concerning symptoms.

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Lung Ultrasound in the Screening of Pulmonary Interstitial Involvement Secondary to Systemic Connective Tissue Disease: A Prospective Pilot Study Involving 180 Patients

Journal of Clinical Medicine ◽

10.3390/jcm10184114 ◽

2021 ◽

Vol 10 (18) ◽

pp. 4114

Author(s):

Natalia Buda ◽

Anna Wojteczek ◽

Anna Masiak ◽

Maciej Piskunowicz ◽

Wojciech Batko ◽

...

Keyword(s):

Connective Tissue ◽

Connective Tissue Disease ◽

Sensitivity And Specificity ◽

Predictive Value ◽

Lung Ultrasound ◽

Imaging Modality ◽

Connective Tissue Diseases ◽

High Sensitivity ◽

Study Group ◽

A Prospective Study

Objectives: The aim of the study was the assessment of lung ultrasound (LUS) as a screening of pulmonary interstitial involvement secondary to systemic connective tissue diseases. Methods: A prospective study was conducted on the study group comprising 180 patients diagnosed with different systemic connective tissue diseases. Each patient underwent lung ultrasound (LUS), high-resolution chest computed tomography (HRCT), and echocardiography (ECHO). Each imaging examination was blinded and performed by an independent operator. LUS was conducted with convex and linear transducers. Results: The sensitivity and specificity of LUS as compared to HRCT in detecting pulmonary interstitial involvement in the study group were 99.3% and 96.4%, respectively; positive predictive value (PPV) 0.7, negative predictive value (NPV) 3.6. Abnormalities indicating interstitial lung disease (ILD) with fibrosis were most frequently localized bilaterally in the lower fields of the lungs, assessed in the dorsal view. Conclusions: LUS is an efficient imaging modality that can detect pulmonary interstitial involvement in patients with systemic connective tissue disease with a high sensitivity and specificity. Further prospective studies conducted on a larger population are deemed necessary.

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Evaluation of tubal patency by sonosalpingography is as good as hysterosalpingography in infertile women

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20175038 ◽

2017 ◽

Vol 6 (11) ◽

pp. 5129

Author(s):

C. Santhana Lakshmi ◽

Kumara Sampath ◽

Parvatha Vardani

Keyword(s):

Sensitivity And Specificity ◽

Predictive Value ◽

High Sensitivity ◽

Tubal Patency ◽

Less Invasive ◽

Significant Difference ◽

Invasive Method ◽

Tubal Factor ◽

Primary Health Care Centers ◽

Health Care Centers

Background: Tubal pathology is one of the causes of infertility in sub fertile couples. Therefore, evaluation of fallopian tubes forms an essential part of evaluation in a sub fertile woman. The aim of the study was to compare the efficacy of sonosalpingography which is a less invasive method when compared to hysterosalpingogram for evaluation of utero-tubal factor in females.Methods: A total of 95 patients 69 with primary infertility and 26 with secondary infertility attending our Obstetrics and Gynecology department were recruited for the study from June 2016 to July 2017. All the study subjects underwent Sonosalpingography on day 5th to 7th and Hysterosalpingography on 7th to 9th day of the menstrual cycle. Data was collected and compared to assess the sensitivity and specificity of sonosalpingography over hysterosalpingography. Statistical analysis was done by using SPSS software version 16.0.Results: Sonosalpingography (SSG) has 97% sensitivity and 94% specificity in comparison to hysterosalpingography (HSG). Analysis of the raw data gave positive predictive value of 98.3% and negative predictive value of 75%. From the results of this study it clear that there is no statistically significant difference (p = 0.237) between the results of the two methods (SSG and HSG).Conclusions: As sonosalpingogrpahy has high sensitivity and specificity and is less invasive. It should be used initially to assess tubal patency in cases of infertility. SSG is found to be a reliable, relatively less expensive diagnostic and therapeutic procedure in the management of infertility in females. Easy availability and accessibility of ultrasound in all primary health care centers definitely can prove superior to conventional method of diagnosis of tubal patency in such patient.

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Mentorship on malaria microscopy diagnostic service in Ethiopia: Baseline competency of microscopists and performance of health facilities

10.21203/rs.3.rs-87991/v2 ◽

2021 ◽

Author(s):

Bokretsion Gidey ◽

Desalegn Nega ◽

Adugna Abera ◽

Abnet Abebe ◽

Sindew Mekasha ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Predictive Value ◽

False Negative ◽

Malaria Diagnosis ◽

Health Facilities ◽

Malaria Parasites ◽

Cross Sectional ◽

Predictive Values ◽

Microscopic Diagnosis ◽

Malaria Microscopy

Abstract Background: In Ethiopia, malaria cases are declining as a result of proven interventions and in 2017, the country launched a malaria elimination strategy in targeted settings. Accurate malaria diagnosis and prompt treatment are the key components of the strategy to prevent morbidity and stop the continuation of transmission. However, the quality of microscopic diagnosis in general is deteriorating as malaria burden declines. Therefore, this study was carried out to evaluate the competency of microscopists and the performance of health facilities on malaria microscopic diagnosis.Methods: A cross-sectional study was conducted from August 1st to September 30th, 2019 in nine regional states and one city administration. A standard checklist was used for on-site evaluation, archived patient slides were re-checked, and proficiency of microscopists was tested using WHO certified slides from the national slide bank at the Ethiopian Public Health Institute (EPHI). The strength of agreement, the sensitivity, the specificity, and the positive and negative predictive values were calculated.Results: In this study, 102 health facilities (84 health centers and 18 hospitals) were included; from which, 202 laboratory professionals participated. In slide re-checking, moderate agreement (Agreement: 76.0%; Kappa: 0.41) was observed between experts and microscopists on malaria detection in all health facilities. The sensitivity and specificity of routine slide reading and the re-checking results were 78.1% and 80.7%, respectively. Likewise, positive predictive value of 65.1% and negative predictive value of 88.8% were scored in the routine diagnosis. By panel testing, a substantial overall agreement (A: 91.8%; K: 0.79) was observed between microscopists and experts in detecting malaria parasites. The sensitivity and specificity in the detection of malaria parasites was 92.7% and 89.1%, respectively. Furthermore, in identifying species, a slight agreement (A: 57%; K: 0.18) was observed between microscopists and experts. Conclusion: The study found significant false positive and false negative results in routine microscopy on slide re-checking of Plasmodium parasites. Moreover, reduced grade in parasite species identification was reported on the panel tests. Therefore, implementing comprehensive malaria microscopy mentorship, in-service training, and supportive supervision are the key strategies to improve the overall performance of health facilities in malaria microscopy.

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Evaluation of a Rapid Kit for Detection of IgM against Leptospira in Human

Canadian Journal of Infectious Diseases and Medical Microbiology ◽

10.1155/2019/5763595 ◽

2019 ◽

Vol 2019 ◽

pp. 1-4 ◽

Cited By ~ 1

Author(s):

Mohan Rao ◽

Fairuz Amran ◽

Nadia Aqilla

Keyword(s):

Sensitivity And Specificity ◽

Predictive Value ◽

Clinical Manifestations ◽

Rapid Test ◽

Febrile Illness ◽

High Sensitivity ◽

Confirmatory Test ◽

Standard Laboratory ◽

Test Efficiency ◽

Sensitivity Specificity

Introduction. Leptospirosis is an acute febrile illness, known for its protean clinical manifestations and the challenge in differentiating from other infectious diseases. Standardized confirmatory test is antibody dependent and not accessible by the suburban community. This study measures efficiency of an immune-chromatographic assay, Leptocheck WB, in detecting acute leptospirosis. Methods. A total of 142 sera were used for kit evaluation. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated by comparing rapid kit results with gold standard laboratory, microscopic agglutination test (MAT). Results. We found this rapid kit to have a sensitivity and specificity of 66.6% and 78.9%, respectively, whereas the PPV and NPV of the kit appeared to be 73.3% and 73.2%, respectively. Discussion. Test efficiency of this rapid kit is reasonable. It is specific in detecting leptospiral antibody and assures clinician of accurate diagnosis by having higher PPV and NPV. It is prompt and efficient in comparison with conventional methods in assisting differential diagnosis. High sensitivity and specificity leptospirosis rapid test is indeed a crucial measure to assist the diagnosis of acute undifferentiated febrile illnesses.

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