S235 – Diagnostic Test Validation: CHAMP in Endolymphatic Hydrops

Objectives The Cochlear Hydrops Analysis Masking Procedure (CHAMP) has been reported with a high sensibility and specificity for the diagnosis of endolymphatic hydrops (ELH). Nevertheless, a complete validation of CHAMP with precise methods has not been done. Our objectives: To determine whether CHAMP has a diagnostic value in patients with definite, probable/possible diagnosis of Meniere's disease or endolymphatic hydrops, based on the criteria of the AAO-HNS. Methods Prospective validation study for a diagnostic test: phase II. Latency of wave V was assessed using CHAMP. We classified subjects in 5 groups: 1-Definite ELH, 2-Probable ELH, 3-Possible ELH, 4-subjects with other otovestibular symptoms, 5-normal hearing subjects. We included cases (groups 1–4) with an episode of vertigo with duration equal or longer than 20 minutes, with or without other otovestibular symptoms. Results We included 67 cases (132 ears). 38 cases (76 ears) completed the follow up and their results are presented. In group 1, the sensibility of CHAMP was 43% and its specificity was 100%. In groups 2–3, the sensitivity was 20% and the specificity 100%, with 0% false positive and 80% false negative results. Other indicators of validity for this diagnostic test are presented. Conclusions CHAMP has a high specificity and low sensibility for the diagnosis of ELH when the delay in wave V latency is used. Future studies may assess the relationship between wave amplitudes to improve the clinical value of CHAMP.

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Diagnostic Value of Endoscopic Ultrasound after Neoadjuvant Chemotherapy for Gastric Cancer Restaging: A Meta-Analysis of Diagnostic Test

Diagnostics ◽

10.3390/diagnostics12010100 ◽

2022 ◽

Vol 12 (1) ◽

pp. 100

Author(s):

Victor Mihai Sacerdotianu ◽

Bogdan Silviu Ungureanu ◽

Sevastita Iordache ◽

Adina Turcu-Stiolica ◽

Antonio Facciorusso ◽

...

Keyword(s):

Gastric Cancer ◽

Diagnostic Test ◽

Endoscopic Ultrasound ◽

Meta Analysis ◽

False Negative ◽

Diagnostic Value ◽

Significant Heterogeneity ◽

True Negative ◽

Negative Results ◽

False Negative Results

This study aimed to evaluate the diagnostic value of endoscopic ultrasound (EUS) after neoadjuvant therapy (NT) for gastric cancer restaging by meta-analysis. We conducted a systematic search of studies published on PubMed and Web of Science up to 30th August 2021. Assessing the risk of bias in the included studies was done with the QUADAS-2 tool. We used R and Review Manager 5.4.1 for calculations and statistical analysis. To evaluate the diagnostic value of EUS after NT for gastric cancer restaging, we performed a meta-analysis on six studies, with a total of 283 patients, including true-positive, true-negative, false-positive, and false-negative results for T1-T4, N0. EUS as a diagnostic test for GC patients after chemotherapy has a relatively low DOR for the T2 (3.96) and T4 stages (4.79) and a relatively high partial AUC for the T2 (0.85) and T4 (0.71) stages. Our results reveal that the pooled sensitivity for T stages after chemotherapy is rather low (29–56%), except for the T3 stage (71%). A potential limitation of our study was the small number of included studies, but no significant heterogeneity was found between them. Our meta-analysis concludes that EUS is not recommended or is still under debate for GC restaging after NT.

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Assessing adrenocortical activity by determining levels of urinary free cortisol and urinary 6β-hydroxycortisol

Acta Endocrinologica ◽

10.1530/acta.0.1200277 ◽

1989 ◽

Vol 120 (3) ◽

pp. 277-283 ◽

Cited By ~ 12

Author(s):

Jiro Nakamura ◽

Minoru Yakata

Keyword(s):

Diurnal Variation ◽

Diagnostic Test ◽

False Negative ◽

Normal Subjects ◽

Urinary Free Cortisol ◽

Negative Results ◽

False Negative Results ◽

Free Cortisol ◽

Cortisol Levels

Abstract. A comparative study of urinary free cortisol and urinary 6β-hydroxycortisol levels as a diagnostic test for hypercortisolemic states was carried out by measuring the excretion in 24-h specimens from 289 apparently healthy subjects and 10 Cushing patients. The diurnal variations of both variables were examined in normal subjects and subjects with altered adrenal activities. Two of the 289 apparently normal subjects had high values of urinary free cortisol; one had a high, the other a normal 6β-hydroxycortisol level; they were later diagnosed as having Cushing's syndrome and infertility, respectively. Three other subjects had high values of the urinary variables, but during 5 years of follow-up did not show any clinical evidence of hypercortisolism. The two urinary variables gave no false-negative results in the Cushing patients. The diurnal variation revealed that levels of 6β-hydroxycortisol change in parallel with those of free cortisol in normal subjects and in subjects with altered adrenal activities. However, the ratio of 6β-hydroxycortisol to free cortisol during the diurnal variation varied from low values when free cortisol levels were high to high values when free cortisol levels were low. In normal subjects, 1 mg of dexamethasone taken orally at 23.00 h completely suppressed the levels of both variables on the following day. It is concluded that urinary 6β-hydroxycortisol is correlated to urinary free cortisol so that measurement of urinary 6β-hydroxycortisol levels can be used as a diagnostic test for hypercortisolism in a way comparable to the method using urinary free cortisol.

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Scoring System for the Diagnosis of COVID-19

The Open Public Health Journal ◽

10.2174/1874944502013010413 ◽

2020 ◽

Vol 13 (1) ◽

pp. 413-414 ◽

Cited By ~ 1

Author(s):

Mohamed Farouk Allam

Keyword(s):

Scoring System ◽

Clinical Symptoms ◽

False Negative ◽

Nasopharyngeal Swab ◽

Rt Pcr ◽

Pcr Assay ◽

Negative Results ◽

False Negative Results ◽

Symptoms And Signs

Due to the international spread of COVID-19, the difficulty of collecting nasopharyngeal swab specimen from all suspected patients, the costs of RT-PCR and CT, and the false negative results of RT-PCR assay in 41% of COVID-19 patients, a scoring system is needed to classify the suspected patients in order to determine the need for follow-up, home isolation, quarantine or the conduction of further investigations. A scoring system is proposed as a diagnostic tool for suspected patients. It includes Epidemiological Evidence of Exposure, Clinical Symptoms and Signs, and Investigations (if available). This scoring system is simple, could be calculated in a few minutes, and incorporates the main possible data/findings of any patient.

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Average Weighted Accuracy: Pragmatic Analysis for a Rapid Diagnostics in Categorizing Acute Lung Infections (RADICAL) Study

Clinical Infectious Diseases ◽

10.1093/cid/ciz437 ◽

2019 ◽

Vol 70 (12) ◽

pp. 2736-2742 ◽

Cited By ~ 1

Author(s):

Ying Liu ◽

Ephraim L Tsalik ◽

Yunyun Jiang ◽

Emily R Ko ◽

Christopher W Woods ◽

...

Keyword(s):

Diagnostic Test ◽

Diagnostic Yield ◽

False Negative ◽

Rapid Diagnostics ◽

Likelihood Ratios ◽

Clinical Value ◽

Predictive Values ◽

Negative Results ◽

Treatment Standard ◽

Lung Infections

Abstract Patient management relies on diagnostic information to identify appropriate treatment. Standard evaluations of diagnostic tests consist of estimating sensitivity, specificity, positive/negative predictive values, likelihood ratios, and accuracy. Although useful, these metrics do not convey the tests’ clinical value, which is critical to informing decision-making. Full appreciation of the clinical impact of a diagnostic test requires analyses that integrate sensitivity and specificity, account for the disease prevalence within the population of test application, and account for the relative importance of specificity vs sensitivity by considering the clinical implications of false-positive and false-negative results. We developed average weighted accuracy (AWA), representing a pragmatic metric of diagnostic yield or global utility of a diagnostic test. AWA can be used to compare test alternatives, even across different studies. We apply the AWA methodology to evaluate a new diagnostic test developed in the Rapid Diagnostics in Categorizing Acute Lung Infections (RADICAL) study.

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False Covid-19 Test Results – Could We Do Things Better? A Personal Opinion

Asian Journal of Pharmacy Nursing and Medical Sciences ◽

10.24203/ajpnms.v8i5.6349 ◽

2020 ◽

Vol 8 (5) ◽

Author(s):

Suzanne Lisbeth Ekelund

Keyword(s):

False Positive ◽

False Negative ◽

Test Results ◽

Negative Results ◽

False Negative Results ◽

Personal Opinion ◽

Potential Problems

This paper describes the problems with false covid-19 test results, both false positive and false negative results. The problems are related to the quality of tests, test sampling and the currently limited follow-up procedures. A test and follow-up strategy that could decrease the potential problems is suggested.

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Imaging-Cytology Correlation of Thyroid Nodules with Initially Benign Cytology

International Journal of Endocrinology ◽

10.1155/2014/491508 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8 ◽

Cited By ~ 7

Author(s):

Shin Hye Hwang ◽

Ji Min Sung ◽

Eun-Kyung Kim ◽

Hee Jung Moon ◽

Jin Young Kwak

Keyword(s):

Thyroid Nodules ◽

False Negative ◽

Needle Aspiration ◽

Malignancy Rate ◽

Negative Results ◽

False Negative Results ◽

Significant Difference ◽

Risk Of Malignancy ◽

Us Findings

Objective. To determine the role of imaging-cytology correlation in reducing false negative results of fine-needle aspiration (FNA) at thyroid nodules.Methods. This retrospective study included 667 nodules 1 cm or larger in 649 patients diagnosed as benign at initial cytologic evaluation and that underwent follow-up ultrasound (US) or FNA following a radiologist’s opinion on concordance between imaging and cytologic results. We compared the risk of malignancy of nodules classified into subgroups according to the initial US features and imaging-cytology correlation.Results. Among included nodules, 11 nodules were proven to be malignant (1.6%) in follow-up FNA or surgery. The malignancy rate was higher in nodules with suspicious US features (11.4%) than in nodules without suspicious US features (0.5%,P<0.001). When a thyroid nodule had discordant US findings on image review after having benign FNA results, malignancy rate increased to 23.3%, significantly higher than that of nodules with suspicious US features (P<0.001). However, no significant difference was found in the risk of malignancy between the nodules without suspicious US features (0.5%) and imaging-cytology concordant nodules (0.6%,P=0.438).Conclusions. Repeat FNA can be effectively limited to patients with cytologically benign thyroid nodules showing discordance in imaging-cytology correlation after initial biopsy, which reduces unnecessary repeat aspirations.

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Spinal arteriovenous shunts: accuracy of shunt detection, localization, and subtype discrimination using spinal magnetic resonance angiography and manual contrast injection using a syringe

Journal of Neurosurgery Spine ◽

10.3171/2015.7.spine15319 ◽

2016 ◽

Vol 24 (4) ◽

pp. 664-670 ◽

Cited By ~ 5

Author(s):

Kittisak Unsrisong ◽

Siriporn Taphey ◽

Kanokporn Oranratanachai

Keyword(s):

False Negative ◽

Injection Technique ◽

Contrast Injection ◽

Accuracy Rate ◽

Negative Results ◽

False Negative Results ◽

Contrast Enhanced ◽

Arteriovenous Shunts ◽

Arterial Feeder

OBJECT The object of this study was to evaluate the accuracy of fast 3D contrast-enhanced spinal MR angiography (MRA) using a manual syringe contrast injection technique for detecting and evaluating spinal arteriovenous shunts (AVSs). METHODS This was a retrospective study of 15 patients and 20 spinal MRA and catheter angiography studies. The accuracy of using spinal MRA to detect spinal AVS, localize shunts, and discriminate the subtype and dominant arterial feeder of the AVS were studied. RESULTS There were 14 pretherapeutic and 6 posttherapeutic follow-up spinal MRA and catheter spinal angiography studies. The spinal AVS was demonstrated in 17 of 20 studies. Spinal MRA demonstrated 100% sensitivity for detecting spinal AVS with no false-negative results. A 97% accuracy rate for AVS subtype discrimination and shunt level localization was achieved using this study's diagnostic criteria. The detection of the dominant arterial feeder was limited to 9 of these 17 cases (53%). CONCLUSIONS The fast 3D contrast-enhanced MRA technique performed using manual syringe contrast injection can detect the presence of a spinal AVS, locate the shunt level, and discriminate AVS subtype in most cases, but is limited when detecting small arterial feeders.

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Repeat FNA Significantly Lowers Number of False Negative Results in Patients with Benign Nodular Thyroid Disease and Features of Chronic Thyroiditis

International Journal of Endocrinology ◽

10.1155/2014/967381 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8 ◽

Cited By ~ 1

Author(s):

Dorota Słowińska-Klencka ◽

Ewa Woźniak-Oseła ◽

Bożena Popowicz ◽

Stanisław Sporny ◽

Mariusz Klencki

Keyword(s):

Thyroid Nodules ◽

Benign Lesion ◽

False Negative ◽

Repeat Biopsy ◽

Chronic Thyroiditis ◽

Negative Results ◽

False Negative Results ◽

Risk Of Malignancy ◽

Ct Features

Purpose. The aim of the study was to compare the risk of thyroid malignancy and efficacy of repeat FNA in patients with thyroid nodules diagnosed cytologically as benign lesion (BL) with features of chronic thyroiditis (BL-CT) and BL without CT features (BL-nCT).Methods. The analysis included 917 patients with BL-CT and 7046 with BL-nCT in the first FNA. Repeat biopsy was carried out in 787 patients of BL-CT and 5147 of BL-nCT; 218 patients of BL-CT and 2462 of BL-nCT were operated; in 88 cases of BL-CT and 563 of BL-nCT both ways of follow-up were available.Results. Outcome of repeat cytology implied surgery more frequently in patients with BL-CT than with BL-nCT—3.2% versus 1.9%,P< 0.05. Incidence of cancer (including incidentalomas) was higher in patients with BL-CT operated after one benign cytology than in patients with two benign FNA outcomes: 10.8% versus 1.6%,P< 0.05. In patients with BL-nCT that difference was not significant: 3.2% versus 2.6%.Conclusions. Patients with thyroid nodules diagnosed as BL with CT features have higher risk of malignancy than patients with BL without CT features. Repeat biopsy significantly lowers percentage of FN results in patients with BL-CT in the first FNA.

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Has the Nitroblue Tetrazolium Test Proved Itself?

PEDIATRICS ◽

10.1542/peds.49.2.311 ◽

1972 ◽

Vol 49 (2) ◽

pp. 311-311

Author(s):

Victor B. Abello

Keyword(s):

False Positive ◽

Bacterial Infections ◽

False Negative ◽

Nitroblue Tetrazolium ◽

Clinical Value ◽

Negative Results ◽

False Negative Results ◽

Nbt Test ◽

Nbt Reduction ◽

Nitroblue Tetrazolium Test

I followed with interest the use of the nitroblue tetrazolium (NBT) reduction test in the differential diagnosis of viral and bacterial infections.1-3 My enthusiasm, however, has been slowly dampened. With more work being done, there has been increasing awareness of the different false-positive and false-negative results.2-5 Consequently, I believe its clinical value is waning even before the test has been generally made available to practitioners. The NBT test will probably fall in the category of WBC and differential in its use in differentiating viral from bacterial infections, which similarly has numerous false-positive and false-negative results and has to be correlated clinically.

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Negative Immunodiffusion Test Results Obtained with Sera of Paracoccidioidomycosis Patients May Be Related to Low-Avidity Immunoglobulin G2 Antibodies Directed against Carbohydrate Epitopes

Clinical and Diagnostic Laboratory Immunology ◽

10.1128/cdli.10.5.802-807.2003 ◽

2003 ◽

Vol 10 (5) ◽

pp. 802-807 ◽

Cited By ~ 23

Author(s):

Andréia R. Neves ◽

Ronei L. Mamoni ◽

Cláudio L. Rossi ◽

Zoilo P. de Camargo ◽

Maria Heloísa S. L. Blotta

Keyword(s):

Paracoccidioides Brasiliensis ◽

False Negative ◽

Enzyme Linked Immunosorbent Assay ◽

Test Results ◽

Sodium Metaperiodate ◽

Negative Results ◽

Carbohydrate Epitopes ◽

False Negative Results ◽

Specific Igg

ABSTRACT Immunodiffusion (ID) is the serologic test most frequently used for the diagnosis and posttherapy follow-up of patients with paracoccidioidomycosis (PCM). The ID test is highly specific (100%), but its sensitivity is relatively low (90%), leading to false-negative results. The aim of this study was to determine the profiles of antibodies in sera from patients with proven PCM and with negative results in the ID test (IDneg) versus positive results in the ID test (IDpos). We analyzed 46 sera from patients with active PCM for total immunoglobulin G (IgG) and IgG subclass responses to Paracoccidioides brasiliensis gp43 antigen (treated or not treated with sodium metaperiodate) by enzyme-linked immunosorbent assay and immunoblotting. Immunoblotting showed that both IDneg and IDpos sera recognized predominantly the gp43 fraction of the P. brasiliensis antigen used in the ID test. IDneg sera contain low-avidity antibodies, low levels of specific IgG (total) and IgG1, and high levels of IgG2 compared with IDpos sera. The antibodies present in IDneg sera were predominantly directed against carbohydrate epitopes, since treatment with sodium metaperiodate resulted in a significant decrease in antibody reactivity. These data suggest that the lack of reactivity of sera from PCM patients in the ID test may be related to the production of low-avidity IgG2 antibodies directed against carbohydrate epitopes.

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