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PubMed2005

Characterization of breast lesion using double phase Tc-99m Tetrofosmin scintimammography: comparison of visual and quantitative analyses.

UNLABELLED: To compare the diagnostic performances of visual and quantitative indices of double phase Tc-99m Tetrofosmin scintimammography (TF-SMM) for the detection of breast cancer. METHODS: Double phase TF-SMM (early, 10 min; delayed, 3h) were performed after injection of 925 MBq of Tc-99m Tetrofosmin in 75 highly suspected breast cancer patients (malignant: 49, benign: 26). For visual analysis, five scoring method was used. For quantitative analysis, early, delayed lesions to non-lesion ratios (L/Ns) and washout rate (%, WR) were calculated. Receiver operating characteristic curve (ROC) analyses were performed to determine the optimal visual grade, to calculate cut-off values of quantitative indices, and to compare visual and quantitative diagnostic performances. RESULTS: When over grade 3 of visual grade was used as cut-off value in the defection of primary breast cancer, the sensitivity and specificity were 75.5 and 80.8%, respectively. The positive and negative predictive values were 88.1 and 63.6%, respectively. The area under curve was 0.824 (95% CI, 0.719-0.902) and standard error (S.E.) was 0.047. The optimal L/N ratios were 3.13 for early and 2.56 for delayed image. When early L/N 3.13 was used as cut-off point, the sensitivity and specificity of TF-SMM were 61.2 and 96.2%, respectively. The positive and negative predictive values were 96.8 and 56.8%, respectively. The AUC was 0.809 (95% CI, 0.702-0.890) and S.E. was 0.049. When delayed L/N 2.56 was used as cut-off value, the sensitivity and specificity were 46.9 and 96.2%, respectively. The positive and negative predictive values were 95.8 and 49%, respectively. The AUC was 0.741 (95% CI, 0.627-0.835) and S.E. was 0.057. No statistical differences between visual assessment and quantitative analysis of early image (difference between area, 0.015; S.E., 0.044; 95% CI, -0.072 to 0.102; p = 0.736) and delayed image (difference between area, 0.083; S.E., 0.054; 95% CI, -0.023 to 0.060; p = 0.189) was noted. However, early L/N was superior to delayed L/N ratio for the detection of breast cancer (difference between area, 0.068; S.E., 0.033; 95% CI, 0.004-0.132; p = 0.038). CONCLUSION: In conclusion, TF-SMM showed a favorable diagnostic accuracy in differentiating benign from malignant breast lesions. The optimal visual interpretation grades for the detection of primary breast cancer of double phase TF-SMM were grade 4 and 5. The optimal quantitative indices for the detection of breast cancer were 3.12 for early L/N and 2.56 for delayed L/N. Visual and quantitative analyses showed similar results. However, early L/N was superior to delayed one for the detection of breast cancer. Therefore, the delayed image should not be routinely performed for the purpose of primary breast cancer detection. These findings deserve further investigation on a larger number of patients to be performed to allow a better validation of the differentiation malignant from benign breast lesions using double phase TF-SMM.

Breast Neoplasms↗
PubMed1992

Usefulness of single-photon emission computed tomography of thallium-201 uptake after dipyridamole infusion for detection of coronary artery disease.

The diagnostic performance of single-photon emission computed tomography (SPECT) and planar imaging of thallium-201 uptake for the detection of coronary artery disease (CAD) was compared in 79 patients who underwent both dipyridamole thallium-201 scintigraphy and coronary angiography. Clinical subgroups were assigned by severity of CAD, presence of a prior myocardial infarction and the number of narrowed coronary arteries. The overall detection of CAD was 89% for SPECT and 67% for planar (p less than 0.001). For the anterior vascular territory, sensitivities for SPECT and planar imaging were 69 and 44% (p less than 0.01), respectively; for the posterior vascular territory, sensitivities were 80 and 54% (p less than 0.01). Receiver-operating characteristic analysis, using a 5-point evaluation scale, was performed for the anterior and posterior vascular territories. Receiver-operating characteristic curves generated for SPECT and planar studies demonstrated improved diagnostic performance by SPECT in the anterior vascular territory, but showed similar performance in the posterior territory because of lower SPECT specificity despite higher sensitivity at clinically relevant decision thresholds. In each clinical subgroup of patients, the detection of CAD by SPECT was significantly superior to that by planar imaging, regardless of the severity of stenosis or the number of significantly narrowed coronary arteries, or whether a myocardial infarction was present. Thus, SPECT thallium-201 scintigraphy is an important and necessary clinical tool for detecting CAD after dipyridamole infusion.

Adult↗
PubMedDate not supplied

The diagnostic value of scoring models for organic and non-organic gastrointestinal disease, including the irritable-bowel syndrome.

Scoring models based on history and physical examination have been developed to discriminate patients with non-organic gastrointestinal disease from those who have organic disease. The application of these models may lead to more efficient diagnosis and prevent somatization. Although the models have high diagnostic accuracy in the population in which they have been developed, their value in other populations has not been established. In this study previously developed models were tested in validation populations defined by the original selection criteria from the studies in which the models were developed and in unselected general practice and outpatient populations. The diagnostic performance of the models are expressed in terms of odds ratio and sensitivity and specificity for the classification of patients as having organic and non-organic disease. The diagnostic performance of all the models were rather low in the validation populations. Relatively few elements of the models had independent diagnostic value. In addition, the correlation between the scoring models, expressed in Cohen's kappa, was extremely low. The diagnostic values of the scoring models were not reproduced in comparable and unselected populations. Therefore, it is concluded that the diagnostic value of such a model has little external validity.

Adolescent↗
PubMed2002

Diagnostic accuracy of dermoscopy.

The accuracy of the dinical diagnosis of cutaneous melanoma with the unaided eye is only about 60%. Dermoscopy, a non-invasive, in vivo technique for the microscopic examination of pigmented skin lesions, has the potential to improve the diagnostic accuracy. Our objectives were to review previous publications, to compare the accuracy of melanoma diagnosis with and without dermoscopy, and to assess the influence of study characteristics on the diagnostic accuracy. We searched for publications between 1987 and 2000 and identified 27 studies eligible for meta-analysis. The diagnostic accuracy for melanoma was significantly higher with dermoscopy than without this technique (log odds ratio 4.0 [95% CI 3.0 to 5.1] versus 2.7 [1.9 to 3.4]; an improvement of 49%, p = 0.001). The diagnostic accuracy of dermoscopy significantly depended on the degree of experience of the examiners. Dermoscopy by untrained or less experienced examiners was no better than clinical inspection without dermoscopy. The diagnostic performance of dermoscopy improved when the diagnosis was made by a group of examiners in consensus and diminished as the prevalence of melanoma increased. A comparison of various diagnostic algorithms for dermoscopy showed no significant differences in their diagnostic performance. A thorough appraisal of the study characteristics showed that most of the studies were potentially influenced by verification bias. In conclusion, dermoscopy improves the diagnostic accuracy for melanoma in comparison with inspection by the unaided eye, but only for experienced examiners.

Dermatology↗
PubMed2006

Meta-analysis of plethysmography and rheography in the diagnosis of deep vein thrombosis.

BACKGROUND: Plethysmography and rheography techniques have been widely studied as diagnostic tests for deep vein thrombosis (DVT). This study aimed to systematically review the accuracy of these tests for diagnosing clinically suspected DVT. METHODS: The following databases were searched: Medline, EMBASE, CINAHL, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, Database of Reviews of Effectiveness, the ACP Journal Club (1966 to 2004), and citation lists of retrieved articles. Studies that compared plethysmography or rheography to a reference standard of ultrasound or contrast venography were selected. Standardised data were extracted and study quality determined against validated criteria. Data were analysed by random effects meta-analysis and meta-regression. RESULTS: The meta-analysis included 78 studies, reporting 82 patient cohorts. Sensitivity and specificity (95% CI) were: 75% (73% to 77%) and 90% (89% to 91%) for impedance plethysmography, 83% (81% to 85%) and 81% (79% to 82%) for strain-gauge plethysmography, 85% (79% to 90%) and 91% (81% to 95%) for air plethysmography, 91% (87% to 94%) and 71% (66% to 75%) for light-reflex rheography, and 86% (83% to 89%) and 93% (91% to 95%) for phleborheography. Meta-regression was limited by poor reporting of studies. There was some evidence that diagnostic performance depended on the proportion of males in the cohort and reporting of study setting. CONCLUSIONS: Although plethysmography and rheography techniques add diagnostic value, they have inadequate diagnostic performance to act as a stand-alone test in DVT diagnosis. Evaluation of their role in combination with other tests, or standardised clinical assessment, is required.

Cohort Studies↗
PubMed2004

Troponin T levels in detection of perioperative myocardial infarction after coronary artery bypass surgery.

OBJECTIVES: The present study was designed to evaluate the clinical relevance of serum cardiac troponinT (cTnT) assay in detection of perioperative myocardial infarction (PMI) after coronary artery bypass grafting (CABG). MATERIALS AND METHODS: The clinical utility of cTnT was compared to that of total CK, CKMB mass, CKMB activity and myoglobin. Serial venous blood samples were obtained before surgery and 4, 8, 16, 24, 48 and 72 hours after aortic unclamping (AU) in 42 patients who underwent CABG. We had 6 PMI patients, 24 patients with minor myocardial damage (MMD) and 12 without ischemic myocardial changes (no IMC). RESULTS: In discriminating no IMC from PMI the diagnostic sensitivity, specificity and the predictive values of cTnT were superior to that of CKMB mass, CKMB activity, myoglobin and total CK during 72 hours after AU. In discriminating MMD from PMI the diagnostic performance for CKMB mass and CKMB activity was superior to that of cTnT during the first 24 hours. After 24 hours the diagnostic performance for cTnT was improved but began to decline for CKMB isoenzymes. The discriminatory power of myoglobin measurements was lower than that of cTnT and CKMB mass. CONCLUSION: Our results indicate that troponin T is an accurate marker for the detection and monitoring of perioperative myocardial damage, especially 24 hours after AU.

Coronary Artery Bypass↗
PubMedDate not supplied

Endofibrosis of iliac arteries in high-performance athletes: diagnostic approach and minimally invasive endovascular treatment.

The aim of this article is to report our experience in the diagnosis of two cases of iliac artery endofibrosis or arteriopathy, a rare entity occurring in high-performance athletes, presenting with intermittent claudication (right-sided in both) after maximal exercise. External iliac artery endofibrosis or arteriopathy is a likely diagnosis in competitive athletes free of cardiovascular risk factors who present with leg claudication. Arteriography and a papaverine-assisted mean pressure gradient across the iliac arteries of more than 10 mmHg is a useful diagnostic approach. Moreover, balloon angioplasty of the iliac artery in that patient, in whom a pressure gradient was detected, resulted in symptomatic relief for 2 months followed by mild symptom recurrence. Thus, although balloon angioplasty is feasible and safe, it might not be adequate to treat this entity and, thus, its value remains undefined.

Adult↗
PubMed1992

Digital subtraction radiography for assessment of simulated root resorption cavities. Performance of conventional and reverse contrast modes.

A previous study of the sensitivity and accuracy of a standardized radiographic technique for the disclosure of root cavities in a cadaver material indicated that it was not possible to perceive small artificial "resorption" cavities. Using the same material, the aim of the present study was to evaluate whether the use of subtraction radiography would improve the detection of root cavities. In an autopsy material of five mandibular blocks each containing two premolars, small, medium, and large cavities were drilled in the cervical, middle, and apical thirds of the proximal and oral root surfaces. Each jaw block was radiographed before (B) and after (A) cavity preparation with three different exposure times resulting in light, medium, and dark film densities. The radiographs were digitized. Digital subtraction was performed between the A- and B images of varying densities by a computer program developed for dental subtraction radiography. Conventional and reverse contrast modes of the subtraction image were assessed independently by four observers. The results showed small inter- and intraobserver differences in diagnostic accuracy for assessment of total number of root cavities. Original film density did not influence the diagnostic performance in the resulting subtraction image. Contrast mode in the subtraction image influenced diagnostic performance as the majority of observers did best with the reverse contrast mode (p < 0.05). Some of the small root cavities were disclosed by the subtraction technique, but overall accuracy was not increased compared to conventional radiography.

Humans↗
PubMed2000

Use of a new monoclonal antibody-based enzyme immunoassay for soluble fibrin to exclude pulmonary embolism. ANTELOPE-Study Group.

We prospectively evaluated the diagnostic performance of a new soluble fibrin assay in 303 consecutive patients with suspected pulmonary embolism and examined potentially useful cut-off levels at which this disease can be safely excluded. In addition, the diagnostic accuracy was calculated in the subgroups of in- and outpatients. The ROC curve of the assay in the total study cohort had an area under the curve of 0.69. The cut-off level associated with a sensitivity and negative predictive value of 100% was 20 ng/ml, but the specificity was only 4%. The cut-off level with a sensitivity of 90% was 30 ng/ml, which corresponded with a specificity and negative predictive value of 27% and 86%. respectively. The diagnostic performance was comparable in the subgroups of in- and outpatients. We conclude that the soluble fibrin assay has a low diagnostic accuracy and seems unsuitable as a screening test for the exclusion of pulmonary embolism.

Adult↗
PubMed2004

Analytical performance and diagnostic accuracy of a fully-automated electrochemiluminescent assay for the N-terminal fragment of the pro-peptide of brain natriuretic peptide in patients with cardiomyopathy: comparison with immunoradiometric assay methods for brain natriuretic peptide and atrial natriuretic peptide.

We evaluated the analytical performance of a fully-automated electrochemiluminescence "sandwich" immunoassay method for the N-terminal fragment of the pro-peptide of brain natriuretic peptide (BNP). We then compared the diagnostic accuracy of this method in discriminating between normal subjects and patients with cardiomyopathy with that found with two previously described immunoradiometric assay methods for the assay of atrial natriuretic peptide (ANP) and BNP. We studied 193 consecutive patients (mean age 64.4 +/- 12.3 years, range 20-89 years, including 56 women and 137 men) with chronic cardiomyopathy and a group of 85 healthy subjects (mean age 52.3 +/- 12.0 years, 42 women and 43 men, range 20-79 years). N-terminal fragment of proBNP1-76 (NT-proBNP) was measured with a fully-automated "sandwich" electrochemiluminescence method using an Elecsys 2010 analyzer, while ANP and BNP were measured with immunoradiometric assay methods. The low detection limit of the NT-proBNP assay was 4.2 pg/ml (0.50 pmol/l), while the functional sensitivity was 22 pg/ml (2.60 pmol/l) with a working range (imprecision profile < or = 10% coefficient of variation) extended up to about 30 000 pg/ml (3540 pmol/l). Healthy women (64.3 +/- 41.6 pg/ml, 7.59 +/- 4.91 pmol/l) showed significantly higher values than men (46.9 +/- 30.9 pg/ml, 5.53 +/- 3.64 pmol/l, p = 0.0118). Moreover, age and sex were significantly and independently related to the NT-proBNP values in healthy subjects, as assessed by a multiple linear regression analysis (R = 0.389, F-value = 7.316, P-value = 0.0012). As expected, the NT-proBNP values of patients with cardiomyopathy were significantly higher than those of normal subjects and progressively increased with the severity of heart failure. The respective diagnostic accuracy of the ANP, BNP and NT-proBNP assays in discriminating between the group of normal subjects and that of patients with cardiomyopathy was tested by the response operating characteristic curve analysis. Our data indicated that the NT-proBNP assay is significantly better than either of the ANP or BNP immunoradiometric assays in discriminating affected patients from healthy subjects, especially when only patients with mild disease severity (New York Heart Association class I and II) are considered.

Adult↗
PubMed1992

[Improvement of the diagnostic value of exercise test by heart-rate adjusted segment depression. Value of ST 20/HR index].

One of the new criteria of positivity of exercise stress testing proposed by Detrano and Kligfield is the ST/HR index, obtained by calculating the ratio of additional ST depression on exercise over the corresponding variation in the heart rate. These authors reported that this ratio improved the diagnostic value of the exercise stress test with respect to the traditional ST segment depression, but that the proportion depended on whether the index was measured 80 or 60 ms after the J point. The object of this study was to assess the diagnostic performance of the ST/HR index measured 0, 20, 40, 60 and 80 ms after the J point by automatic analysis and to compare these five diagnostic indices with the classical ST segment depression (standard criterion) by ROC graphs and the Mac Nemar test. One hundred consecutive patients (73 men and 27 women) all symptomatic, underwent submaximal or symptom-limited exercise stress testing and accepted coronary angiography. The prevalence of greater than or equal to 50% coronary stenosis on at least one main vessel was 48%. None had previous myocardial infarction. The ROC graphs and areas under the curve demonstrated generally the superiority of the ST/HR index over the standard criteria. The optimal diagnostic performance was observed when the index was calculated 20 ms after the J point (ST 20/HR index).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1990

How to perform a diagnostic peritoneal lavage.

Peritoneal lavage can be a very helpful investigation in the initial management of trauma patients. The technique demands some basic surgical skills but has been shown to be relatively safe and accurate when performed by appropriately trained junior doctors.

Abdominal Injuries↗
PubMed2001

Diagnostic accuracy of simultaneous acquisition of transmission and emission data with technetium-99m transmission source on thallium-201 myocardial SPECT.

PURPOSE: This study evaluates not only the clinical usefulness but also the problems in attenuation correction for thallium-201 (Tl-201) myocardial SPECT by means of simultaneous transmission and emission data acquisition in the detection of coronary artery disease (CAD). METHODS: A three-detector SPECT system equipped with a Tc-99m line source and fan-beam collimators was used for simultaneous transmission and emission data acquisition for Tl-201 myocardial SPECT in 73 patients (18 patients for normal database and 55 patients for the evaluation of diagnostic accuracy). Attenuation-corrected (AC) images and non-attenuation-corrected (NC) images were reconstructed with an iterative maximum-likelihood estimation-corrected (ML-EM) algorithm. Both sets of images were reoriented into the short axis. Normal database polar maps were constructed from the AC and NC images for quantitative analysis. RESULTS: There was a significant difference in specificity between NC and AC images in the RCA territory and those in specificity and accuracy in the LCX territory. There was no significant difference in sensitivity found between NC and AC images in either territory, but sensitivity in both territories tended to decrease with attenuation correction. In the LAD territory, there were various changes in sensitivity and specificity observed with attenuation correction in cases with each quantitative criterion. CONCLUSIONS: Diagnostic performance of significant stenosis in the RCA and LCX territories quantitatively improved with attenuation correction because of an increase in specificity, but no significant improvement in diagnostic performance was obtained in the LAD territory with attenuation correction. We recommend combined interpretation of AC and NC images and careful evaluation of any SPECT image by means of transmission computed tomography.

Coronary Disease↗
PubMed2006

A systematic literature review of magnetic resonance spectroscopy for the characterization of brain tumors.

BACKGROUND AND PURPOSE: Proton MR spectroscopy ((1)H-MR spectroscopy) is a potentially useful adjunct to anatomic MR imaging in the characterization of brain tumors. We performed an updated systematic review of the evidence. METHODS: We employed a standardized search strategy to find studies published during 2002-2004. We reviewed studies measuring diagnostic accuracy and diagnostic, therapeutic, or health impact of (1)H-MR spectroscopy. We abstracted information on study design, (1)H-MR spectroscopy technique, and methodologic quality. We categorized studies into 5 subgroups: (1) metastasis versus high-grade tumor; (2) high-versus low-grade tumor; (3) recurrent tumor versus radiation necrosis; (4) tumor extent; and (5) tumor versus non-neoplastic lesion. RESULTS: We identified 26 studies evaluating diagnostic performance, diagnostic impact, or therapeutic impact. No articles evaluated patient health or cost-effectiveness. Methodologic quality was mixed; most used histopathology as the reference standard but did not specify blinded interpretation of histopathology. One large study demonstrated a statistically significant increase in diagnostic accuracy for indeterminate brain lesions from 55%, based on MR imaging, to 71% after analysis of (1)H-MR spectroscopy. Several studies have found that (1)H-MR spectroscopy is highly accurate for distinguishing high- and low-grade gliomas, though the incremental benefit of (1)H-MR spectroscopy in this setting is less clear. Interpretation for the other clinical subgroups is limited by the small number of studies. CONCLUSION: The current evidence on the accuracy of (1)H-MR spectroscopy in the characterization of brain tumors is promising. However, additional high-quality studies are needed to convince policy makers. We present guidelines to help focus future research in this area.

Astrocytoma↗
PubMed2026

Human Wings Apart-Like Protein as a Serum Diagnostic Biomarker in Cervical Cancer: An Integrative Bioinformatics Analysis with Serum Validation.

Cervical cancer remains a major threat to women's health worldwide, and reliable serum biomarkers for early detection and therapeutic stratification remain limited. Human wings-apart-like (hWAPL) protein has been implicated in cervical carcinogenesis, but its diagnostic and clinical value has not been fully elucidated. To address this gap, this study integrated public multi-omics datasets, including The Cancer Genome Atlas, GEPIA2, the Human Protein Atlas, and single-cell transcriptomic data, to characterize hWAPL expression, clinicopathological associations, immune infiltration, co-expression networks, post-translational modifications, and drug sensitivity predictions. These findings were evaluated in an independent single-center serum cohort comprising 89 patients with histologically confirmed cervical squamous cell carcinoma and 89 healthy female controls. Serum hWAPL and squamous cell carcinoma antigen (SCC) levels were measured, and diagnostic performance was assessed by receiver operating characteristic curve analysis. In silico, hWAPL was broadly upregulated across multiple malignancies, particularly cervical cancer, enriched in malignant epithelial cells and monocytes/macrophages, and associated with shorter progression-free interval, predicted reduced sensitivity to cisplatin, paclitaxel, and 5-fluorouracil, and predicted sensitivity to MCL-1 and Wee1 inhibitors. In the serum cohort, hWAPL levels were significantly higher in patients than controls and discriminated cervical cancer with an area under the curve of 0.961, exceeding SCC alone. Combining hWAPL with SCC further improved diagnostic performance (area under the curve, 0.974; sensitivity, 93.3%; specificity, 95.5%). These findings suggest that serum hWAPL is a potential novel diagnostic biomarker for cervical squamous cell carcinoma whose performance is enhanced by SCC, whereas the observed associations with chemoresistance and immune microenvironment remodeling are hypothesis-generating and require experimental confirmation.

Humans↗
PubMed2005

18F-FDG PET for evaluation of bone marrow infiltration in staging of lymphoma: a meta-analysis.

UNLABELLED: The ability of PET with (18)F-FDG to evaluate bone marrow infiltration in patients with lymphoma has been a matter of extensive investigation with controversial results. Therefore, we aimed to evaluate systematically, with a meta-analysis, the diagnostic performance of (18)F-FDG PET in this setting. METHODS: Relevant studies were identified with MEDLINE and EMBASE searches (last update, August 2004). Data on the diagnostic performance of (18)F-FDG PET were combined quantitatively across eligible studies. We estimated weighted summary sensitivities and specificities, summary receiver-operating-characteristic (SROC) curves, and weighted summary likelihood ratios. We also conducted separate analyses according to various subgroups. Bone marrow biopsy (BMB) was used as the reference standard. RESULTS: Thirteen eligible nonoverlapping studies, which enrolled a total of 587 patients, were included in the meta-analysis. The independent random-effects weighted estimates of sensitivity and specificity against BMB were 51% (95% confidence interval [CI], 38%-64%) and 91% (95% CI, 85%-95%), respectively. Results were consistent in the SROC curve: a sensitivity of 51% corresponds to a specificity of 92%, whereas a specificity of 91% corresponds to a sensitivity of 55%. The weighted positive likelihood ratio (LR+) was 5.75 (95% CI, 348-9.48) and the negative likelihood ratio (LR-) was 0.67 (95% CI, 0.55-0.82). Six of 12 patients with positive (18)F-FDG PET and negative initial biopsy were found to have bone marrow involvement when biopsy was performed at the sites with positive imaging signals. Subgroup analyses showed better sensitivity in patients with Hodgkin's disease and in aggressive histologic types of non-Hodgkin's lymphoma than in patients with less aggressive histologic types and in studies using unilateral BMB compared with those using bilateral biopsy. CONCLUSION: This meta-analysis showed that (18)F-FDG PET has good, but not excellent, concordance with the results of BMB for the detection of bone marrow infiltration in the staging of patients with lymphoma. (18)F-FDG PET may complement the results of BMB and its performance may vary according to the type of lymphoma.

Bone Marrow↗
PubMed1993

DECIDE: a software for computer-assisted evaluation of diagnostic test performance.

The evaluation of the performance of clinical tests is a complex problem involving different steps and many statistical tools, not always structured in an organic and rational system. This paper presents a software which provides an organic system of statistical tools helping evaluation of clinical test performance. The program allows (a) the building and the organization of a working database, (b) the selection of the minimal set of tests with the maximum information content, (c) the search of the model best fitting the distribution of the test values, (d) the selection of optimal diagnostic cut-off value of the test for every positive/negative situation, (e) the evaluation of performance of the combinations of correlated and uncorrelated tests. The uncertainty associated with all the variables involved is evaluated. The program works in a MS-DOS environment with EGA or higher performing graphic card.

Clinical Laboratory Techniques↗
PubMed2026

Metagenomic next-generation sequencing for tuberculosis diagnosis: enhanced performance and cost-effectiveness.

UNLABELLED: Metagenomic next-generation sequencing (mNGS) is a promising tool for diagnosing challenging infections like tuberculosis (TB). However, previous studies largely focused on case-specific application of mNGS in TB diagnosis. Thus, we conducted a retrospective observational study to first systematically evaluate the diagnostic performance and cost-effectiveness of mNGS for TB diagnosis. We retrieved a total of 16,776 results of the seven TB diagnostic assays, including mNGS, tuberculosis IgG antibody, TB interferon-&#x3b3; release assay (TB-IGRA), TB-DNA, Xpert MTB/RIF (Xpert), culture, and acid-fast bacilli staining (AFS) from 3,757 participants with suspected TB infection at Sichuan Provincial People's Hospital from September 2021 to July 2024. Diagnostic metrics were compared against a composite reference standard. Microbial composition and a cost-utility analysis were performed. Among seven TB assays studied, the World Health Organization (WHO)-recommended assays AFS, culture, and Xpert, as well as TB-IGRA, were requested most frequently for TB diagnosis, whereas mNGS ranked last. mNGS demonstrated the highest specificity (100%), accuracy (72.3%), and area under the curve (AUC) (0.795). Its sensitivity in bronchoalveolar lavage fluid and tissue was 71.0% and 72.7%, respectively. Sequential use of mNGS after initial WHO-recommended tests (Xpert/Culture/AFS) significantly improved diagnostic performance (sensitivity, 70.4%; AUC, 0.823). Microbial analysis associated Candida albicans with TB. Cost-utility analysis showed sequential mNGS became cost-effective at higher willingness-to-pay thresholds (>200,000 RMB per correct diagnosis). mNGS offers superior specificity for TB diagnosis. A sequential strategy applying mNGS to conventional-test-negative cases provides enhanced diagnostic performance and is cost-effective at higher healthcare investment values, supporting its utility for diagnostically challenging TB. IMPORTANCE: This study systematically assesses the diagnostic performance and cost utility of metagenomic next-generation sequencing (mNGS) for tuberculosis (TB) in a large real-world cohort of 3,757 suspected patients, comparing it against six conventional assays (tuberculosis IgG antibody, TB interferon-&#x3b3; release assay, TB-DNA, Xpert, culture, and acid-fast bacilli staining). mNGS demonstrated the highest specificity (100%), accuracy (72.3%), and area under the curve (AUC) (0.795), with sensitivities of 71.0% in bronchoalveolar lavage fluid and 72.7% in tissue. Notably, sequential use of mNGS after the World Health Organization-recommended tests significantly improved sensitivity to 70.4% and AUC to 0.823. Candida albicans showed significant differences among the three groups. The sequential mNGS strategy was cost-effective compared with no mNGS, and its cost-effectiveness increased with a rising willingness-to-pay threshold. Overall, these results highlight mNGS as a valuable supplementary tool for challenging TB cases, especially when conventional tests are inconclusive, and provide strong evidence for integrating it into diagnostic algorithms to optimize clinical decision-making and resource allocation.

Adult↗