Prospective Diagnostic Test Accuracy Study Research Articles

68Ga-FAPI-04 positron emission tomography/CT and laparoscopy for the diagnosis of occult peritoneal metastasis in newly diagnosed locally advanced gastric cancer: study protocol of a single-centre prospective cohort study

IntroductionAccurate baseline clinical staging is critical to inform treatment decision-making for patients with gastric cancers. Peritoneal metastasis (PM) is the most common form of metastasis in gastric cancer and mainly...

Diagnostic performance of Mycoplasmopsis bovis antibody ELISA tests on bulk tank milk from dairy herds

BackgroundTesting of bulk tank milk (BTM) for Mycoplasmopsis bovis (previously Mycoplasma bovis) antibodies is increasingly popular. However the performance of some commercially available tests is unknown, and cutoff values possibly need to be adjusted in light of the purpose. Therefore, the aim of this study was to compare the diagnostic performance of three commercially available M. bovis antibody ELISAs on BTM, and to explore optimal cutoff values for screening purposes. A prospective diagnostic test accuracy study was performed on 156 BTM samples from Belgian and Swiss dairy farms using Bayesian Latent Class Analysis. Samples were initially classified using manufacturer cutoff values, followed by generated values.ResultsFollowing the manufacturer’s guidelines, sensitivity of 91.4%, 25.6%, 69.2%, and specificity of 67.2%, 96.8%, 85.8% were observed for ID-screen, Bio K432, and Bio K302, respectively. Optimization of cutoffs resulted in a sensitivity of 89.0%, 82.0%, and 85.5%, and a specificity of 83.4%, 75.1%, 77.2%, respectively.ConclusionsThe ID-screen showed the highest diagnostic performance after optimization of cutoff values, and could be useful for screening. Both Bio-X tests may be of value for diagnostic or confirmation purposes due to their high specificity.

Spanish transcultural adaptation of the 4AT score for the evaluation of delirium in the emergency department: a prospective diagnostic test accuracy study

BackgroundDelirium is one of the most common adverse events in older people during hospitalization, especially in the emergency department. Reliable, easy-to-use instruments are necessary to properly manage delirium in this setting. This study aims to evaluate the diagnostic validity of the Spanish version of the 4 ‘A’s Test (4AT) in the ED.MethodsA diagnostic accuracy study was conducted in patients over 65 years old admitted to the Emergency Department who did not have a formal diagnosis of dementia or a severe mental health disorder. Face and content validity were evaluated by an expert panel. Emergency nurses performed the evaluation with 4AT, whilst blinded and trained researchers assessed patients with the Revised Delirium Rating Scale as the gold standard. The content validity index, sensitivity, specificity, positive and negative predictive values, likelihood ratios, Youden’s Index and ROC curves were calculated to evaluate the diagnostic accuracy of the instrument.ResultsOf 393 eligible patients, 380 were finally analyzed. Content validity yielded a median content validity index of 4 (interquartile range: 0). The Spanish 4AT sensitivity (95.83%; 95% ECI: 78.9–99.9%), specificity (92.98%; 95% CI: 89.8–95.4%), positive predictive value (47.92%) and negative predictive value (99.7%) were satisfactory. Youden’s index was 0.89. Positive likelihood ratio was 13.65, and negative likelihood ratio 0.045. The area under the curve was 0.97.ConclusionsThe Spanish version of the 4AT for use in the Emergency Departments is easy-to-use and applicable. The validation results indicate that it is a valid instrument with sufficient predictive validity to identify patients at risk of delirium in the Emergency Departments. Moreover, it is a tool that facilitates the management of an adverse event that is associated with increased mortality and morbidity.

Pleural fluid soluble Fas ligand and tuberculous pleural effusion: a prospective diagnostic test accuracy study.

The diagnosis of tuberculous pleural effusion (TPE) is challenging for pulmonologists. Adenosine deaminase (ADA), interferon-gamma (IFN-γ), and interleukin-27 (IL-27) have some limitations for diagnosing TPE. Soluble Fas ligand (sFasL) had a high diagnostic value for TPE. However, it remains unknown: (I) whether sFasL has an additional diagnostic value to the traditional markers (e.g., ADA); (II) whether sFasL provides a net benefit in patients with undiagnosed pleural effusion; (III) factors affecting the diagnostic accuracy of sFasL for TPE. This study aimed to evaluate the additional diagnostic value and benefit of pleural fluid sFasL for TPE. We prospectively enrolled 211 patients with undiagnosed pleural effusion. The concentration of sFasL in pleural fluid was measured by an enzyme-linked immunosorbent assay (ELISA). The diagnostic accuracy and net benefit of sFasL and ADA for TPE were analyzed by a receiver operating characteristic (ROC) curve, decision curve analysis (DCA), net reclassification improvement (NRI), and integrated discriminant improvement (IDI). The area under the ROC curves (AUCs) of sFasL and ADA were 0.74 (95% CI: 0.65-0.83) and 0.80 (95% CI: 0.71-0.90), respectively. The decision curve of sFasL revealed net benefit. The continuous NRI and IDI of sFasL were 0.36 (0.00-0.72, P=0.05) and 0.02 (-0.01-0.06, P=0.18), respectively. Pleural fluid sFasL has moderate diagnostic accuracy for TPE.

Active close contact investigation of tuberculosis through computer-aided detection and stool Xpert MTB/RIF among people living in Oromia Region, Ethiopia (CADOOL Study): protocol for a prospective, cross-sectional study

IntroductionPulmonary tuberculosis (TB) is an infectious disease with high incidence in low-income countries (LICs); it remains one of the infectious diseases with the highest mortality in the world, especially in...

Can Non-Invasive Spectrophotometric Hemoglobin Replace Laboratory Hemoglobin Concentrations for Preoperative Anemia Screening? A Diagnostic Test Accuracy Study.

Preoperative assessment of hemoglobin concentration in blood is important to diagnose anemia. The primary aim of this prospective diagnostic test accuracy study was to monitor non-invasive spectrophotometric hemoglobin (SpHb, g/dL) concentrations among adults prior to elective surgery and to investigate the correlation and agreement of SpHb with laboratory hemoglobin (Hb, g/dl). A secondary aim was to identify the anemia cut-off values for SpHb based on the World Health Organization (WHO) definitions for anemia. This study included 151 consecutive patients (age ≥ 18 year) presenting for preoperative evaluation prior to scheduled elective general or orthopedic surgery. Results identified the mean ± SD of SpHb at 11.43 ± 2.01 g/dL, which underestimated the mean laboratory Hb (12.64 ± 2.29 g/dL, p < 0.001). A bias mean difference (SpHb-Hb) of -1.21 g/dL, with a SD of 1.76, was reported. This bias (SpHb-Hb) was inversely correlated with the mean Hb concentrations. A positive correlation existed between SpHb and Hb, with a good degree of reliability and a significant Intra Class Correlation (ICC). SpHb diagnosed anemia in 32.3% and 60.3% of males and females, respectively. The SpHb cut-off values to identify anemia were 11.3 and 10.2 g/dL for males and females, respectively, with a sensitivity of 83.3% for males and only 62.9% for females. The specificity for males and females were 81% and 91.3%, respectively. SpHb sensitivity allows for anemia diagnosis among males, but not females. However, the specificity allows SpHb to rule out anemia for both.

Validation of Two Screening Tools for Detecting Delirium in Older Patients in the Post-Anaesthetic Care Unit: A Diagnostic Test Accuracy Study

(1) Background: Delirium is a common complication among surgical patients after major surgery, but it is often underdiagnosed in the post-anaesthetic care unit (PACU). Valid and reliable tools are required for improving diagnoses of delirium. The objective of this study was to evaluate the diagnostic test accuracy of the Three-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) and the 4A's Test (4AT) as screening tools for detection of delirium in older people in the PACU. (2) Methods: A prospective diagnostic test accuracy study was conducted in the PACU and surgical wards of a university-affiliated tertiary care hospital in Victoria, Australia. A consecutive prospective cohort of elective and emergency patients (aged 65 years or older) admitted to the PACU were recruited between July 2021 and December 2021 following a surgical procedure performed under general anaesthesia and expected to stay in the hospital for at least 24 h following surgery. The outcome measures were sensitivity, specificity positive predictive value and negative predictive value for 3D-CAM and 4AT. (3) Results: A total of 271 patients were recruited: 16.2% (44/271) had definite delirium. For a diagnosis of definite delirium, the 3D-CAM (area under curve (AUC) = 0.96) had a sensitivity of 100% (95% CI 92.0 to 100.0) in the PACU and during the first 5 days post-operatively. Specificity ranged from 93% (95% CI 87.8 to 95.2) to 91% (95% CI 85.9 to 95.2) in the PACU and during the first 5 days post-operatively. The 4AT (AUC = 0.92) had a sensitivity of 93% (95% CI 81.7 to 98.6) in the PACU and during the first 5 days post-operatively, and specificity ranged from 89% (95% CI 84.6 to 93.1) to 87% (95%CI 80.9 to 91.8) in the PACU and during the first 5 days post-operatively. (4) Conclusions: The 3D-CAM and the 4AT are sensitive and specific screening tools that can be used to detect delirium in older people in the PACU. Screening with either tool could have an important clinical impact by improving the accuracy of delirium detection in the PACU and hence preventing adverse outcomes associated with delirium.

Validation of a focused echocardiographic training program in first opinion practice.

The EPIC study defines criteria, including echocardiographic assessments of left atrial to aortic ratio (LA:Ao) and left ventricular internal diameter in diastole normalized for body weight (LVIDdN), for dogs with preclinical myxomatous mitral valve disease (MMVD) likely to benefit from pimobendan therapy. Access to echocardiography by a cardiologist is not universally available. Completion of a focused echocardiographic training program would result in accurate identification of dogs fulfilling the EPIC criteria by primary care veterinarians (PC). Six PCs with no previous echocardiographic experience. Prospective diagnostic test accuracy study. After training, each PC evaluated ≤10 dogs that they believed to have preclinical MMVD. The evaluation was repeated by 1 of 3 cardiology diplomates, blinded to the PC's findings. Agreement between clinical assessments and echocardiographic measurements was assessed. Fifty-seven dogs were evaluated by PCs; 1 dog was withdrawn because of congestive heart failure. The median time between PC and cardiologist evaluation was 0 days (range, 0-8). One incorrect diagnosis of MMVD was made by a PC (this dog had dilated cardiomyopathy [DCM]); preclinical MMVD was confirmed by the cardiologist in 55 dogs. No difference in LA:Ao (P= .96; CV=6.9%) was detected between PCs and cardiologists. LVIDdN (1.69 cm/kg0.294 (1.26-2.21) vs 1.73 cm/kg0.294 (1.32-2.73); P= .001; CV=6.5%), was significantly lower when measured by PCs vs cardiologists. PCs and cardiologists agreed regarding assessment of EPIC criteria in 49/56 dogs (Alpha=.761, 95% confidence interval 0.697-0.922). The program effectively trained PCs to accurately assess EPIC criteria in dogs with preclinical MMVD.

Prediction models for SIRS, sepsis and associated organ dysfunctions in paediatric intensive care: study protocol for a diagnostic test accuracy study

IntroductionSystemic inflammatory response syndrome (SIRS), sepsis and associated organ dysfunctions are life-threating conditions occurring at paediatric intensive care units (PICUs). Early recognition and treatment within the first hours of onset...

Comparison and optimisation of screening cutoff values for Mycoplasma bovis antibody ELISAs using serum from youngstock.

Mycoplasma bovis-associated disease can cause tremendous production losses, welfare issues and high antimicrobial use. Therefore, screening cattle for M. bovis antibodies before entering the herd is a popular and possibly cost-efficient way to reduce disease introduction. However, interpretation of results can be challenging due to variable accuracy between tests and populations. This study's objectives were to compare the diagnostic test accuracy of three commercially available M. bovis antibody ELISAs (ID-screen, Bio K302 and Bio K432) and to explore optimal cutoff values for screening purposes. A prospective diagnostic test accuracy study was performed on 170 serum samples from youngstock using Bayesian latent class modelling. Samples were categorised using manufacturer and generated cutoff values. Using the manufacturers' guidelines, ID-screen, Bio K432 and Bio K302 showed 97.6%, 67.4% and 33.6% sensitivity, and 78.8%, 97.6% and 99.1% specificity, respectively. Optimised cutoffs resulted in 94.8%, 82.6% and 78.3% sensitivity, and 94.2%, 92.5% and 79.4% specificity, respectively. The highest diagnostic accuracy for detecting M. bovis antibodies was obtained by ID-screen (≥110%). However, by adjusting cutoff values, the sensitivity of Bio-X tests could be markedly increased, making these tests also applicable as screening tools. Interpretation needs to be careful as antibodies may be linked to both infectious and non-infectious status.

AI software detection of large vessel occlusion stroke on CT angiography: a real-world prospective diagnostic test accuracy study

BackgroundArtificial intelligence (AI) software is increasingly applied in stroke diagnostics. However, the actual performance of AI tools for identifying large vessel occlusion (LVO) stroke in real time in a real-world...

CT perfusion for response evaluation after interventional ablation of hepatocellular carcinoma: a prospective study

BackgroundComputed tomography (CT) perfusion was found to be useful in assessing treatment response in a variety of cancers through the evaluation in the arterial perfusion changes. We investigated the performance of CT perfusion parameters for assessment of hepatocellular carcinoma (HCC) response to radiofrequency ablation (RFA) and trans-arterial chemoembolization (TACE). We conducted a prospective diagnostic test accuracy study that recruited 70 HCC patients who were scheduled to undergo TACE or RFA. For each dynamic CT scan acquisition, four single perfusion CT image maps were generated, including functional maps of blood flow (BF), blood volume (BV), mean transit time (MTT), and permeability surface (PS).ResultsIn TACE-treated lesions, the BV achieved a sensitivity and specific of 100% and 83.3%, at a cutoff level of ≤ 122 ml/min/100 gm, for responders. Likewise, at a cutoff level of > 10 s, transit time had a sensitivity of 90.5% and specificity of 100%. At a cutoff level of ≤ 14 ml/min/100 gm, the PS had a sensitivity of 100% and specificity of 83.33% for responders. In RFA-treated lesions, at a cutoff level of ≤ 170 ml/min/100 gm and ≤ 11 ml/100 gm, the BF and BV had a sensitivity of 100% and specificity 100%, respectively, for responders. At a cutoff level of ≤ 11 ml/min/100 gm, PS had a sensitivity 77.27% and specificity 80%.ConclusionsThe present study confirms the feasibility of CT perfusion for assessment of response to TACE and RFA among patients with HCC.

Comparison of Structural, Functional, Tonometric, and Visual Acuity Testing for Glaucoma: A Prospective Diagnostic Accuracy Study

To determine the diagnostic accuracy of potential screening tests for moderate to advanced glaucoma. Prospective diagnostic test accuracy study. The study enrolled a consecutive series of patients aged ≥50 years who presented to a glaucoma clinic in South India without ever having received automated visual field testing. All participants underwent 8 index tests: OCT of the peripapillary retinal nerve fiber layer, optic disc photography, Moorfield's Motion Displacement Test (MDT), frequency doubling technique perimetry, noncontact tonometry, pneumatonometry, presenting visual acuity, and best-corrected visual acuity. Participants also underwent stereoscopic photographs and Humphrey visual fields, which were used by 2 ophthalmologists to arrive at the reference standard diagnosis of moderate to advanced glaucoma. Sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio. A total of 217 people were enrolled; 321 eyes from 180 participants had all tests performed. Of these, 127 eyes (40%) were classified as having moderate to advanced glaucoma. Among the 8 tests, OCT best optimized sensitivity (84%, 95% confidence interval [CI], 76-90) and specificity (75%, 95% CI, 68-81). Moorfield's Motion Displacement Test was the best perimetric test, with a sensitivity of 91% (95% CI, 85-96) and specificity of 53% (95% CI, 44-61). Pressure and vision tests were not sensitive (e.g., sensitivity of 16%, 95% CI, 9-23 for noncontact tonometry and 23%, 95% CI, 15-31 for best-corrected visual acuity). Moorfield's Motion Displacement Test identified 16 of 127 eyes (13%) with glaucoma that were not captured by OCT, but also had false-positive results in 65 of 194 eyes (34%) without glaucoma that OCT correctly classified as negative. OCT had moderate sensitivity and fair specificity for diagnosing moderate to advancedglaucoma and should be prioritized during an initial assessment for glaucoma.

Evaluation of Four Rapid Antigen Tests for Detection of SARS-CoV-2 virus.

ObjectivesConsidering the increasing, significant burden that coronavirus disease 2019 (COVID-19) imposes on the healthcare system, the need for simple, rapid, and affordable diagnostic tests to support the existing costly and demanding polymerase chain reaction (PCR) assay becomes required. This prospective diagnostic test accuracy study aims to evaluate the performance of four different COVID-19 rapid antigen tests compared to real-time reverse transcription PCR (rRT-PCR) between June and July 2020 to determine the feasibility of integrating these tests into the diagnostic algorithm in clinical settings.MethodsSwabs were collected from 306 patients and analyzed using rRT-PCR and antigen tests from four different providers.ResultsThe antigen tests’ sensitivities were 65.8%, 69.8%, 64.0%, and 64.3% for the STANDARD™ Q COVID-19 Ag test, PCL COVID-19 Ag Rapid fluorescent immunoassay (FIA) test, BIOCREDIT COVID-19 Ag test, and Sofia SARS-CoV-2 antigen FIA test, respectively. Specificity was 94.1% for PCL COVID-19 Ag Rapid test and 100% for the other three assays. All assays showed a significant negative correlation between the reference rRT-PCR Ct values and Ag test results. Besides, sensitivities of the STANDARD™ Q COVID-19 Ag test, PCL COVID-19 Ag Rapid FIA test, and BIOCREDIT COVID-19 Ag test improved to ≥ 85% after exclusion of samples with PCR Ct values > 30.ConclusionsThe high specificity of the rapid antigen tests and other parameters like simplicity, rapidity, and affordability suggest that antigen tests are likely to be helpful if integrated and interpreted appropriately in stepwise diagnostic algorithms. Given the low sensitivity of 64.0–69.8% of the antigen tests, we recommend that clinically relevant negative results undergo further testing Ag to confirm or exclude a COVID-19 diagnosis.

Diagnostic performance of platelet count/spleen diameter ratio to detect esophageal varices in patients with cirrhosis

Introduction: The platelet count/spleen diameter (PC/SD) ratio is a noninvasive method for the diagnosis of esophageal varices (EV) used as an alternative to endoscopy in patients with cirrhosis. Objective: To evaluate the diagnostic performance of the PC/SD ratio (cut-off point &lt;909) to detect EV in patients with cirrhosis treated at a tertiary referral hospital in Bogotá D.C., Colombia. Materials and methods: A prospective diagnostic test accuracy study was conducted in 66 patients with cirrhosis treated at the Hospital Universitario de La Samaritana between July and December 2018. A descriptive analysis of the data was performed. In addition, the diagnostic performance of the PC/SD ratio (cut-off point &lt;909) for the detection of EV was compared with the findings reported in the esophagogastroduodenoscopy (gold standard), calculating its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-). A significance level of p&lt;0.05 was considered. Results: The mean age of the participants was 65.5 years, 53.03% were female, and the most common causes of cirrhosis were alcohol consumption (40.90%) and autoimmune hepatitis (22.72%). EV was diagnosed in 48 patients (72.72%). The PC/SC ratio showed sensitivity of 60%, specificity of 78%, PPV of 0.88, NPV of 0.42, LR+ of 2.73, and LR- of 0.51. Conclusion: The low sensitivity, specificity, and NPV found in the present study suggest that the PC/SD ratio (cut-off point &lt;909) may not be a useful diagnostic test for detecting EV in patients with cirrhosis.

Validation of the 4AT tool for delirium assessment in specialist palliative care settings: protocol of a prospective diagnostic test accuracy study [version 1; peer review: 2 approved

BackgroundDelirium is a serious and distressing neuropsychiatric condition, which is prevalent across all palliative care settings. Hypoactive delirium is particularly common, but difficult to recognize, partly due to overlapping symptoms with depression and dementia. Delirium screening tools can lead to earlier identification and hence better management of patients. The 4AT (4 ‘A’s Test) is a brief tool for delirium detection, designed for use in clinical practice. It has been validated in 17 studies in over 3,700 patients. The test is currently used in specialist palliative care units, but has not been validated in this setting. The aim of the study is to determine the diagnostic accuracy of the 4AT for delirium detection against a reference standard, in hospice inpatients.Methods240 participants will be recruited from the inpatient units of two hospices in Scotland. If a patient lacks capacity to consent, agreement will be sought from a legal proxy. Each participant will complete the 4AT and a reference standard assessment based on the diagnostic delirium criteria in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This will be supplemented by tests of cognition and attention, including reverse days of the week, counting down from 20 to 1, Vigilance 'A', the Observational Scale for Level of Arousal, the modified Richmond Agitation Sedation Scale and the Delirium Rating Scale-Revised-98. The assessments will be conducted in a randomized order by two independent clinicians, who will be blinded to the results until both are complete. Primary outcomes will be the sensitivity and specificity of the 4AT in detecting delirium.DiscussionThe findings will inform clinical practice regarding delirium assessment in palliative care settings.Trial registrationISRCTN ISRCTN97417474 (21/02/2020).

The association between cardiac risk factors and the probability of acute myocardial infarction in the emergency department: analysis from a multicentre prospective observational study in the high sensitivity troponin era.

Hypertension, hyperlipidaemia, diabetes mellitus, smoking and family history are established risk factors for coronary artery disease. This study sought to determine the diagnostic value these factors have in patients presenting to an emergency department (ED) with suspected acute myocardial infarction (AMI). This secondary analysis of a prospective diagnostic test accuracy study took place across 14 hospitals in England. A total of 1273 patients, presenting with suspected cardiac chest pain, were included for analysis - 179 (14.1%) had an adjudicated diagnosis of AMI. AMI diagnosis was adjudicated with serial troponin testing conducted on arrival and 3-12 hours later. The presence of any risk factors was documented at the time of initial presentation. The post-test probability of AMI in the absence of risk factors (9.7%) shifts to only 23.5% when 4-5 factors are present. Associations of risk factors with AMI diagnosis were found as follows; hypertension [odds ratio (OR) 1.47, confidence interval (CI) 1.07-2.02], hyperlipidaemia (OR 1.57, CI 1.14-2.16), diabetes mellitus (OR 1.51, CI 1.04-2.20), smoking (OR 1.51, CI 1.05-2.17) and family history (OR 0.98, CI 0.71-1.37). The area under the receiver operating characteristic curve was 0.58. Traditional cardiac risk factors have limited association with AMI in the ED, but an increasing risk factor burden is associated with increasing prevalence of AMI. These findings suggest that future work to refine existing decision aids used in this patient group may be of value.

Dual-Energy CT for Suspected Radiographically Negative Wrist Fractures: A Prospective Diagnostic Test Accuracy Study.

Background Patients with wrist trauma and negative findings on radiographs often undergo additional MRI examinations to assess for radiographically occult fractures. Dual-energy CT may be more readily available than MRI in some settings. Purpose To evaluate the diagnostic test accuracy of dual-energy CT in helping detect bone marrow edema and fracture in participants with wrist trauma and clinical suspicion of a wrist fracture but with negative findings on radiographs. Materials and Methods Adults were prospectively enrolled between January 2018 and November 2018. Wrists were examined with dual-energy CT and MRI, and images were read by four readers who were blinded to clinical information. The presence of bone marrow edema and fracture was rated per bone. The reference standard for bone marrow edema was the combined reading of MRI scans. The reference standard for fracture was a combined reading of MRI and dual-energy CT scans. A fifth radiologist arbitrated results in case of discrepancies. Diagnostic test accuracy was calculated per reader and for readers combined using exact binomial tests. Results Forty-six participants (mean age, 47 years ± 19 [standard deviation]; 24 men [52%]) were enrolled, and 750 bones (50 wrists) were assessed. Dual-energy CT had an average sensitivity of 94% (95% confidence interval [CI]: 80%, 99%; 31 of 33 wrists) and specificity of 65% (95% CI: 38%, 86%; 11 of 17 wrists) in the detection of wrists with bone marrow edema and a sensitivity of 69% (95% CI: 55%, 81%; 36 of 52 bones) and a specificity of 98% (95% CI: 97%, 99%; 682 of 696 bones) in the detection of edema in individual bones. MRI had a sensitivity of 80% (95% CI: 63%, 91%; 28 of 35 wrists) and a specificity of 93% (95% CI: 68%, 100%; 14 of 15 wrists) in helping detect wrists with fractures. Dual-energy CT had a sensitivity of 91% (95% CI: 77%, 98%; 32 of 35 wrists) and a specificity of 87% (95% CI: 60%, 98%; 53 of 60 wrists) in helping detect wrists with fractures. McNemar tests showed no significant differences between MRI and dual-energy CT (P = .07 to >.99) for all readers. Conclusion Dual-energy CT had a high sensitivity and a moderate specificity in the detection of bone marrow edema of the wrist. Dual-energy CT had high sensitivity and specificity in depicting fractures of the wrist in patients with suspected wrist fractures and negative findings on radiographs. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Fukuda in this issue.

Comparison of intraoperative imprint cytology with frozen section for lymph node metastasis in patients with head and neck cancer.

e18548 Background: Intraoperative evaluation of lymph nodal metastasis in head and neck carcinoma assumes importance in deciding the extent of lymph node dissection. Frozen section is the most commonly employed technique. But it requires significant investment in terms of resources, time and personnel. Intraoperative imprint cytology is a rapid, reliable and an inexpensive alternative. So we conducted a prospective diagnostic test accuracy study to assess the diagnostic accuracy of intraoperative imprint cytology and frozen section for lymph node metastasis in Head and neck Cancer when compared to Gold standard, which is the final Histopathology. Methods: All patients presenting with squamous cell carcinoma of head and neck with clinically N0 neck undergoing surgery as primary treatment were included in the study. For patients undergoing surgery, neck nodal tissue were sent for intraoperative assessment of clinically suspicious nodes. Intraoperative assessment was done by imprint cytology and frozen section and was reviewed and reported by two independent pathologist. The sensitivity, specificity and accuracy of imprint cytology and frozen section were calculated with reference to the final histopathology report. Time duration for reporting were also calcuted for both. Results: Total 34 patients with clinically N0 neck were included in the study and 85 slides were examined for frozen section and imprint cytology. Occult nodal metastasis was found in 16 patients (47.06%). The mean time duration for reporting for frozen was 41.18 ±3.62 minutes where as for imprint cytology it was 18.12 ±2.01 minutes. The concordance rate between the frozen section and imprint cytology was 94.12%. The sensitivity of frozen section was 100 % where as for imprint cytology it was 85.7 %( p = 0.00). The specificity was 98.6 % for frozen section and 95.8 % for imprint cytology (p = 0. 27). The positive predictive value was 93.3 % and 80 % for frozen section and imprint cytology respectively (p = 0.01). The negative predictive value was 100% for frozen section and 97.1% for imprint cytology (p = 0.12). The accuracy for frozen section was 98.8 % where as for imprint cytology it was 94.1%(p = 0.09). Conclusions: Imprint cytology provides a cheaper, accurate, reliable and a rapid alternative for frozen section for intraoperative assessment of neck nodes in squamous cell carcinoma of head and neck and it assumes importance in resource driven countries like India.

Single test rule-out of acute myocardial infarction using the limit of detection of a new high-sensitivity troponin I assay

ObjectivesTo determine the diagnostic accuracy of a high-sensitivity cardiac troponin I (hs-cTnI) assay in patients presenting to the Emergency Department (ED) with suspected acute coronary syndromes. Specifically, we evaluated the use of a single blood test at the time of arrival in the ED, using low hs-cTnI cut-offs. MethodsIn a prospective diagnostic test accuracy study at 14 centers, we included patients presenting to the ED with suspected ACS within 12 h of symptom onset. We drew blood for hs-cTnI (Siemens ADVIA Centaur, overall 99th percentile 47 ng/L, limit of quantification [LoQ] 2.50 ng/L) on arrival. Patients underwent serial cardiac troponin testing over 3–6 h. The primary outcome was an adjudicated diagnosis of acute myocardial infarction (AMI). We evaluated the incidence of major adverse cardiac events (MACE: death, AMI or revascularization) after 30 days. Test characteristics for hs-cTnI were calculated using previously reported cut-offs set at the LoQ and 5 ng/L. ResultsWe included 999 patients, including 131 (13.1%) with an adjudicated diagnosis of AMI. Compared to the LoQ (100.0% sensitivity [95% CI 95.9–100.0%]), 99.7% negative predictive value [NPV; 95% CI 97.6–100.0%]), a 5 ng/L cut-off had slightly lower sensitivity (99.2%; 95% CI 95.8–100.0%) and similar NPV (99.8%; 95% CI 98.6–100.0%) but would rule out more patients (28.6% at the LoQ vs 50.4% at 5 ng/L). MACE occurred in 2 (0.7%) patients with hs-cTnI below the LoQ and 7 (1.4%) patients with hs-cTnI < 5 ng/L. Accounting for time from symptom onset or ECG ischemia did not further improve sensitivity. ConclusionThe Siemens ADVIA Centaur hs-cTnI assay has high sensitivity and NPV to rule out AMI with a single blood test in the ED. At the LoQ cut-off a sensitivity > 99% can be achieved. At a 5 ng/L cut-off it may be possible to rule out AMI for over 50% patients.