Advances in laboratory medicine最新文献

In recent years, with the rapid development of artificial intelligence technology, chatbots have demonstrated significant potential in the medical field, particularly in medical laboratories. This study systematically analyzes the advantages and challenges of chatbots in this field and delves into their potential applications in disease diagnosis. However, the reliability and scientific nature of chatbots are influenced by various factors, including data quality, model bias, privacy protection, and user feedback requirements. To ensure the accuracy and reliability of output content, it is essential to not only rely on legal frameworks such as the EU AI Act for necessary protection but also to employ two assessment tools, METRICS and CLEAR. These tools are designed to comprehensively evaluate the quality of AI-generated health information, thereby providing a solid theoretical foundation and support for clinical practice.

Objectives: Emergency department (ED) crowding is a quality of care and financial problem. Among its causes are long length of stay in the ED (ED LoS). One of identified causes is prolonged Turnaround Time (TAT) for complementary tests, including laboratory tests. The main aim of this study is to design and validate a cost-effective model for improving resolution of hospital emergencies at the Virgen Macarena University Hospital (VMUH) based on application of point-of-care testing (POCT) on patients classified as priority 3 (P3), according to VMUH's triage system.

Methods: P3 patients who met inclusion criteria were randomly assigned into: POCT group (laboratory tests in ED using POCT) or LAB group (laboratory tests in central laboratory). Previously, a correlation study of analytical parameters was done between both groups. Gender, age, reason for consultation, pre-intervention TAT, disposition-decision time (DDT) and ED LoS with or without imaging tests were analysed. A cost study and an extrapolation of strategy at national level were performed.

Results: The correlation study proved favorable. POCT achieved a median reduction of DDT and ED LoS of 107.00 and 118.50 min respectively. This trend was maintained for non-pain related consultations and irrespective of imaging tests. Use of POCT resulted in a saving of €119.85/episode and a favorable incremental cost-effectiveness ratio (ICER) of €60.68 saved/ED LoS hour. Applying POCT to 50 % of national P3 EDs, potential savings of €284,206,701.19 were estimated.

Conclusions: In conclusion, our strategy was shown to reduce DDT and, consequently, ED LoS in a cost-effective way.

Objectives: Prostate-specific antigen (PSA) circulates bound to extracelular vesicles (EVs). Levels of this PSA form (ev-PSA) are higher in prostate cancer (PCa) compared to benign pathologies and healthy controls, being the PSA extracellular vesicles/serum (ev/srm) ratio potentially useful as PCa diagnostic biomarker. We evaluated the utility of ev-PSA as a follow-up biomarker for detecting relapse or monitoring response to systemic treatments in advanced PCa.

Methods: Samples were obtained sequentially (baseline, response and progression) from 10 patients with advanced PCa undergoing hormonal therapy or chemotherapy. EVs were isolated from serum by size exclusion chromatography. Total PSA (T-PSA) and free PSA (F-PSA) were quantified in serum and EVs in a c602 module of a Cobas 8000 (Roche Diagnostics) using Elecsys immunoassays, and PSA ev/srm ratio was calculated.

Results: T-PSA in EVs (ev-T-PSA) was quantified in all samples and T-PSA ev/srm ratio median was 1.4 % (Q1-Q3: 1.1-1.9 %). At clinical response, there was not a significant decrease in ev-T-PSA (p=0.055) and neither an increase in T-PSA ev/srm ratio values (p=0.078). During progression, the T-PSA ev/srm ratio decreased significantly with respect to baseline (p=0.037) and clinical response values (p=0.008), although srm-T-PSA and ev-T-PSA concentrations did not change (p=0.625 and p=0.482, respectively). The greatest decrease in srm-T-PSA and ev-T-PSA concentrations was observed in patients undergoing hormonal therapy.

Conclusions: T-PSA ev/srm ratio could be useful for detecting tumor progression and relapses in advanced PCa. However, its utility as a follow-up biomarker for assessing clinical response to hormonal treatments and chemotherapy would be limited.

Objectives: Six sigma methodology (SM) measures process performance using defects per million opportunities (DPMOs). SM has traditionally used the Westgard equation (WM), by which DPMOs are calculated indirectly. An alternative for directly calculate DPMOs is the Z-transformation method in combination with the Schmidt-Launsbyn equation. The implementation of SM in External Quality Assurance (EQA) programs is limited, which hampers their evaluation. A study was conducted to compare SM values obtained with the two equations.

Materials and methods: Sigma value (SV) was estimated based on data from a Type I EQA Program (SCR-EQA-SEQC^ML) using two methods: the Westgard equation, and the Z-transformation + Schmidt-Launsbyn method (S-LM). A comparison of the SVs obtained with the two methods was performed.

Results: SVs were calculated from 949 values provided by the EQA program. The results indicate that WM underestimates SV, as compared to S-LM, independently of whether outliers were removed (2.9) or not (1.9). This underestimation occurs as a result of treatment bias rather than imprecision.

Conclusions: Unlike MW, S-LM adjusts for bias, thereby preventing negative SVs. S-LM is not as influenced by outliers as MW and yields more robust SV estimates in EQA programs. This guarantees a more precise evaluation of results and classification of method/system performance.

Objectives: The aim of this study was to verify Buhlmann fCAL turbo reagent, used for analysing calprotectin in stool, on serum samples.

Methods: Leftover patients' serum samples were used. Verification protocol included: precision performed in accordance with Clinical and Laboratory Standards Institute (CLSI) EP15-A3 guidelines; comparison of Buhlmann fCAL turbo and serum GCAL Gentian reagents; verification of reference intervals (RI) proposed from literature (0.68-5.45 mg/L) in accordance with CLSI EP28-A3C guidelines; limit of blank (LoB) and limit of quantitation (LoQ) performed in accordance with CLSI EP17-A2 guidelines; linearity performed in accordance with CLSI EP6-A guidelines; carry-over and lastly, hook effect. Acceptance criteria were based on manufacturer specifications stated in the package insert for the fCAL turbo Buhlmann reagent designed for analysing calprotectin in stool samples.

Results: The CVs% for precision were within acceptance criteria, ≤10 %. Bland-Altman analysis showed the presence of a bias of 3.4 mg/L (95 % confidence interval 2.00-4.79). The equation for the Passing-Bablok regression was y= -0.01 (-0.08 to 0.06) + 0.37 (0.36-0.40)x, and it showed proportional difference. The obtained LoB was 0 mg/L, while the LoQ was 0.04 mg/L (CV% ≤ 20 %). The method was linear in the range 0.04-4.14 mg/L, and carry-over (0.1 %) and hook effect were not detected. The proposed RI in the literature was verified using 20 leftover patients' samples.

Conclusions: Despite being declared for analysing stool samples only, Buhlmann fCAL turbo reagent can be used to determine serum calprotectin. Buhlmann fCAL turbo reagent is not comparable to the GCAL Gentian reagent.

Blood-based circulating tumor DNA (ctDNA) analysis has emerged as a highly relevant non-invasive method for molecular profiling of solid tumors, offering valuable information about the genetic landscape of cancer. Somatic mutation analysis of ctDNA is now used clinically to guide targeted therapies for advanced cancers. Recent advancements have also revealed its potential in early detection, prognosis, minimal residual disease assessment, and prediction/monitoring of therapeutic response. In recent years, significant progress has been made with the development of various PCR and NGS-based methods designed for assessing gene variants in ctDNA of patients with cancer. However, despite the transformative possibilities that ctDNA analysis presents, challenges persist. Standardization of preanalytical and analytical protocols, assay sensitivity, and the interpretation of results remain critical hurdles that need to be addressed for the widespread clinical implementation of ctDNA testing. In addition to somatic mutations, emerging studies on DNA methylation (epigenomics) and fragment size patterns (fragmentomics) in several types of biological fluids are yielding promising results as non-invasive biomarkers for effective cancer management. This review addresses the clinical applications of somatic gene variants in ctDNA, emphasizes their potential as cancer biomarkers, and highlights essential factors for successful implementation in clinical laboratories and cancer management.

Objectives: Various analyzers are available for measuring first-trimester combined screening for trisomy 21 (T21) serum biomarkers (free-beta subunit of the human chorionic gonadotropin (β-hCG) and the pregnancy-associated plasma protein A (PAPP-A)). Our aim is to compare the analytical performance of four different analyzers and their false positive rates (FPR) for T21 risk.

Methods: A 6-month study analyzed data from 1,136 pregnant women for first-trimester combined screening. Serum samples were processed using four analyzers (IMMULITE 2000, Centaur XP, Cobas e-411, KRYPTOR compact PLUS), each with its own risk calculation software. Comparative analyses of the biochemical markers and their multiples of the median (MoMs) were conducted using Passing-Bablok and Bland-Altman methods.

Results: Significant variability was observed among the analyzers. For free β-hCG, only Centaur XP and KRYPTOR compact PLUS were interchangeable. For PAPP-A, only IMMULITE 2000 and Cobas e-411 were comparable. However, no analyzer pair was interchangeable for both markers simultaneously. Free β-hCG multiples of the median (MoMs) were highest in IMMULITE 2000 (1.85 MoM (IQR: 1.4-2.97)) and lowest in KRYPTOR compact PLUS (1.5 MoM (IQR: 1.23-2.21)). PAPP-A MoMs were lowest in IMMULITE 2000 (0.52 MoM (IQR: 0.38-0.82)) and highest in Cobas e-411 (0.58 MoM (IQR: 0.39-0.90)). In risk assessment, all analyzers detected true T21 cases but varied in their FPR, with Centaur XP (3.8 %), Cobas e-411 (2.5 %) and KRYPTOR compact PLUS (2.3 %) showing a FPR below 5 %.

Conclusions: Measurement of serum biomarkers by the four analyzers is not interchangeable. KRYPTOR compact PLUS showed the lowest FPR for risk assessment.