Evaluation Of Diagnostic Tests Research Articles

Abstract 4135746: Assessing Coronary Artery Disease Severity: Leveraging Inflammatory Markers As a Prognostic Indicators

Introduction: Cardiovascular disease continues to be the leading cause of death and a significant cause of morbidity in the United States. In recent years, there has been increased interest in the role of inflammation in predicting and modifying the risk of coronary artery disease. Of the multitude of inflammatory markers studied subsequently, two of the most easily and widely obtained is the neutrophil to lymphocyte ratio (NLR) and the monocyte to lymphocyte ratio (MLR), which can be calculated from a complete blood count with differential. Multiple retrospective studies have demonstrated that the NLR and MLR have been used to diagnose ACS, predict mortality at a year after ACS, and risk stratify patients prior to percutaneous coronary intervention. Research Question: Are the NLR/MLR useful tools in predicting the severity of coronary artery disease (CAD) in patients admitted to a tertiary medical center in Southern Nevada for ACS between 2021 and 2023? Methods: A sample of n=344 patients was used to examine the potential significance of NLR/MLR to diagnose ACS and for predicting CAD severity. Traditional diagnostic test evaluation was used for determining CAD with a ratio of NLR=3.5 + MLR=0.35 (data medians) as the cut-off value. Patient risk group status (1:low risk to 4:high risk) was used as a binary outcome to test NLR/MLR between low and high risk groups using a nonparametric MWW test of medians. Additionally, ROC analysis was used to estimate an optimized cut-off for NLR/MLR as determined by AUC. Results: Results demonstrate for predicting ACS using the median NLR, sensitivity=88.07; specificity=14.88; PPV=52.01; NPV=54.35), LR(+)=1.03 and LR(-)= 0.80, using the median MLR results showed sensitivity=87.28; specificity=14.11; PPV=50.84; NPV=52.17, LR(+)=1.01 and LR(-)= 0.90. Subpopulation analysis demonstrated a statistically significant difference in NLR between “high risk ACS” vs “Low Risk ACS” (p<0.001). Examination of the ROC curve for predicting the high-risk group suggested an optimized cutoff of NLR=3.7; however, AUC was only 0.617, and sensitivity and specificity were not improved compared to using the median NLR. Conclusion: Our findings suggest that an NLR greater than 3.7 may indicate multivessel involvement or proximal/left main disease in CAD patients. However, due to its low specificity and AUC, NLR alone cannot reliably distinguish between single-vessel and multivessel CAD.

Concordance between Preoperative #ENZIANi Score and Postoperative #ENZIANs Score Classification-Why Do We Choose #ENZIAN and How Does It Impact the Future Classification Trend?

Objectives: To assess the concordance of the preoperative application of the #ENZIAN classification (#ENZIANi) with the postoperative result (#ENZIANs) using surgical findings as the reference standard. Methods: This retrospective study included 282 consecutive patients with deep endometriosis undergoing surgical treatment. Preoperative assessment with transvaginal sonography and magnetic resonance imaging was compared with postoperative assessment. Concordance and diagnostic test evaluation were calculated. Results: The highest concordance was observed in the F (abdominal wall endometriosis) with k Cohen of 0.837, following the values for pelvic locations, with 0.795 for T left, 0.791 for T right, 0.776 for F (adenomyosis), 0.766 for C (rectum), and 0.75 and 0.72 for O right k and O left, respectively. The highest sensitivity was demonstrated for the P compartment *(98%), T compartment (both sides 97%), and A, B, C (94-96%), corresponding with deep endometriosis. Conclusions: Preoperative assessment using TVS/TAS + MRI with the ENZIANi score correlates well with the ENZIANs postoperative score and demonstrates good concordance in the detection and localization of deep endometriosis, thereby minimizing false negative results and ensuring accurate preoperative staging. The ENZIAN classification is well-suited to surgeon needs and benefits from continuous development. Future improvements, such as adding the expanded C module, may be considered in the next edition.

Evaluation of a novel biplex rapid diagnostic test for antibody responses to Loa loa and Onchocerca volvulus infections.

Endemic to Central Africa, loiasis, caused by the vector-borne worm Loa loa, affects approximately 10 million individuals. Clinical manifestations include transient angioedema (Calabar swellings), migration of the adult worm under the eye conjunctiva (eye worm) and less specific general symptoms. Loiasis presents a significant public health challenge because L. loa-infected individuals can develop serious adverse events after taking ivermectin, the drug used to combat onchocerciasis. In this context, alternative interventions and rigorous diagnostic approaches are needed. Diagnosing loiasis is challenging because its main clinical manifestations are sporadic and non-specific. The definitive diagnosis relies on identifying adult worms migrating beneath the conjunctiva, or microfilariae (pre-larvae) in blood smears. However, "occult loiasis" (infection without blood microfilariae) is frequent. Serological rapid antibody diagnostic tests (ARTs) can provide an alternative diagnostic method. We compared a novel ART simultaneously targeting onchocerciasis (IgG4 to Ov-16 and OvOC3261, test line 1) and loiasis (IgG4 to L1-SXP-1, test line 2), called IgG4-SXP-1 biplex test) to the already established Loa-ART (all IgG isotypes to Ll-SXP-1, called pan-IgG-SXP-1 test). Blood samples underwent both ARTs, read qualitatively and semi-quantitatively. Additionally, blood smears, skin snips, Kato-Katz method for soil-transmitted helminthiases identification and eosinophilia measurements were performed. Questionnaires gathered demographic details and loiasis-related signs. ARTs performance was compared using specific loiasis-related signs and microfilaremia as references. Discordances between the two ARTs were investigated using logistic regression models. Out of 971 participants, 35.4% had L. loa microfilaremia, 71.9% had already experienced loiasis-related signs, 85.1% were positive in the pan-IgG-SXP-1 test and 79.4% were positive in the IgG4-SXP-1 biplex test. In the microfilariae-positive population, the sensitivity of the rapid tests was 87.4% for the pan-IgG-SXP-1 test and 88.6% for the prototype IgG4-SXP-1 biplex test. Sensitivity was similar for both ARTs when using eye worm or Calabar swelling as references, but diagnostic performance varied based on microfilaremia levels and occult loiasis. Overall, IgG4-SXP-1 biplex test demonstrated a sensitivity of 84.1% and specificity of 47.6% for loiasis compared to the pan-IgG-SXP-1 test, leading to a Kappa coefficient estimated at 0.27 ± 0.03 for the qualitative results of the 2 ARTs. In the group that tested positive with the Pan-IgG test but negative with the IgG4-specific test, there was a lower prevalence of STH infection (p = 0.008) and elevated eosinophilia (p<0.001) compared to the general tested population. The sensitivity of each test was good (84-85%) but the diagnostic agreement between the two ARTs was poor, suggesting that IgG and IgG4 antibody responses should be interpreted differently. The assessment of the innovative rapid diagnostic IgG4-SXP-1 biplex test, designed for onchocerciasis and loiasis, shows encouraging sensitivity but underlines the necessity for further in vitro assessment.

DxGoals: A Software Tool for Determining and Analyzing Clinically Meaningful Classification Accuracy Goals for Diagnostic Tests.

To evaluate diagnostic tests for low prevalence conditions, classification accuracy metrics such as sensitivity, specificity, and positive likelihood ratio (PLR) and negative likelihood ratio (NLR) are advantageous because they are prevalence-independent and thus estimable in studies enriched for the condition. However, classification accuracy goals are often chosen without a clear understanding of whether they are clinically meaningful. Pennello (2021) proposed a risk stratification framework for determining classification accuracy goals. A software application is needed to determine the goals and provide data analysis. We introduce DxGoals, a freely available, R-Shiny software application for determining, visualizing, and analyzing classification accuracy goals for diagnostic tests. Given prevalence p for the target condition and specification that a test's positive and negative predictive values PPVand NPV=1-cNPV should satisfy PPV>PPV* and cNPV<cNPV*, DxGoals uses Bayes Theorem to determine equivalent goals for PLR and NLR and implied goals for sensitivity and specificity. When study data are provided, DxGoals analyzes whether the determined goals are met with statistical significance. When comparing 2 tests, DxGoals translates a superiority or noninferiority goals for the differences PPV-p and p-cNPV to equivalent goals for PLR and NLR and analyzes the goals when data are provided. We illustrate DxGoals on tests for penicillin allergy, ovarian cancer, and cervical cancer. The inputs cNPV*,p, and PPV* were informed by clinical management guidelines. DxGoals facilitates determination, visualization, and analysis of clinically meaningful standalone and comparative classification accuracy goals. It is a potentially useful tool for diagnostic test evaluation.

All that glitters is not gold: An interpretive framework for diagnostic test evaluation using Ascaris lumbricoides as a conceptual example.

All that glitters is not gold: An interpretive framework for diagnostic test evaluation using Ascaris lumbricoides as a conceptual example.

RT-qPCR Testing and Performance Metrics in the COVID-19 Era.

The COVID-19 pandemic highlighted the crucial role of diagnostic testing in managing infectious diseases, particularly through the use of reverse transcription-quantitative polymerase chain reaction (RT-qPCR) tests. RT-qPCR has been pivotal in detecting and quantifying viral RNA, enabling the identification and management of SARS-CoV-2 infections. However, despite its widespread use, there remains a notable gap in understanding fundamental diagnostic metrics such as sensitivity and specificity among many scientists and healthcare practitioners. This gap is not merely academic; it has profound implications for interpreting test results, making public health decisions, and affecting patient outcomes. This review aims to clarify the distinctions between laboratory- and field-based metrics in the context of RT-qPCR testing for SARS-CoV-2 and summarise the global efforts that led to the development and optimisation of these tests during the pandemic. It is intended to enhance the understanding of these fundamental concepts among scientists and healthcare professionals who may not be familiar with the nuances of diagnostic test evaluation. Such knowledge is crucial for accurately interpreting test results, making informed public health decisions, and ultimately managing infectious disease outbreaks more effectively.

Evaluation of an electricity-independent method for IS2404 Loop-mediated isothermal amplification (LAMP) diagnosis of Buruli ulcer in resource-limited settings.

Buruli ulcer (BU) caused by Mycobacterium ulcerans (MU) is a devastating necrotic skin disease. PCR, recommended for confirmation of BU by WHO, requires an adequately equipped laboratory, therefore often delaying timely diagnosis and treatment of BU patients in remote settings. Loop-mediated isothermal amplification (LAMP) is a PCR-based protocol for isothermal amplification of DNA that has been suggested for diagnosis of BU in low-resource settings. This is an exploratory diagnostic test evaluation study, with an embedded qualitative sub-study. Its aims are two-fold: First, to evaluate a simple rapid syringe-based DNA extraction method (SM) in comparison with a more elaborate conventional DNA extraction method (CM), followed by a LAMP assay targeting IS2404 for the detection of MU, either using a commercially available pocket warmer (pw) or a heat block (hb) for incubation. Second, to complement this by exploring the diagnostic workflow for BU at a community-based health centre in an endemic area in rural Ghana as an example of a potential target setting, using interviews with researchers and health care workers (HCWs). Diagnostic test evaluation results are discussed in relation to the requirements of a target product profile (TPP) for BU diagnosis and the target setting. A protocol using SM for DNA extraction followed by IS2404 PCR (IS2404 PCRSM) was able to identify MU DNA in 73 out of 83 BU clinical specimens submitted for diagnosis. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of IS2404 PCRSM were 90.12%, 100%, 100% and 65.21% respectively, as compared to the reference standard IS2404 PCR in combination with a standard extraction protocol for mycobacterial DNA. Evaluation of the LAMP assay on 64 SM DNA extracts showed a sensitivity, specificity, PPV and NPV of 83.6%, 100%, 100% and 50%, respectively, using either pocket warmer (pwLAMPSM) or heat block (hbLAMPSM) for incubation of the reaction, as compared to the same reference standard. The limit of detection of pwLAMPSM was found to be 30 copies of the IS2404 target. Interview findings explored barriers to BU diagnosis and treatment, including perceptions of the disease, costs, and availability of transport. Participants confirmed that a diagnosis at the PoC, in addition to screening based on clinical criteria, would be advantageous in order to prevent delays and loss to follow-up. The high diagnostic and analytic accuracy of the pwLAMP, evaluated by us in combination with a syringe-based DNA extraction method, supports its potential use for the rapid detection of MU in suspected BU samples at the community or primary health care level without reliable electricity supply. Further optimization needs include a lysis buffer, evaluation directly at the PoC and/or other sites, assessing staff training requirements and quality control.

Comparative Analysis of 24-2C, 24-2, and 10-2 Visual Field Tests for Detecting Mild-Stage Glaucoma With Central Visual field Defects

This study sought to identify the most effective testing program for detecting visual-field defects in mild-stage glaucoma with central visual-field defects. A multicenter, retrospective diagnostic testing evaluation. The study involved 93 eyes (83 patients) with mild-stage glaucoma (median mean deviation [interquartile range]: -1.79 [2.16] dB) with central visual-field defects and 69 eyes (63 patients; median mean deviation, -1.38 [2.31] dB) with mild-stage glaucoma without central visual-field defects, from Jikei University School of Medicine and Tajimi Iwase Eye Clinic. Patients underwent 10-2 Swedish Interactive Thresholding Algorithm (SITA) Standard, 24-2 SITA Standard, and 24-2C SITA Faster tests. Central visual-field defects were defined using 10-2 SITA Standard and optical coherence tomography (OCT). A detection power of 4 points in the 24-2 that coincided with 10-2 (Center4), 12 points that lie within 10° (24-2-12), and 22 points that lie within 10° of 24-2C (24-2C-22) were analyzed using receiver operating characteristic (ROC) curves based on logistic regression analysis, using total deviation (TD) and pattern deviation (PD) probability plots. Area under the receiver operating characteristic curve (AUC) of the Center4, 24-2-12, and 24-2C-22 tests. In the upper-central visual field, AUCs of the TD plot were 0.50 (0.40-0.58) for the Center4, 0.75 (0.67-0.83) for 24-2-12, and 0.85 (0.78-0.91) for 24-2C-22, with 24-2C-22 AUC significantly exceeding 24-2-12 AUC. For the PD plot, AUCs were 0.53 (0.44-0.63), 0.81 (0.74-0.89), and 0.84 (0.77-0.90), respectively. In the lower-central visual field, using a total plot, AUCs were 0.27 (0.18-0.36), 0.57 (0.47-0.69), and 0.57 (0.46-0.68) for the Center4, 24-2-12, and 24-2C-22, respectively. Using the PD plot in the upper field, AUCs were 0.27 (0.19-0.36), 0.64 (0.53-0.75), and 0.81 (0.72-0.90), respectively, with the AUC of the 24-2C-22 significantly exceeding that of 24-2-12. The 24-2C test was significantly faster than both the 24-2 and 10-2 tests, reducing testing duration by 46% and 52%, respectively. The 24-2C SITA Faster test is highly effective and efficient for detecting mild-stage glaucoma with central visual-field defects. This, and its reduced duration, makes it a valuable tool in clinical settings.

The Combined Use of Fine-Needle Aspiration (FNA) and BRAF V600E Gene Testing: Can it Increase the Definitive Diagnosis Rate of Nodules Categorized as Bethesda III for Papillary Thyroid Carcinoma?

This study aimed to analyze the malignant probability of thyroid nodules diagnosed as indeterminate cytology, including atypia of undetermined significance or follicular lesion of undetermined significance (AUS/FLUS), and investigate the diagnostic value of combining BRAF V600E gene testing within this classification. We conducted a retrospective analysis of 126 patients who underwent fine-needle aspiration (FNA) examination of thyroid nodules and subsequent surgical treatment at Beijing Haidian Hospital between October 2021 and November 2022. Among them, there were 22 male and 104 female patients, aged between 18 and 75years old. Surgical pathology results were considered the gold standard for diagnosing the nature of thyroid nodules, evaluating the malignant incidence of cytological results categorized as AUS/FLUS. Fisher's exact test and diagnostic test evaluation methods were used to analyze the discriminatory diagnostic efficacy of preoperative FNA combined with BRAF V600E gene testing for papillary thyroid carcinoma (PTC). Statistical analysis was performed using SPSS 22.0 software. In PTC patients, the BRAF V600E gene mutation rate was 87.93% (102/116). Within the category of FNA results as AUS/FLUS, the proportion of PTC was 60.00% (15/25). The specificity, sensitivity, positive predictive value, and negative predictive value of the BRAF V600E gene mutation in diagnosing PTC within the AUS/FLUS category were 10/10, 6/15, 6/6, and 10/19, respectively. The BRAF V600E gene mutation significantly increased the detection rate of PTC in patients classified under this cytology (P = 0.028, <0.05). Preoperative FNA combined with BRAF V600E gene mutation testing significantly enhances the malignant detection rate of thyroid nodules diagnosed cytologically as AUS/FLUS. This combined approach provides a potent tool to improve diagnostic accuracy in this indeterminate classification.

Evaluating Chatbot responses to patient questions in the field of glaucoma.

The aim of this study was to evaluate the accuracy, comprehensiveness, and safety of a publicly available large language model (LLM)-ChatGPT in the sub-domain of glaucoma. Evaluation of diagnostic test or technology. We seek to evaluate the responses of an artificial intelligence chatbot ChatGPT (version GPT-3.5, OpenAI). We curated 24 clinically relevant questions in the domain of glaucoma. The questions spanned four categories: pertaining to diagnosis, treatment, surgeries, and ocular emergencies. Each question was posed to the LLM and the responses obtained were graded by an expert grader panel of three glaucoma specialists with combined experience of more than 30 years in the field. For responses which performed poorly, the LLM was further prompted to self-correct. The subsequent responses were then re-evaluated by the expert panel. Accuracy, comprehensiveness, and safety of the responses of a public domain LLM. There were a total of 24 questions and three expert graders with a total number of responses of n = 72. The scores were ranked from 1 to 4, where 4 represents the best score with a complete and accurate response. The mean score of the expert panel was 3.29 with a standard deviation of 0.484. Out of the 24 question-response pairs, seven (29.2%) of them had a mean inter-grader score of 3 or less. The mean score of the original seven question-response pairs was 2.96 which rose to 3.58 after an opportunity to self-correct (z-score - 3.27, p = 0.001, Mann-Whitney U). The seven out of 24 question-response pairs which performed poorly were given a chance to self-correct. After self-correction, the proportion of responses obtaining a full score increased from 22/72 (30.6%) to 12/21 (57.1%), (p = 0.026, χ2 test). LLMs show great promise in the realm of glaucoma with additional capabilities of self-correction. The application of LLMs in glaucoma is still in its infancy, and still requires further research and validation.

Evaluation of a Rapid Diagnostic Test (TUBEX-TF) for Diagnosis of Enteric Fever

Abstract Background and Aim: Enteric fever is a systemic febrile disease caused by Salmonella enterica serovars Typhi and Paratyphi. Culture provides a conclusive diagnosis of enteric fever. The main difficulties are a longer turnaround time and practicality in a developing nation with a huge population. The two RDTs that are now most often used are TUBEX-TF and Enterocheck-WB, where TUBEX-TF can identify IgM antibodies against S. Typhi and S. Paratyphi which are anti-O9 and anti-O2. The aim of this study was to evaluate the performance of the TUBEX-TF test in a typhoid fever endemic area of North India. Materials and Methods: In this cross-sectional study, we have performed TUBEX-TF, Enterocheck-WB /Immuno-chromatographic card test, Enzyme linked immunosorbent assay (ELISA), and Widal tests on the sera of 94 clinically suspected cases of enteric fever It was a cross-sectional comparative study that was carried out at a tertiary care institute in North India. In the present study, the ELISA test was taken as a comparative reference test. Results: ELISA, TUBEX-TF, Widal, and Immunochromatographic card test were performed on serum samples collected from 94 clinically suspected enteric fever cases, in which 50(53.19%) were positive by ELISA, 45 (47.87%) were positive by TUBEX- TF, 40 (42.5%) were positive by Typhidot and 19 (20.2%) were positive by Widal. For evaluation of TUBEX-TF, sensitivity specificity, diagnostic accuracy, positive predictive and negative predictive values, a comparison with IgM Anti-LPS ELISA test results was performed &amp; it was found 75%,79.55%,80%,74.47%, and 77.17% respectively. Conclusion: We conclude that the TUBEX-TF test has a greater sensitivity and specificity than other rapid tests currently on the market. It is a simple, rapid test to diagnose enteric fever. The necessity for large-scale research to evaluate TUBEX-TF is necessary due to interviewer variances so that it can become a novel RDT test for the diagnosis of enteric fever.

Evaluation of a rapid diagnostic test for detection of Vibrio cholerae O1 in the Democratic Republic of the Congo: Preventative intervention for cholera for 7 days (PICHA7 program).

Globally, there are estimated to be 2.9 million cholera cases annually. Early detection of cholera outbreaks is crucial for resource allocation for case management and for targeted interventions to be delivered to stop the spread of cholera. In resource limited settings such as Eastern Democratic Republic of the Congo (DRC), there is often limited laboratory capacity for analysing stool samples for cholera by bacterial culture. Therefore, rapid diagnostic tests (RDTs) for cholera present a promising tool to rapidly test stool samples in a health facility setting for cholera. Our objective is to evaluate the Crystal VC O1 RDT for cholera detection compared with bacterial culture and polymerase chain reaction (PCR) for Vibrio cholerae. From March 2020 to December 2022, stool samples were collected from 644 diarrhoea patients admitted to 94 health facilities in Bukavu in Eastern DRC. Patient stool samples were analysed by Crystal VC O1 RDT for cholera and by bacterial culture and PCR for V. cholerae O1. Twenty six percent of diarrhoea patients (166/644) had stool samples positive for cholera by RDT, and 24% (152/644) had stool samples positive for V. cholerae O1 by bacterial culture or PCR. The overall specificity and sensitivity of the Crystal VC O1 RDT by direct testing was 94% (95% confidence interval [CI]: 92%-96%) and 90% (95% CI, 84%-94%), respectively, when compared with either a positive result by bacterial culture or PCR. Our findings suggest that the Crystal VC O1 RDT presents a promising tool for cholera surveillance in this cholera endemic setting in sub-Saharan Africa.

Comparative evaluation of RT-PCR and antigen-based rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 detection: performance, variant specificity, and clinical implications.

The COVID-19 pandemic has highlighted the critical need for accurate and efficient diagnostic tools for detecting severe acute respiratory coronavirus 2 (SARS-CoV-2) infections. This study presents a comparison of two diagnostic tests: RT-PCR and antigen detection rapid diagnostic tests (Ag-RDTs). This study focused on their performance, variant specificity, and their clinical implications. A simultaneous testing of 268 samples was carried out for SARS-CoV-2 using RT-PCR and Ag-RDTs [flourescence immunoassay (FIA) and lateral flow immunoassay (LFIA)]. Viral load was quantified, and variant identification was performed using a PCR-based assay. The prevalence was found to be 30.2% using reverse transcription PCR (RT-PCR), 26.5% using FIA, and 25% using LFIA. When comparing the FIA and LFIA, the overall diagnostic performance was found to be 80.25% vs 76.54%, 96.79% vs 97.33%, 91.55% vs 90.51%, and 91.88% vs 92.56% for sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), respectively. Both Ag-RDTs showed a strong agreement with RT-PCR (κ = 0.78-0.80). The overall accuracies of the FIA and LFIA were 92.41% and 92.13%, respectively. The FIA showed higher sensitivity (73.68%) and PPV (92.08%) than the LFIA (65.79% and 90.56%, respectively) in asymptomatic patients. At low Ct values (<25), both Ag-RDTs had 100% sensitivity, but the sensitivity reduced to 31.82% for FIA and 27.27% for LFIA at Ct values > 30. The diagnostic sensitivity of FIA compared to LFIA for detecting the Alpha variant was 78.85% vs. 69.23% and 72.22% vs. 83.33% for the Delta variant. Both Ag-RDTs had 100% sensitivity for detecting Omicron. Both Ag-RDTs performed well in patients with high viral loads and Omicron variant infections compared to those infected with Alpha and Delta variants. This study confirms the comparable performance of RT-PCR and Ag-RDTs, specifically FIA and LFIA, for SARS-CoV-2 detection. The FIA showed higher sensitivity and PPV in asymptomatic cases, while both Ag-RDTs exhibited strong agreement with RT-PCR results. Notably, Ag-RDTs, particularly FIA, proved effective in detecting the Omicron variant and cases with high viral loads, highlighting their potential clinical utility in managing the COVID-19 pandemic.IMPORTANCEThis study is of utmost importance in providing effective responses to manage the COVID-19 pandemic. It rigorously compares the diagnostic accuracy, variant specificity, and practical considerations of reverse transcription PCR (RT-PCR) and antigen detection rapid diagnostic tests (Ag-RDTs) for severe acute respiratory coronavirus 2 (SARS-CoV-2), answering critical questions. The results of this study will help healthcare professionals choose the appropriate testing methods, allocate resources effectively, and enhance public health strategies. Given the evolution of the virus, understanding the performance of these diagnostic tools is crucial to adapting to emerging variants. Additionally, the study provides insights into logistical challenges and accessibility issues, which will contribute to refining testing workflows, particularly in resource-limited settings. Ultimately, the study's impact extends to global healthcare, providing valuable information for policymakers, clinicians, and public health officials as they work together for mitigating the impact of the pandemic.

CT-like images based on T1-weighted gradient echo MRI sequences for the assessment of fractures of the hand and wrist compared to CT

ObjectiveTo evaluate the performance of a 3D T1-weighted gradient-echo (3D T1GRE) computed tomography (CT)-like magnetic resonance imaging (MRI) sequence for detecting and assessing wrist and hand fractures compared to conventional CT.MethodsSubjects with acute wrist or hand fracture in CT underwent additional 3 T MRI including a CT-like 3D T1GRE sequence and were compared to patients without fractures. Two radiologists assessed fracture morphology on both modalities according to the Arbeitsgemeinschaft Osteosynthese (AO) and graded image quality and diagnostic confidence on a 5-point Likert scale.Besides diagnostic test evaluation, differences in image quality and diagnostic confidence between CT-like MRI and CT were calculated using the Wilcoxon test. Agreement of AO classification between modalities and readers was assessed using Cohen’s Kappa.ResultsTwenty-eight patients with 43 fractures and 43 controls were included. Image quality (3D T1GRE 1.19 ± 0.37 vs. CT 1.22 ± 0.42; p = 0.65) and diagnostic confidence (3D T1GRE 1.28 ± 0.53 vs. CT 1.28 ± 0.55; p = 1.00) were rated excellent for both modalities. Regarding the AO classification, intra- (rater 1 and rater 2, κ = 0.89; 95% CI 0.80–0.97) and interrater agreement were excellent (3D T1GRE, κ = 0.82; 95% CI, 0.70–0.93; CT, κ = 0.85; 95% CI, 0.75–0.94). CT-like MRI showed excellent sensitivity, specificity and accuracy for fracture detection (reader 1: 1.00, 0.92, 0.96; reader 2: 0.98, 0.94, 0.96).ConclusionCT-like MRI is a comparable alternative to CT for assessing hand and wrist fractures, offering the advantage of avoiding radiation exposure.

Diagnostic performance of the GGT/HDL-C ratio for NAFLD in adults with obesity undergoing bariatric surgery

BackgroundNon-alcoholic fatty liver disease (NAFLD) has become the most frequent liver disease, closely related with metabolic risk factors such as obesity, insulin resistance, dyslipidemia, diabetes mellitus, and metabolic syndrome. In this context, γ-Glutamyl transpeptidase (GGT) and high-density lipoprotein cholesterol (HDL-C) have shown correlations with steatosis severity and metabolic syndrome, respectively. This positions the GGT/HDL-C ratio as a potential diagnostic indicator for NAFLD. ObjectiveTo assess the diagnostic performance of the GGT/HDL-C ratio for NAFLD in adults with obesity undergoing bariatric surgery. MethodsWe conducted an analytical cross-sectional study, designed as a diagnostic test evaluation. A secondary database of 249 adults with obesity was analyzed. The optimal cut-off point was ascertained using three methodologies, and five adjustment models were constructed for the total population, further stratified by sex. ResultsThe optimal cut-off point was 20.5 U/mmol and the AUC of the ratio was 0.81 (95% CI: 0.64–0.98), with sensitivity and specificity being 82.5% and 77.8%, respectively. In the overall group with an elevated GGT/HDL-C ratio, the prevalence of NAFLD increased by 14% (PR: 1.14; 95% CI: 1.04–1.33). Specifically, women displaying this altered ratio showed a 19% increased prevalence (PR: 1.19; 95% CI: 1.07–1.42) compared to those with normal values. ConclusionsThe GGT/HDL-C ratio is a promising biomarker for the diagnosis of NAFLD in an adult population living with obesity.

Evaluation of Diagnostic and Screening Test in Veterinary Medicine

Evaluation of Diagnostic and Screening Test in Veterinary Medicine

Evaluation of COVID-19 antigen rapid diagnostic tests for self-testing in Lesotho and Zambia.

The use of antigen rapid tests (Ag-RDTs) for self-testing is an important element of the COVID-19 control strategy and has been widely supported. However, scale-up of self-testing for COVID-19 in sub-Saharan Africa is still insufficient and there is limited evidence on the acceptability of self-testing and agreement between Ag-RDT self-testing and Ag-RDT testing by professional users. A joint collaboration (Botnar Research Centre for Child Health-European & Developing countries Clinical Trials Partnership)was established between Lesotho and Zambia to address these gaps in relation to Ag-RDT self-testing and contribute to increasing its use in the region. A cross-sectional study was conducted with qualitative and quantitative data analysis. Firstly, 14 in-depth cognitive interviews (5 in Zambia and 9 in Lesotho) were performed to assess the participants' understanding of the instructions for use (IFU) for self-testing. In a second step, evaluation of test agreement between Ag-RDT self-testing and Ag-RDT testing by professional user using SD Biosensor STANDARD Q COVID-19 Ag-RDT was performed. In Zambia, usability and acceptability of self-testing were also assessed. Cognitive interviews in Lesotho and Zambia showed overall good understanding of IFU. In Zambia, acceptability of self-testing was high, though some participants had difficulties in conducting certain steps in the IFU correctly. Agreement between Ag-RDT self-test and Ag-RDT by professional users in Lesotho (428 participants) and Zambia (1136 participants) was high, 97.3% (403/414, 95% CI: 95.3-98.7) and 99.8% (1116/1118, 95% CI: 99.4-100) respectively. Findings from this study support the use of Ag-RDT self-testing within COVID-19 control strategies in sub-Saharan Africa, contributing to increase the testing capacity and access in hard-to reach settings.

A User-friendly Approach for the Diagnosis of Diabetic Retinopathy Using ChatGPT and Automated Machine Learning

To assess the capabilities of Chat Generative Pre-trained Transformer (ChatGPT) and Vertex AI in executing code-free preprocessing, training machine learning (ML) models, and analyzing the data. Evaluation of diagnostic test or technology. ChatGPT and Vetrex AI as publicly available large language model and ML platform, respectively. ChatGPT was employed to improve the resolution of fundus photography images from the Methods to Evaluate Segmentation and Indexing Techniques in the field of Retinal Ophthalmology (Messidor-2) open-source dataset using the Contrast Limited Adaptive Histogram Equalization (CLAHE) technique by Fiji software. Subsequently, Vertex AI, an automated ML (AutoML) platform, was utilized to develop 2 classification models. The first model served as a binary classifier for detecting the presence of diabetic retinopathy (DR), while the second determined its severity. Finally, ChatGPT was used to provide scripts for R and Python programming languages for data analysis and was also directly employed in analyzing the data in a code-free method. Evaluating the utility of ChatGPT in generating scripts for preprocessing images using Fiji and analyzing data across Python and R and assessing its potential in analyzing data through a code-free method. Investigating the capabilities of Vertex AI to train image classification models for detection of DR and its severity. Two ML models were trained using 1740 images from the Messidor-2 database. The first model, designed to detect the severity of DR, achieved an area under the precision-recall curve (AUPRC) of 0.81, with a precision rate of 81.81% and recall of 72.83%. The second model, tailored for the detection of the presence of DR, recorded a precision and recall of 84.48% with an AUPRC of 0.90. ChatGPT and Vertex AI have the potential to enable physicians without coding expertise to preprocess images, analyze data, and train ML models. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Evidence Synthesis and Linkage for Modelling the Cost-Effectiveness of Diagnostic Tests: Preliminary Good Practice Recommendations.

To develop preliminary good practice recommendations for synthesising and linking evidence of treatment effectiveness when modelling the cost-effectiveness of diagnostic tests. We conducted a targeted review of guidance from key Health Technology Assessment (HTA) bodies to summarise current recommendations on synthesis and linkage of treatment effectiveness evidence within economic evaluations of diagnostic tests. We then focused on a specific case study, the cost-effectiveness of troponin for the diagnosis of myocardial infarction, and reviewed the approach taken to synthesise and link treatment effectiveness evidence in different modelling studies. The Australian and UK HTA bodies provided advice for synthesising and linking treatment effectiveness in diagnostic models, acknowledging that linking test results to treatment options and their outcomes is common. Across all reviewed models for the case study, uniform test-directed treatment decision making was assumed, i.e., all those who tested positive were treated. Treatment outcome data from a variety of sources, including expert opinion, were utilised for linked clinical outcomes. Preliminary good practice recommendations for data identification, integration and description are proposed. Modelling the cost-effectiveness of diagnostic tests poses unique challenges in linking evidence on test accuracy to treatment effectiveness data to understand how a test impacts patient outcomes and costs. Upfront consideration of how a test and its results will likely be incorporated into patient diagnostic pathways is key to exploring the optimal design of such models. We propose some preliminary good practice recommendations to improve the quality of cost-effectiveness evaluations of diagnostics tests going forward.

Local anesthetics allergy in children: Evaluation of diagnostic tests with Real-Life data.

Local anesthetic (LA) drugs are commonly used in clinical practice to provide effective analgesia, including in dentistry and minor surgical procedures. The perception of a high risk of allergy in daily applications leads to the referral of atopic patients and those with other drug allergies to allergy clinics for the evaluation of allergic reactions to LA. The aim of this study was to determine who should be referred to the allergy clinic for LA allergy testing, assess the frequency of LA allergy in pediatric patients, and identify the negative predictive value of skin tests in diagnosis. January 2017-July 2023, the clinical and laboratory data, as well as the results of drug allergy tests, of patients referred to our pediatric allergy clinic by dentists and physicians performing minor surgical procedures with suspected LA allergy were retrospectively evaluated. Our study included a total of 153 patients, comprising 84 girls (54.9%) and 69 boys (45.1%), with a mean age of 8.9 (±3.3) years. The most common reason for referral was a history of non-LA drug allergies (n = 66, 43.2%), followed by asthma (n = 25, 16.3%). Hypersensitivity reactions (HRs) with LA were most commonly associated with articaine (n = 7, 4.8%), followed by lidocaine (n = 6, 4.1%). When intradermal tests were evaluated, 17 patients (11.1%) had a positive test result. The positivity for lidocaine was 70.6% (n = 12), and prilocaine was 29.4% (n = 5). Subcutaneous provocation was administered to 109 patients (71.2%), and one patient exhibited local erythema and swelling with prilocaine. Although LA allergy is a rare occurrence, consultations of this nature are frequently requested from allergy clinics in real life. Considering the negative predictive value of skin tests performed with LA drugs, the reaction rate appears to be low in patients with atopy or other drug allergies. It is crucial for all relevant healthcare professionals to be knowledgeable about the appropriate approach to suspected LA allergies to avoid unnecessary tests. To the best of our knowledge, our study is the most comprehensive work in the literature that evaluates the results of diagnostic tests in children referred with a suspicion of LA allergy.