scholarly journals Serological tests in leprosy. The sensitivity, specificity and predictive valueof ELISA tests based on phenolic glycolipid antigens, and the implications for their use in epidemiological studies

1988 ◽  
Vol 101 (1) ◽  
pp. 159-171 ◽  
Author(s):  
P. J. Burgess ◽  
P. E. M. Fine ◽  
J. M. Ponnighaus ◽  
C. Draper

SUMMARYThis paper examines the sensitivity and specificity of two ELISA assays for IgM antibodies toMycobacterium leprae, one employing natural phenolic glycolipid and the other employing a synthetic disaccharide glycoconjugate as antigen. Estimates of sensitivity and specificity are derived, based on a panel of sera from leprosy cases in Malawi and various non-leprosy controls from the UK. Though both assays were able to identify a high proportion of multibacillary patients, neither was able to detect a high proportion of paucibacillary patients without considerable loss of specificity. The implications of the inverse relationship between sensitivity and specificity are discussed with reference to the predictive value of such tests in such areas as Malawi, where the large majority of cases are paucibacillary.

2021 ◽  
pp. 028418512110418
Author(s):  
Katerina Vassiou ◽  
Michael Fanariotis ◽  
Ioannis Tsougos ◽  
Ioannis Fezoulidis

Background Apparent diffusion coefficient (ADC) measurements are not incorporated in BI-RADS classification. Purpose To assess the probability of malignancy of breast lesions at magnetic resonance mammography (MRM) at 3 T, by combining ADC measurements with the BI-RADS score, in order to improve the specificity of MRM. Material and Methods A total of 296 biopsy-proven breast lesions were included in this prospective study. MRM was performed at 3 T, using a standard protocol with dynamic sequence (DCE-MRI) and an extra echo-planar diffusion-weighted sequence. A freehand region of interest was drawn inside the lesion, and ADC values were calculated. Each lesion was categorized according to the BI-RADS classification. Logistic regression analysis was employed to predict the probability of malignancy of a lesion. The model combined the BI-RADS classification and the ADC value. Sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy were calculated. Results In total, 153 malignant and 143 benign lesions were analyzed; 257 lesions were masses and 39 lesions were non-mass-like enhancements. The sensitivity and specificity of the combined method were 96% and 86%, respectively, in contrast to 95% and 81% with BI-RADS classification alone. Conclusion We propose a method of assessing the probability of malignancy in breast lesions by combining BI-RADS score and ADC values into a single formula, increasing sensitivity and specificity compared to BI-RADS classification alone.


2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Heather Paul ◽  
Nadia Moledina ◽  
Jason Robinson ◽  
Alex Chin ◽  
Gregory A Kline ◽  
...  

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.


2014 ◽  
Vol 80 (7) ◽  
pp. 720-722 ◽  
Author(s):  
Rebeccah B. Baucom ◽  
William C. Beck ◽  
Michael D. Holzman ◽  
Kenneth W. Sharp ◽  
William H. Nealon ◽  
...  

Patients with incisional hernias or abdominal pain are frequently referred with abdominal computed tomography (CT) scans. The purpose of this study was to determine the sensitivity and specificity of a CT radiology report for the detection of incisional hernias. General surgery patients with a history of an abdominal operation and a recent viewable abdominal CT scan were enrolled prospectively. Patients with a stoma, fistula, or soft tissue infection were excluded. The results of the radiology reports were compared with blinded, surgeon-interpreted CT for each patient. Testing characteristics including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. One hundred eighty-one patients were enrolled with a mean age of 54 years. Sixty-eight per cent were women. Hernia prevalence was 55 per cent, and mean hernia width was 5.2 cm. The radiology report had a sensitivity and specificity of 79 per cent and 94 per cent, respectively, for hernia diagnosis. The PPV and NPV were 94 and 79 per cent, respectively. Reliance on the CT report alone underestimates the presence of incisional hernia. Referring physicians should not use CT as a screening modality for detection of hernias. Referral to a surgeon for evaluation before imaging may provide more accurate diagnosis and potentially decrease the cost of caring for this population.


Cephalalgia ◽  
2014 ◽  
Vol 35 (5) ◽  
pp. 437-442 ◽  
Author(s):  
Sylvie Streel ◽  
Anne-Françoise Donneau ◽  
Nadia Dardenne ◽  
Axelle Hoge ◽  
Olivier Bruyère ◽  
...  

Introduction Migraine has a considerable social, economic, physical and emotional burden but remains underdiagnosed and undertreated. A specific migraine screening tool could help remove barriers to health care and be an attractive instrument for epidemiological studies. The objective of this work was to assess the validity of an extended French version of ID Migraine™ as a migraine-screening tool. Methods Sixty-seven subjects from the NESCaV study (2010–2012) completed the migraine screen and were diagnosed by a neurologist specializing in headache medicine using the International Classification of Headache Disorders, 2nd edition criteria (gold standard). Agreement between the two diagnoses was evaluated by Cohen kappa coefficient (κ). Sensitivity, specificity and predictive values of the migraine screen were calculated. Results Migraine was diagnosed in 21 (31.3%) of the 67 subjects according to the screening tool and in 24 (35.8%) by the neurologist (κ = 0.90). The prevalence of migraine was unrelated to age, gender, education and perception of financial resources. Sensitivity and specificity of the screen were 87.5% and 100%, respectively. The screen prevalence of migraine with aura was 10.4% (sensitivity and specificity: 83.3% and 96.7%, respectively). Conclusion The extended French version of ID Migraine™ (ef-ID Migraine) is a validated tool to screen migraine in French-speaking countries.


Author(s):  
Friska O ◽  
Tristina N ◽  
Suraya N

Acute coronary syndrome (ACS) is the most common heart disease and has been a leading cause of mortality in Indonesia’s and developed countries population aged over 45 years endemic. The diagnosis of ACS is made by fulfilling 2 of 3 WHO criteria: typicalishemic chest pain, electrocardiogram (ECG) changes specific for ACS and the raise of cardiac biochemical markers. Cardiac troponin T(cTnT) or I (cTnI) are two novel biomarkers with high diagnostic sensitivity and specificity for early diagnosis of ACS especially acutemyocardial infarction (AMI). Troponin I and T are proteins of cardiac myofibrils, released into the bloodstream in the death damages ofcardiomyocyte caused by AMI or injury.The level of cTnI will not increased in patients with decreased renal functions, which is distinctfrom cTnT. The aims of study are to define the sensitivity and specificity of cTnI and cTnT to be cardiac biochemical markers for AMIpatients. From 41 subjects; 29 AMI and 12 subjects non AMI patients in Cardiac Intensive Care Units (CICU) and Emergency Room(ER) of Rumah Sakit Dr. Hasan Sadikin (RSHS) Bandung from September to October 2007 was evaluated. Design of the study was cross sectional and quantitative observational study. The cTnI and cTnT assay using the quantitative immunochromatography method.Sensitivity, spesificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) in subjects who met 2 WHO criteria for AMI,Troponin I was 74%, 86%, 96% and 40%. Sensitivity, spesificity, PPV and NPV In subjects who met 3 WHO criteria for AMI, Troponin Iwas 89%, 57%, 62% and 87%. Sensitivity, specificity, PPV and NPV cTnI was 90%, 100% 100 and 80% for diagnosis of AMI. In subjectswho met 2 WHO criteria for AMI, Troponin T Sensitivity, specificity, PPV and NPV has 88%, 71%, 94% and 56%. In subjects who met3 WHO criteria for AMI sensitivity, specificity, PPV and NPV Troponin T was 94%, 35%, 53% and 89%. And Sensitivity, specificity, PPVand NPV Troponin T was 97%, 67%, 88%, and 89% for diagnosis of AMI. Troponin T is more sensitive than troponin I, but troponin Ihas greater specificity than troponin T in AMI. Troponin I is more specific because no influence from renal dysfunction.


Author(s):  
Mohan Rao ◽  
Fairuz Amran ◽  
Nadia Aqilla

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.


2013 ◽  
Vol 1 (2) ◽  
Author(s):  
Alejandra Hernández-Ceruelos ◽  
Patricia Vázquez-Alvarado ◽  
Nadia Pelallo-Martínez ◽  
Sergio Muñoz-Juárez

The health of an ecosystem can be examined through the use of bioindicators (BI), while the health of a human being can be determined using some molecules such as biomarkers (BM). BI are complete organisms or part of them that can be measured to detect changes in the environment, the presence of pollution and its effect on the ecosystem, as well as the observation of the progress of environmental clean-up. On the other hand, specific kinds of BI are the BM, which are biomolecules, secondary metabolites or measurable parameters used in medical research and practice to provide an insight into the mechanics and course of a disease. In general BM are classified into three groups: exposure, effects or susceptibility, and their role depends on the sensitivity, specificity, reliability and reproducibility of the methods used in the determination of the target molecule selected to be an specific BM, and it has to be validated under the development of guidelines, supported with good laboratory practice, epidemiological studies and clinical trials. BM can be used to detect subclinical stages, to become a diagnostic tool, to observe the efficacy of the treatment or monitoring the different stages on the development of the pathology.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
hisayasu saito ◽  
Satoshi Kuroda ◽  
Kenji Hirata ◽  
Keiichi Magota ◽  
Tohru Shiga ◽  
...  

Background and Purpose - Recent studies have disclosed that inflamed and vulnerable plaques in the carotid artery are at high risk for subsequent ischemic stroke, suggesting the importance of non-invasive diagnostic modalities with high sensitivity and specificity to detect them in patients with carotid artery stenosis. Although many investigators have reported that MR imaging is a useful tool to predict the components of carotid plaque, its validity is not established. On the other hand, 18 F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may be an alternative modality to directly identify the inflamed plaque in carotid artery stenosis. Therefore, this study was aimed to evaluate the validity of MR imaging and 18 F-FDG PET to predict the components of carotid plaques. Methods - Totally 19 patients were included in this study. Prior to carotid endarterectomy (CEA), 18 F-FDG PET, black-blood fat-suppressed T1-weighted (FS-T1) imaging, and 3-dimensional time-of-flight (TOF) imaging were performed in all of them. During CEA, macroscopic observation of carotid plaque was performed under surgical microscope. The specimens were stained with primary antibodies against CD68 and MMP9. Results - 18 F-FDG PET revealed that 11 of 19 patients had the carotid plaque with significantly high 18 F-FDG uptake (SUVmax >2.0). All of them had lipid-rich soft plaque with strong immunoreactivity against CD68 and MMP9. Its sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) to identify lipid-rich soft plaque were all 100%. On the other hands, 6 out of 19 patients had the carotid plaque with high signal intensity on both FS-T1 and TOF imaging. Carotid plaque had a large intraplaque hematoma in these 6 patients. Their sensitivity, specificity, PPV, and NPV to identify intraplaque hematoma were 86%, 100%, 100%, and 92%, respectively. Conclusions - These findings strongly suggest that MRI and 18 F-FDG PET are complementary to predict the components of carotid plaque. The former would be useful to detect vulnerable plaque with subintimal hemorrhage, and the latter would be sensitive to identify vulnerable plaque with lipid-rich component. Therefore, combination of these two modalities may be quite valuable to non-invasively predict the carotid plaque at higher risk for subsequent ischemic stroke.


2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 125-126
Author(s):  
T Hansen ◽  
B Baraty ◽  
C Lu ◽  
D Tanyingoh ◽  
C Maaser ◽  
...  

Abstract Background Higher demands for colonoscopy and magnetic resonance imaging (MRI) for long term disease monitoring can be expected as the prevalence of IBD continues to rise in Canada. As resources are perpetually constrained, timely access to effective monitoring strategies important to direct care are increasingly compromised. Intestinal ultrasound provides a cost-effective solution to these challenges. Intestinal ultrasound (IUS) is a patient-centered, accurate modality used during clinic by non-radiologists to enhance clinical decision making. Minimum IUS training standards have yet to be established. Aims The aim of this study is to report a single operator IUS performance characteristics after completion of 4 weeks of training with 100 completed supervised scans. Methods A single center, prospective, observational study over 4 years utilizing a convenience sample of patients presenting to the inflammatory bowel disease (IBD) clinic at the University of Calgary. A single operator compared IUS to gold standard (either colonoscopy, or alternative cross-sectional imaging) with sensitivity, specificity, positive and negative predictive value calculated for each year. Joinpoint regression was performed to analyze the trend for sensitivity and specificity over the study period. Results A total of 235 IUS were performed on 235 individuals diagnosed with IBD between 2013 and 2016. There were individuals with 26 ulcerative colitis and 209 persons diagnosed with Crohn’s disease. There was a non-significant increase in sensitivity and specificity point estimates over the 4 year period (Table 1). The sensitivity, specificity, positive predictive value, and accuracy of IUS in 2016 were 100% (95% CI: 81%-100%), 92% (95% CI: 62%-100%), 94% (95% CI: 72%-99%) and 97% (95% CI: 8%-100%) respectively. Conclusions IUS provision by a gastroenterologist having completed 100 supervised scans during training within an expert center is sufficient, resulting in high accuracy. Although there is some improvement over time, the trend towards improvement over time is not significant. This study provides evidence to inform IUS training programs with a minimum training standard benchmark, imperative with expanding demand and development of new expert centers. Funding Agencies None


2021 ◽  
Vol 9 (B) ◽  
pp. 1128-1134
Author(s):  
Saif Hassan Alrasheed ◽  
Amel Mohamed Yousif ◽  
Majid A. Moafa ◽  
Abd Elaziz Mohamed Elmadina ◽  
Mohammad Alobaid

BACKGROUND: Sheard and Percival assumed that symptoms from latent strabismus can be avoided if the relevant fusional vergence is adequate to support the heterophoria. AIM: The aim of the study was to determine the sensitivity and specificity of Sheard’s and Percival’s criterion for the diagnosis of heterophoria. METHODS: A cross-sectional hospital-based study was performed at Al-Neelain Eye Hospital Khartoum, Sudan from February to October 2019. Heterophoria was measured using Maddox Wing and fusional vergence using a prism bar. Thereafter, Sheard’s and Percival’s criteria were used for the diagnosis of heterophoria. RESULTS: A total of 230 participants (age = 15–30 years; mean age = 19.34 ± 3.325 years) were recruited for this study. The Sheard’s criteria showed a high sensitivity of 87.2% and a low specificity of 8.0% for the diagnosing of exophoria, with positive and negative predictive values of 65.5% and 26%, respectively. The criteria showed a relatively low sensitivity of 77.8% and a specificity of 9.0% in the diagnosis of esophoria, with a positive and negative predictive values of 56% and 20%, respectively. Percival criteria showed high sensitivity 84.2% and low specificity 9.1% in diagnosing esophoria, with a positive and negative predictive value of 61.5% and 25%, respectively. On the other hand, the criteria showed low sensitivity 67.4% and specificity 13.8% in diagnosing exophoria, with positive and negative predictive value 61.9% and 17%, respectively. CONCLUSION: Sheard’s and Percival’s criteria are useful in diagnosing binocular vision problems. Sheard’s criteria are accurate in diagnosing near exophoria and Percival’s criteria are more accurate in diagnosing near esophoria. Therefore, these criteria provide good clues and predictions for the diagnosis of binocular vision problems.


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