Predictive analysis of catecholamines and electrolytes for recurrence of orthostatic intolerance in children.

Background: Orthostatic intolerance (OI) is usually mediated by the autonomic nerve and most often happens in the upright position. However, it can also occur in other positions and can be relieved by lying down while likely to have another attack after relief. In the current study, we aim to evaluate the predictive effect of catecholamines and electrolytes on the recurrence of OI in children. Materials and methods: Children who were diagnosed with vasovagal syncope (VVS), postural tachycardia syndrome (POTS), and VVS combined with POTS were enrolled in this retrospective study and were followed up after 1-year physical treatment. Catecholamines in urine collected within 24 h, renin, angiotensin II, aldosterone in plasma, and electrolytes in both blood and urine collected in the morning were tested. A multivariate analysis and a receiver operating characteristic curve were used to validate the prediction effect. Results: In the VVS cohort, the 24 h urine adrenaline (AD) and norepinephrine (NE) levels of the non-recurrence group were lower than the 24 h urine AD and NE levels of the recurrence group, with a significant difference of P < 0.05. A different content can also be witnessed in the POTS cohort that the urine of the non-recurrence group contained lower sodium and chlorine. As for the VVS + POTS cohort, the non-recurrence group has lower AD and NE levels and higher potassium and phosphorus levels in urine, the difference of which proved prominent as well. Conclusion: The study provides further evidence that AD, NE, and electrolytes in urine are promising factors that are closely related to the recurrence of OI in children. The integrated evaluation system merging AD and NE may have better predictive ability.

Application of analytical performance specifications for urine test strip methods: Importance of reflectance signals.

INTRODUCTION: Urinalysis is essential for diagnosing kidney-related medical conditions. Urine test strip analysis serves as an initial and efficient screening method for reflex testing with accurate quantitative methods. MATERIALS AND METHODS: Freshly voided urines (n = 206) were analysed using two urine test strip brands on UC-MAX (Menarini) and cobas u 601 (Roche Diagnostics) instruments. Ordinal scale categories and reflectance signals (if available) were both used for the comparison with reference quantitative methods for glucose, proteins and albumin (cobas 503). Samples were considered positive when glucose > 15 or ≥ 54 mg/dL, proteins ≥ 200 mg/L and albumin ≥ 10 mg/L. Optimized reflectance thresholds were calculated by ROC curve analysis. Analytical performance specifications (APS) for trueness of test strip were gathered from the EFLM guideline (FPD, FNG, FNC). RESULTS: Reflectance signals were significantly lower in urine samples considered positive by the reference method (p < 0.0001). Reflectance signals were also correlated with quantitative measurements, showing strong correlation (0.754 to 0.969). Only the use of optimized reflectance thresholds on cobas u 601 achieved at least the minimum EFLM APS (FPD < 20%, FNG < 50% and FNC < 10%). CONCLUSION: The use of reflectance signals from urine test strips enhanced accuracy for glucose, proteins, and albumin measurement and may contribute to improve diagnosis of diverse kidney-related conditions.

Urine transfer devices may impact urinary particle results: a pre-analytical study.

OBJECTIVES: Well-standardized procedures in the pre-analytical phase of urine diagnostics is of utmost importance to obtain reliable results. We investigated the effect of different urine collection methods and the associated urine transfer tubes on urine test strip and particle results. METHODS: In total, 146 selected urine samples were subdivided into three different collection containers and subsequently transferred into its accompanying transfer tube (BD, Greiner, Sarstedt vacuum and Sarstedt aspiration). As reference, the original urine sample was directly measured on the analyser. Both chemical test strip analysis (Sysmex UC-3500) and fluorescence flow cytometry particle analysis (Sysmex UF-5000) were performed on all samples. RESULTS: No statistically significant differences in test strip results were found between the studied transfer methods. On the contrary, transfer of urine samples to the secondary tubes affected their particle counts. Clinically significant reductions in counts of renal tubular epithelial cells and hyaline casts were observed using the BD and Greiner transfer tubes and in counts of pathological casts using the BD, Greiner and Sarstedt vacuum tubes. CONCLUSIONS: The results of this study indicate that the use of urine transfer tubes may impact counts of fragile urine particles. Clinical laboratories need to be aware about the variation that urine collection methods can induce on urine particle counts.

A simple urine test by 3D-plus-3D immunoassay guides precise in vitro cancer diagnosis.

Although a variety of urinary cancer markers are available for in vitro diagnosis, inherent problems of urine environment-containing various inorganic/organic ions/molecules that vary in concentration over a 20-fold range or more and significantly attenuate antibody avidity for markers-render conventional immunoassays unsuitable, remaining unresolved and a major challenge. Here we developed a 3D-plus-3D (3p3) immunoassay method, based on a single-step urinary marker detection by 3D-antibody probes, which are free of steric hindrance and capable of omnidirectional capture of markers in a 3D solution. The 3p3 immunoassay showed an excellent performance in the diagnosis of prostate cancer (PCa) through detecting PCa-specific urinary engrailed-2 protein, demonstrating 100% sensitivity and 100% specificity with the urine specimens of PCa-related and other related disease patients and healthy individuals. This innovative approach holds a great potential in opening up a novel clinical route for precise in vitro cancer diagnosis and also pushing urine immunoassay closer to more widespread adoption.

Sensitive Urine Immunoassay for Visualization of Lipoarabinomannan for Noninvasive Tuberculosis Diagnosis.

Lipoarabinomannan (LAM) is a prospective noninvasive biomarker for tuberculosis (TB) diagnosis. Here, we report a visual immunoassay of high sensitivity for detecting LAM in urine samples toward TB diagnosis. This method uses a DNA-linked immunosorbent of LAM, followed by a transduction cascade into amplified visual signals using quantum dots (QDs) and calcein reaction with Cu2+ and copper nanoparticles (Cu NPs). The limit of detection (LOD) for LAM in the urine reaches 2.5 fg/mL and 25 fg/mL using a fluorometer and length readouts on strips, respectively, demonstrating an ultrahigh sensitivity. The clinical validation of the proposed assay was performed with 147 HIV-negative clinical urine specimens. The results show the sensitivity of test is 94.1% (16/17) for confirmed TB (culture-positive) and 85% (51/60) for unconfirmed TB (clinical diagnosis without positive culture results), respectively, when the test cutoff value is 40 fg/mL for TB. Its specificity is 89.2% (25/28) in non-TB and nontuberculous mycobacterial patients. The area under the curve (AUC) was 0.86 when controls were non-TB and LTBI patients, while the AUC was 0.92 when controls were only non-TB patients. This highly sensitive visual immunoassay of LAM has shown potential for noninvasive diagnosis of TB using urine samples.

Metabolic stone workup abnormalities are not as important as stone culture in patients with recurrent stones undergoing percutaneous nephrolithotomy.

To investigate the association between metabolic urinary abnormalities and urinary tract infection (UTI) and the stone recurrence status in patients undergoing percutaneous nephrolithotomy (PCNL). A prospective evaluation was performed for patients who underwent PCNL between November 2019 and November 2021 and met the inclusion criteria. Patients with previous stone interventions were classified as recurrent stone formers. Before PCNL, a 24 h metabolic stone workup and midstream urine culture (MSU-C) were done. Renal pelvis (RP-C) and stones (S-C) cultures were collected during the procedure. The association between the metabolic workup and UTI results with stone recurrence was evaluated using univariate and multivariate analyses. The study included 210 patients. UTI factors that showed significant association with stone recurrence included positive S-C [51 (60.7%) vs 23 (18.2%), p < 0.001], positive MSU-C [37 (44.1%) vs 30 (23.8%), p = 0.002], and positive RP-C [17 (20.2%) vs 12 (9.5%), p = 0.03]. Other factors were mean ± SD GFR (ml/min) (65 ± 13.1 vs 59.5 ± 13.1, p = 0.003), calcium-containing stones [47 (55.9%) vs 48 (38.1%), p = 0.01], median (IQR) urinary citrate levels (mg/day) [333 (123-512.5) vs 221.5 (120.3-412), p = 0.04], and mean ± SD urinary pH (6.1 ± 1 vs 5.6 ± 0.7, p < 0.001). On multivariate analysis, only positive S-C was the significant predictor of stone recurrence (odds ratio: 9.9, 95% confidence interval [CI] (3.8-28.6), p < 0.001). Positive S-C, and not metabolic abnormalities, was the only independent factor associated with stone recurrence. A focus on preventing UTI might prevent further stone recurrence.

Association Between Buprenorphine Dose and the Urine "Norbuprenorphine" to "Creatinine" Ratio: Revised.

Background: Utilizing a 1-year chart review as the data, Furo et al. conducted a research study on an association between buprenorphine dose and the urine "norbuprenorphine" to "creatinine" ratio and found significant differences in the ratio among 8-, 12-, and 16-mg/day groups with an analysis of variance (ANOVA) test. This study expands the data for a 2-year chart review and is intended to delineate an association between buprenorphine dose and the urine "norbuprenorphine" to "creatinine" ratio with a higher statistical power. Methods: This study performed a 2-year chart review of data for the patients living in a halfway house setting, where their drug administration was closely monitored. The patients were on buprenorphine prescribed at an outpatient clinic for opioid use disorder (OUD), and their buprenorphine prescription and dispensing information were confirmed by the New York Prescription Drug Monitoring Program (PDMP). Urine test results in the electronic health record (EHR) were reviewed, focusing on the "buprenorphine," "norbuprenorphine," and "creatinine" levels. The Kruskal-Wallis H and Mann-Whitney U tests were performed to examine an association between buprenorphine dose and the "norbuprenorphine" to "creatinine" ratio. Results: This study included 371 urine samples from 61 consecutive patients and analyzed the data in a manner similar to that described in the study by Furo et al. This study had similar findings with the following exceptions: (1) a mean buprenorphine dose of 11.0 ± 3.8 mg/day with a range of 2 to 20 mg/day; (2) exclusion of 6 urine samples with "creatinine" level <20 mg/dL; (3) minimum "norbuprenorphine" to "creatinine" ratios in the 8-, 12-, and 16-mg/day groups of 0.44 × 10-4 (n = 68), 0.1 × 10-4 (n = 133), and 1.37 × 10-4 (n = 82), respectively; however, after removing the 2 lowest outliers, the minimum "norbuprenorphine" to "creatinine" ratio in the 12-mg/day group was 1.6 × 10-4, similar to the findings in the previous study; and (4) a significant association between buprenorphine dose and the urine "norbuprenorphine" to "creatinine" ratios from the Kruskal-Wallis test (P < .01). In addition, the median "norbuprenorphine" to "creatinine" ratio had a strong association with buprenorphine dose, and this association could be formulated as: [y = 2.266 ln(x) + 0.8211]. In other words, the median ratios in 8-, 12-, and 16-mg/day groups were 5.53 × 10-4, 6.45 × 10-4, and 7.10 × 10-4, respectively. Therefore, any of the following features should alert providers to further investigate patient treatment compliance: (1) inappropriate substance(s) in urine sample; (2) "creatinine" level <20 mg/dL; (3) "buprenorphine" to "norbuprenorphine" ratio >50:1; (4) buprenorphine dose >24 mg/day; or (5) "norbuprenorphine" to "creatinine" ratios <0.5 × 10-4 in patients who are on 8 mg/day or <1.5 × 10-4 in patients who are on 12 mg/day or more. Conclusion: The results of the present study confirmed those of the previous study regarding an association between buprenorphine dose and the "norbuprenorphine" to "creatinine" ratio, using an expanded data set. Additionally, this study delineated a clearer relationship, focusing on the median "norbuprenorphine" to "creatinine" ratios in different buprenorphine dose groups. These results could help providers interpret urine test results more accurately and apply them to outpatient opioid treatment programs for optimal treatment outcomes.

Image dataset of urine test results on petri dishes for deep learning classification.

Recent advancements in image analysis and interpretation technologies using computer vision techniques have shown potential for novel applications in clinical microbiology laboratories to support task automation aiming for faster and more reliable diagnostics. Deep learning models can be a valuable tool in the screening process, helping technicians spend less time classifying no-growth results and quickly separating the categories of tests that deserve further analysis. In this context, creating datasets with correctly classified images is fundamental for developing and improving such models. Therefore, a dataset of urine test Petri dishes images was collected following a standardized process, with controlled conditions of positioning and lighting. Image acquisition was conducted by applying a hardware chamber equipped with a led lightning source and a smartphone camera with 12 MP resolution. A software application was developed to support image classification and handling. Experienced microbiologists classified the images according to the positive, negative, and uncertain test results. The resulting dataset contains a total of 1500 images and can support the development of deep learning algorithms to classify urine exams according to their microbial growth.

Expanded targeted screening for congenital cytomegalovirus infection.

An early diagnosis and intervention for congenital cytomegalovirus infection can reduce long-term disability; however, the introduction of universal neonatal screening has been controversial worldwide. The present study clarified the outcome of a targeted screening protocol for detecting congenital cytomegalovirus infection based on suggestive perinatal conditions. In addition, the positive rate was compared to those from the reported studies and the validity of the targeted screening criteria was discussed. A total of 2121 newborn infants were admitted to our hospital between October 2018 and October 2021. Cytomegalovirus DNA was examined by the isothermal nucleic acid amplification method for urine samples from newborns with any of the following: microcephaly, abnormal ultrasound findings in the brain and visceral organs, repeated failure in neonatal hearing screening, suspicious maternal cytomegalovirus infection during pregnancy, and other abnormal findings suggestive of congenital cytomegalovirus infection. Among 2121 newborns, 102 (4.8%) were subject to the urine cytomegalovirus DNA test based on the abovementioned criteria. Of them, three were cytomegalovirus DNA-positive. According to the protocol, the cytomegalovirus DNA-positive rates were 0.14% among the total enrollment of 2121 newborns and 2.9% (3/102) among the targeted newborns. This protocol may overlook congenital cytomegalovirus infection that is asymptomatic or exhibits inapparent clinical manifestations only at birth; however, it is feasible and helps lead to the diagnosis of congenital cytomegalovirus infection that may otherwise be overlooked.

Cxbladder Monitor testing to reduce cystoscopy frequency in patients with bladder cancer.

PURPOSE: Bladder cancer surveillance is associated with high costs and patient burden. CxMonitor (CxM), a home urine test, allows patients to skip their scheduled surveillance cystoscopy if CxM-negative indicating a low probability of cancer presence. We present outcomes from a prospective multi-institutional study of CxM to reduce surveillance frequency during the coronavirus pandemic. MATERIALS AND METHODS: Eligible patients due for cystoscopy from March-June 2020 were offered CxM and skipped their scheduled cystoscopy if CxM-negative. CxM-positive patients came for immediate cystoscopy. The primary outcome was safety of CxM-based management, assessed by frequency of skipped cystoscopies and detection of cancer at immediate or next cystoscopy. Patients were surveyed on satisfaction and costs. RESULTS: During the study period, 92 patients received CxM and did not differ in demographics nor history of smoking/radiation between sites. 9 of 24 (37.5%) CxM-positive patients had 1 T0, 2 Ta, 2 Tis, 2 T2, and 1 Upper tract urothelial carcinoma (UTUC) on immediate cystoscopy and subsequent evaluation. 66 CxM-negative patients skipped cystoscopy, and none had findings on follow-up cystoscopy requiring biopsy. Six of these patients did not attend follow-up, 4 elected to undergo additional CxM instead of cystoscopy, 2 stopped surveillance, and 2 died of unrelated causes. CxM-negative and positive patients did not differ in demographics, cancer history, initial tumor grade/stage, AUA risk group, or number of prior recurrences. Median satisfaction (5/5, IQR 4-5) and costs (26/33, 78.8% no out-of-pocket costs) were favorable. CONCLUSIONS: CxM safely reduces frequency of surveillance cystoscopy in real-world settings and appears acceptable to patients as an at-home test.

At-home urine estrone-3-glucuronide quantification predicts oocyte retrieval outcomes comparably with serum estradiol.

Objective: To investigate the feasibility of monitoring urine estrone-3-glucuronide (E3G) with an at-home device during gonadotropin stimulation for in vitro fertilization and oocyte cryopreservation. Design: Prospective, observational cohort study. Setting: Private fertility clinic. Patients: Thirty patients undergoing stimulation with a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization or oocyte cryopreservation. Interventions: Daily collection of the first urine in the morning during stimulation and analysis performed at home by each patient with the Mira Fertility Tracker. Main Outcome Measures: Primary outcomes were correlation of urine E3G and serum estradiol (E2) concentrations on the day of trigger to the number of total and metaphase 2 oocytes (MII). Secondary outcomes of interest were the correlation of matched E3G and E2 measurements and the daily trends of E3G and E2 during stimulation. Results: Both urine E3G and serum E2 concentrations on the day of trigger significantly correlated with retrieval outcomes to a similar extent, with E3G demonstrating slightly higher correlation to the number of MII oocytes than that demonstrated by E2 (r = 0.485 vs. 0.391, respectively). The Pearson correlation coefficient for matched E3G and E2 levels was 0.761. The correlation coefficients of determination for daily trends of E3G and E2 during stimulation were 0.7066 and 0.6102, respectively. Conclusions: Measured on the day of trigger, urine E3G monitoring during gonadotropin stimulation was comparable with serum E2 for predicting oocyte retrieval outcomes. Matched daily samples confirmed good correlation of urine E3G and serum E2. The option of at-home estrogen monitoring with devices such as Mira offers an alternative to traditional serum monitoring that may improve patient experience. Clinical Trial Registration Number: NCT05493202.

Identification of urinary biomarkers of colorectal cancer: Towards the development of a colorectal screening test in limited resource settings.

BACKGROUND: African colorectal cancer (CRC) rates are rising rapidly. A low-cost CRC screening approach is needed to identify CRC from non-CRC patients who should be sent for colonoscopy (a scarcity in Africa). OBJECTIVE: To identify urinary metabolite biomarkers that, combined with easy-to-measure clinical variables, would identify patients that should be further screened for CRC by colonoscopy. Ideal metabolites would be water-soluble and easily translated into a sensitive, low-cost point-of-care (POC) test. METHODS: Liquid-chromatography mass spectrometry (LC-MS/MS) was used to quantify 142 metabolites in spot urine samples from 514 Nigerian CRC patients and healthy controls. Metabolite concentration data and clinical characteristics were used to determine optimal sets of biomarkers for identifying CRC from non-CRC subjects. RESULTS: Our statistical analysis identified N1, N12-diacetylspermine, hippurate, p-hydroxyhippurate, and glutamate as the best metabolites to discriminate CRC patients via POC screening. Logistic regression modeling using these metabolites plus clinical data achieved an area under the receiver-operator characteristic (AUCs) curves of 89.2% for the discovery set, and 89.7% for a separate validation set. CONCLUSIONS: Effective urinary biomarkers for CRC screening do exist. These results could be transferred into a simple, POC urinary test for screening CRC patients in Africa.

Assessing the Content Quality of Online Parental Resources about Newborn Metabolic Disease Screening: A Content Analysis.

Parents increasingly utilise the internet to obtain information on health practices, but the quality of online information about screening for inherited metabolic diseases (IMD) needs to be improved. A content analysis examined how IMD blood and urine tests were described online in local healthcare sectors between May and June 2021. Among the nine resources, four were blood test providers and five were urine test providers. All mentioned the test benefits and procedures. Other information, such as false-positive/negative or risk of pain, was infrequently mentioned. The descriptions of urine tests are advertised as outperforming blood tests and can be purchased from commercial laboratory sites without medical guidance. Two urine test providers claimed no false results were reported. A few commercial advertisements highlighted the simplicity of the urine test and potentially overstated the invasiveness of the blood test. We found that some advertisements described IMD as "silent killers" and emphasised the advantage of getting "reassurance" in controlling the child's developmental health and well-being. To better protect the parents, or broadly, the public interest, regulatory and oversight measures on the urine tests should be implemented to promote the proper use of genetic tests. Without timely regulation and oversight, the incorrect descriptions might create a public misconception about utilising these commercial laboratory tests to inform health decisions.

Diagnostic capabilities of self-reported psychoactive substance use among patients admitted to psychiatric consultations in Benin, West Africa.

BACKGROUND: There is a high prevalence of psychoactive substance use among patients with mental health disorders. The optimal treatment of patients with mental health disorders requires an awareness of their history pertaining substance use. Several methods are used to assess the use of substance. Each of them embodies its limitations. This study aimed at assessing the diagnostic capability of a self-report psychoactive substance use among patients at the National Psychiatric University Hospital of Cotonou, Benin. METHODS: A cross-sectional survey was conducted from August 1, 2021 to November 24, 2021. A total of 157 consenting patients admitted to psychiatric consultations were successively enrolled in the ongoing study. They were screened for the use of psychoactive substance with Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), followed by urine test using the NarcoCheck® kit for qualitative detection of substances or its metabolites. To assess the diagnostic capability, the participants' self-responses were compared with their urine test results. The sensitivity, specificity, positive and negative predictive values, and kappa coefficient were also calculated. RESULTS: The frequency of lifetime psychoactive substance use according to self-report was 81.5% (95% CI: 0.746-0.873), while over the past three months (recent use) was 52.2% (95% CI: 0.441-0.603) and 58.6% based on the urine test. Alcohol, tobacco and cannabis were the most prevalent psychoactive substance used. The overall concordance between self-reported psychoactive substance use and the urine test (gold standard) was moderate (sensitivity = 66%; kappa = 0.46). Self-report cocaine use compared with urine test showed the highest concordance (sensitivity = 100%; kappa = 79%), followed by tobacco (sensitivity = 58%, kappa = 41%). On an average 70% of urine test results were consistent with self-report (VPP). Participants' were more accurate when they were reporting no psychoactive substance use as suggested by the high negative predictive value (NPV). CONCLUSION: Diagnostic capability of self-reporting of psychoactive substance use among patients admitted to psychiatric consultations was moderate. Therefore self-reporting may not estimate the exact prevalence of psychoactive substance use. Optimal identification of psychoactive substances use in psychiatric patients requires both history and urine testing. The integration of these two approaches is an excellent method to find out the level, frequency and nature of drug used.

BladMetrix: a novel urine DNA methylation test with high accuracy for detection of bladder cancer in hematuria patients.

BACKGROUND: Cystoscopy is the gold standard for bladder cancer detection, but is costly, invasive and has imperfect diagnostic accuracy. We aimed to identify novel and accurate DNA methylation biomarkers for non-invasive detection of bladder cancer in urine, with the potential to reduce the number of cystoscopies among hematuria patients. RESULTS: Biomarker candidates (n = 32) were identified from methylome sequencing of urological cancer cell lines (n = 16) and subjected to targeted methylation analysis in tissue samples (n = 60). The most promising biomarkers (n = 8) were combined into a panel named BladMetrix. The performance of BladMetrix in urine was assessed in a discovery series (n = 112), consisting of bladder cancer patients, patients with other urological cancers and healthy individuals, resulting in 95.7% sensitivity and 94.7% specificity. BladMetrix was furthermore evaluated in an independent prospective and blinded series of urine from patients with gross hematuria (n = 273), achieving 92.1% sensitivity, 93.3% specificity and a negative predictive value of 98.1%, with the potential to reduce the number of cystoscopies by 56.4%. CONCLUSIONS: We here present BladMetrix, a novel DNA methylation urine test for non-invasive detection of bladder cancer, with high accuracy across tumor grades and stages, and the ability to spare a significant number of cystoscopies among patients with gross hematuria.

Introducing Audio Podcasts into a Practical Laboratory Course for Pharmacy Students as a Novel Tool for Performance Assessment.

The use of digital tools can positively impact higher education for both scholars and faculty. In recent years, it has become apparent that podcasts are a suitable medium for use in teaching. They are provided almost exclusively by lecturers for students, with students passively listening to them rather than actively participating in their production. However, this could also be valuable for students. Therefore, this pilot study investigated the extent to which the creation of a podcast would be accepted by students as a method for capturing pharmacy students' understanding of the learning content. The evaluation was performed as part of the "Clinical Chemistry" practical course, which was attended by third-year pharmacy students in groups of three. After passing the station dealing with practical clinical chemistry relevant diagnostic systems, the groups were asked to produce an educational podcast covering the essential content on the topics of urine test strips or pulse oximetry, respectively. Student attitudes toward the adoption of podcasts as a tool for performance assessment were determined with an anonymous and voluntary survey. The respondents reported that they had fun creating the podcast, which enabled them to look at the instructional content from a different perspective. Competencies such as social and communication skills and media literacy as well as self-organized and self-directed learning were also promoted. However, the students assumed that the tool is not ideally suited for dealing with extensive topics. Nonetheless, the students clearly support the continued creation of podcasts as a performance assessment tool. In addition, they suggest integrating podcasts into other courses within the pharmacy curriculum. This may also be related to the infrequent use of novel technologies, such as podcasts, in their education thus far.

Design of automatic urine collection system for medical system applications.

BACKGROUND: The results of urine tests are often affected by improper midstream urine collection time, urine spilling, and urine pollution, all of which can lead to an increase in the test error. OBJECTIVE: To solve this problem, aiming at improving the toilet environment at the hospitals and public physical examination centers, this paper designs an automatic urine collection system. It can automatically adjust the position of the urine cup with an infrared remote controller, or manually, adjust the position of the urine cup in special situations according to the needs of the user. It also has an alarm function. METHODS: The overall size and shape are designed based on the squatting pan, suitable for disposable plastic urine cups of different shapes and sizes. It can realize the automatic collection of midstream urine, manual collection in exceptional cases, emergency stops, and rescue calls. RESULTS: Through the trial survey, there was a significant difference between the statistical results of using the device and not using the device (t= 13.937, P= 0.000). 96% of the subjects thought that the design of the system was reasonable, 22% thought that it was inconvenient to use, and 91.7% of the medical staff thought that the system met the sampling requirements. CONCLUSIONS: Therefore, the trial evaluation is satisfactory, and the proposed collection system is suitable for use in hospitals at all levels and public health examination centers with a large amount of inspection.

Non-invasive Urine Test for Molecular Classification of Clinical Significance in Newly Diagnosed Prostate Cancer Patients.

Objective: To avoid over-treatment of low-risk prostate cancer patients, it is important to identify clinically significant and insignificant cancer for treatment decision-making. However, no accurate test is currently available. Methods: To address this unmet medical need, we developed a novel gene classifier to distinguish clinically significant and insignificant cancer, which were classified based on the National Comprehensive Cancer Network risk stratification guidelines. A non-invasive urine test was developed using quantitative mRNA expression data of 24 genes in the classifier with an algorithm to stratify the clinical significance of the cancer. Two independent, multicenter, retrospective and prospective studies were conducted to assess the diagnostic performance of the 24-Gene Classifier and the current clinicopathological measures by univariate and multivariate logistic regression and discriminant analysis. In addition, assessments were performed in various Gleason grades/ISUP Grade Groups. Results: The results showed high diagnostic accuracy of the 24-Gene Classifier with an AUC of 0.917 (95% CI 0.892-0.942) in the retrospective cohort (n = 520), AUC of 0.959 (95% CI 0.935-0.983) in the prospective cohort (n = 207), and AUC of 0.930 (95% 0.912-CI 0.947) in the combination cohort (n = 727). Univariate and multivariate analysis showed that the 24-Gene Classifier was more accurate than cancer stage, Gleason score, and PSA, especially in the low/intermediate-grade/ISUP Grade Group 1-3 cancer subgroups. Conclusions: The 24-Gene Classifier urine test is an accurate and non-invasive liquid biopsy method for identifying clinically significant prostate cancer in newly diagnosed cancer patients. It has the potential to improve prostate cancer treatment decisions and active surveillance.

Health Economic Evidence for Liquid- and Tissue-based Molecular Tests that Inform Decisions on Prostate Biopsies and Treatment of Localised Prostate Cancer: A Systematic Review.

CONTEXT: Several liquid- and tissue-based biomarker tests (LTBTs) are available to inform the need for prostate biopsies and treatment of localised prostate cancer (PCa) through risk stratification, but translation into routine practice requires evidence of their clinical utility and economic impact. OBJECTIVE: To review and summarise the health economic evidence on the ability of LTBTs to inform decisions on prostate biopsies and treatment of localised PCa through risk stratification. EVIDENCE ACQUISITION: A systematic search was performed in the EMBASE, MEDLINE, Health Technology Assessment, and National Health Service Health Economic Evaluation databases. Eligible publications were those presenting health economic evaluations of an LTBT to select individuals for biopsy or risk-stratify PCa patients for treatment. Data on the study objectives, context, methodology, clinical utility, and outcomes were extracted and summarised. EVIDENCE SYNTHESIS: Of the 22 studies included, 14 were focused on test-informed biopsies and eight on treatment selection. Most studies performed cost-effectiveness analyses (n = 7), followed by costing (n = 4) or budget impact analyses (n = 3). Most (18 of 22) studies concluded that biomarker tests could decrease health care costs or would be cost-effective. However, downstream consequences and long-term outcomes were typically not included in studies that evaluated LTBT to inform biopsies. Long-term effectiveness was modelled by linking evidence from different sources instead of using data from prospective studies. CONCLUSIONS: Although studies concluded that LTBTs would probably be cost-saving or -effective, the strength of this evidence is disputable because of concerns around the validity and transparency of the assumptions made. This warrants prospective interventional trials to inform health economic analyses to ensure collection of direct evidence of clinical outcomes based on LTBT use. PATIENT SUMMARY: We reviewed studies that evaluated whether blood, urine, and tissue tests can reduce the health and economic burden of prostate cancer. Results indicate that these tests could be cost-effective, but clinical studies of long-term outcomes are needed to confirm the findings.