Practical Laboratory Medicine最新文献

Liquid biopsy is an innovative, minimally invasive diagnostic tool revolutionizing cancer management by enabling the detection and analysis of cancer-related biomarkers from bodily fluids such as blood, urine, or cerebrospinal fluid. Unlike traditional tissue biopsies, which require invasive procedures, liquid biopsy offers a more accessible and repeatable method for tracking cancer progression, detecting early-stage cancers, and monitoring therapeutic responses. The technology primarily focuses on analyzing circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and other cancer-derived genetic materials. These biomarkers provide critical information on tumor heterogeneity, mutation profiles, and potential drug resistance. In clinical practice, liquid biopsy has demonstrated its utility in identifying actionable mutations, guiding personalized treatment strategies, and assessing minimal residual disease (MRD). While liquid biopsy holds immense promise, challenges related to its sensitivity, specificity, and standardization remain. Efforts to optimize pre-analytical and analytical processes, along with the establishment of robust regulatory frameworks, are crucial for its widespread clinical adoption. This abstract highlights the transformative potential of liquid biopsy in cancer diagnosis, prognosis, and treatment monitoring, emphasizing its role in advancing personalized oncology. Further research, clinical trials, and regulatory harmonization will be vital in realizing its full potential in precision cancer care.

Background: Human infection with Ureaplasma urealyticum(UU) is mainly manifested as non-gonococcal urethritis, where it can lead to cervicitis, premature rupture of membranes and abortion in women, as well as infertility in males, which becomes a major problem in clinical diagnosis and treatment. At present, real-time fluorescence quantitative PCR and culture are the two main methods for detecting UU. The real-time fluorescence quantitative PCR method is cumbersome and cannot accomplish absolute quantification on nucleic acids, while the cultivation method has limitations such as low sensitivity and being time-consuming. The aim of this study is to establish a more rapid and accurate droplet digital PCR(ddPCR) method for the detection of UU.

Methods: Primers were designed for the ParC gene of UU. Nucleic acids from a standard strain of UU were extracted. Specificity, sensitivity, and repeatability detection was performed using ddPCR, and the detection performance of ddPCR was evaluated.

Results: The detection process could be completed in 92 min. It has a high sensitivity of up to 3.8 pg/μL. With a high specificity, no positive microdrop were detected in eight negative control pathogens in this experiment. In addition, ddPCR detection of UU has good repeatability, and the calculated CV is 2.1 %.

Conclusion: Our data indicated that ddPCR detection technology has the characteristics of absolute quantification, high stability, high specificity and high sensitivity of UU. It can promote the accurate detection of UU, providing a more scientific basis for clinical diagnosis and treatment.

Introduction/objectives: Following the IFCC (The International Federation of Clinical Chemistry and Laboratory Medicine) guidelines concerning high-sensitivity cardiac troponin assays, we performed an assessment of the VIDAS® High-Sensitive Troponin I (TNHS) assay. The test was evaluated on its capacity to detect at least 50 % of healthy individuals and checked that the coefficient of variation was less than 10 % at the 99th percentile.

Methods: High-sensitivity performance was assessed by examining the limits of detection, the determination of the 99th percentile value, the evaluated imprecision at said value and the detectable results above limit of detection (LoD) in a cohort of healthy European individuals. The capacity of detection on a healthy population of VIDAS® TNHS was validated on a total of 808 plasma samples.

Results: One thousand six hundred and nineteen values (888 values for male samples and 731 values for female samples) were included in the analysis. The total imprecision of VIDAS® High-Sensitive Troponin I assay at the 99th percentile was 5.2 %, and 57.4 % of healthy individuals had troponin I values exceeding the LoD. Since the test detected more than 50 % of healthy individuals and had a coefficient of variation less than 10 % at the 99th percentile, it met the criteria of high-sensitivity cardiac troponin assays.

Conclusion: VIDAS® High-Sensitive Troponin I assay is a high-sensitivity cardiac troponin assays meeting the definition provided by IFCC guidelines.

[This corrects the article DOI: 10.1016/j.plabm.2024.e00413.].