The preliminary study of delta checks for immunoglobulins and complements in the clinical laboratory.

BACKGROUND: To determine delta check limits for immunoglobulins and complements in outpatients and inpatients based on patient data and biological variation due to the lack of relevant studies. METHODS: Patient data for IgA, IgG, IgM, IgE, C3 and C4 from January 1st, 2022 to December 31st, 2023 was collected from laboratory information system (LIS) in our clinical laboratory of wuhan union hospital, which includes both outpatients and inpatients. The delta difference (DD), delta percent change (DPC) and reference change value (RCV) were calculated based on patient data and biological variation. RESULTS: For DDs, there are significant differences between outpatients and inpatients in C4, IgE, IgG, and IgM. For DPCs, the corresponding analytes which are significantly different are C3, C4, IgE, IgG, and IgM. Two sources of CVI to calculate the RCV of IgA, IgG, IgM, C3 and C4 were applied in this study, which revealed that two kinds of RCVs based on different biological variation databases are similar to each other, but both were smaller than delta check limits based on patient data, except for C4. CONCLUSIONS: The delta check is a useful tool to monitor potential errors which may occur in total testing process. We hope our findings could be helpful for future studies focused on delta checks in immunological analytes.

Roles of TRIM21/Ro52 in connective tissue disease-associated interstitial lung diseases.

Multiple factors contribute to the development of connective tissue diseases (CTD), often alongside a range of interstitial lung diseases (ILD), including Sjögren's syndrome-associated ILD, systemic sclerosis-associated ILD, systemic lupus erythematosus-associated ILD, idiopathic inflammatory myositis-associated ILD. TRIM21(or Ro52), an E3 ubiquitin ligase, plays a vital role in managing innate and adaptive immunity, and maintaining cellular homeostasis, and is a focal target for autoantibodies in various rheumatic autoimmune diseases. However, the effectiveness of anti-TRIM21 antibodies in diagnosing CTD remains a matter of debate because of their non-specific nature. Recent studies indicate that TRIM21 and its autoantibody are involved in the pathogenesis of CTD-ILD and play an important role in diagnosis and prognosis. In this review, we focus on the contribution of TRIM21 in the pathogenesis of CTD-ILD, as well as the potential diagnostic value of its autoantibodies in different types of CTD-ILD for disease progression and potential as a novel therapeutic target.

The Efficacy and Safety of Programmed Death-1 and Programmed Death Ligand 1 Inhibitors for the Treatment of Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis.

BACKGROUND: Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage where only systemic treatment can be offered. The emergence of immune checkpoint inhibitors (ICIs) provides hope for the treatment of HCC. In this study, we performed a meta-analysis to provide evidence for the efficacy and safety of ICIs in the treatment of HCC. METHODS: The following databases and websites were searched: Embase, PubMed, Cochrane Library and ClinicalTrials.gov. The primary endpoints were response rate (RR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). RESULTS: Finally, twelve studies were included in this meta-analysis. When the corresponding outcome indicators and their 95% confidence intervals (CIs) were pooled directly, the overall RR, DCR, PFS and OS were 0.17 (0.15-0.19, I2 = 56.2%, P=0.009), 0.58 (0.55-0.61, I2 = 75.9%, P<0.001), 3.27 months (2.99-3.55, I2 = 73.0%, P=0.001), 11.73 months (10.79-12.67, I2 = 90.3%, P<0.001). Compared to the control group, treatment with ICIs significantly improved RR, PFS and OS, the OR and HRs were 3.11 (2.17-4.44, P<0.001), 0.852 (0.745-0.974, P=0.019) and 0.790 (0.685-0.911, P=0.001), respectively. However, no significant improvement in DCR was found in ICIs treatment in this meta-analysis. CONCLUSION: HCC patients would benefit from ICIs treatment, however, more studies are needed in the future to provide more useful evidence for the treatment of HCC by programmed death-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitors.

National Survey on Patient Satisfaction of Clinical Laboratories in China.

BACKGROUND: Customer satisfaction is one of quality indicators which can be used to identify quality defects in the total process and remind clinical laboratories to take measures to improve the process. This study mainly reviewed and analyzed the general situation through a customer satisfaction survey in clinical laboratories in China and described the overall customer satisfaction of outpatients and inpatients. METHODS: Surveys in this study could be divided into two stages. The first stage was to investigate the general situation through a customer satisfaction survey in Chinese clinical laboratories. In the second stage, clinical laboratories carried out nationwide surveys on the satisfaction of outpatients and inpatients. Chi-square test and logistic regression analysis were applied to determine the relationship between the general characteristics of patients and patient satisfaction. RESULTS: The recovery rate in the first stage was 34.54%. In the second stage, we received 12,919 outpatient questionnaires and 11,818 inpatient questionnaires. Outpatients and inpatients had a common trend: satisfaction rates increased with age and decreased with frequency of visit. Patients who possessed a bachelor degree or above had a higher satisfaction rate than those who had only received a high school education or below. CONCLUSIONS: There was a high level of patient satisfaction with clinical laboratory services, but aspects of dissatisfaction still existed, which provided opportunities for clinical laboratories in China to improve their service quality.

National survey on delta checks in clinical laboratories in China.

Background This study aimed to understand the status quo of delta checks in Chinese clinical laboratories through a nationwide online survey. Methods The survey was divided into two parts. The first part was a general situation survey in which clinical laboratories had to provide information about the laboratories, including delta checks used. In the second part, clinical laboratories were asked to record the delta check alerts generated in their laboratories from June 1st, 2019 to June 30th, 2019. Results The most frequently used analytes in delta checks were potassium (K), glucose (Glu), creatinine (Cre) for clinical chemistry and hemoglobin (Hgb), platelet (PLT) count and white blood cell (WBC) count for clinical hematology. The median maximum time interval between specimens for all analytes was 5 days. The most commonly used delta check calculation modes in Chinese clinical laboratories were percentage change and absolute change. K and Hgb were the analytes most involved in clinical chemistry and clinical hematology delta check alerts. The most common causes of delta check alerts were that the patients had received treatment, which was followed by the change in the patient's physiological state and interference from hemolysis, lipemia and icterus. The two most common outcomes of delta check alerts were 'no problems found, standard report issued' and 'no problems found, report issued with comment'. Conclusions This study was the first nationwide survey of delta checks in China, the results of which help us to understand the current situation of delta checks in Chinese clinical laboratories.

The Observation and Analysis of Internal Quality Control of Cystatin C in China from 2014 to 2017.

BACKGROUND: This study observed and analyzed the internal quality control (IQC) of cystatin C (CysC) so that we can have overall knowledge about imprecision levels in Chinese medical laboratories. METHODS: Using the software developed by the National Center for Clinical Laboratories (NCCL), we can get the IQC information of CysC from 2014 to 2017. Then the proportion of laboratories meeting five quality specifications (pass rates) were calculated and the current CVs (coefficient of variation) were also compared among subgroups and years. RESULTS: We find that the current CVs between 2014 and 2017 show significant differences (p = 0.016) and the proportion of laboratories meeting the 1/3 TEa specification distributes randomly from 2014 to 2017 but all of them exceed 80 percent. When the optimum specification is applied, the pass rates all become very low and the distributions are wide spread (from 3.63% to 6.74%). Beckman, Roche, and Hitachi are mainstream analyzers, making up as much as 78% to 85% of all. We can see a significant difference of the pass rate between Beckman and Hitachi in 2014 (p = 0.005). The primary means of detecting CysC is particle-enhanced turbidimetric immunoassay (PETIA) which makes up 30.57% - 32.64% of detection methods. The good news is that the IQC practice has improved greatly from 2014 to 2017 in laboratories in China. CONCLUSIONS: Medical laboratories have made some progress in IQC from 2014 to 2017, but it is still not satisfactory. As a result, there is a long way to go to improve detection quality of laboratories in China.