Comparable Diagnostic Performance Research Articles

Integrating Contrast-enhanced US to O-RADS US for Classification of Adnexal Lesions with Solid Components: Time-intensity Curve Analysis versus Visual Assessment.

Purpose To compare the diagnostic performance of time-intensity curve (TIC) analysis and subjective visual assessment of contrast-enhanced US (CEUS) when integrated with the Ovarian-Adnexal Reporting and Data System (O-RADS) US risk stratification system for characterizing adnexal lesions with solid components. Materials and Methods In this prospective multicenter study conducted from September 2021 to December 2022, female individuals with suspected adnexal lesions containing solid components detected at routine US were enrolled. All participants underwent preoperative CEUS examinations. Histopathologic findings were used as the reference standard for diagnosis. Lesions were classified according to the O-RADS US system. Enhancement of solid tissue compared with the outer myometrium was evaluated using both TIC analysis and subjective visual assessment. The diagnostic performance of O-RADS alone and each CEUS assessment method when integrated with the O-RADS US system was assessed and compared using receiver operating characteristic curve analysis. Results A total of 180 lesions (80 malignant and 100 benign histopathologic outcomes) in 175 participants (median age, 47 years [IQR, 33-56]) were analyzed. Incorporating CEUS (assessed through both TIC analysis and subjective visual assessment) with O-RADS US showed significantly improved diagnostic performance over O-RADS US alone, with an area under the receiver operating characteristic curve (AUC) of 0.86 (95% CI: 0.80, 0.91) compared with 0.78 (95% CI: 0.71, 0.84). No evidence of a difference was observed between the AUCs of TIC analysis and subjective visual assessment in the enhancement evaluation of solid tissue with CEUS for adnexal malignancy categorization (P = .83). Conclusion Subjective visual assessment and TIC analysis of CEUS features when integrated with the O-RADS US scoring system showed comparable diagnostic performance in assigning adnexal malignancy risk. Keywords: Adnexal Lesions, Contrast-enhanced US, O-RADS, Time-intensity Curve Analysis Supplemental material is available for this article. © RSNA, 2024.

Same-Day Positron Emission Tomography/Computed Tomography with 68Ga-Radiolabeled Fibroblast Activation Protein Inhibitors and 18F-Fluorodeoxyglucose Imaging for Gastrointestinal Cancers.

Objective: We investigated the clinical practicability of same-day 68Ga-radiolabeled fibroblast activation protein inhibitors (68Ga-FAPI)-first and 18F-fluorodeoxyglucose (18F-FDG) imaging and compared it with same-day 18F-FDG-first or 2-day procedures in diagnosing gastrointestinal cancers. Materials and Methods: Sixty-five patients with confirmed gastrointestinal cancers were divided into same-day 68Ga-FAPI-first group (Group A), same-day 18F-FDG-first group (Group B), and 2-day group (Group C). Low-dose CT and low injection activity were performed on 68Ga-FAPI positron emission tomography/computed tomography (PET/CT). Interval times, radiation dose, diagnostic performance, and detectability were assessed among groups. Additionally, the uptake, tumor-to-liver ratio (TLR), diagnostic efficacy, and TNM stage were compared between the two modalities. Results: The total waiting time for Group C was significantly longer than that for Group A or B (both p < 0.001). The total dose-length product and effective dose decreased in all groups. There were comparable detectability and diagnostic performance among groups (all p > 0.05). The within-group analysis in Group B indicated that 68Ga-FAPI PET/CT had higher uptake in the primary and recurrent lesions than 18F-FDG without differences in TLR, due to higher liver background on 68Ga-FAPI PET than Group A or C (both p < 0.001).68Ga-FAPI PET/CT possessed higher accuracy than 18F-FDG and changed staging in 14 patients (14/65, 21.54%). Conclusions: The same-day 68Ga-FAPI-first and 18F-FDG imaging reduced examination waiting time without increased radiation dose, simultaneously achieving excellent diagnostic performance and improving clinical staging in diagnosing gastrointestinal cancers.

Study on screening and diagnosis of aortic dissection based on non-enhanced CT and deep learning

Abstract Objective To develop a machine learning algorithm to detect aortic dissection on non-contrast-enhanced CT and evaluate the diagnostic ability of the algorithm compared with those of radiologists. Methods This study developed a machine learning algorithm using single-center data collected between May 1st, 2022, and April 30th, 2023. Included in the study were 220 patients (110 with AD and 110 without AD). An AD detection algorithm was developed using a 3D full-resolution U-net architecture. We have continuously trained and developed an algorithm based on machine learning to segment the true and false lumens of the aorta and then determine whether there is aortic dissection. The diagnostic capabilities of our algorithm and three radiologists were also compared. Results The developed algorithm achieved an accuracy of 95.8%, a sensitivity of 93.2%, and a specificity of 92.6%. For radiologists, accuracy, sensitivity, and specificity were 88.6%, 90.6%, and 94.2%, respectively. The algorithm's performance was not significantly different from the mean performance of radiologists in terms of accuracy, sensitivity, or specificity. Conclusion The proposed algorithm showed comparable diagnostic performance to radiologists for detecting AD on non-contrast-enhanced CT, which suggests that the proposed algorithm has the potential to reduce misdiagnosis of AD to improve clinical outcomes.Aortic SegmentationAlgorithm development

CCTA and CTP imaging for detecting clinically suspected in-stent restenosis: a meta-analysis

Abstract Background The evaluation of coronary artery stents via Coronary Computed Tomography Angiography (CCTA) can be compromised by artefacts, potentially undermining its diagnostic accuracy. The integration of CT Perfusion (CTP) with CCTA (CCTA+CTP) has been proposed to enhance the diagnostic yield in detecting in-stent restenosis (ISR). Purpose This meta-analysis aims to assess the diagnostic performance of CCTA and combined CCTA+CTP in detecting ISR. Methods A comprehensive literature search of studies from 2005 to 2022 identified 13,747 articles. Inclusion criteria comprised the utilization of multidetector CT scanners with ≥64 slices and invasive coronary angiography as the reference standard. Studies that systematically evaluated stent patency in asymptomatic patients as part of their protocol were excluded. Results After removing duplicates, screening titles and abstracts, and conducting full-text reviews, 20 studies met the inclusion criteria (17 CCTA, 3 CCTA+CTP). Data on 2,674 CCTA-assessed stents and 752 CCTA+CTP-assessed stents were analyzed. The meta-analysis revealed that CCTA alone achieved a sensitivity of 90% (95% CI; 84-94%) and a specificity of 89% (95% CI; 86-92%)(Figure 1). CCTA+CTP exhibited comparable diagnostic performance, with a per-stent sensitivity of 88% (95% CI; 80-94%) and a specificity of 88% (95% CI; 84-93%) (Figure 2). The summary Receiver Operating Characteristic (sROC) Area Under the Curve (AUC) was 0.96 (95% CI; 0.94-0.97) for CCTA and 0.96 (95% CI; 0.89-1.00) for CCTA+CTP, indicating a high overall performance for both diagnostic modalities. Conclusion Utilizing contemporary imaging hardware, both CCTA and CCTA+CTP demonstrate high diagnostic performance in evaluating ISR. The findings suggest that the presence of coronary artery stents should not preclude the use of these non-invasive diagnostic tests in clinical practice.Figure 1Figure 2

Feasibility of knee magnetic resonance imaging protocol using artificial intelligence-assisted iterative algorithm protocols: comparison with standard MRI protocols.

To evaluate the image quality and diagnostic performance of AI-assisted iterative algorithm protocols (AIIA) in accelerated fast spin-echo magnetic resonance imaging (MRI) versus standard (SD) fast spin-echo MRI for clinical 3.0 T rapid knee scans. The accelerated sequence, which includes fat-suppression proton density-weighted imaging (FS-PDWI), T2-weighted imaging (T2WI), and T1-weighted imaging (T1WI), was used in conjunction with the SD sequence in 61 patients who underwent MRI scans. SD images were processed using standard reconstruction techniques, while accelerated images utilized AIIA reconstruction. Quantitative assessments of image quality were conducted, measuring noise levels, signal-to-noise ratio (SNR) and contrast signal-to-noise ratio (CNR). Additionally, subjective evaluations were performed using a Likert five-point scale to assess image quality. The SD group completed the entire knee scan in 466 s, while the AIIA group completed the scan in 312 s. Compared to the SD group, the AIIA group had a noticeably higher SNR of T1WI in the femur and subpatellar fat pad (p = 0.04, 0.001). On the other hand, T2WI femur SNR was noticeably higher in the SD group (p = 0.004). Measurements of SNR, CNR and other noise levels showed no statistically significant changes. Compared to the SD group, the AIIA group had significantly higher subjective image quality scores for every sequence (p < 0.05). There was a modest to large intraclass correlation value (ICC = 0.65-0.90) for the anomalies that were examined among readers. Both the AIIA and SD procedures were shown to have comparable diagnostic performance for meniscal and cruciate ligament rupture (p > 0.05). Images processed using AIIA reconstruction were acquired faster while maintaining comparable image quality and diagnostic capability, meeting the requirements for clinical diagnosis.

A multi-institutional study on Ultrasound image analysis for staging HBV-derived liver fibrosis: a potential non-invasive alternative to liver stiffness measurement

Background: Liver stiffness measurement is principal for staging liver fibrosis but not included in routine examinations. We investigated whether comparable diagnostic performance can be achieved by mining ultrasound images and developing a novel serum index (NSI). Methods: Texture features were extracted from ultrasound images. Spearman correlation and logistics regression selected independent variables for significant (F≥2) and advanced (F≥3) fibrosis. We compared the diagnostic performance of transient elastography (TE), ultrasound image biomarker (UIB), conventional serum indices (APRI, FIB-4, GPR), and NSI in 365 chronic hepatitis B patients. Results: Among patients, 52.1% had significant fibrosis and 24.2% had advanced fibrosis. PLT, GGT, prealbumin, and globulin were incorporated into NSI. In the validation group, TE achieved the best performance (AUC: 0.765 [0.690-0.849] for significant fibrosis; 0.812 [0.745-0.878] for advanced fibrosis), followed by UIB (AUC: 0.712 [0.629-0.795]; 0.678 [0.595-0.763]) and NSI (AUC: 0.630 [0.534-0.725]; 0.659 [0.572-0.745]), outperforming conventional indices. Conclusions: Texture analysis enhances ultrasound's diagnostic utility, but TE remains superior. When TE is unavailable, ultrasound image analysis and NSI, incorporating prealbumin, can serve as alternative tools for fibrosis staging.

A controlled study of MR DWI, FS-PDW, and CE-T1W imaging for the evaluation of the internal opening of anal fistulas.

Anal fistula (AF) is an abnormal tunnel under the skin connecting the anal canal in the colon to the skin of buttocks. Fat-suppressed (FS) proton density-weighted (PDW) imaging is mainly used for the diagnosis of diseases involving bones and joints. Until now, its value in the diagnosis of anal fistula has been rarely reported. To compare three magnetic resonance imaging (MRI) sequences - diffusion-weighted imaging (DWI), FS-PDW), and contrast-enhanced (CE) T1-weighted (T1W) imaging - for the diagnostic value of the internal opening of AF. MRI scans of 132 patients suspected of having AF between December 2021 and April 2023 were retrospectively analyzed. In total, 65 patients who underwent preoperative MRI and were treated surgically were included. The lesion conspicuity and accuracy for featuring AF were calculated by evaluating the three imaging datasets DWI, FS-PDW, and CE-T1W imaging, with surgical findings serving as the reference standard for the presence of fistulas. The statistical analysis included the application of the chi-square test and Kruskal-Wallis test. In 65 patients with AF, 87 internal openings of AF were confirmed. In terms of the diagnostic accuracy of the internal openings, both FS-PDW and CE-T1W imaging sequences were significantly better than DWI sequences, and the difference was statistically significant (P < 0.05). The FS-PDW imaging sequence showed comparable diagnostic performance of the internal opening of AF to CE-T1W imaging, which can provide an important diagnostic basis for clinical procedures.

B-101 Assessing the Performance of Cerebrospinal Fluid Kappa Immunoglobulin Free Light Chain as a Diagnostic Marker for Multiple Sclerosis Using Automated Chart Review

Abstract Background Multiple sclerosis (MS) is an immune-mediated central nervous system (CNS) demyelinating disease which is diagnosed based on CNS lesions' spatial and temporal dissemination. The 2017 revised McDonald Criteria include cerebrospinal fluid (CSF) specific oligoclonal bands (OCBs) to indicate dissemination in time, but their assessment is labor-intensive and requires a paired serum sample. Kappa immunoglobulin free light chain in CSF (KCSF) has emerged as a more sensitive but less specific MS biomarker, measured from a single CSF sample. Our institution's MS testing panel uses KCSF initially to rule out MS, with reflex to OCB for positive confirmation if KCSF is borderline positive (≥0.06 mg/dL). However, manual correlation of laboratory and clinical data hinders the direct comparison of the diagnostic performance between these markers. Herein we report a retrospective assessment of KCSF and OCB diagnostic performance using automated chart review. Methods Between January 1st, 2021 and December 31st, 2022, there were 1,237 patients with simultaneously measured OCB and KCSF. CSF-specific OCBs were measured by separating CSF and serum proteins using an agarose isoelectric focusing gel with a pH gradient from 3-10 (Sebia). After transfer to nitrocellulose paper, antisera were applied to visualize IgG specific bands and quantify CSF-specific OCBs. KCSF was quantitated using nephelometry by applying free light chain antisera (Binding Site) to CSF samples using a Siemens BNII analyzer. An automated chart review process utilizing keyword matching was implemented to identify patients with MS. An initial filter phase required presence of the term “multiple sclerosis”, while a second required the presence of any of the following terms: “primary progressive,” “secondary progressive,” “relapsing remitting,” “progressive relapsing,” or “tumefactive” to identify patients with diagnosed MS. The automated method’s performance was then compared to a manual chart review of 200 randomly selected patients. Subsequently, the automated process was used to determine the MS diagnosis status of all 1,237 patients. Results Of the 200 manually reviewed patients, 44 MS diagnoses were found. The automated process correctly identified 41 of these with a resulting sensitivity and specificity of 93.18% and 95.51%, respectively. Applied to the entire cohort, the automated review identified 275 MS diagnoses. For the entire cohort, the area under the curve (AUC) for the receiver operating characteristic (ROC) curves for OCB and KCSF were 0.824 (95% confidence interval: 0.794, 0.854) and 0.808 (0.777, 0.839) respectively. Our institution’s diagnostic cutoff of ≥2 for OCB yielded a sensitivity and specificity of 74.2% (68.3%, 79.1%) and 84.9% (73.8%, 89.5%), respectively. The best combination for sensitivity and specificity for KCSF with the Youden index yielded a cutoff ≥0.0654 mg/dL (sensitivity of 79.6% [73.1%, 84.0%] and specificity of 72.4% [62.8%, 76.8%]), which is similar to previous publications. This supports the use of automated chart review and suggests the KCSF cutoff has been stable over time. Conclusions KCSF exhibits comparable MS diagnostic performance to OCB yet only requires one CSF sample and can be measured rapidly. When validated, mining unstructured data allows for test performance characterization in large patient cohorts without the need for manual chart review.

A Recognition System for Diagnosing Salivary Gland Neoplasms Based on Vision Transformer

Salivary gland neoplasms (SGNs) represent a group of human neoplasms characterized by a remarkable cyto-morphological diversity, which frequently poses diagnostic challenges. Accurate histological categorization of salivary tumors is crucial to make precise diagnoses and guide decisions regarding patient management. Within the scope of this study, a computer-aided diagnosis model utilizing Vision Transformer, a cutting-edge deep-learning model in computer vision, has been developed to accurately classify the most prevalent subtypes of SGNs. These subtypes include pleomorphic adenoma, myoepithelioma, Warthin's tumor, basal cell adenoma, oncocytic adenoma, cystadenoma, mucoepidermoid carcinoma and salivary adenoid cystic carcinoma. The dataset comprised 3046 whole slide images (WSIs) of histologically confirmed salivary gland tumors, encompassing nine distinct tissue categories. SGN-ViT exhibited impressive performance in classifying the eight salivary gland tumors, achieving an accuracy of 0.9966, an AUC value of 0.9899, precision of 0.9848, recall of 0.9848, and an F1-score of 0.9848. When compared to benchmark models, SGN-ViT surpassed them in terms of diagnostic performance. In a subset of 100 WSIs, SGN-ViT demonstrated comparable diagnostic performance to that of the chief pathologist while significantly reducing the diagnosis time, indicating that SGN-ViT held the potential to serve as a valuable computer-aided diagnostic tool for salivary tumors, enhancing the diagnostic accuracy of junior pathologists.

Head-to-Head Comparison of the Diagnostic Performance of FDG PET/CT and FDG PET/MRI in Patients With Cancer: A Systematic Review and Meta-Analysis.

BACKGROUND. The available evidence on the use of FDG PET/MRI performed using an integrated system in patients with cancer has grown substantially. OBJECTIVE. The purpose of this study was to perform a systematic review and meta-analysis comparing the diagnostic performance of FDG PET/CT and FDG PET/MRI in patients with cancer. EVIDENCE ACQUISITION. MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched for studies reporting a head-to-head comparison of the diagnostic performance of FDG PET/CT and FDG PET/MRI in patients with cancer from July 1, 2015, to January 25, 2023. The two modalities' diagnostic performance was summarized, stratified by performance end point. For end points with sufficient data, a meta-analysis was performed using bivariate modeling to produce summary estimates of pooled sensitivity and specificity. For the remaining end points, reported performance in individual studies was recorded. EVIDENCE SYNTHESIS. The systematic review included 29 studies with a total of 1656 patients. For patient-level detection of regional nodal metastases (five studies), pooled sensitivity and specificity for PET/MRI were 88% (95% CI, 74-95%) and 92% (95% CI, 71-98%), respectively, and for PET/CT were 86% (95% CI, 70-94%) and 86% (95% CI, 68-95%). For lesion-level detection of recurrence and/or metastases (five studies), pooled sensitivity and specificity for PET/MRI were 94% (95% CI, 78-99%) and 83% (95% CI, 76-88%), respectively, and for PET/CT were 91% (95% CI, 77-96%) and 81% (95% CI, 72-88%). In individual studies not included in the meta-analysis, PET/MRI in comparison with PET/CT showed staging accuracy in breast cancer of 98.0% versus 74.5% and in colorectal cancer of 96.2% versus 69.2%; sensitivity for primary tumor detection in cervical cancer of 93.2% versus 66.2%; and sensitivity, specificity, and accuracy for lesion-level liver metastasis detection of 91.1-98.0% versus 42.3-71.1%, 100.0% versus 83.3-98.6%, and 96.5-98.2% versus 44.7-86.7%, respectively. In three studies, management was more commonly impacted by information from PET/MRI (5.2-11.1%) than PET/CT (0.0-2.6%). CONCLUSION. PET/MRI showed comparable or superior diagnostic performance versus PET/CT across a range of cancers and end points. CLINICAL IMPACT. The findings help to identify clinical settings where PET/MRI may provide clinical benefit for oncologic evaluation. TRIAL REGISTRATION. Prospective Register of Systematic Reviews CRD42023433857.

Image-guided multiparametric magnetic resonance imaging-transrectal ultrasound fusion biopsy augmented with a sextant versus an extended template random biopsy: Comparison of cancer detection rates, complication and functional outcomes.

To compare the efficacy of a novel fusion template "reduced six-core systemic template and multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion targeted biopsy" (TBx+6c), with mpMRI/TRUS fusion-targeted biopsy and 12-core systematic biopsy template (TBx+12c) in the diagnosis of prostate cancer (PCa). This is an institutional review board approved single-center observational study involving adult men undergoing fusion-targeted biopsies for the diagnosis of PCa. Patients were sorted into cohorts of TBx+6c or TBx+12c based on the systematic biopsy template used. The study's main objective was to determine the cancer detection rate (CDR) for overall PCa and clinically significant PCa (csPCa) and the secondary objectives were to compare complication rates and functional outcome differences between the cohort. A total of 204 patients met study's inclusion criteria. TBx+6c group had 120 patients, while TBx+12c cohort had 84 patients. The groups had similar baseline characteristics and overall CDR in the TBx+6c cohort was 71.7% versus 79.8%, compared to the TBx+12c (p = 0.18) whereas, the csPCa detection rate in the TBx+6c group was 50.8% versus 54.8% in the TBx+12c group (p = 0.5). TBx+6c cohort had lower overall complication rate of 3% versus 13%, (p = 0.01) and ≥ grade 2 complication rates (1 (1%) vs. 3(4%), p = 0.03) compared to the TBx+12c cohort. There were no differences in IIEF-5 (p = 0.5) or IPSS (p = 0.1) scores at baseline and 2-weeks and 6-weeks post-biopsy. TBx+6c cohort, when compared to the TBx+12c cohort, demonstrated comparable diagnostic performance along with similar functional outcomes and lower complication rates. These results suggest the importance of further exploring the clinical implications of adopting a TBx+6c schema for PCa diagnosis in comparison to the widely used TBx+12c schema through a multicenter randomized controlled trial.

"Amr Sign": A Case-Control Study Evaluating the Diagnostic Value of a New Clinical Sign in the Diagnosis of Acute Appendicitis.

Introduction Acute appendicitis, a prevalent cause of acute abdominal pain and a common indication for emergency surgery, presents a diagnostic challenge due to its diverse clinical presentation and variability in appendix location and symptoms. Traditional diagnostic approaches, including physical examination, clinical scoring systems, and imaging techniques, have limitations. This study introduces the "Amr sign," a new diagnostic indicator characterized by sudden reflex hyperextension of the neck upon palpation of the right iliac fossa, which is hypothesized to reflect local peritoneal irritation from an inflamed appendix. Methods We conducted a prospective observational study at Alwakra Hospital from November 2016 to January 2019 that included 195 patients aged 15 years and older with right iliac fossa pain and an Alvarado score of four or more. The "Amr sign" was evaluated alongside standard clinical examination and imaging results. Diagnostic accuracy was assessed via histopathological confirmation, which is the gold standard. Results The "Amr sign" had a sensitivity of 68.6% and a specificity of 67.3%. The positive predictive value (PPV) was 89%, whereas the negative predictive value (NPV) was 45%. Receiver operating characteristic (ROC) analysis revealed an area under the curve (AUC) of 0.679 for the "Amr sign" compared with 0.622 for the other imaging modalities, suggesting comparable diagnostic performance. The "Amr sign" demonstrated a higher likelihood ratio of a positive test (2.3) and a lower likelihood ratio of a negative test (0.46). Conclusion The "Amr sign" is a promising diagnostic tool for acute appendicitis, offering a simple, reliable, and quick test that can be performed by less experienced physicians. While its sensitivity and specificity are moderate, its high PPV suggests that it is particularly useful in confirming appendicitis. Further research and validation are needed to fully establish its role in clinical practice.

Comparison of micro-flow imaging and contrast-enhanced ultrasonography in assessing segmental congestion after right living donor liver transplantation.

This study aimed to determine whether micro-flow imaging (MFI) offers diagnostic performance comparable to that of contrast-enhanced ultrasonography (CEUS) in detecting segmental congestion among patients undergoing living donor liver transplantation (LDLT). Data from 63 patients who underwent LDLT between May and December 2022 were retrospectively analyzed. MFI and CEUS data collected on the first postoperative day were quantified. Segmental congestion was assessed based on imaging findings and laboratory data, including liver enzymes and total bilirubin levels. The reference standard was a postoperative contrast-enhanced computed tomography scan performed within 2 weeks of surgery. Additionally, a subgroup analysis examined patients who underwent reconstruction of the middle hepatic vein territory. The sensitivity and specificity of MFI were 73.9% and 67.5%, respectively. In comparison, CEUS demonstrated a sensitivity of 78.3% and a specificity of 75.0%. These findings suggest comparable diagnostic performance, with no significant differences in sensitivity (P=0.655) or specificity (P=0.257) between the two modalities. Additionally, early postoperative laboratory values did not show significant differences between patients with and without congestion. The subgroup analysis also indicated similar diagnostic performance between MFI and CEUS. MFI without contrast enhancement yielded results comparable to those of CEUS in detecting segmental congestion after LDLT. Therefore, MFI may be considered a viable alternative to CEUS.

Performance evaluation of microfluidic microplate-based fluorescent ELISA for qualitative detection of SARS-CoV-2–specific IgG and IgM

We evaluated the diagnostic performance of newly developed microfluidic microplate-based fluorescent ELISA for anti-SARS-CoV-2 antibody detection: the Veri-Q opti COVID-19 IgG and IgM ELISAs (hereafter, “Opti IgG/M”; MiCo BioMed, Gyeonggi-do, Republic of Korea), in comparison with conventional ELISAs. A total of 270 serum samples were analyzed, among which 90 samples were serially obtained from 25 COVID-19 patients. Another 180 samples were collected from 180 SARS-CoV-2–negative individuals. As comparative assays, we used SCoV-2 Detect IgG/M ELISA (hereafter, “InBios IgG/M”; InBios, Seattle, WA, USA) and Veri-Q COVID-19 IgG/IgM ELISA (hereafter, “Veri-Q IgG/M”; MiCo BioMed). Compared with conventional ELISAs, the Opti IgG yielded 97.1–100.0% positive percent agreement, 95.2–98.0% negative percent agreement, 96.3–97.8% total percent agreement, and kappa values of 0.90–0.94. Between the Opti IgM and the InBios IgM, the values were 93.7%, 96.6%, 95.9%, and 0.89, respectively. For the Opti IgG, sensitivities for the samples collected from 0–7, 8–14, 15–21, and ≥ 22 days after symptom onset were 40.0, 58.3, 94.1, and 100.0%, respectively. The values for the Opti IgM were 30.0, 54.2, 88.2, and 80%, respectively. The diagnostic specificities of the Opti IgG and IgM were 99.4 and 97.2%, respectively. The microfluidic microplate-based fluorescent ELISAs showed comparable diagnostic performance to conventional ELISAs for detecting anti-SARS-CoV-2 antibodies. With the combination of high throughput, a simplified workflow, and the ability to analyze reduced volumes, this new technology has great potential for improving SARS-CoV-2 serologic testing.

The Aspergillus galactomannan Ag VIRCLIA® Monotest and the sõna Aspergillus galactomannan lateral flow assay show comparable performance for the diagnosis of invasive aspergillosis.

Rapid galactomannan tests, such as the sõna Aspergillus GM Lateral Flow Assay (GM-LFA) and the Aspergillus Galactomannan Ag VIRCLIA® Monotest (GM-Monotest), which are suitable for the analysis of single samples, have the potential to accelerate diagnosis of invasive aspergillosis (IA). To compare the performance of the GM-Monotest and the GM-LFA for the diagnosis of IA. Two patient cohorts were analysed: adults who had received an allogeneic haematopoietic stem-cell transplant (alloHSCT-cohort) and patients with proven/probable IA from a 5-year period (cross-sectional IA-cohort). In the alloHSCT-cohort, weekly serum samples were tested, whereas in the cross-sectional IA-cohort sera and bronchoalveolar lavage fluids were analysed. The diagnostic performance was calculated using two definitions for positivity: (1) a single positive GM result and (2) at least two positive GM results from consecutive samples. IA classification followed EORTC/MSG 2019. The alloHSCT-cohort included 101 patients. Four had proven/probable IA, 26 possible IA and 71 no IA. The specificity for one positive serum and two consecutively positive sera was 88.7% and 100% (GM-Monotest) and 85.9% and 98.6% (GM-LFA). Comparison of ROC curves in the alloHSCT-cohort showed no significant difference. The cross-sectional IA-cohort included 59 patients with proven/probable IA. The sensitivity for one positive sample and two consecutively positive samples was 83.1% and 55.1% (GM-Monotest) and 86.4% and 71.4% (GM-LFA). Both assays showed comparable diagnostic performance with a higher sensitivity for the GM-LFA if two consecutive positive samples were required for positivity. However, due to poor reproducibility, positive GM-LFA results should always be confirmed.

Diagnostic Performance of Point-of-Care High-Sensitivity Troponin in the Exclusion of Non-ST-Elevation Myocardial Infarction in the Emergency Department.

This study evaluates the diagnostic performance of high-sensitivity troponin using point-of-care testing (POCT) devices compared with main laboratory measurements for ruling out non-ST-elevation myocardial infarction (NSTEMI) in emergency department (ED) patients presenting with non-traumatic chest pain. This multicenter, observational, prospective, non-interventional study was conducted in two Spanish hospitals from 1 June to 31 December 2023 and included adult patients presenting with non-traumatic chest pain admitted to the ED. High-sensitivity troponin levels were measured using both the Siemens Atellica® VTLi POCT device and main laboratory testing, with data collected on analytical results and measurement times. Of the 201 patients who met the inclusion criteria, a significant correlation was observed between the POCT and laboratory assays. The area under the curve (AUC) of the ROC curve was consistently greater than 0.9, indicating a high diagnostic accuracy for ruling out NSTEMI. In addition, measurement times were significantly reduced using POCT compared to the core laboratory. These results suggest that high-sensitivity troponin POCT devices offer comparable diagnostic performance to traditional laboratory methods for the diagnosis of NSTEMI in the emergency department, potentially speeding up clinical decisions and optimizing resource utilization.

Diagnostic performance of ADC and ADCratio in MRI-based prostate cancer assessment: Asystematic review and meta-analysis.

To identify factors influencing the diagnostic performance of the quantitative imaging biomarkers ADC and ADCratio in prostate cancer (PCa) detection. A systematic literature search was conducted in Embase, Medline and Web of Science, for studies evaluating ADC values and ADCratio for PCa diagnosis, using the same patient cohorts and using histopathological references as ground truth. Pooled sensitivities, specificities, summary ROC curves and AUCs were calculated from constructed contingency data tables. Diagnostic performance (AUC) was quantitatively pooled using a bivariate mixed effects model. For identifying influencing factors, subgroup analysis, publication bias and heterogeneity assessment were investigated. Thirteen studies, involving 1038 patients and 1441 lesions, were included. For ADC, the pooled sensitivity and specificity was 80% (95% CI: 74-85%) and 78% (95% CI: 70-85%), respectively. For ADCratio pooled sensitivity and specificity was 80% (95% CI: 74-84%) and 80% (95% CI: 71-87%). Summary ROC analysis revealed AUCs of 0.86 (95% CI: 0.83-0.89) and 0.86 (95% CI: 0.83-0.89), respectively. Meta-regression showed heterogeneity between both imaging biomarkers. Subgroup analysis showed that ADCratio improved diagnostic performance in comparison to ADC when including both peripheral and transitional zone lesions (AUC: 0.87 [95% CI: 0.84-0.90] and 0.82 [95% CI: 0.79-0.85], respectively). Both ADC and ADCratio imaging biomarkers showed good and comparable diagnostic performance in PCa diagnosis. However, ADCratio shows better diagnostic performance than ADC in diagnosing transition zone cancers. In quantitative MRI-based PCa diagnosis, the imaging biomarker ADCratio is useful in challenging MRI readings of lesions. Understanding the performance of quantitative imaging biomarkers better can aid diagnostic MRI protocols, enhancing the precision of PCa assessments. MRI diffusion-weighted imaging-based ADC and ADCratio have comparable diagnostic performance in PCa assessment. In contrast to ADC, the ADCratio improves diagnostic performance, when assessing whole gland lesions. Compared to ADCratio, the ADC demonstrates enhanced diagnostic performance when evaluating peripheral zone lesions.

FET PET provides adjunctive value to FDG PET in distinction of spinal cord tumors

ObjectiveThis study aimed to compare the diagnostic efficacy of O-(2-18F-fluoroethyl)-l-tyrosine (18F-FET) PET and 2-deoxy-2-[18F]fluoro-d-deoxyglucose (18F-FDG) PET for spinal cord lesions. Materials and methodsPaired preoperative 18F-FDG PET/MRI and 18F-FET PET/MRI scans were conducted on patients with suspected spinal cord tumors. Clinical manifestations and PET performance, including SUVmean, SUVmax, TBRmean, TBRmax, metabolic tumor volume (MTV), and total lesion metabolism (TLM), and tumor volume, were compared using group analysis and receiver operating characteristic (ROC) curves. ResultsThirty-five patients were categorized into three groups based on their pathological diagnosis: high-grade tumors (HGTs, n = 6), low-grade tumors (LGTs, n = 19), and non-tumor diseases (NTDs, n = 10). The background SUVmean of 18F-FET PET was significantly lower than that of 18F-FDG PET (p < 0.0001), while the delineated tumor volumes showed no significant difference (p > 0.05). The mass SUVmean, SUVmax, MTV, and TLM values of both 18F-FDG PET and 18F-FET PET were statistically different between HGTs and LGTs (p < 0.05). Similarly, the mass SUVmax, TBRmax, MTV, and TLM values of both 18F-FDG PET and 18F-FET PET, as well as the mass SUVmean of 18F-FET PET, exhibited statistical differences between HGTs and NTDs (p < 0.05). But none were able to distinguish LGTs and NTDs (p > 0.05). Notably, 18F-FET PET provided valuable supporting diagnostic evidence in 1 case of mixed neuronal-glial tumor (MNGT) and 2 cases of intramedullary inflammatory lesions. Optimal cut-off values of all measured parameters for distinguishing tumors and NTDs were determined through ROC analysis. Conclusion18F-FET PET presented comparable diagnostic performance to 18F-FDG PET in differentiating HGTs, LGTs, and NTDs, but exhibited particular utility in MNGT and inflammatory lesions.

Characterization of prostatic cancer lesion and gleason grade using a continuous-time random-walk diffusion model at high b-values

BackgroundDistinguishing between prostatic cancer (PCa) and chronic prostatitis (CP) is sometimes challenging, and Gleason grading is strongly associated with prognosis in PCa. The continuous-time random-walk diffusion (CTRW) model has shown potential in distinguishing between PCa and CP as well as predicting Gleason grading.PurposeThis study aimed to quantify the CTRW parameters (α, β &amp;amp; Dm) and apparent diffusion coefficient (ADC) of PCa and CP tissues; and then assess the diagnostic value of CTRW and ADC parameters in differentiating CP from PCa and low-grade PCa from high-grade PCa lesions.Study typeRetrospective (retrospective analysis using prospective designed data).PopulationThirty-one PCa patients undergoing prostatectomy (mean age 74 years, range 64–91 years), and thirty CP patients undergoing prostate needle biopsies (mean age 68 years, range 46–79 years).Field strength/SequenceMRI scans on a 3.0T scanner (uMR790, United Imaging Healthcare, Shanghai, China). DWI were acquired with 12 b-values (0, 50, 100, 150, 200, 500, 800, 1200, 1500, 2000, 2500, 3000 s/mm2).AssessmentCTRW parameters and ADC were quantified in PCa and CP lesions.Statistical testsThe Mann-Whitney U test was used to evaluate the differences in CTRW parameters and ADC between PCa and CP, high-grade PCa, and low-grade PCa. Spearman’s correlation of the pathologic grading group (GG) with CTRW parameters and ADC was evaluated. The usefulness of CTRW parameters, ADC, and their combinations (Dm, α and β; Dm, α, β, and ADC) to differentiate PCa from CP and high-grade PCa from low-grade PCa was determined by logistic regression and receiver operating characteristic curve (ROC) analysis. Delong test was used to compare the differences among AUCs.ResultsSignificant differences were found for the CTRW parameters (α, Dm) between CP and PCa (all P&amp;lt;0.001), high-grade PCa, and low-grade PCa (α:P=0.024, Dm:P=0.021). GG is correlated with certain CTRW parameters and ADC(α:P&amp;lt;0.001,r=-0.795; Dm:P&amp;lt;0.001,r=-0.762;ADC:P&amp;lt;0.001,r=-0.790). Moreover, CTRW parameters (α, β, Dm) combined with ADC showed the best diagnostic efficacy for distinguishing between PCa and CP as well as predicting Gleason grading. The differences among AUCs of ADC, CTRW parameters and their combinations were not statistically significant (P=0.051–0.526).ConclusionCTRW parameters α and Dm, as well as their combination were beneficial to distinguish between CA and PCa, low-grade PCa and high-grade PCa lesions, and CTRW parameters and ADC had comparable diagnostic performance.

Analysis of potential microRNA biomarkers for multiple sclerosis

Multiple sclerosis (MS) is a chronic demyelinating autoimmune neurodegenerative disorder for which no specific blood biomarker is available. MicroRNAs (miRNAs) have been investigated for their diagnostic potential in MS. However, MS-associated miRNAs are rarely replicated in different MS populations, thus impeding their use in clinical testing. Here, we evaluated the fold expression of seven reported MS miRNAs associated with MS incidence and clinical characteristics in 76 MS patients and 75 healthy control plasma samples. We found miR-23a-3p to be upregulated in relapsing-remitting MS (RRMS), while miR-326 was downregulated. MiR-150-5p and -320a-3p were significantly downregulated in secondary progressive MS (SPMS) patients compared to RRMS. High disability was associated with low miR-320a-3p, whereas low BDNF levels were associated with upregulation of miR-150-5p and downregulation of miR-326 expression in the total cohort. MiR-23a-3p and miR-326 showed significant diagnostic sensitivity, specificity, and accuracy for RRMS diagnosis. In addition, miR-150-5p and miR-320a-3p had comparable significant diagnostic test performance metrics distinguishing SPMS from RRMS. Therefore, there is potential for including miR-23a-3p and miR-326 in an RRMS diagnostic miRNA panel. Moreover, we have shown that miR-150-5p and miR-320a-3p could be novel RRMS conversion to SPMS biomarkers. The use of these miRNAs in MS diagnosis and prognosis warrants further investigation.