Specimen Quality Research Articles

ArtiSentialⓇ versus conventional laparoscopic colorectal cancer surgery: a multicenter retrospective matched cohort study

Background: This study aims to compare outcomes of colorectal cancer surgeries performed using the newly developed articulating laparoscopic instrument, ArtiSential®, with those using conventional non-articulating or rigid laparoscopic instruments. Methods: This multicenter, retrospective, matched cohort study enrolled patients with colorectal cancer undergoing laparoscopic surgery in seven tertiary referral hospitals from January 2021 to October 2022. A 1:1 propensity score matching was performed between the articulating (Arti-LAP) and conventional (Rigid-LAP) laparoscopic groups. The primary outcome was the overall incidence of short-term complications. Results: The study initially comprised 694 and 2008 patients in the Arti-LAP and Rigid-LAP groups, respectively. After matching, each group consisted of 694 patients, with no significant differences in baseline clinical characteristics. Mean operation time was 161 ± 32 min in Arti-LAP and 152 ± 25 min in Rigid-LAP groups (P=0.105). Open conversion rates were 0% (0/694) in Arti-LAP and 1.0% (7/694) in Rigid-LAP groups (P=0.024). Overall morbidity rates were 9.5% (66/694) in Arti-LAP and 12.8% (89/694) in Rigid-LAP (P=0.061), with similar rates of severe morbidities. Specimen quality was acceptable in both groups. Multivariable regression analysis showed that the choice of instrument type (articulating or rigid) was not associated with perioperative morbidity. Despite a short median follow-up period of 19.5 months, no significant difference in disease-free survival was observed between the groups. Conclusion: Laparoscopic surgery using ArtiSential® was performed safely and effectively for patients with colorectal cancer. Articulating laparoscopic instruments may offer an advantage in reducing open conversion rates.

A Systematic Review of the Use of Surgical Checklists in Transurethral Resection of Bladder Tumour.

Surgical checklists have previously been shown to improve surgical quality and patient outcomes. However, their use in transurethral resection of bladder tumour (TURBT), one of the most commonly performed urological procedures, has yet to be explored in depth. To evaluate the effect of surgical checklist implementation in TURBT on documentation quality, specimen quality, and oncological outcomes according to the existing literature. We then hope to develop an optimised TURBT checklist by identifying the most pertinent parameters for inclusion. A literature search using PubMed was performed to identify literature pertaining to the use of surgical checklists in the context of TURBT. A systematic review was then performed on the 41 identified studies, of which six were included in the final analysis. We explored three primary outcomes that arose from the literature, namely: (1) comprehensiveness of documentation; (2) resection quality; and (3) recurrence rates and recurrence-free survival (RFS). We found agreement in the literature that surgical checklist implementation does lead to an overall improvement in documentation. The effect of surgical checklists on resection quality and recurrence rates, however, was mixed in the literature, with some studies showing statistically significant improvements and others showing no significant change. There are multiple benefits to surgical checklist implementation in TURBT procedures. We propose an optimised 14-item surgical checklist that should be implemented in every TURBT report to ensure sufficient information documentation for risk stratification and post-operative management.

Total Mesorectal Excision with New Robotic Platforms: A Scoping Review.

Colorectal surgery is one of the specialties that have significantly benefited from the adoption of robotic technology. Over 20 years since the first robotic rectal resection, the Intuitive Surgical Da Vinci system remains the predominant platform. The introduction of new robotic systems into the market has enabled the first documented total mesorectal excision (TME) using alternative platforms. This scoping review aimed to assess the role and adoption of these emerging robotic systems in performing TME for rectal cancer surgery. Methods: A comprehensive search of the Medline, Embase, and Cochrane databases was conducted up to August 2024, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Results: Thirty-six studies were included in the review. The majority of rectal surgical procedures were performed using eight different robotic platforms. Intraoperative, short-term, and functional outcomes were generally favorable. However, pathological results were frequently incomplete. Several studies identified the lack of advanced robotic instruments as a significant limitation. Conclusions: The quality of the resected specimen is critical in rectal cancer surgery. Although TME performed with new robotic platforms appears to be feasible and safe, the current body of literature is limited, particularly in the assessment of pathological and long-term survival outcomes.

Surface Quality Evaluation of 3D-Printed Carbon-Fiber-Reinforced PETG Polymer During Turning: Experimental Analysis, ANN Modeling and Optimization

This work presents an experimental analysis related to 3D-printed carbon-fiber-reinforced-polymer (CFRP) machining. A polyethylene-terephthalate-glycol (PETG)-based composite, reinforced with 20% carbon fibers, was selected as the test material. The aim of the study was to evaluate the influence of cutting conditions used in light operations on the generated surface quality of the 3D-printed specimens. For this purpose, nine specimens were fabricated and machined under a wide range of cutting parameters, including cutting speed, feed, and depth of cut. The generated surface roughness was measured with a mechanical gauge and the acquired data were used to develop a shallow artificial neural network (ANN) for prediction purposes, showing that a 3-6-1 structure is the best solution. Following this, a genetic algorithm (GA) was utilized to minimize the response, revealing that the optimal combination is 205 m/min speed, 0.0578 mm/rev feed, and 0.523 mm depth of cut, contributing to the fabrication of low friction parts and shafts with a high quality surface, as well as to the reduction of resource waste. A validation study supported the accuracy of the developed model, by exhibiting errors below 10%. Finally, a set of enhanced images were taken to assess the machined surfaces. It was found that 1.50 mm depth of cut is responsible for the generation of defects across the circumference of the specimens. Especially, combined with 150 m/min cutting speed and 0.11 mm/rev feed, more flaws are produced.

The feasibility and acceptability of home phlebotomy for patients with cancer.

Time toxicity is a considerable burden for oncology patients. This study evaluated the feasibility and acceptability of integrating mobile phlebotomy into standard of care procedures. From September 26, 2022, through December 31, 2023, a total of 345 patients had 1464 home laboratory test collection visits completed. These mobile phlebotomy laboratory collection visits occurred in New York (68.6% of visits), New Jersey (29.9%), Connecticut (1.1%), and Pennsylvania (0.5%). Specimen quality for home laboratory test collection surpassed the Memorial Sloan Kettering Department of Pathology and Laboratory Medicine benchmarks. Acceptability was high, 173 patients were approached, and 149 responded (86% response rate); most respondents (147 of 149, 99%) would use the service again or recommend it to others. This study assessed the integration of mobile phlebotomy into standard of care management for the collection of routine cancer laboratory tests. Mobile phlebotomy results in high patient satisfaction with superior specimen quality, offering a valuable solution to oncology patients for improved efficiency and convenience.

Clinical Utility of Broad Range PCR for Infectious Organisms

Abstract Broad range PCR is used to identify infectious organisms when bacterial, fungal, and mycobacterial cultures are negative despite clinical evidence of infection. We performed a 6-month retrospective chart review to assess the actionability of broad range PCR and identify opportunities to improve the utility of this referral test at our institution. One hundred eleven broad range PCR tests were ordered from July to December 2023. Seventy-five (67.6%) results did not affect patient management, 18 (16.2%) results affected patient management, and the treatment impact of 18 (16.2%) results is unknown because they were from outside consult cases. There were no instances in which antibiotic therapy was completely discontinued due to a negative broad range PCR result. Concurrent in-house microbiology testing yielded a positive result in 15 (13.5%) cases, of which 8 (53%) had a negative broad range PCR result and 2 (13.3%) had a conflicting broad range PCR result. Thirty-eight (34.2%) specimens were formalin fixed paraffin embedded tissue, 29 (26.1%) were fresh tissue, 13 (11.7%) were ESWABS, and the remaining 31 specimens were various fluid types (27.9%). While fresh tissue is the preferred specimen, broad range PCR detected an organism in 20 (53%) formalin fixed paraffin embedded tissue specimens, 11 (37.9%) fresh tissue specimens, 3 (23.1%) ESWAB specimens, and 2 (6.5%) fluid specimens (abscess aspirate and cerebrospinal fluid). Improvements in physician communication and laboratory workflow are necessary to improve the specimen quality and thus the utility of this referral test at our institution.

A-122 Evaluation of the Performance of the BD MiniDraw™ Capillary Blood Collection System Under Various Transport Conditions

Abstract Background Specimen transport is a vital component of the preanalytical phase. External factors such as temperature fluctuations, vibrations, shock, and prolonged transport times may negatively impact specimen integrity and compromise test results. A study was performed to evaluate the effects of temperature extremes and simulated transportation on specimen quality in the BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H and SST™ Capillary Blood Collection Tubes (BD MiniDraw™ H&H, BD MiniDraw™ SST™). The BD MiniDraw™ Capillary Blood Collection System enables capillary blood collection by trained healthcare workers in non-traditional settings (i.e., retail pharmacies and clinics). Methods Sixteen adult participants were enrolled from the on-site Associate Sample Collection Program. Venous blood was collected via venipuncture into reference comparator and no-additive tubes. Venous blood from no-additive tubes was then pooled into a secondary container for aliquoting into BD MiniDraw™ SST™ and MiniDraw™ H&H tubes. Thirty tubes per tube type were separated into 6 groups with storage and simulated transport conditions conducted in accordance with ASTM D7386-16 and ASTM D4169-22, as applicable: Group 1a: No transport, 2-8°C storage uncontrolled humidity, 49-52-hour storage; Group 1b: Air/road transport, 2-8°C storage uncontrolled humidity, 49-52-hour storage; Group 2a: No transport, 20-24°C storage, uncontrolled humidity, 5-7-hour storage; Group 2b: Road transport, 20-24°C storage, uncontrolled humidity, 5-7-hour storage; Group 3a: Road transport, 38-40°C storage, 90% relative humidity, 5-7-hour storage; Group 3b: Air/road transport, 38-40°C storage, 90% relative humidity, 49-52-hour storage Following clotting, centrifugation, and storage for the BD MiniDraw™ SST™ tubes, testing was performed for selected chemistry analytes (Albumin, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALKP), Blood Urea Nitrogen, Chloride, Calcium, Cholesterol, Creatinine, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Sodium, Total Bilirubin (TBIL), Total Protein, Triglycerides) on the Siemens Atellica® Solution. Testing was performed for hemoglobin/hematocrit on the Sysmex XN-1000 in the BD MiniDraw™ H&H Tubes. Visual quality (barrier formation, hemolysis) and tube integrity (physical damage, blood leakage, cap removal, tube fit into adaptor) were also evaluated. Mean biases and confidence intervals within the specific analyte clinical acceptance limit for each group comparison was considered clinically equivalent. Results Clinical equivalence was demonstrated for all analytes for each group comparison except ALKP, ALT, HDL, LDL, TBIL and hematocrit for the extreme transport/storage conditions for Group 3b versus Group 3a. Complete barrier formation with acceptable visual hemolysis was noted in all specimens post transport. Tube integrity was maintained post transport as well. Conclusions Analytes were not impacted across a wide range of temperature and transport conditions. However, exposing samples to extreme high temperature, high humidity conditions may affect analyte performance. This reiterates the importance of monitoring conditions to ensure accurate test results. No impact to visual observations of sample quality and tube physical integrity was noted at different storage and transportation extremes.

A-357 Evaluation of a home kit for lay user collection, centrifugation, and refrigeration of capillary blood specimens

Abstract Background While solutions enabling at-home self-collection of capillary blood samples are maturing, many analytes require blood separation and controlled shipping temperatures for stable analysis in centralized laboratories. Here we present results of a pilot lay user study evaluating usability and specimen quality of at-home blood collection with centrifugation and refrigerated shipping of capillary serum specimens. Methods N=45 consented subjects were mailed kits including supplies for a capillary blood self-collection using a Tasso+™ device, a Labcorp TrueTherm™ reusable shipper containing a temperature tracker, a Labcorp TrueSpin™ battery-powered centrifuge, written instructions, and a usability survey. Subjects independently followed the instructions for blood collection, separation, and thermal protection and returned the kits to Labcorp via overnight shipping. Received kits were evaluated for correct return, volume of blood collected, volume of serum, visual hemolysis, and temperature throughout shipment. Results Of the n=45 consented subjects, 39 subjects returned the kits, one subject unsuccessfully attempted to collect blood two times, and the remaining five subjects did not return the kits. Primary analysis parameters are outlined in Table 1. Conclusions Untrained subjects were able to collect their own capillary blood samples, process them, and ship them using the investigational home collection kits. While kit return can be a challenge with home collection, the vast majority of subjects were able to return a testable sample. Combining blood separation prior to shipment using the Labcorp TrueSpin centrifuge and temperature control with the reusable Labcorp TrueTherm device successfully protected samples from hemolysis. These results indicate that such kits are a promising at-home blood collection method and may increase test accuracy and menu availability for sensitive analytes.

Clinical utility of rapid on-site evaluation of brush cytology during bronchoscopy using endobronchial ultrasound with a guide sheath

Previous studies have shown that rapid on-site evaluation (ROSE) improves the diagnostic yield of bronchoscopy using endobronchial ultrasound with a guide sheath (EBUS-GS) for peripheral pulmonary lesions (PPL). While ROSE of imprint cytology from forceps biopsy has been widely discussed, there are few reports on ROSE of brush cytology. This study investigated the utility of ROSE of brush cytology during bronchoscopy. We retrospectively analyzed data from 214 patients who underwent bronchoscopy with EBUS-GS for PPL. The patients in the ROSE group had significantly higher diagnostic sensitivity through the entire bronchoscopy process than in the non-ROSE group (96.8% vs. 83.3%, P = 0.002). The use of ROSE significantly increased the sensitivity of brush cytology with Papanicolaou staining (92.9% vs. 75.0%, P < 0.001). When ROSE was sequentially repeated on brushing specimens, initially negative ROSE results converted to positive in 79.5% of cases, and the proportion of specimens with high tumor cell counts increased from 42.1 to 69.0%. This study concludes that ROSE of brush cytology improves the diagnostic accuracy of bronchoscopy and enhances specimen quality through repeated brushing.

Drying kinetics, energy, colour and FTIR spectroscopy analysis on indirect solar dryer with paraffin wax and glass pieces as thermal storage material

This research focuses on developing an innovative Indirect Solar Dryer (ISD) incorporating paraffin wax and glass pieces as Thermal Storage Material (TSM) within the solar collector towards sustainable food preservation for future usage. Experiments were conducted using three distinct configurations of solar dryers: one with glass pieces and paraffin wax, another with glass pieces only, and a third without TSM. Additionally, conventional Open Solar Drying (OSD) was examined for comparison. Comparative analyses were performed on drying kinetics and energy efficiency. Results from the drying kinetics demonstrated a significant decrease in the Moisture Content (MC) of turmeric, from 84.2 % (w.b.) to 8.3 % (w.b.) within 29 h employing the configuration incorporating paraffin wax and glass pieces as TSM. Furthermore, this same configuration exhibited the highest dryer efficiency of 68.3 %. In addition to drying kinetics, Moisture Ratio (MR) was forecasted using twelve drying mathematical models, with the logarithmic model producing the most accurate forecasts (χ2 = 0.0009843 and R2 = 0.9782). Colour and Fourier Transform Infrared (FTIR) analyses have been investigated to assess the quality of the dried turmeric specimens. The configuration utilizing glass pieces and paraffin wax as integrated TSM yielded the best colour quality. FTIR spectroscopy investigation discovered peaks of the C-H Stretch within the range of 2830–2900 cm−1 in the ISD configuration spectrum, whereas these peaks were absent in the OSD spectrum, indicative of uneven drying in OSD. Based on these experimental findings, the designed ISD configuration with integrated glass pieces and paraffin wax TSM demonstrates effective results in reduced drying time and improved food specimen quality. It suggests that the proposed ISD configuration could serve as a sustainable and preferable method for drying in various industries.

Optimized biomarker evaluation and molecular testing in the era of breast cancer precision medicine

ABSTRACT Ground breaking advances in medicine, driven in part by major technologic developments in molecular biology have led us to a new model for cancer care that has been termed personalized, or precision medicine. Precision medicine is a model for making medical decisions that employs an innovative clinical approach and advanced tumor testing methods that are tailored to understanding an individual patient’s tumor biology and the molecular drivers of their disease. This medical model includes a combination of diagnostic testing and specific treatment options that can be offered to patients at presentation and in theory throughout the course of their disease as new mutations arise with the development of disease recurrence. Although the precision medicine model offers incredible potential to transform cancer care, these advances are only meaningful when they reach the correct patients. The evolving paradigm of precision medicine is changing the practice of pathology, and the pathology community needs to be mindful of these changes because every tissue specimen represents a patient’s life, and those patients are depending on the pathology community to handle their tissue correctly. The diagnostic tests performed in the pathology laboratory for precision medicine are increasingly complex, and pathologists along with the entire laboratory and clinical communities need to take steps to ensure that the right diagnosis is given to the right patient to inform the right treatment options, at the right time, along every step of the continuum of care for cancer patients. While hormone receptors and human epidermal growth factor receptor 2 (HER2) overexpression and/or amplification have been the mainstay for risk-stratification, and treatment decision making in breast cancer since the early 2000’s, the seminal work on gene expression by Perou and colleagues in the early 2000’s opened the door for molecular testing in the prognostic and predictive assessment of breast cancer. Molecular testing is now part of the standard of care in the precision medicine model for breast cancer care. In this article, the reader will gain a better understanding of how the lack of standardization of pre-analytic factors has the potential to negatively impact the quality of the tissue specimen for downstream biomarker and molecular testing, which ultimately can negatively affect patient care. The reader will also gain insight into the current climate surrounding molecular testing in breast cancer.

Consistency in the Assessment of Dried Blood Spot Specimen Size and Quality in U.K. Newborn Screening Laboratories.

In 2015, U.K. newborn screening (NBS) laboratory guidelines were introduced to standardize dried blood spot (DBS) specimen quality acceptance and specify a minimum acceptable DBS diameter of ≥7 mm. The UK 'acceptable' avoidable repeat rate (AVRR) is ≤2%. To assess inter-laboratory variability in specimen acceptance/rejection, two sets of colored scanned images (n = 40/set) of both good and poor-quality DBS specimens were distributed to all 16 U.K. NBS laboratories for evaluation as part of an external quality assurance (EQA) assessment. The mean (range) number of specimens rejected in the first EQA distribution was 7 (1-16) and in the second EQA distribution was 7 (0-16), demonstrating that adherence to the 2015 guidelines was highly variable. A new minimum standard for DBS size of ≥8 mm (to enable a minimum of six sub-punches from two DBS) was discussed. NBS laboratories undertook a prospective audit and demonstrated that using ≥8 mm as the minimum acceptable DBS diameter would increase the AVRR from 2.1% (range 0.55% to 5.5%) to 7.8% (range 0.55% to 22.7%). A significant inverse association between the number of specimens rejected in the DBS EQA distributions and the predicted AVVR (using ≥8 mm minimum standard) was observed (r = -0.734, p = 0.003). Before implementing more stringent standards, the impact of a standard operating procedure (SOP) designed to enable a standardized approach of visual assessment and using the existing ≥7 mm diameter (to enable a minimum of four sub-punches from two DBS) as the minimum standard was assessed in a retrospective audit. Implementation of the SOP and using the ≥7 mm DBS diameter would increase the AVRR from 2.3% (range 0.63% to 5.3%) to 6.5% (range 4.3% to 20.9%). The results demonstrate that there is inconsistency in applying the acceptance/rejection criteria, and that a low AVVR is not an indication of good-quality specimens being received into laboratories. Further work is underway to introduce and maintain standards without increasing the AVRR to unacceptable levels.

Retrospective Analysis of Specimen Quality in Temporal Artery Biopsies for Giant Cell Arteritis and Disease Association in North Midlands, England.

Background Temporal artery biopsy (TAB) is the recommended index diagnostic method for giant cell arteritis (GCA). Per the British Society for Rheumatology (BSR) guidelines, we assessed our procedural performance. Additionally, we evaluated the occurrence of GCA diagnosis in immunosuppressed patients and other comorbidities. Methods Following the audit registration, a retrospective analysis of prospectively collected data was conducted from 2017 to 2022 at a large university hospital in North Midlands, England. Data on demographics and comorbidities were gathered. The study's primary outcome was adherence to BSR guidelines and our service provisions. Secondary outcomes included examining the relationship between biopsy-confirmed GCA and other comorbidities. Statistical analysis was carried out using SPSS version 29 (IBM Corporation, Armonk, New York, United States of America). Two-sample t-test and Chi-square/Fisher exact test were used for continuous and categorical variables, respectively. Holm-Bonferroni method was incorporated to adjust for multiple comparisons. Results A total of 156 patients who underwent temporal artery biopsy (TAB) were included in the study, with a male-to-female ratio of 0.44:1. The median age was 73. Among the patients, 19% were smokers. The procedures were performed by either a vascular surgeon (119, 76%) or by an ophthalmologist (37, 24%). Two-thirds of the patients underwent TAB within seven days of referral. In 73, 47% of cases, the post-fixation biopsy sample size exceeded 10 mm. Positive biopsy results were found in 45 patients (29%). GCA was confirmed in 39% of patients with polymyalgia rheumatica (PMR), 24% with diabetics, 20% with hypothyroidism, 29% with hypertension, 32% with hyperlipidaemia,and 26% with other inflammatory diseases. However, the p-value was below the statistically significant threshold. The biopsy outcome was also not dependent on the speciality, time from referral to biopsy, nor on the length of the post-fixation specimen. Conclusions Temporal artery biopsy remains a valuable and crucial diagnostic tool in challenging equivocal cases of giant cell arteritis (GCA), although it is limited by its sensitivity, but there is also room for improvement. There is still uncertainty regarding the relationship between biopsy positivity, post-fixation sample size, and the interval between referral and procedure. Additionally, the speciality of the clinician performing the biopsy does not appear to significantly influence the likelihood of a positive result. We still do not fully understand why this is, but the association of the GCA with other comorbidities was unpredictably insignificant.

Enhanced recovery and reduced conversion rates in robotic rectal cancer surgery: a single-center retrospective cohort study.

This study aimed to compare the outcomes of robotic-assisted rectal resection with conventional laparoscopic and open approaches, focusing on complication rates, conversion rates, length of hospital stay, and oncologic outcomes. A retrospective single-center cohort study included 106 patients with non-metastatic rectal cancer (UICC stages I-III) who underwent rectal resection from January 2013 to December 2023. Patients were assigned to open surgery (n = 23), conventional laparoscopic surgery (n = 55), or robotic-assisted surgery (n = 28). Robotic surgery demonstrated significantly lower conversion rates compared to minimal-invasive surgeries (p = 0.047) and shorter hospital stays (11.5 ± 8days) compared to open (17.91 ± 12days) and laparoscopic (17.2 ± 14days) surgeries (p = 0.001). The quality of the specimen was significantly better (Score 1) in robotic (85.71%) and open (89.09%) cases compared to laparoscopic approaches (47.83%) (p < 0.001). Laparoscopic surgery was identified as a risk factor for worse specimen quality (p < 0.001). Older patients (> 63years) had a higher risk for conversion in univariate analysis (p = 0.049). Morbidity was comparable between the groups (p = 0.131), and the anastomotic leakage rate did not differ significantly (laparoscopic: 18.18%, open: 13.04%, robotic: 17.86%). Kaplan-Meier survival curves showed no significant differences in overall survival probabilities among the groups. Robotic-assisted rectal resection provides significant advantages in terms of lower conversion rates, better specimen quality, and shorter hospital stays while maintaining comparable complication rates and oncologic outcomes to conventional laparoscopic and open approaches. These findings support robotic surgery as a standard treatment option for rectal cancer.

Molecular Diagnostic Yield and Safety Profile of Ultrasound-Guided Lung Biopsies: A Cross-Sectional Study.

The recent advances in precision oncology for lung cancer treatment has focused attention on the importance of obtaining appropriate specimens for tissue diagnosis as well as comprehensive molecular profiling. CT scan-guided biopsies and bronchoscopy are currently the main procedures employed for tissue sampling. However, growing evidence suggests that ultrasound-guided biopsies may represent an effective as well as safe approach in this diagnostic area. This study explores the safety and the diagnostic yield for cancer molecular profiling in ultrasound-guided percutaneous lung lesion biopsies (US-PLLB). One hundred consecutive patients with suspected lung cancer, between January 2021 and May 2024, who had ultrasound-guided lung biopsies have been retrospectively analyzed. Molecular profiling was conducted with next-generation sequencing Genexus using Oncomine precision assay or polymerase chain reaction according to specimen quality. Qualitative immunohistochemical assay of programmed death ligand 1 (PD-L1) expression was evaluated by the Dako PD-L1 immunohistochemistry 22C3 pharmDx assay. The co-primary endpoints were the molecular diagnostic yield and the safety profile of US-guided lung biopsies. From January 2021 to May 2024, 100 US-guided lung biopsies were carried out and 95 were considered for inclusion in the study. US-PLLB provided informative tissue for a histological evaluation in 93 of 95 patients with an overall diagnostic accuracy of 96.84% [Sensitivity: 92.63%; Specificity: 96.84%; PPV: 100%; NPV: 100%]. Sixty-Six patients were diagnosed with NSCLC (69.47%) and were considered for molecular diagnostic yield evaluation and PD-L1 testing. Four patients had malignant lymphoid lesions. US-PLLB was not adequate to achieve a final diagnosis in three patients (3.16%). Complete molecular profiling and PD-L1 evaluation were achieved in all patients with adenocarcinoma (molecular diagnostic yield: 100%). PD-L1 evaluation was achieved in 28 of 29 patients (96.55%) with either SCC or NOS lung cancer. The overall complication rate was 9.47% (n = 9). Six patients (6.31%) developed pneumothorax, while three patients (3.16%) suffered mild haemoptysis without desaturation. According to our findings, US-guided lung biopsy is a safe, minimally invasive procedure in patients with suspected lung malignancies, providing an excellent diagnostic yield for both comprehensive molecular profiling and PD-L1 testing. In addition, our results suggest that US-guided biopsy may also be an effective diagnostic approach in patients with suspected lung lymphoma.

Comparison between Endobronchial Ultrasound-Guided Transbronchial Node Biopsy and Transbronchial Needle Aspiration: A Meta-Analysis.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) can be limited by the inadequacy of intact tissues, especially in patients with lymphoma, sarcoidosis, and lymph node tuberculosis. A novel technique called transbronchial node biopsy (TBNB) by forceps or cryoprobe has been proposed and studied to improve specimen quality and diagnostic yield. We performed a systematic review of studies describing the safety and sensitivity of EBUS-TBNB versus EBUS-TBNA in diagnosing intrathoracic lymphadenopathy/masses. We systematically searched MEDLINE, Embase, Cochrane, and China National Knowledge Infrastructure to identify studies focusing on the application of EBUS-TBNB for diagnosis of intrathoracic lymphadenopathy. The quality of each study was evaluated using the QUADAS-2 tool. Using inverse-variance (I-V) weighting, we performed a meta-analysis of diagnostic yield estimations. We also reviewed the complications related to the procedure. Thirteen studies were included in the final analysis. The meta-analysis yielded a pooled overall diagnostic yield of 77.80% (939/1,207) for EBUS-TBNA and 86.01% (834/958) for EBUS-TBNB, with an inverse-variance-weighted odds ratio of 3.13 (95% confidence interval [CI], 1.61-6.01; p = 0.0008) and I2 of 82%. The pooled diagnostic yield of EBUS-TBNB versus EBUS-TBNA for the diagnosis of malignancy (including primary lung cancer and extrapulmonary malignancy) was 84.53% (590/698) for EBUS-TBNA and 90.84% (476/524) for EBUS-TBNB, with an I-V-weighted OR of 2.33 (95% CI, 1.15-4.74; p = 0.02) and I2 of 64%. The pooled diagnostic yield of EBUS-TBNB versus EBUS-TBNA for the diagnosis of benignancy was 71.19% (252/354) for EBUS-TBNA and 86.62% (233/269) for EBUS-TBNB, with an I-V-weighted OR of 4.39 (95% CI, 2.00-9.65; p = 0.002) and I2 of 59%. The overall complications included bleeding (n = 11, 0.90%), pneumomediastinum (n = 6, 0.49%), pneumothorax (n = 6, 0.49%), pneumonia (n = 4, 0.33%), respiratory failure (n = 1, 0.08%), and haemoptysis (n = 1, 0.08%). The funnel plot analysis illustrated no major publication bias. EBUS-TBNB improves the overall diagnostic yield of sampling intrathoracic lymphadenopathy and mass lesions relative to EBUS-TBNA. The complication rate of EBUS-TBNB is higher than that of EBUS-TBNA but reportedly lower than that of surgical biopsies.

Lubricating gel influence on vaginal microbiome sampling

Gel lubrication is routinely used during gynecological examination to prevent or reduce pain, yet its impact on microbial composition during sampling remains unclear. This study aimed to investigate whether lubricating gel affects the microbial composition of vaginal samples. We included 31 pregnant women presenting during their third trimester to clinics or emergency room and collected 143 unique vaginal samples for 16S amplicon microbial analysis. Vaginal samples were obtained using sterile swabs under various conditions: without gel—immediately frozen (n = 30), with gel—immediately frozen, without gel—at room temperature (RT) for 5 h before freezing, with gel—at RT for 5 h before freezing, and additional sampling after 24 h without gel—immediate freezing. We found that sample collection with gel lubrication influenced specimen quality—half of the gel samples failing to meet processing limitation compared to those without gel. The effect of gel on testing quality dissipated after 24 h. However, when samples met post-sequencing filters, gel lubrication did not alter the microbial composition, individual taxa abundance or alpha and beta diversity. We recommend sampling either before gel exposure or 24 h after. These findings underscore the importance of considering sample collection methodologies in vaginal microbiome studies to ensure high-quality microbial data for accurate analysis.

The influence of the hot-pressing process on the mechanical properties of continuous aramid fiber-reinforced PA12 composites

Abstract Hot-pressing post-treatment can effectively improve the mechanical properties of composite specimens. In order to improve the impact resistance of continuous aramid fiber-reinforced nylon 12 (CAF/PA12) composites, the effect of hot-pressing parameters on the interlaminar shear strength of the composite was studied. The effects of hot-pressing temperature, hot-pressing time, and hot-pressing pressure on the interlaminar shear strength of composite formed specimens were studied by single factor test. Based on the optimized parameters of hot-pressing, the influence of hot-pressing on low-speed impact performance was analyzed. The results shown that the interlaminar shear strength first increased and then decreased with the increase of hot-pressing temperature and pressure. With the extension of hot-pressing time, the interlaminar shear strength continued to increase. When the hot-pressing parameters were 170°C, 30 min, and 600 kPa, the shear strength and specimen quality were the best. Under this hot-pressing process, the low-speed impact performance was increased by 36.0%. In this paper, the research content of the hot-pressing process of composite materials was expanded, which provided a reference for the research of impact resistance of continuous aramid fiber-reinforced PA12 composite materials.

Prospective non-randomized comparison of transurethral laser en bloc resection vs. conventional resection of bladder tumors larger than 3 cm.

En bloc resection of bladder tumor (ERBT) is an established surgical treatment method for patients with non-muscle invasive bladder cancer (NMIBC) in tumors less than 3 cm. Data regarding the efficacy and safety of ERBT on larger than 3 cm tumors are sparse and its efficacy compared to conventional transurethral resection (TURBT) remains unclear. The aim of this study was to prospectively compare the feasibility, safety and oncological outcomes of laser (Tm-fiber) ERBT and TURBT in patients with primary bladder lesions ≥3 cm. A cohort of 45 patients who underwent surgery for primary NMIBC between February 2018 and March 2022 was collected prospectively. There was no randomization. All procedures were performed by two experienced surgeons. Inclusion criteria were as follows: age >18 years, primary Ta or T1 bladder tumor with a diameter of ≥3 cm, no more than 3 tumors and no history of upper tract urothelial carcinoma. Exclusion criteria were carcinoma in situ or invasion into muscle layer (≥T2). ERBT was performed with thulium fiber laser (IPG, Russia). Primary endpoints included efficacy with recurrence-free survival (RFS) at 3, 6 and 12 months. Secondary endpoints were safety parameters, perioperative data and specimen quality (the presence of muscle layer in specimens). Twenty-eight patients underwent laser ERBT and 17 conventional TURBT. The location and size of the tumors were comparable in both groups. The success rate was 93.3% in the ERBT group with two cases of conversion from ERBT to TURBT. Detrusor muscle was present in 92.8% patients in the ERBT group versus 70.5% in the TURBT group (P=0.04). Obturator nerve reflex was observed only in the TURBT group: 17.6% vs. 0.0% (P=0.02). The frequency of other complications was comparable between the two groups. RFS was not statistically different between the two methods at 3 (93.9% vs. 94.1%, P=0.87), 6 (89.3% vs. 82.3%, P=0.5) and 12 months (89.3% vs. 70.6%, P=0.11). Laser ERBT is a feasible and safe procedure to manage bladder tumors larger than 3 cm. While it seems safer than TURBT, its effect on efficacy remains to be assessed in larger trials.

Critical quality indicators of high-performance polyetherimide (ULTEM) over the MEX 3D printing key generic control parameters: Prospects for personalized equipment in the defense industry

Additive Manufacturing (AM) can provide customized parts that conventional techniques fail to deliver. One important parameter in AM is the quality of the parts, as a result of the material extrusion 3D printing (3D-P) procedure. This can be very important in defense-related applications, where optimum performance needs to be guaranteed. The quality of the Polyetherimide 3D-P specimens was examined by considering six control parameters, namely, infill percentage, layer height, deposition angle, travel speed, nozzle, and bed temperature. The quality indicators were the root mean square (Rq) and average (Ra) roughness, porosity, and the actual to nominal dimensional deviation. The examination was performed with optical profilometry, optical microscopy, and micro-computed tomography scanning. The Taguchi design of experiments was applied, with twenty-five runs, five levels for each control parameter, on five replicas. Two additional confirmation runs were conducted, to ensure reliability. Prediction equations were constructed to express the quality indicators in terms of the control parameters. Three modeling approaches were applied to the experimental data, to compare their efficiency, i.e., Linear Regression Model (LRM), Reduced Quadratic Regression Model, and Quadratic Regression Model (QRM). QRM was the most accurate one, still the differences were not high even considering the simpler LRM model.