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At least 19 recordsLinked to original sources
PubMed2026

MIC-based tuberculosis drug susceptibility testing using Sensititre MYCOTB: a diagnostic accuracy meta-analysis.

Accurate drug susceptibility testing (DST) is crucial for designing effective regimens for multidrug-resistant (MDR) and pre-extensively drug-resistant tuberculosis (pre-XDR TB). Sensititre MYCOTB enables simultaneous determination of minimum inhibitory concentrations (MICs) for multiple drugs, but its diagnostic performance varies across studies. This meta-analysis evaluated the diagnostic performance of Sensititre MYCOTB for key MDR and pre-XDR TB drugs. The protocol was registered in PROSPERO (CRD420251230599). PubMed, Cochrane, Google Scholar, Scopus, ONOS, Web of Science, ScienceDirect, and registries were systematically searched for studies published between 2010 and 2025. Studies comparing the Sensititre MYCOTB with reference DST for Mycobacterium tuberculosis complex (MTBC) were included. Bias assessment and pooled diagnostic accuracy estimates were generated. Fourteen studies, including 1,728 isolates, were analyzed. Rifampicin and isoniazid demonstrated high sensitivity (0.976 [95% CI: 0.94-0.99] and 0.977 [95% CI: 0.95-0.99]) and specificity (0.958 [95% CI: 0.84-0.98] and 0.957 [95% CI: 0.83-0.99], respectively) with low heterogeneity. Amikacin, kanamycin, and ofloxacin demonstrate good diagnostic accuracy, with high specificity (>0.98 [95% CI]). Moderate diagnostic accuracy was observed for ethambutol, streptomycin, ethionamide, and rifabutin. Cycloserine, moxifloxacin, and para-aminosalicylic acid showed inconsistent performance despite excellent specificity (>0.97 [95% CI]). Sensitivity analysis partially improved pooled sensitivity for moxifloxacin 0.801 (95% CI: 0.585-0.924) and para-aminosalicylic acid 0.76 (95% CI: 0.518-0.894), whereas cycloserine remained at 0.436 (95% CI: 0.190-0.725), although heterogeneity persisted. Sensititre MYCOTB DST demonstrates high diagnostic accuracy for MDR-TB and pre-XDR-TB drugs, while caution is required with cycloserine, moxifloxacin, and para-aminosalicylic acid. These findings support the integration of MIC-based testing into clinical decision-making.

Microbial Sensitivity Tests↗
PubMed2026

Diagnostic Accuracy of a CRISPR-Based Assay in Smear- and Culture-Negative Fungal Keratitis.

IMPORTANCE: Diagnosing fungal keratitis (FK) in patients with negative smear and culture results remains clinically challenging, highlighting the need for alternative diagnostic approaches. OBJECTIVE: To determine the diagnostic accuracy of the clustered regularly interspaced short palindromic repeats (CRISPR)-based Rapid Identification of Mycoses using CRISPR (RID-MyC) assay for detecting FK in patients with negative smear and culture results using in vivo confocal microscopy (IVCM) as the reference standard. DESIGN, SETTING, AND PARTICIPANTS: This prospective diagnostic accuracy study was conducted from December 2024 to March 2025 at Aravind Eye Hospital, a tertiary ophthalmology referral hospital in Coimbatore, India. Consecutive patients clinically suspected to have microbial keratitis with negative smear and culture results were eligible for inclusion. Data were analyzed from March 2025 to June 2025. INTERVENTIONS: All included participants underwent corneal scraping for RID-MyC assay and imaging by IVCM. MAIN OUTCOMES AND MEASURES: The primary outcomes were sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic concordance of the RID-MyC assay compared with IVCM results. RESULTS: Of 245 consecutive patients clinically suspected to have microbial keratitis, 82 were smear negative. After exclusions due to contraindications or positive subsequent cultures, 41 patients with smear- and culture-negative results were ultimately included in the final analysis. Of these 41 patients (mean [SD] age, 51.0 [14.6] years; 21 [51.2%] women), RID-MyC demonstrated sensitivity of 82.1% (95% CI, 63%-94%) and specificity of 76.9% (95% CI, 46%-95%). Positive predictive value was 88.5% (95% CI, 74%-95%) and negative predictive value was 66.7% (95% CI, 46%-82%). Concordance between RID-MyC and IVCM was observed in 33 cases (80.5%). Notably, prior antifungal treatment was most frequent (4 of 5 [80%]) among patients with positive IVCM but negative RID-MyC results. Conversely, all patients (3 of 3 [100%]) with negative IVCM but positive RID-MyC findings had smaller, peripheral, or paracentral lesions. CONCLUSIONS AND RELEVANCE: In this diagnostic study, in patients with smear- and culture-negative FK, the RID-MyC assay showed good diagnostic accuracy comparable with IVCM and was feasible in all cases, including those in whom imaging was not possible. With its rapid turnaround and minimal equipment needs, RID-MyC may serve as a practical adjunct to conventional diagnostics, particularly in high-burden, resource-limited settings where IVCM is unavailable or contraindicated.

Humans↗
PubMed1977

Comparison of diagnostic accuracy of different peripheric parameters of thyroid function.

Diagnostic value of a scope of peripheric parameters of thyroid function was assessed in an unselected group of untreated patients with suspected thyroid disorder, further in untraeted selected patients (without cardiac involvement) and in treated patients. Comparison of relative values of individual tests was performed, based on relation to plasma thyroid hormone level represented by PBI. It was found that: 1. The diagnostic value of heart rate, plasma cholesterol level, B. M. R. and Hegglin's sign (T-2s interval) is of a very limited degree. 2. The diagnostic accuracy of AJT, Q-Kd interval and PEP was found to be of considerable interest even in unselected patients. Values of IRVD and D indices found for these tests are comparable and allow the immediate estimation of thyroid function in bedside diagnosis. 3. The diagnostic value of PEP could be enhanced by exclusion of patients with suspected or proved cardiac disorder or myocardial failure; this may be useful for physiologic studies. 4. While heart rate is profoundly and inconsistently influenced by beta-blockade, AJT is influenced to a minimal degree only and Q-Kd and PEP are uniformly shifted to higher values, allowing thus diagnostic evaluation during this form of treatment also. 5. As Q-Kd is considerably age-and height-dependent, AJT and PEP are believed to be the most suitable test for immediated clinical diagnosis.

Achilles Tendon↗
PubMed1979

[Studies on the diagnostic accuracy of lymphography (author's transl)].

Contradictory reports in the literature on the reliability of lymphography stimulated the authors to test the diagnostic accuracy, employing methods which are approximately analogous to practice, using carcinoma of the cervix as the model on which the study was carried out. Using 21 observers it was found that there was no correlation between their experience and on-target accuracy of the diagnosis. Good observers obtained an accuracy of 85% with good proportions between sensitivity in the recognition of detail, specificity and readiness to arrive at a decision on the basis of discriminatory ability. With the help of the concept of the ROC curves, the position taken up by the observers in respect of diagnostic decisions, and a complex manner of assessing the various characteristic factors determining diagnostic accuracy, are demonstrated. This form of test, which permits manipulation of different variants of diagnosis, is recommended, among other things, for performance control at the end of training and continuing education courses in other fields of x-ray diagnosis as well.

Female↗
PubMed1979

Fine-needle aspiration cytology in gynecologic oncology. I. Diagnostic accuracy.

A prospective study was undertaken to determine the diagnostic accuracy of fine-needle aspiration (FNA) cytology in gynecology. A total of 77 aspirations were performed on 74 patients. In 34 instances the purpose was to rule out or confirm a diagnosis of primary disease, and in 43 cases the procedure was used for suspected metastatic disease or disease recurrent after surgery, radiation therapy, and/or chemotherapy. Excellent correlation was noted between the cytologic and subsequent histopathologic diagnoses of 58 aspirations from patients who also underwent surgical biopsy. Two specimens were false negatives as the result of sampling errors. The applicability of FNA cytology in the field of gynecolotic oncology is discussed.

Adult↗
PubMed1979

[The diagnostic accuracy of the dipyridamole test in coronary heart disease (author's transl)].

The diagnostic accuracy of the dipyridamole test in provoking coronary insufficiency was investigated in 79 patients with chest pain and the results were compared with the findings on angiography and exercise electrocardiogram. 58 patients had documented severe coronary artery stenosis, 21 had patent coronary vessels (cardiomyopathy 8, aortic stenosis 1, ectopic origin of coronary artery 1, normal 11). Anginal pain after dipyridamole was a non-specific finding. Approximately half the subjects in whom coronary insufficiency would be expected according to the coronary angiographic and ventriculographic findings evidenced ischaemic ST-segment depression after dipyridamole, which was comparable to the number of positive exercise electrocardiograms. In 23 patients, most of whom had shown an inadequate frequency response during the initial exercise test, ergometry was repeated after the administration of dipyridamole. This resulted in an increase in ischaemic ECG response from 26 to 70%. It is concluded that a stress test combining dipyridamole and submaximum exercise increases the incidence of ischaemic ST-segment depression in comparison with ergometry alone. Anginal pain without ST-segment depression proved to be without diagnostic value.

Adult↗
PubMed2026

Diagnostic accuracy of bronchoalveolar lavage fluid-based testing for pulmonary cryptococcosis: A systematic review and meta-analysis.

BACKGROUND: Pulmonary cryptococcosis(PC) presents diagnostic challenges because of its non-specific clinical and radiological manifestations. Bronchoalveolar lavage fluid (BALF)-based testing, which includes latex agglutination (LA) and lateral flow assay (LFA), offers a minimally invasive diagnostic method, yet its pooled diagnostic accuracy remains unclear. METHODS: We systematically searched PubMed, Embase, Cochrane Library, and Scopus from inception to May 2026. Studies evaluating BALF-based testing for PC with extractable 2 × 2 data were included. The methodological quality of relevant studies was assessed by the QUADAS-2 tool. Pooled sensitivity, specificity, likelihood ratios, and diagnostic odds ratio (DOR) were estimated using a bivariate random-effects model. Subgroup analyses were performed by testing method and reference standard type. Heterogeneity was evaluated through paired forest plots, HSROC visualization, and exploratory bivariate meta-regression. RESULTS: The pooled sensitivity was 0.87 (95% CI: 0.81-0.91), and the specificity was 0.99 (95% CI: 0.982 - 0.995). The pooled positive likelihood ratio (PLR) was 88.00 (95% CI: 47.39 - 163.42), the negative likelihood ratio (NLR) was 0.13 (95% CI: 0.09 -0.20), and the DOR was 658.50 (95% CI: 285.36-1519.55). No significant threshold effect or publication bias was detected. Exploratory meta-regression suggested a possible assay-method effect in the joint model (P = 0.03), mainly driven by specificity (P = 0.01). CONCLUSIONS: The study demonstrates the high accuracy of CrAg in BALF for the diagnosis of pulmonary cryptococcosis, supporting its role as an important adjunctive diagnostic tool, particularly when tissue biopsy is not feasible or rapid results are needed. Larger prospective studies with standardized protocols are needed to validate these estimates.

Humans↗
PubMed1979

CT resolution and diagnostic accuracy.

To justify CT purchases and document certificates of need, the clinical effectiveness of CT scanners with different cost and resolution must be compared. The diagnostic accuracy and anatomic detail in three scanners with different resolution were studied. Seventeen patients were studied with both a first or a second generation CT scanner and a third-generation scanner. Appearance of normal and pathologic structures was compared. Cerebral sulci, corticomedullary discrimination, basal cistern vessels, and some pathologic lesions were seen in third generation images that were not seen in the others. Higher resolution scans provide significantly better anatomic detail and accuracy in detecting pathologic processes.

Adolescent↗
PubMed2026

Evaluation of three Aspergillus antibody assays for screening of chronic pulmonary aspergillosis: prospective diagnostic accuracy study.

OBJECTIVES: Chronic pulmonary aspergillosis (CPA) is a frequent complication of pulmonary tuberculosis (PTB), particularly in high-burden settings where access to reliable serological diagnostics remains limited. We evaluated the diagnostic performance of two immunochromatographic technology (ICT) lateral flow assays (LFAs) and an ELISA for CPA screening among patients with active or previously treated PTB. METHODS: In this two-year prospective multicentre diagnostic evaluation, serum from adults with prior or active PTB was tested using the Era Biology Aspergillus IgG ICT LFA, LDBio Aspergillus IgG/IgM ICT LFA, and Bordier Aspergillus fumigatus IgG ELISA. CPA diagnosis was established using a consensus composite reference standard incorporating clinical, immunological, radiological, and microbiological criteria. The Bordier ELISA was used as part of the immunological component of the consensus CPA diagnosis, with a cutoff optical density of ≥1.0. Diagnostic accuracy, agreement statistics, receiver operating characteristic analysis, and latent class analysis (LCA) were performed. RESULTS: Among 340 participants, 24 (7.06%) had CPA. Proportion of participants with positive antibody tests among all tested individuals were 6.76% for LDBio ICT LFA, 20.0% for Era Biology ICT LFA, and 11.47% for Bordier ELISA. Against consensus CPA diagnosis, Bordier ELISA showed 87.50% sensitivity and 94.30% specificity, LDBio ICT LFA 58.33% sensitivity and 97.15% specificity, and Era Biology LFA 66.67% sensitivity and 83.54% specificity. LCA estimated CPA prevalence at 7.72%. LCA-derived sensitivities and specificities were 86.58% and 99.92% for LDBio ICT LFA, 83.39% and 85.31% for Era Biology LFA, and 79.10% and 94.19% for Bordier ELISA. CONCLUSIONS: The Bordier ELISA showed high sensitivity and specificity, while the LDBio ICT LFA demonstrated very high specificity with strong LCA-derived performance. These findings support the use of ELISA for laboratory diagnosis and ICT as a point-of-care screening tool for CPA in resource-limited settings. Era Biology Aspergillus IgG LFA demonstrated moderate sensitivity and acceptable diagnostic performance, indicating its potential utility as a supplementary screening assay for CPA in settings where rapid, point-of-care testing is required.

Humans↗
PubMed1979

Diagnostic accuracy in peripheral lung lesions. Factors predicting success with flexible fiberoptic bronchoscopy.

Ninety-seven consecutive peripheral lung lesions were evaluated by biplane fluoroscopically guided flexible fiberoptic bronchoscopy and analyzed to define features that predict diagnostic yield. The overall diagnostic accuracy was 56 percent (63 percent for malignant and 38 percent for benign lesions). The most important characteristic associated with a positive cyto- or histopathologic diagnosis was size of the lesion; the yield was 28 percent when the diameter was less than 2.0 cm compared to 64 percent if the diameter was greater than or equal to 2.0 cm (P = 0.0035). The diagnostic yield was similar for lesions located in the outer and middle third of the lung if the diameter was greater than 2.0 cm; inner one-third lesions were correctly diagnosed more frequently, related in part to the larger size of these lesions. There was no significant difference in diagnostic yield for the following: segmental location, greatest distance from carcina on either the posteroanterior or lateral radiograph, or radiographic characteristics of the lesion. We conclude that biplane fluoroscopically guided flexible fiberoptic bronchoscopy is a reasonable diagnostic procedure for peripheral lesions greater than or equal to 2.0 cm in diameter, but that alternative procedures should be used for lesions under 2.0 cm in diameter.

Adult↗
PubMed2025

Artificial Intelligence in Diagnosing Depression Through Behavioural Cues: A Diagnostic Accuracy Systematic Review and Meta-Analysis.

AIM: To synthesise existing evidence concerning the application of AI methods in detecting depression through behavioural cues among adults in healthcare and community settings. DESIGN: This is a diagnostic accuracy systematic review. METHODS: This review included studies examining different AI methods in detecting depression among adults. Two independent reviewers screened, appraised and extracted data. Data were analysed by meta-analysis, narrative synthesis and subgroup analysis. DATA SOURCES: Published studies and grey literature were sought in 11 electronic databases. Hand search was conducted on reference lists and two journals. RESULTS: In total, 30 studies were included in this review. Twenty of which demonstrated that AI models had the potential to detect depression. Speech and facial expression showed better sensitivity, reflecting the ability to detect people with depression. Text and movement had better specificity, indicating the ability to rule out non-depressed individuals. Heterogeneity was initially high. Less heterogeneity was observed within each modality subgroup. CONCLUSIONS: This is the first systematic review examining AI models in detecting depression using all four behavioural cues: speech, texts, movement and facial expressions. IMPLICATIONS: A collaborative effort among healthcare professionals can be initiated to develop an AI-assisted depression detection system in general healthcare or community settings. IMPACT: It is challenging for general healthcare professionals to detect depressive symptoms among people in non-psychiatric settings. Our findings suggested the need for objective screening tools, such as an AI-assisted system, for screening depression. Therefore, people could receive accurate diagnosis and proper treatments for depression. REPORTING METHOD: This review followed the PRISMA checklist. PATIENTS OR PUBLIC CONTRIBUTION: No patients or public contribution.

Humans↗
PubMed1979

Diagnostic accuracy of cytology and biopsy in primary bronchial carcinoma.

The accuracy of diagnosis of cell type obtained from sputum cytology, bronchial aspirate, bronchial biopsy, or percutaneous lung biopsy in 161 cases of confirmed primary lung cancer has been examined and the pretreatment histological diagnosis has been compared with the final diagnosis made after surgical resection or necropsy. The yield of positive diagnoses of malignancy obtained by each method of investigation in each cell type showed that cytological examination of sputum was the most accurate method, but a high degree of accuracy was also obtained by bronchoscopic aspiration and bronchial biopsy. Percutaneous lung biopsy was the most effective, but the least accurate, means of obtaining carcinoma cells. The level of diagnostic accuracy was highest in patients with squamous cell carcinoma. Accurate pretreatment diagnosis of patients with adenocarcinoma was particularly difficult, and only 20% of these cases were correctly diagnosed by investigation. Of seven patients with adenocarcinoma and a positive diagnosis of malignancy made on percutaneous lung biopsy, none was correctly diagnosed. The causes of error in diagnosis of cell type of primary lung cancer are discussed.

Adenocarcinoma↗
PubMed1979

[Multi-institution, multidisciplinary radiology and endoscopy trial of the diagnostic accuracy of the double contrast examination of the stomach surface].

In 12 X-ray and gastroenterology departments 1570 patients, clinically suspected to have a gastric pathology, have been examined by double contrast (surface) examination of the stomach followed by gastroscopy. Diagnostic accuracy was 93% in respect of endoscopic data, assumed correct by hypothesis. On the basis of a cost and benefit evaluation, made according to the well known criteria, a wider routine use of the double contrast technique is proposed.

Adolescent↗
PubMed2026

Feasibility of implementation, diagnostic accuracy, and end-user impact of an electronic health record (EHR)-based ureteral stent tracking tool in a pediatric population.

INTRODUCTION & OBJECTIVES: Ureteral stent tracking systems have reduced stent retention in adults, but their accuracy and impact in pediatrics have been minimally explored. With low event rates in children, such tools may yield high false positives, raising questions on balancing event prevention with provider burden. We aimed to evaluate the feasibility, diagnostic accuracy, and end-user impact of an Electronic Surveillance Tool for Evaluating Nephroureteral stent Tracking (eSTENT) at our institution. STUDY DESIGN: eSTENT, implemented in 1/2024, flags ureteral stents at risk for retention based on implant documentation, expected explant date, and explant documentation. Monthly reports are generated for stents missing explant documentation. We retrospectively evaluated the diagnostic performance of eSTENT from 1/2024-8/2025 at our pediatric hospital. A usability survey including a validated 1-7 implementation score (higher = easier implementation) was distributed to pediatric urologists and operating room nurses. RESULTS: Of 172 cases with ureteral stent placement, eSTENT flagged 28 events (16%) in 24 patients. Of these, 26 represented documentation gaps where explant had been appropriate. Two flags had no documentation of explant, representing near miss events that were identified. No retained stents occurred, consistent with high sensitivity and modest specificity. There were no flags in the last 6 months of the study period. Survey response rate was 100% for surgeons and 55% for nurses. Before eSTENT, stents were not routinely tracked. All surgeons and 93% of nurses reported no added burden, despite occasional misidentification of retained stents. Three surgeons found eSTENT beneficial, four were neutral, and free-text responses generally cited eSTENT's "fail safe" nature as positive. Nurses suggested improvements, including user support and integrated documentation reminders. The average implementation score among both groups was 6/7, indicating easy adoption. DISCUSSION: While the impact of stent tracking tools in adult literature has been positive, our study emphasizes the feasibility of broader adoption at a pediatric hospital. Integration of eSTENT may avoid the potentially devastating consequences of a retained stent. Prioritizing sensitivity over specificity appears acceptable for a "never event" in patient safety. Our study is limited by the retrospective nature of data collection and survey bias. CONCLUSIONS: Though no stents were retained in the study period, eSTENT appropriately flagged two cases without added burden to most end-users. Further optimization is warranted, but adoption in pediatric centers may enhance care reliability.

Humans↗
PubMed1977

The diagnostic accuracy of lymphography in Hodgkin's disease (author's transl).

Between 1972 and 1975, exploratory laparotomies were carried out on 52 otherwise untreated patients with histologically verified Hodgkin's disease in stages I, II and III following lymphography. 84% of patients with negative lymphograms had histologically normal lymph nodes. 16% of negative lymphograms were shown to have to have histologically positive lymph nodes. Two out of eight patients diagnosed as positive on lymphography (25%) proved to be false positives caused by extensive lymph node involution. The diagnostic accuracy lymphography was therefore 83%. Surgical exploration was of value only in histologically positive cases. Post-operative control by means of lymphanigiography is essential for the evaluation of the course of Hodgkin's disease.

Adolescent↗
PubMed1978

Changing electrocardiographic recording technology and diagnostic accuracy of myocardial infarction criteria. Improved standards for evaluation of ECG measurement precision.

An analytical study was performed to estimate the magnitude of the visual Q wave duration bias produced by pressurized ink round stylus electrocardiographic (ECG) recorders. With a paper speed of 25 mm/sec and the ECG tracing width of 0.25 mm, the visually measured Q waves are on the average 8 msec too short. The corresponding error with the older type flat stylus recorder is less than 2 msec. Considerable differences can thus be anticipated in the frequency of observed ECG abnormalities in studies which use different types of electrocardiographs. The effect of the visual Q wave duration measurement bias on the diagnostic ECG classification was investigated in a group of 237 patients with old myocardial infarction and 299 subjects with no clinical evidence of infarction. An 8 msec measurement bias toward too short Q wave duration was observed to result in a potential loss of diagnostic accuracy of about 25% in some ECG coding categories. As a corrective procedure, it is recommended that the baseline width produced by a round recording stylus of uniform thickness irrespective of the vertical deflection velocity should be less.

Diagnosis, Computer-Assisted↗
PubMed2025

Construction and accuracy assessment of an efferocytosis-related prognostic model for ovarian cancer: A diagnostic accuracy study.

The study aimed to investigate the prognostic significance of efferocytosis-related genes in ovarian cancer (OC) with regard to cancer development, progression, invasion, and metastasis. OC cohorts were assembled from bioinformatics repositories. Utilizing consensus clustering analysis, distinct clusters were delineated based on the intersection of OC-related genes and efferocytosis-related genes. A prognostic signature specific to efferocytosis in OC was developed using data from The Cancer Genome Atlas, validated against the gene expression omnibus database, and subjected to independent prognostic analysis. Subsequently, a nomogram model was formulated. Moreover, investigations encompassed the immune microenvironment, immunotherapy, mutation profiling, drug sensitivity assessments, drug prediction models, and molecular docking analyses. Finally, quantitative reverse transcription polymerase chain reaction (qRT-PCR) assays were employed to ascertain the mRNA expression levels of key genes. Five key genes, FCGBP, BTN3A3, WDR91, SLC25A45, and BTNL3, were identified as significantly associated with OC. Both datasets and qRT-PCR demonstrated elevated expression levels of FCGBP and WDR91 in OC. Notably, AFLATOXIN B1 exhibited strong binding affinity to SLC25A45, ciclopirox to BTN3A3, and irinotecan to WDR91. The risk score, age, and stage were identified as independent prognostic factors, with the nomogram displaying efficacy in predicting OC patient survival. Variations in the immune cell infiltration profiles, including naive B cells, and expression levels of 6 immune checkpoint genes, such as CTLA4, were notable. High tumor mutation burden scores were associated with improved survival outcomes. Additionally, significant differences in the IC50 values of 123 anticancer drugs were observed between the 2 risk groups. This findings of this study highlight the efficacy of the efferocytosis-associated risk model in predicting the survival outcomes of OC patients, thus providing a novel reference for prognostic prediction in OC patients.

Humans↗
PubMed2026

Diagnostic accuracy of nuclear STAT6 immunohistochemistry for solitary fibrous tumour: a systematic review and meta-analysis.

Nuclear STAT6 immunohistochemistry is the diagnostic surrogate for the NAB2::STAT6 fusion of solitary fibrous tumour (SFT); its sensitivity is established, but specificity varies for unexamined reasons. This review quantified pooled accuracy and tested whether antibody clone and nuclear threshold govern specificity. PubMed, Scopus and Web of Science were searched to 29 June 2026 for studies reporting nuclear STAT6 immunohistochemistry against a reference standard (NAB2::STAT6 confirmation and/or expert consensus) in SFT and comparators, with extractable two-by-two data. Two reviewers screened, extracted data and applied QUADAS-2. A bivariate generalised linear mixed model gave summary sensitivity and specificity, and exploratory subgroup analysis and meta-regression tested antibody clone, anatomical site and reference-standard type. Twenty-three studies (1216 SFT and 4715 comparators) were included. Summary sensitivity was 98.7% (95% confidence interval 96.7-99.5) and specificity 99.1% (97.8-99.6); the diagnostic odds ratio was approximately 8656. The monoclonal YE361 subgroup (8 studies) reached specificity 99.9% (99.3-100), with one false positive among 861 comparators, versus 98.1% (96.0-99.1) for polyclonal and other antibodies. False positives concentrated in dedifferentiated liposarcoma and prostatic stromal tumours. Estimates were stable after removing studies at higher risk of bias (98.9%/99.1%) and on leave-one-out analysis; the Deeks test was non-significant (p = 0.08). Nuclear STAT6 immunohistochemistry is therefore highly sensitive and specific for SFT, and the residual specificity loss is structured and largely avoidable: the monoclonal YE361 read at a strict nuclear threshold is preferred, with MDM2 and CDK4 applied to exclude dedifferentiated liposarcoma when nuclear STAT6 is unexpectedly positive.

Humans↗