Assessment and clinical utility of metagenomic next-generation sequencing for suspected lower respiratory tract infections.

OBJECTIVES: This study aims to compare the diagnostic efficacy of metagenomic next-generation sequencing (mNGS) to traditional diagnostic methods in patients with lower respiratory tract infections (LRTIs), elucidate the etiological spectrum of these infections, and explore the impact of mNGS on guiding antimicrobial therapy. METHODS: We retrospectively analyzed data from 128 patients admitted to the Respiratory Department of Anqing 116 Hospital between July 2022 and July 2023. All patients had undergone both mNGS and conventional microbiological techniques (CMT) for LRTI diagnosis. We assessed the diagnostic performance of these methods and examined the influence of mNGS on antimicrobial decision-making. RESULTS: Overall, mNGS demonstrated superior sensitivity (96.8%) and accuracy (96.8%) compared to CMT. For Mycobacterium tuberculosis detection, the accuracy and sensitivity of mNGS was 88.8% and 77.6%, which was lower than the 94.7% sensitivity of the T-spot test and the 79.6% sensitivity of CMT. In fungal pathogen detection, mNGS showed excellent sensitivity (90.5%), specificity (86.7%), and accuracy (88.0%). Bacteria were the predominant pathogens detected (75.34%), with Mycobacterium tuberculosis (41.74%), Streptococcus pneumoniae (21.74%), and Haemophilus influenzae (16.52%) being most prevalent. Bacterial infections were most common (62.10%), followed by fungal and mixed infections (17.74%). Of the 118 patients whose treatment regimens were adjusted based on mNGS results, 102 (86.5%) improved, 7 (5.9%) did not respond favorably, and follow-up was lost for 9 patients (7.6%). CONCLUSIONS: mNGS offers rapid and precise pathogen detection for patients with suspected LRTIs and shows considerable promise in diagnosing Mycobacterium tuberculosis and fungal infections. By broadening the pathogen spectrum and identifying polymicrobial infections, mNGS can significantly inform and refine antibiotic therapy.

Validity and reliability of the Turkish version of the Informant Assessment of Geriatric Delirium Scale.

Background and purpose:

Delirium is a common complication developing in el­der­ly patients. Therefore, it is important to diagnose delirium earlier. Family caregivers play an active role in early diagnosis of de­lirium and build a bridge between health pro­fessionals and patients. The purpose of this research was to achieve the validity and reliability of the Turkish version of the Informant Assessment of Geriatric Delirium Scale (I-AGeD).

This is a methodological study. The sample comprised 125 caregivers ac­cepting to participate in the study and offering care to older patients with hip fracture aged ≥60 years. Data were gathered preoperatively and on postoperative days 0, 1 and 2. After achieving the linguistic and content validity of the scale, the known-groups comparison was used to achieve its construct validity. The ROC curve analysis was made to determine the sensitivity and specificity of the scale. Item-total correlations, item analysis based on the difference between the upper 27% and lower 27%, Kuder–Richardson 20 (KR-20) coefficient and parallel forms reliability with the NEECHAM Confusion Scale were adapted to assess discriminant indices of the items in the I-AGeD.

The item-total correlation coeffi­cients of the scale ranged from 0.54 to 0.89 and KR-20 coefficient ranged from 0.09 to 0.91 depending on the measurement times. According to the ROC curve analysis, the sensitivity and specificity of the scale were ≥ 91% and ≥ 96% respectively. The parallel forms reliability analysis showed a highly significant, strong negative relation at each measurement between the I-AGeD and the NEECHAM Confusion Scale. 

The I-AGeD is valid and reliable to diagnose delirium in older Turkish patients in perioperative processes.

Assessment of dental pulp response to carries via MR T2mapping and histological analysis.

OBJECTIVES: The aim of our study was to assess the correlation between T2 relaxation times and their variability with the histopathological results of the same teeth in relation to caries progression. MATERIALS AND METHODS: 52 extracted permanent premolars were included in the study. Prior to extractions, patients underwent magnetic resonance imaging (MRI) scanning and teeth were evaluated using ICDAS classification. Pulps of extracted teeth were histologically analysed. RESULTS: MRI T2 relaxation times (ms) were 111,9 ± 11.2 for ICDAS 0, 132.3 ± 18.5* for ICDAS 1, 124.6 ± 14.8 for ICDAS 2 and 112. 6 ± 18.2 for ICDAS 3 group (p = 0,013). A positive correlation was observed between MRI T2 relaxation times and macrophage and T lymphocyte density in healthy teeth. There was a positive correlation between vascular density and T2 relaxation times of dental pulp in teeth with ICDAS score 1. A negative correlation was found between T2 relaxation times and macrophage density. There was a positive correlation between T2 relaxation time variability and macrophage and T lymphocyte density in teeth with ICDAS score 2. In teeth with ICDAS score 3, a positive correlation between T2 relaxation times and T2 relaxation time variability and lymphocyte B density was found. CONCLUSION: The results of our study confirm the applicability of MRI in evaluation of the true condition of the pulp tissue. CLINICAL RELEVANCE: With the high correlation to histological validation, MRI method serves as a promising imaging implement in the field of general dentistry and endodontics.

Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in Pakistan.

Despite of the global unity against COVID-19 pandemic, the threat of SARS-CoV-2 variants on the lives of human being is still not over. SARS-CoV-2 pandemic has urged the need of rapid viral detection at earliest. To cope with gradually expanding scenario of SARS-CoV-2, accurate diagnosis is extremely crucial factor which should be noticed by international health organizations. Limited research followed by sporadic marketing of SARS-CoV-2 rapid pharmaceutical detection kits raises critical questions against quality assurance and quality control measures. Herein we aimed to interrogate effectivity and specificity analysis of SARS-CoV-2 pharmaceutical rapid detection kits (nasopharyngeal swab based) using conventional gold standard triple target real-time polymerase chain reaction (USFDA approved). A cross-sectional study was conducted over 1500 suspected SARS-CoV-2 patients. 100 real time-PCR confirmed patients were evaluated for pharmaceutical RDT kits based upon nasopharyngeal swab based kits. The SARS-CoV-2 nasopharyngeal swab based rapid diagnostic kit (NSP RDTs) analysis showed 78% reactivity. Among real time PCR confirmed negative subjects, 49.3% represented false positivity. The positive predictive analysis revealed 67.82%, while negative predictive values were 64.40%. The NSP RDTs showed limited sensitivities and specificities as compared to gold standard real time PCR. Valid and authentic detection of SARS-CoV-2 is deemed necessary for accurate COVID-19 surveillance across the globe. Current study highlights the potential consequences of inadequate detection of SARS-CoV-2 and emerging novel mutants, compromising vaccine preventable diseases. Current study emphasizes need to wake higher authorities including strategic organizations for designing adequate measures to prevent future SARS-CoV-2 epidemics.

Assessment and validation of glottic motion using cone-beam CT and real-time cine MRI.

PURPOSE: This study aimed to assess the margin for the planning target volume (PTV) using the Van Herk formula. We then validated the proposed margin by real-time magnetic resonance imaging (MRI). METHODS: An analysis of cone-beam computed tomography (CBCT) data from early glottic cancer patients was performed to evaluate organ motion. Deformed clinical target volumes (CTV) after rigid registration were acquired using the Velocity program (Varian Medical Systems, Palo Alto, CA, USA). Systematic (Σ) and random errors (σ) were evaluated. The margin for the PTV was defined as 2.5 Σ + 0.7 σ according to the Van Herk formula. To validate this margin, we accrued healthy volunteers. Sagittal real-time cine MRI was conducted using the ViewRay system (ViewRay Inc., Oakwood Village, OH, USA). Within the obtained sagittal images, the vocal cord was delineated. The movement of the vocal cord was summed up and considered as the internal target volume (ITV). We then assessed the degree of overlap between the ITV and the PTV (vocal cord plus margins) by calculating the volume overlap ratio, represented as (ITV∩PTV)/ITV. RESULTS: CBCTs of 17 early glottic patients were analyzed. Σ and σ were 0.55 and 0.57 for left-right (LR), 0.70 and 0.60 for anterior-posterior (AP), and 1.84 and 1.04 for superior-inferior (SI), respectively. The calculated margin was 1.8 mm (LR), 2.2 mm (AP), and 5.3 mm (SI). Four healthy volunteers participated for validation. A margin of 3 mm (AP) and 5 mm (SI) was applied to the vocal cord as the PTV. The average volume overlap ratio between ITV and PTV was 0.92 (range 0.85-0.99) without swallowing and 0.77 (range 0.70-0.88) with swallowing. CONCLUSION: By evaluating organ motion by using CBCT, the margin was 1.8 (LR), 2.2 (AP), and 5.3 mm (SI). The margin acquired using CBCT fitted well in real-time cine MRI. Given that swallowing during radiotherapy can result in a substantial displacement, it is crucial to consider strategies aimed at minimizing swallowing and related motion.

Assessment of the performance of the plasma separation card for HIV-1 viral load monitoring in South Africa.

Scaling up of newer innovations that address the limitations of the dried blood spot and the logistics of plasma monitoring is needed. We employed a multi-site, cross-sectional assessment of the plasma separation card (PSC) on blood specimens collected from all consenting adults, assenting young and pediatric patients living with HIV from 10 primary healthcare clinics in South Africa. Venous blood for EDTA-plasma samples was collected and analyzed according to the standard of care assay, while collected capillary blood for the PSC samples was analyzed using the Roche COBAS AmpliPrep/Cobas TaqMan (CAP/CTM) HIV-1 Test at the National Reference laboratories. McNemar tests assessed the differences in concordance between the centrifuged plasma and dried plasma spots. The usability of PSC by blood spotting, PSC preparation, and pre-analytical work was assessed by collecting seven-point Likert-scale data from healthcare and laboratory workers. We enrolled 538 patients, mostly adults [n = 515, 95.7% (95% CI: 93.7%-97.1%)] and females [n = 322, 64.2% (95% CI: 60.0%-68.1%)]. Overall, 536 paired samples were collected using both PSC- and EDTA-plasma diagnostics, and 502 paired PSC- and EDTA-plasma samples assessed. Concordance between the paired samples was obtained for 446 samples. Analysis of these 446 paired samples at 1,000 copies per milliliter threshold yielded an overall sensitivity of 87.5% [95% CI: 73.2%-95.8%] and specificity of 99.3% [95% CI: 97.9%-99.8%]. Laboratory staff reported technical difficulties in most tasks. The usability of the PSC by healthcare workers was favorable. For policymakers to consider PSC scale-up for viral load monitoring, technical challenges around using PSC at the clinic and laboratory level need to be addressed. IMPORTANCE: Findings from this manuscript emphasize the reliability of the plasma separation card (PSC), a novel diagnostic method that can be implemented in healthcare facilities in resource-constrained settings. The agreement of the PSC with the standard of care EDTA plasma for viral load monitoring is high. Since the findings showed that these tests were highly specific, we recommend a scale-up of PSC in South Africa for diagnosis of treatment failure.

Validation of the Slovenian version of the Montreal Cognitive Assessment Scale as a screening tool for the detection of mild cognitive impairment.

OBJECTIVE: The Montreal cognitive assessment scale (MoCA) is commonly used for detecting individuals with mild cognitive impairment (MCI). The aim of the present study was to evaluate the validity of the Slovenian MoCA as a screening tool for MCI and to determine the optimal cut-off point to detect MCI in the elderly population. METHODS: Mini-Mental State Examination (MMSE), MoCA, and neuropsychological testing assessment were conducted on 93 individuals aged ≥ 60 years. MCI was found in 35 individuals with 58 cognitively asymptomatic controls. Cut-off values, sensitivity, and specificity of MoCA were calculated with the receiver operating characteristic curve. RESULTS: MCI and healthy individuals did not differ with respect to age and education. Healthy individuals (M = 24.5, SD = 1.7) performed significantly better on MoCA compared to MCI individuals (M = 21.4, SD = 3.2) (p < 0.001). The Cronbach's α of MoCA as an index of internal consistency was 0.64. MoCA distinguished between healthy controls and MCI individuals with a sensitivity of 77% and specificity of 74%, using a cut-off of 23/24 points. CONCLUSION: The Slovenian version of MoCA demonstrates an optimal cut-off value of 23/24 points for detecting older individuals with MCI. As a screening tool for MCI, its better diagnostic accuracy makes it preferable to using MMSE.

Low-Cost Arduino Reverse Transcriptase Loop-Mediated Isothermal Amplification (RT-LAMP) for Sensitive Nucleic Acid Detection.

This work presents a low-cost transcription loop-mediated isothermal amplification (RT-LAMP) instrument for nucleic acid detection, employing an Arduino Nano microcontroller. The cooling system includes customized printed circuit boards (PCBs) that serve as electrical resistors and incorporate fans. An aluminum block is designed to accommodate eight vials. The system also includes two PCB heaters-one for sample heating and the other for vial lid heating to prevent condensation. The color detection system comprises a TCS3200 color 8-sensor array coupled to one side of the aluminum heater body and a white 8-LED array coupled to the other side, controlled by two Multiplexer/Demultiplexer devices. LED light passes through the sample, reaching the color sensor and conveying color information crucial for detection. The top board is maintained at 110 ± 2 °C, while the bottom board is held at 65 ± 0.5 °C throughout the RT-LAMP assay. Validation tests successfully demonstrated the efficacy of the colorimetric RT-LAMP reactions using SARS-CoV-2 RNA amplification as a sample viability test, achieving 100% sensitivity and 97.3% specificity with 66 clinical samples. Our instrument offers a cost-effective (USD 100) solution with automated result interpretation and superior sensitivity compared to visual inspection. While the prototype was tested with SARS-CoV-2 RNA samples, its versatility extends to detecting other pathogens using alternative primers, showcasing its potential for broader applications in biosensing.

ORCA-EFCD consensus report on clinical recommendation for caries diagnosis. Paper I: caries lesion detection and depth assessment.

OBJECTIVES: The aim of the present consensus paper was to provide recommendations for clinical practice considering the use of visual examination, dental radiography and adjunct methods for primary caries detection. MATERIALS AND METHODS: The executive councils of the European Organisation for Caries Research (ORCA) and the European Federation of Conservative Dentistry (EFCD) nominated ten experts each to join the expert panel. The steering committee formed three work groups that were asked to provide recommendations on (1) caries detection and diagnostic methods, (2) caries activity assessment and (3) forming individualised caries diagnoses. The experts responsible for "caries detection and diagnostic methods" searched and evaluated the relevant literature, drafted this manuscript and made provisional consensus recommendations. These recommendations were discussed and refined during the structured process in the whole work group. Finally, the agreement for each recommendation was determined using an anonymous Delphi survey. RESULTS: Recommendations (N = 8) were approved and agreed upon by the whole expert panel: visual examination (N = 3), dental radiography (N = 3) and additional diagnostic methods (N = 2). While the quality of evidence was found to be heterogeneous, all recommendations were agreed upon by the expert panel. CONCLUSION: Visual examination is recommended as the first-choice method for the detection and assessment of caries lesions on accessible surfaces. Intraoral radiography, preferably bitewing, is recommended as an additional method. Adjunct, non-ionising radiation methods might also be useful in certain clinical situations. CLINICAL RELEVANCE: The expert panel merged evidence from the scientific literature with practical considerations and provided recommendations for their use in daily dental practice.

Accuracy and Feasibility of Three-Dimensional Ultrasound Testing in Eye Clinic and Emergency Department Patients with Vision Complaints.

BACKGROUND: Ocular emergencies comprise 2-3% of emergency department (ED) visits, with retinal detachment requiring emergency surgery. Two-dimensional ultrasound is a rapid bedside tool but is highly operator dependent. OBJECTIVE: We determined three-dimensional ultrasound (3DUS) feasibility, acceptability, and usability in eye pathology detection using the ophthalmologist examination as reference standard. METHODS: We performed a prospective, blinded cohort study of a 3DUS-enabling device in 30 eye clinic and ED patients with visual symptoms and calculated 3DUS performance characteristics. Two expert readers interpreted the 3DUS images for pathology. All participants completed surveys. RESULTS: 3DUS sensitivity was 0.81, specificity 0.73, positive predictive value 0.54, negative predictive value 0.91, and likelihood ratio (LR)+/LR- 3.03 and 0.26, respectively. Novice and expert sonographers had "substantial" agreement in correct diagnosis of abnormal vs. normal (κ = 0.68, 95% confidence interval 0.48-0.88). Most patients indicated that 3DUS is fast, comfortable, helps them understand their problem, and improves provider interaction/care, and all sonographers agreed; 4/5 sonographers felt confident performing ultrasound. Expert readers correctly identified an abnormal eye in 83/120 scans (76%) and correct diagnosis in 72/120 scans (65%), with no statistical difference between novice (79%; 69%) and expert (72%; 61%) sonographers (p = 0.39, p = 0.55), suggesting reduced operator dependence. Reader diagnosis confidence and image quality varied widely. Image acquisition times were fast for novice (mean 225 ± 83 s) and expert (201 ± 51) sonographers, with fast expert reader interpretation times (225 ± 136). CONCLUSIONS: A 3DUS-enabling device demonstrates a sensitivity of 0.81 and specificity of 0.73 for disease detection, fast image acquisition, and may reduce operator dependence for detecting emergent retinal pathologies. Further technological development is needed to improve diagnostic accuracy in identifying and characterizing retinal pathology.

A cost-consequence analysis of the Xpert Xpress CoV-2/Flu/RSV plus test strategy for the diagnosis of influenza-like illnesses.

AIMS: Influenza-like illnesses (ILI) affect millions each year in the United States (US). Determining definitively the cause of symptoms is important for patient management. Xpert Xpress CoV-2/Flu/RSV plus (Xpert Xpress) is a rapid, point-of-care (POC), multiplex real-time polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV). The objective of our analysis was to develop a cost-consequence model (CCM) demonstrating the clinico-economic impacts of implementing PCR testing with Xpert Xpress compared to current testing strategies. METHODS: A decision tree model, with a 1-year time horizon, was used to compare testing with Xpert Xpress alone to antigen POC testing and send-out PCR strategies in the US outpatient setting from a payer perspective. A hypothetical cohort of 1,000,000 members was modeled, a portion of whom develop symptomatic ILIs and present to an outpatient care facility. Our main outcome measure is cost per correct treatment course. RESULTS: The total cost per correct treatment course was $1,131 for the Xpert Xpress strategy compared with a range of $3,560 to $5,449 in comparators. POC antigen testing strategies cost more, on average, than PCR strategies. LIMITATIONS: Simplifying model assumptions were used to allow for modeling ease. In clinical practice, treatment options, costs, and diagnostic test sensitivity and specificity may differ from what is included in the model. Additionally, the most recent incidence and prevalence data was used within the model, which is not reflective of historical averages due to the SARS-CoV-2 pandemic. CONCLUSION: The Xpert Xpress CoV-2/Flu/RSV plus test allows for rapid and accurate diagnostic results, leading to reductions in testing costs and downstream healthcare resource utilization compared to other testing strategies. Compared to POC antigen testing strategies, PCR strategies were more efficient due to improved diagnostic accuracy and reduced use of confirmatory testing.

In-phase and opposed-phase Dixon chemical shift imaging for the assessment of skeletal marrow lesions: comparison of measurements from longitudinal sequences to those from axial sequences.

OBJECTIVE: In-phase and opposed-phase chemical shift imaging (CSI) is a useful technique for assessing skeletal lesions. This study determined the frequency of significant differences in measurements obtained from longitudinal (coronal or sagittal) sequences to those obtained from axial sequences. METHODS: Chemical shift imaging was undertaken in 96 consecutive patients referred from the Musculoskeletal Sarcoma and Spinal Oncology services for assessment of possible bone tumours as part of a standard tumour protocol, which included turbo spin echo and inversion recovery sequences. For spinal lesions, CSI was obtained in the sagittal and axial planes, while for all other sites, it was obtained in the coronal and axial planes. RESULTS: The study included 49 (51.0%) males and 47 (49.0%) females with mean age 42.4 years (range 2-91 years). In 4 cases, 2 individual lesions were assessed, making a total of 100 lesions. Based on typical imaging features (n = 57) or histology (n = 43), 22 lesions (22%) were classified as non-neoplastic, 44 (44%) as benign neoplasms, 6 (6%) as intermediate-grade neoplasms, and 28 (28%) as malignant neoplasms. A significant discrepancy, wherein a lesion was classified as fat-containing (% SI drop >20%-25%) in the longitudinal plane, while in the axial plane it was classified as fat-replacing (% SI drop <20%-25%), or vice versa, occurred in 9%-14% of cases. However, this discrepancy had no appreciable effect on overall diagnostic accuracy, which was calculated at 79% for the longitudinal plane and 75%-80% for the axial plane. CONCLUSIONS: Significant differences in CSI measurements occur in 9%-14% of cases based on imaging plane, but with no significant effect on diagnostic accuracy. ADVANCES IN KNOWLEDGE: Radiologists should be aware that CSI measurements in different planes appear to have significant differences in up to 14% of lesions. However, diagnostic accuracy does not seem to be significantly affected.

External quality assessment to support the WHO ProSPeRo study for the evaluation of two dual HIV/syphilis point-of-care tests in seven countries.

BACKGROUND: Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries. METHODS: HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated. RESULTS: Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing. CONCLUSIONS: Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.

Transvaginal Sonography for the Preoperative Assessment of Parametrial Deep Infiltrating Endometriosis: A Diagnostic Accuracy Study.

OBJECTIVE: The aim of the study was to evaluate the diagnostic accuracy for parametria endometriosis (PE) of transvaginal sonography (TVS) performed following a systematic approach for the assessment of the lateral parametria. DESIGN: A diagnostic accuracy study was employed based on a prospective observational design. PARTICIPANTS: All consecutive patients who underwent laparoscopic surgery for endometriosis between January 2016 and December 2020 were considered. SETTING: The study was conducted at endometriosis referral hospitals. METHODS: We prospectively collected clinical, imaging, and surgical data of all consecutive patients who underwent laparoscopic surgery for endometriosis between January 2016 and December 2020. A standardized technique with a systematic approach for the assessment of the lateral parametria following specific anatomic landmarks was used for the TVS. The diagnostic accuracy for PE in TVS was assessed using the intraoperative and pathologic diagnosis of PE as the gold standard. RESULTS: In 476 patients who underwent surgery, PE was identified in 114 out of 476 patients (23.95%): 91 left and 54 right PE out of 476 surgical procedures were identified (19.12% vs. 11.34%; p = 0.001); bilateral involvement in 27.19% (31/114 patients) cases. The sensitivity of TVS for PE was 90.74% (79.70-96.92%, 95% CI) for the right side and 87.91% (79.40-93.81%, 95% CI) for the left side. The specificity was almost identical for both sides (98.58% vs. 98.18%). For the right parametrium, the positive likelihood ratio (PLR) and negative likelihood ratio (NLR) were 63.82 (28.70-141.90, 95% CI) and 0.09 (0.04-0.22, 95% CI), respectively. On the left parametrium, the PLR and NLR were 48.35 (23.12-101.4, 95% CI) and 0.12 (0.07-0.21, 95% CI), respectively. The diagnostic accuracy for right and left PE was 97.69% (95.90-98.84%, 95% CI) and 96.22% (94.04-97.74%, 95% CI), respectively. LIMITATIONS: The principal limit is the high dependence of TVS on the operator experience. Therefore, although a standardized approach following precise definitions of anatomical landmarks was used, we cannot conclude that the observed accuracy of TVS for PE is the same for all sonographers. In this regard, the learning curve was not assessed. In the case of negative TVS for parametrial involvement with an absent intraoperative suspect, a complete dissection of the parametrium was not performed to avoid surgical complications; therefore, cases of minor PE may be missed, underestimating false negatives. CONCLUSIONS: TVS performed following a systematic approach for assessing the lateral parametria seems to have good diagnostic accuracy for PE with large changes in the posttest probability of parametrial involvement based on the TVS evaluation. Considering the clinical and surgical implications of PE, further studies implementing a standardized approach for assessing the parametrium by TVS are recommended to confirm our observations and implement a standardized protocol in clinical practice.

Sonographic Assessment of Breast Implants Using Strain Elastography and Shear Wave Elastography in an Animal Model.

BACKGROUND/AIM: To date, magnetic resonance imaging (MRI) remains the gold standard for diagnosing breast implant rupture. As MRI is an expensive procedure with limited availability, the improvement of sonographic assessment is desirable. A potentially useful tool in this regard is elastography. To evaluate the diagnostic benefits of strain elastography and shear wave elastography under standardized conditions we developed an animal model. MATERIALS AND METHODS: An animal model was created by preparing an implant site in a chicken breast, imitating tissue layers covering a breast implant after mastectomy. Different broken and intact implants were inserted. Thereby, measurements were performed using strain elastography and shear wave elastography. For strain elastography, the resulting images were investigated on repeated patterns. The data generated by shear wave elastography were analyzed for significant differences between the ruptured and intact implants. RESULTS: The animal model using chicken breast generated realistic images and measurements comparable to those of a human breast. Hence, ruptured and intact implants could be compared under standardized conditions. Statistical analysis showed no significant difference between intact and ruptured implants with respect to the data generated by shear wave elastography. Qualitative analysis using strain wave elastography showed different patterns between intact and ruptured implants in the animal model. Intact implants showed a characteristic sonographic image of three layers in certain levels. CONCLUSION: Shear wave elastography does not seem to produce reliable data for the evaluation of breast implants, whereas qualitative analysis using strain elastography might be a useful tool to improve diagnostic accuracy.

Computed tomography/magnetic resonance imaging for mandibular boundary invasion of oral squamous cell carcinoma assessment.

BACKGROUND: The range of mandibular invasion by a tumour needs to be determined accurately to minimize unnecessary damage to the mandible. This study aimed to compare tumour boundary lines on computed tomography/magnetic resonance (CT/MR) images with those from pathological findings during the preoperative assessment of mandibular invasion by oral squamous cell carcinoma (OSCC). By comparing the methods, the potential of CT/MR for this application could be further elucidated. METHODS: Eight patients with OSCC were imaged with CT/MR, mandibular specimens were collected, and the material site was measured. Haematoxylin-eosin staining was used for histopathological assessment. The presence and boundaries of bone invasion were evaluated. The CT/MR and histopathological boundaries of bone invasion were delineated and merged to compare and calculate the deviation of CT/MR and histopathological boundaries using the Fréchet distance. RESULTS: The mean Fréchet distance between the CT and pathological tumour boundaries was 2.69 mm (standard error 0.46 mm), with a minimum of 1.18 mm, maximum of 3.64 mm, median of 3.10 mm, and 95% confidence interval of 1.40-3.97 mm. The mean Fréchet distance between the tumour boundaries on the MR and pathological images was 3.07 mm (standard error 0.56 mm), with a minimum of 1.53 mm, maximum of 4.74 mm, median of 2.90 mm, and 95% confidence interval of 1.53-4.61 mm. CONCLUSIONS: CT/MR imaging can provide an effective preoperative assessment of mandibular invasion of OSCC. Pathology images can be positioned on CT/MR scans with the help of computer software to improve the accuracy of the findings. The introduction of the Fréchet distance to compare tumour boundary lines is conducive to computer image diagnosis of tumour invasion of jaw boundaries.

Enhancing malaria detection in resource-limited areas: A high-performance colorimetric LAMP assay for Plasmodium falciparum screening.

Malaria eradication efforts in resource-limited areas require a rapid, economical, and accurate tool for detecting of the low parasitemia. The malaria rapid diagnostic test (mRDT) is the most suitable for on-site detection of the deadliest form of malaria, Plasmodium falciparum. However, the deletions of histidine rich protein 2 and 3 genes are known to compromise the effectiveness of mRDT. One of the approaches that have been explored intensively for on-site diagnostics is the loop-mediated isothermal amplification (LAMP). LAMP is a one-step amplification that allows the detection of Plasmodium species in less than an hour. Thus, this study aims to present a new primer set to enhance the performance of a colorimetric LAMP (cLAMP) for field application. The primer binding regions were selected within the A-type of P. falciparum 18S rRNA genes, which presents a dual gene locus in the genome. The test result of the newly designed primer indicates that the optimal reaction condition for cLAMP was 30 minutes incubation at 65°C, a shorter incubation time compared to previous LAMP detection methods that typically takes 45 to 60 minutes. The limit of detection (LoD) for the cLAMP using our designed primers and laboratory-grown P. falciparum (3D7) was estimated to be 0.21 parasites/µL which was 1,000-fold higher than referencing primers. Under optimal reaction condition, the new primer sets showed the sensitivity (100%, 95% CI: 80.49-100%) and specificity (100%, 95% CI: 94.64-100%) with 100% (95% CI: 95.70-100%) accuracy on the detection of dried blood spots from Malawi (n = 84). Briefly, the newly designed primer set for P. falciparum detection exhibited high sensitivity and specificity compared to referenced primers. One great advantage of this tool is its ability to be detected by the naked eye, enhancing field approaches. Thus, this tool has the potential to be effective for accurate early parasite detection in resource-limited endemic areas.

Body Core Temperature Assessment in Emergency Care Departments.

BACKGROUND: There is concern that the values provided by devices using infrared thermometry in emergency departments (EDs) do not reflect body core temperature accurately. OBJECTIVES: Evaluation of three thermometers commonly used in the ED. METHODS: Two infrared ear thermometers and an infrared forehead thermometer were evaluated using 1) the Voltcraft IRS-350 calibration device, 2) comparing temperature values to a rectal end-exercise temperature (T-RECT) of 38.1°C in 12 participants, and 3) comparing temperature values to rectal temperature in 133 ED patients. RESULTS: Calibration across the human core temperature range revealed that the ear thermometers underestimated radiant temperature by 0.77 ± 0.39°C and 1.84 ± 0.26°C, respectively, whereas the forehead thermometer overestimated radiant temperature by 0.90 ± 0.51°C. After cycling exercise, all thermometers underestimated T-RECT (0.54 ± 0.27°C and 1.03 ± 0.48°C for the ear thermometers and 1.14 ± 0.38°C for the forehead thermometer). In the ED, the ear thermometers underestimated T-RECT by 0.31 ± 0.37°C and 0.46 ± 0.50°C, whereas the forehead thermometer exhibited a nonsignificant overestimation of 0.04 ± 0.46°C. If the threshold for fever in all systems had been set to 37.5°C instead of 38.0°C, the sensitivity and specificity of the systems for real fever (T-RECT ≥ 38°C) are, respectively, 71% and 96% (ear thermometer 1), 57% and 97% (ear thermometer 2), and 86% and 90% (forehead thermometer). CONCLUSION: We conclude that the investigated thermometers are not reliable as devices to measure radiant temperature, cannot be used to assess body core temperature during exercise, but may be used as a screening device, with 37.5°C as a threshold for fever in emergency care settings.

Occlusal caries detection and monitoring using a 3D intraoral scanner system. An in vivo assessment.

OBJECTIVE: To assess the agreement in detecting and monitoring occlusal caries over thirty months using conventional visual and radiographic assessment and an intraoral scanner system which supports automated caries scoring. METHODS: Ninety-one young participants aged 12-19 years were included in the study. All occlusal surfaces were examined visually, radiographically (when indicated), and scanned with the TRIOS 4 intraoral scanner. TRIOS Patient Monitoring software (vers. 2.3, 3Shape TRIOS A/S, Denmark) was used for automated caries detection on the 3D digital models. RESULTS: Fifty-five of the study participants were re-examined after 30-months. Significant differences regarding caries detection were found between the conventional methods and the automated caries scoring system (p < 0.01), with moderate positive percent agreement (49-61%) and high negative percent agreement (87-98%). All methods reported significant caries progression over the follow-up period (p < 0.01). However, the automated system showed significantly more caries progression than the other methods (p < 0.01). CONCLUSIONS: The software for automated caries detection and classification showed moderate positive agreement and strong negative agreement with the conventional methods considering both the baseline and the follow-up assessments. The automated caries scoring system detected significantly fewer caries lesions and tended to underestimate the caries severity. All methods indicated significant caries progression over the follow-up period, while the automated system detected more caries progression. CLINICAL SIGNIFICANCE: The TRIOS system supporting automated occlusal caries detection and classification can assist in detecting and monitoring occlusal caries on permanent teeth as a complementary tool to the conventional methods. However, the operator should be aware that the automated system shows a tendency to underestimate the caries presence and lesion severity.