To explore how to apply quality indicators to improve laboratory testing quality by rationally setting limits for 18 specific quality indicators.

Based on the relevant data from the Department of Clinical Laboratory, Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College for 2023 and the preliminary national quality specifications for clinical laboratory quality indicators in 2023, the 2024 quality indicator limits for the laboratory department were established.

Compared to 2023, 5 indicators demonstrated continuous improvement in 2024, including blood culture contamination rate, unacceptable internal quality control coefficient of variation rate and participation rate of national external quality assessment project. 13 indicators remained unchanged, including specimen type error rate, specimen container error rate and specimen collection volume error rate.

Clinical laboratories can establish feasible quality indicator limits for the coming year by referencing both the quality specifications provided by the National Center for Clinical Laboratories and their own laboratory-specific performance data. This approach enables comprehensive quality monitoring throughout the entire testing process. It facilitates timely identification of problems, implementation of corrective actions, and evaluation of their effectiveness. Ultimately, this systematic approach supports continuous quality improvement, ensuring efficient and reliable service delivery to clinicians and patients.

To compare the correlation and consistency of fluorescence immunochromatography (FIC) assay and latex immunochromatography (LIC) assay with ELISA, and to evaluate their clinical utility for SARS-CoV-2 antibody monitoring in fully vaccinated populations.

511 serum and plasma samples were collected from vaccinated subjects recruited by Macao University of Science and Technology Hospital. All samples were tested for SARS-CoV-2 antibodies by ELISA, FIC assay and LIC assay, respectively. Negative-positive compliance rate, positive and negative predictive values, and Cohen's Kappa values for inter-assay agreement were calculated.

The performance test results showed that the FIC minimum detection limit was 50 ng/ml with linear detection range was 50~2000 ng/ml, while LIC minimum detection limit was 200 ng/ml. There were no cross reaction with antibodies produced by other respiratory viral and bacterial infections. For serum samples, overall compliance rate for FIC assay and LIC assay was 88.26% and 90.41%, respectively. The Cohen's Kappa values were 0.766 and 0.809, respectively. Plasma samples exhibited higher compliance rate (90.80% for both methods) with Kappa values of 0.816 and 0.817, respectively, indicating significantly stronger compliance and consistency than serum samples. Longitudinal monitoring of vaccinated populations revealed that antibody positivity increased gradually after the first two doses of vaccination (ELISA: 60.38%, FIC: 54.72%, LIC: 69.81%), but declined by 180 days (ELISA: 43.24%, FIC: 53.15%, LIC: 66.67%), and rebounded post-booster to 98.75% across all assays. The plasma and serum antibody patterns were similar.

FIC assay and LIC assay have good agreement with ELISA in detecting antibody levels to SARS-CoV-2, which can quantify neutralizing and total antibody levels in a timely manner, and are both suitable for monitoring immunization levels in large-scale populations.

To investigate the value of combining transrectal ultrasound (TRUS), multiparametric magnetic resonance imaging (mpMRI), prostate specific antigen density (PSAD) in diagnosing prostate cancer (PCa) and improving the early diagnosis rate.

The clinical data of 233 patients with suspected PCa were retrospectively analyzed. Patients were stratified into 4 diagnostic groups: Group A was TRUS diagnosis group, group B was mpMRI diagnosis group, group C was PSAD diagnosis group, and group D was combined application group. The sensitivity, specificity, accuracy and Youden index were calculated and compared for each group. Kappa statistics was used to assess the consistency between the diagnostic results and pathological findings, and the area under the receiver operating characteristic curve (AUC) was compared across groups.

There was no significant difference in age among the four groups (P=0.546). The sensitivity (91%), specificity (85%), accuracy (87%) and Youden index (0.76) of group D were higher than those of group A, group B and group C. The consistency between the diagnostic results of the 4 diagnostic methods and pathological results was statistically significant (all P<0.05). The Kappa value of group D was 0.729, which was higher than that of group A、B、C (Kappa=0.253、0.438、0.447). The AUC of group D was 0.880, which was better than that of group A、B、C (AUC=0.640、0.742、0.770), and the differences were statistically significant (all P<0.05).

The combination of TRUS, mpMRI and PSAD significantly improves the diagnostic efficiency of early PCa compared to any single modality.

To analyze the impact of different clinical characteristics and endocrine drugs on blood coagulation in breast cancer patients.

The clinical data and pathological features of 209 female patients with breast invasive ductal carcinoma treated at the First Affiliated Hospital of Guangzhou Medical University from 2016 to 2020 were retrospectively analyzed. Associations between clinicopathological features and coagulation parameters were evaluated, with longitudinal assessment of coagulation changes before and after endocrine therapy.

Among the 209 patients with invasive ductal carcinoma of the breast prior to treatment, the levels of fibrinogen (FIB) and thrombin time (TT) were higher in patients older than 55 years compared to those 55 years or younger. Additionally, postmenopausal patients exhibited higher levels of FIB and TT than non-menopausal patients. However, there was no significant difference in coagulation indicators between the lymph node metastasis group and the non-metastatic group (P>0.05). In patients with tumor node metastasis classification (TNM) stage Ⅲ-Ⅳ breast cancer, levels of prothrombin time, international normalized ratio, TT, and PLT were higher than those in stage Ⅰ-Ⅱ patients. Conversely, prothrombin time test activity levels were lower (P<0.05). There was no significant difference in various coagulation indicators, PLT value, and red cell distribution width-coefficient of variation (RDW-CV) between different expression intensities of estrogen receptor, progestin recetor, human epidermal growth factorreceptor 2, and Ki-67 (P>0.05). After endocrine therapy, RDW-CV levels were lower in patients treated with aromatase inhibitor (AI) compared to pre-therapy levels (P<0.05). The levels of activated partial thromboplastin time (APTT), RDW-CV and PLT in patients treated with tamoxifen (TAM) were lower while TT was higher than those in pre-therapy (P<0.05). The levels of APTT and RDW-CV in patients treated with toremifene (TOR) were lower than those in pre-therapy (P<0.05). The TT of patients receiving combination therapy was higher, while the PLT level was lower than that in pre-therapy (P<0.05).

Advanced age, menopause and higher TNM stage are risk factors for hypercoagulability in patients with invasive ductal carcinoma of the breast. TAM and TOR exert procoagulant effects, and the combination therapy has a tendency to promote coagulation, while AI minimally affects coagulation. Monitoring the coagulation indicators is essential for selecting treatment options and optimizing care for patients with invasive ductal carcinoma of the breast.

To investigate the relationship between complete blood count-derived inflammatory indices and lower extremity atherosclerotic disease (LEAD) in patients with type 2 diabetes mellitus (T2DM).

This cross-sectional study enrolled 227 T2DM patients without LEAD (T2DM group), 127 T2DM patients with LEAD (T2DM+LEAD group), and 100 healthy controls. Demographic and clinical data were collected. Absolute counts of WBC, neutrophils, lymphocytes, monocytes, and PLT were measured. Inflammatory indices including systemic immune-inflammation index (SII), neutrophil-to-lymphocyte ratio (NLR), derived NLR (d-NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and neutrophil-to-monocyte ratio (NMR) were calculated. Statistical analyses were performed to evaluate the associations between these indices and T2DM and T2DM-LEAD patients.

Compared with the T2DM group, the T2DM+LEAD group exhibited significantly higher SII, NLR, d-NLR, and PLR values (all P<0.05), while LMR was significantly lower (P<0.05). Multivariate regression analysis identified age (β=0.124, OR=1.132, P<0.001), SII (β=0.004, OR=1.004, P<0.001), NLR (β=0.426, OR=1.531, P=0.027), and PLR (β=0.003, OR=1.003, P=0.032) as independent risk factors for LEAD in T2DM patients. Receiver operating characteristic (ROC) curve analysis revealed an area under the curve of 0.749 (95% CI: 0.700~0.793) for SII and 0.682 (95% CI: 0.631~0.731) for NLR.

The SII may serve as a significant biomarker for predicting LEAD in T2DM patients, demonstrating moderate predictive efficacy.

To establish a rapid molecular detection method for Klebsiella pneumoniae carbapenemase (KPC) carbapenemase (bla_KPC) genes based on recombinase aided amplification (RAA)-clusteredregularly interspaced short palindromic repeats (CRISPR)-CRISPR associated (Cas)12a (CRISPR-Cas12a) technology.

Specific RAA primers and CRISPR RNA(crRNA) were designed targeting the bla_KPC gene sequence to construct a RAA-CRISPR-Cas12a detection assay. 4 strains of Klebsiella pneumoniae carrying the bla_KPC gene stored in Lecong Hospital of Shunde, Foshan from 2022 to 2023 were collected for method research, and 40 clinical strains of Klebsiella pneumoniae for method evaluation. At the same time, quantitative real-time polymerase chain reactio (qPCR) method was performed in parallel to compare detection rates and concordance between the two methods.

The RAA-CRISPR-Cas12a method achieved a sensitivity of 10 copies/µl for bla_KPC gene detection. At the same time, RAA-CRISPR-Cas12a and qPCR methods were used to detect 40 clinical strains of Klebsiella pneumoniae. Both methods simultaneously detected 5 bla_KPC-positive and 35 bla_KPC-negative isolates. Using qPCR as the gold standard, the sensitivity of the method established in this study was 100% (5/5), and the sensitivity was 100% (35/35), with a 100% agreement rate between the two methods.

The established RAA-CRISPR-Cas12a method provides a reliable and efficient tool for bla_KPC gene detection, facilitating rapid clinical screening of bla_KPC gene.

To establish and verify the reference intervals of serum osteocalcin (OST) data were used in different age groups based on the serum OST data of physical examination population.

Serum OST data from health checkup specimens sent to Guangzhou KingMed Center for Clinical Laboratory from January 2017 to June 2023 were collected. Skewness-Kurtosis was used to analyze the normality of data, and Tukey method and box graph method were used to eliminate outliers. Data were grouped by Mann-Whitney U, Kruskal-Wallis H and Z tests. Reference intervals and 95% confidence intervals were established according to the non-parametric method in Guideline EP28-A3, and qualified physical specimens were screened for verification of the reference intervals.

The data collected in this study encompassed individuals from 17 provinces or municipalities in China, including 10 294 males and 9664 females. The reference ranges of serum OST in different age groups were as follows: For males, ≤ 18 years old is 18.13-97.35 ng/ml, 19-29 years old is 9.94-26.76 ng/ml, 30-39 years old is 8.70-24.05 ng/ml, 40-49 years old is 7.81-22.71 ng/ml, 50-59 years old is 6.69-22.69 ng/ml, ≥ 60 years old is 6.26-22.50 ng/ml; for females,≤18 years old is 10.17-107.23 ng/ml, 19-29 years old is 7.63-24.45 ng/ml, 30-39 years old is 6.91-22.37 ng/ml, 40-49 years old is 6.47-22.83 ng/ml, ≥ 50 years old is 7.73-30.38 ng/ml. The reference ranges for each age group have been validated. Serum OST levels differed significantly across male age groups (all P<0.001), showing a progressive decline with age. Among females, serum OST levels decreased sequentially from the ≤18 years group to the 30-39 years group (all P<0.001), with no significant difference between the 30-39 years and 40-49 years groups (P>0.05). The 50-59 years group exhibited higher levels than the 40-49 years group (P<0.001), while no significant difference was observed between the 50-59 years and ≥60 years groups (P>0.05), indicating an overall pattern of initial decline followed by an increase. Gender comparisons revealed that males aged 19-29, 30-39, and 40-49 years had significantly higher serum OST levels than females in the same age groups (all P<0.001), whereas males aged 50-59 and ≥60 years had lower levels than their female counterparts (all P<0.001).

This study established reference ranges of serum OST in different age groups of Chinese, providing a valuable reference for the application of serum OST across various age brackets.

Acute ischemic stroke (AIS), also known as cerebral infarction, is an acute cerebrovascular disease with more than 7 million new cases worldwide every year, which is the second leading cause of death in the world. There are more than 24 million patients in China. Among the many risk factors, hypertension is the most important independent related factor of AIS, which is closely related to its morbidity and mortality. The hemodynamic changes after AIS affect the prognosis of the disease, so the management of blood pressure in the acute phase should be throughout the whole process. However, for patients with AIS, the management of blood pressure with different treatment methods is still an important outstanding issue. This paper reviews the research progress of blood pressure management in AIS in recent years.

Taking the clinical microbiology laboratory techniques course as an example to explore how to integrate ideological and political education into the "student-centered, position competence-oriented" specialized course, and create a comprehensive classroom where knowledge, belief and behavior were united.

First of all, the teaching team design the ideological and political education based on the teaching objects and the teaching goal, exploit the connotation of ideology from the position characteristics, and closely integrate the professional knowledge with ideological and political education. Secondly, with the concrete classroom implementation, the teaching team put forward the ideological education innovation of the concept of research feeding back teaching, project-based course. And the knowledge-belief-behavior united innovation of the cultivation mode, which combines the students' practice with the teachers setting an example. Finally, the effectiveness of the ideological construction of the course with knowledge-belief-behavior united synergistic education was examined through evaluation and reflection.

The comprehensive classroom combined with featured innovative practices successfully constructed an effective carrier for delivering the ideological and political elements of professional courses, which helps students consolidate the theoretical knowledge, improve the practical ability, enhance the professionalism, practice the position skills, and lay the foundation for their post-graduation development.

Through the experience sharing of ideological and political education in the course of clinical microbiology laboratory techniques, it is hoped that the ideological construction experience of this course can provide reference for ideological education in other medical laboratory professional courses.

In view of the problems existing in molecular diagnostics clinical training for medical laboratory science students, including low degree of laboratory automation, intricate manual procedures, lengthy workflows, and short rotation periods, which lead to superficial clinical exposure, inadequate integration of theoretical knowledge with clinical practice, and hindered development of comprehensive competencies, this paper aim to explores an effective teaching reform plan.

Basing on the technical characteristics and frontier advancements of molecular diagnostics, the teaching team developed a training model that included restructuring key content of text according to different knowledge modular, implementation of comprehensive, fine-grained supervision throughout the training process, and development and application of diverse teaching methodologies to ensure effective execution.

The novel training model significantly improved student outcomes during their clinical internships, and the consolidation of foundational knowledge, the cultivation of clinical thinking skills, and the improvement of comprehensive practical abilities has been effectively promoted.

This restructured training approach effectively overcomes the unique challenges of molecular diagnostics internships. It substantially elevates the quality of clinical training and the overall competency development of medical laboratory science students.