Objective To detect the expression level of serum LncRNA P53RRA in patients with primary hepatocellular carcinoma(HCC)and explore its clinical application value in the diagnosis of HCC.Methods Ninety-three patients with primary HCC visited Zhongshan Hospital Affiliated to Fudan University from November 2019 to December 2020 were selected as the HCC group and 88 healthy individuals undergone physical examination as the control group.Their serum samples were collected and the expression levels of serum LncRNA P53RRA were detected by real-time fluorescence quantitative PCR(qRT-PCR).The correlations of serum P53RRA levels with clinicopathological parameters and clinical biochemical indicators such as alanine aminotransferase(ALT),glutamate amin-otransferase(AST),gamma-glutamyl transpeptidase(GGT),and alkaline phosphatase(ALP)in HCC patients were analyzed.The diagnostic value of serum P53RRA for HCC was evaluated by the receiver operating characteristic(ROC)curve.Results The expres-sion levels of serum P53RRA in HCC patients(2.15±0.22)were significantly lower than that in healthy controls(3.54±0.33),and the difference was statistically significant(t=3.489,P＜0.05).The analysis of clinicopathological parameters showed that the expres-sion levels of serum P53RRA in HCC patients were correlated with tumor staging(χ2=9.590,P＜0.05),α-fetoprotein(AFP,χ2=5.732,P＜0.05),and GGT(χ2=5.732,P＜0.05).ROC curve analysis showed that the area under the ROC curve(AUCROC)of ser-um P53RRA in the diagnosis of HCC was 0.750(95%CI:0.679-0.821),with a sensitivity of 65.6%and specificity of 64.8%.The AUCROC,sensitivity and specificity of P53RRA combined with AFP and GGT in the diagnosis of HCC were 0.911(95%CI:0.867-0.953),88.2%and 70.5%,respectively,which were higher than those of single indicator.Conclusion LncRNA P53RRA is expec-ted to serve as a novel non-invasive biomarker,effectively assisting in the clinical diagnosis of HCC.

To evaluate the analytical performance of a specific IgE (sIgE) quantitative detection system and explore the clinical application effect of dust mite extract and component detection. The fluorescent magnetic particle chemiluminescence method was used to verify the analytical performance of sIgE for house dust mite (D1), dust mite (D2) extracts, and their components (Der p 1, Der p 2, Der p 10, and Der p 23), including precision, limit of blank (LoB), limit of detection (LoD), linear range, and interfering factors. This is a retrospective cohort study. A total of 50 patients with allergic rhinitis and 50 patients with allergic asthma diagnosed at Zhongshan Hospital Affiliated to Fudan University from January 2022 to August 2023 were selected, along with 70 apparently healthy individuals who underwent physical examinations in the hospital as the healthy control group. The positive rates of each sIgE component in the three groups were compared, and the receiver operating characteristic (ROC) curve for diagnosing dust mite allergy was plotted. The results showed that the fluorescent magnetic particle chemiluminescence method for detecting sIgE demonstrated good repeatability and intermediate precision within the range of 0.1-100 kU/L. The LoB, LoD, and linear range all met the specified requirements. Except for Der p 10, which was interfered by the presence of conjugated bilirubin and free bilirubin (exceeding 40 mg/dl), the detection of other allergens was not significantly affected by common endogenous substances. In healthy individuals, 10% had positive sIgE for dustmite extract; in asthmatic and allergic rhinitis patients, the positive rates were 70% and 82%, respectively. The double positive rate of D1 and D2 in the healthy group was 8.6%, while in asthmatic and allergic rhinitis patients, it was 66% and 70%, respectively. When 0.35 kU/L was used as the threshold, the sensitivity of sIgE for dust mite extract to predict component positivity was 100%, specificity was 61.5%, positive predictive value (PPV) was 80.2%, and negative predictive value (NPV) was 100%. When the threshold was optimized to 0.78 kU/L, the sensitivity was 96.8%, specificity was 92.1%, PPV was 95.2%, and NPV was 94.6%. In conclusion, the repeatability, intermediate precision, LoB, LoD, linear range, and anti-interference ability of the fluorescent magnetic particle chemiluminescence method for detecting sIgE meet the requirements of laboratory quality management. This ensures detection quality, meets clinical needs, and can be used for the auxiliary diagnosis of allergic diseases.

Objective:To evaluate the diagnostic performance of the 0-2 h high-sensitivity cardiac troponin T (hs-cTnT) cutoff recommended by the guidelines for the rule-out and rule-in diagnosis of suspected non-ST-segment elevation myocardial infarction (NSTEMI) patients of different age groups.Methods:This is a retrospective cohort study. Clinical data of 4 050 suspected NSTEMI patients who visited the Chest Pain Center of Zhongshan Hospital affiliated with Fudan University from January 2020 to December 2021 were retrospectively analyzed. Patients who visited from January 2020 to April 2021 (2 650 patients) were included as derivation cohort, and those who visited from May to December 2021 (1 400 patients) were included as validation cohort. The diagnostic performance of the guideline-recommended hs-cTnT 0-2 h cutoff for the rule-out and rule-in of NSTEMI diagnosis was compared among subgroups of patients aged ≤60, >60-70, and >70 years in the derivation group. Rule-out sensitivity, negative predictive value, and rule-out proportion, rule-in specificity, positive predictive value, and rule-in proportion were assessed. Cutoffs were established for subgroups with relatively lower diagnostic performance and validated in the validation group. Major adverse cardiovascular events (MACE) within 30 days after patient visit were used as the outcome, and survival curves were plotted using Kaplan-Meier curves, log-rank tests were used to analyze the incidence of MACE.Results:The sensitivity for ruled-out NSTEMI using the guideline-recommended 0-2 h cutoff in the subgroups of patients aged ≤60, >60-70, and >70 years in the derivation group was 100%; the negative predictive value was 100%; the ruled-out rates were 47.6% (331/696), 45.9% (491/1 070), and 28.5% (252/884), respectively. The specificity for ruled-in NSTEMI was 88.3%, 90.9%, and 86.4%, respectively; the positive predictive values were 55.3%, 59.3%, and 58.2%, respectively; the ruled-in rates were 22.6% (157/696), 19.5% (209/1 070), and 27.0% (239/884), respectively. With a requirement of sensitivity and negative predictive value >99%, the ruled-out cutoff for the subgroup of patients aged >70 years in the derivation group was established as 0 h hs-cTnT <6 ng/L or 0 h hs-cTnT<22 ng/L and 0-2 h Δhs-cTnT <5 ng/L, which increased the ruled-out rate of the subgroup aged >70 years to 45.6% (403/884). In the validation group, 42.2% (196/465) patients could be ruled-out. The incidence of MACE within 30 days for ruled-out patients aged >70 years using the established cutoff was 0.Conclusion:The diagnostic performance for the ruled-out and ruled-in diagnosis using the guideline-recommended 0-2 h hs-cTnT cutoff are relatively consistent across different age groups, but the ruled-out rate for patients aged >70 years is lower than for those aged ≤60 and >60-70 years. The ruled-out cutoff established in this study can be used to improve diagnostic performance of thus indicator on suspected NSTEMI patients.

Objective To detect the expression level of serum LncRNA P53RRA in patients with primary hepatocellular carcinoma(HCC)and explore its clinical application value in the diagnosis of HCC.Methods Ninety-three patients with primary HCC visited Zhongshan Hospital Affiliated to Fudan University from November 2019 to December 2020 were selected as the HCC group and 88 healthy individuals undergone physical examination as the control group.Their serum samples were collected and the expression levels of serum LncRNA P53RRA were detected by real-time fluorescence quantitative PCR(qRT-PCR).The correlations of serum P53RRA levels with clinicopathological parameters and clinical biochemical indicators such as alanine aminotransferase(ALT),glutamate amin-otransferase(AST),gamma-glutamyl transpeptidase(GGT),and alkaline phosphatase(ALP)in HCC patients were analyzed.The diagnostic value of serum P53RRA for HCC was evaluated by the receiver operating characteristic(ROC)curve.Results The expres-sion levels of serum P53RRA in HCC patients(2.15±0.22)were significantly lower than that in healthy controls(3.54±0.33),and the difference was statistically significant(t=3.489,P＜0.05).The analysis of clinicopathological parameters showed that the expres-sion levels of serum P53RRA in HCC patients were correlated with tumor staging(χ2=9.590,P＜0.05),α-fetoprotein(AFP,χ2=5.732,P＜0.05),and GGT(χ2=5.732,P＜0.05).ROC curve analysis showed that the area under the ROC curve(AUCROC)of ser-um P53RRA in the diagnosis of HCC was 0.750(95%CI:0.679-0.821),with a sensitivity of 65.6%and specificity of 64.8%.The AUCROC,sensitivity and specificity of P53RRA combined with AFP and GGT in the diagnosis of HCC were 0.911(95%CI:0.867-0.953),88.2%and 70.5%,respectively,which were higher than those of single indicator.Conclusion LncRNA P53RRA is expec-ted to serve as a novel non-invasive biomarker,effectively assisting in the clinical diagnosis of HCC.

To evaluate the analytical performance of a specific IgE (sIgE) quantitative detection system and explore the clinical application effect of dust mite extract and component detection. The fluorescent magnetic particle chemiluminescence method was used to verify the analytical performance of sIgE for house dust mite (D1), dust mite (D2) extracts, and their components (Der p 1, Der p 2, Der p 10, and Der p 23), including precision, limit of blank (LoB), limit of detection (LoD), linear range, and interfering factors. This is a retrospective cohort study. A total of 50 patients with allergic rhinitis and 50 patients with allergic asthma diagnosed at Zhongshan Hospital Affiliated to Fudan University from January 2022 to August 2023 were selected, along with 70 apparently healthy individuals who underwent physical examinations in the hospital as the healthy control group. The positive rates of each sIgE component in the three groups were compared, and the receiver operating characteristic (ROC) curve for diagnosing dust mite allergy was plotted. The results showed that the fluorescent magnetic particle chemiluminescence method for detecting sIgE demonstrated good repeatability and intermediate precision within the range of 0.1-100 kU/L. The LoB, LoD, and linear range all met the specified requirements. Except for Der p 10, which was interfered by the presence of conjugated bilirubin and free bilirubin (exceeding 40 mg/dl), the detection of other allergens was not significantly affected by common endogenous substances. In healthy individuals, 10% had positive sIgE for dustmite extract; in asthmatic and allergic rhinitis patients, the positive rates were 70% and 82%, respectively. The double positive rate of D1 and D2 in the healthy group was 8.6%, while in asthmatic and allergic rhinitis patients, it was 66% and 70%, respectively. When 0.35 kU/L was used as the threshold, the sensitivity of sIgE for dust mite extract to predict component positivity was 100%, specificity was 61.5%, positive predictive value (PPV) was 80.2%, and negative predictive value (NPV) was 100%. When the threshold was optimized to 0.78 kU/L, the sensitivity was 96.8%, specificity was 92.1%, PPV was 95.2%, and NPV was 94.6%. In conclusion, the repeatability, intermediate precision, LoB, LoD, linear range, and anti-interference ability of the fluorescent magnetic particle chemiluminescence method for detecting sIgE meet the requirements of laboratory quality management. This ensures detection quality, meets clinical needs, and can be used for the auxiliary diagnosis of allergic diseases.

Objective:To establish and optimize an autoverification system for thyroid function test reports of 5 items using historical test data.Methods:Based on the docoment' Autoverification of Clinical Laboratory Quantitative Test Results′, CLSI AUTO 10-A and AUTO 15 guidelines, an autoverification system for thyroid function test reports of 5 items was established combining with manual verification experience. A total of 193 860 thyroid function test reports of 5 items in 2021 were collected for the assessment of the original system. Totally 210 097 thyroid function test reports of 5 items in 2022 and 299 198 reports in 2023 were collected for the optimization of the autoverification system. There were 160 666 thyroid function test reports of 5 items from the first half of 2024 for the manual and autoverification comparison after optimization.Results:The pass rate of the autoverification system based on original thyroid function report in 2021 was 69.56%(134 849/193 860). The optimized system utilizing historical data from 2022 and 2023 covered 21 pattern rules and established verification for different patterns including range rules, delta check rules, and review rules. Taking manual verification as the standard for the data from the first half of 2024, the sensitivity and specificity of the optimized system were 100% (499/499) and 81.57% (130 646/160 167), respectively, with a false-negative rate of 0. The concordance rate between autoverification and manual verification was 81.63% (131 145/160 666), and the pass rate was 81.32% (130 646/160 666).Conclusion:Establishing and optimizing the autoverification system for thyroid function tests of 5 items using historical test data, and formulating verification rules for different patterns can be applied to clinical practise, which not only ensures the accuracy of test reports but also improves work efficiency, allowing continuously optimized and perfected of the system.

Objective To explore the use of indirect methods to establish a reference interval for serum car-bohydrate antigen 242(CA242)in adults in Shanghai and to validate it.Methods A total of 51 897 cases of CA242 testing data from the laboratory information management system of the Department of Clinical Labo-ratory at the hospital from August 2022 to July 2023 were collected.After data cleaning and normal transfor-mation,the Turkey method was used to remove outliers,and 19 653 cases of data were finally included in the study.Then,the Hoffmann method was used to establish the P95 reference interval for serum CA242.The study selected 691 apparently healthy individuals from January to March 2024 to validate the self built refer-ence interval for CA242.The physical examination population with the reference interval recommended by the reagent instructions≤CA242 value

Objective:To establish and optimize an autoverification system for thyroid function test reports of 5 items using historical test data.Methods:Based on the docoment' Autoverification of Clinical Laboratory Quantitative Test Results′, CLSI AUTO 10-A and AUTO 15 guidelines, an autoverification system for thyroid function test reports of 5 items was established combining with manual verification experience. A total of 193 860 thyroid function test reports of 5 items in 2021 were collected for the assessment of the original system. Totally 210 097 thyroid function test reports of 5 items in 2022 and 299 198 reports in 2023 were collected for the optimization of the autoverification system. There were 160 666 thyroid function test reports of 5 items from the first half of 2024 for the manual and autoverification comparison after optimization.Results:The pass rate of the autoverification system based on original thyroid function report in 2021 was 69.56%(134 849/193 860). The optimized system utilizing historical data from 2022 and 2023 covered 21 pattern rules and established verification for different patterns including range rules, delta check rules, and review rules. Taking manual verification as the standard for the data from the first half of 2024, the sensitivity and specificity of the optimized system were 100% (499/499) and 81.57% (130 646/160 167), respectively, with a false-negative rate of 0. The concordance rate between autoverification and manual verification was 81.63% (131 145/160 666), and the pass rate was 81.32% (130 646/160 666).Conclusion:Establishing and optimizing the autoverification system for thyroid function tests of 5 items using historical test data, and formulating verification rules for different patterns can be applied to clinical practise, which not only ensures the accuracy of test reports but also improves work efficiency, allowing continuously optimized and perfected of the system.

Objective:To evaluate the diagnostic performance of the 0-2 h high-sensitivity cardiac troponin T (hs-cTnT) cutoff recommended by the guidelines for the rule-out and rule-in diagnosis of suspected non-ST-segment elevation myocardial infarction (NSTEMI) patients of different age groups.Methods:This is a retrospective cohort study. Clinical data of 4 050 suspected NSTEMI patients who visited the Chest Pain Center of Zhongshan Hospital affiliated with Fudan University from January 2020 to December 2021 were retrospectively analyzed. Patients who visited from January 2020 to April 2021 (2 650 patients) were included as derivation cohort, and those who visited from May to December 2021 (1 400 patients) were included as validation cohort. The diagnostic performance of the guideline-recommended hs-cTnT 0-2 h cutoff for the rule-out and rule-in of NSTEMI diagnosis was compared among subgroups of patients aged ≤60, >60-70, and >70 years in the derivation group. Rule-out sensitivity, negative predictive value, and rule-out proportion, rule-in specificity, positive predictive value, and rule-in proportion were assessed. Cutoffs were established for subgroups with relatively lower diagnostic performance and validated in the validation group. Major adverse cardiovascular events (MACE) within 30 days after patient visit were used as the outcome, and survival curves were plotted using Kaplan-Meier curves, log-rank tests were used to analyze the incidence of MACE.Results:The sensitivity for ruled-out NSTEMI using the guideline-recommended 0-2 h cutoff in the subgroups of patients aged ≤60, >60-70, and >70 years in the derivation group was 100%; the negative predictive value was 100%; the ruled-out rates were 47.6% (331/696), 45.9% (491/1 070), and 28.5% (252/884), respectively. The specificity for ruled-in NSTEMI was 88.3%, 90.9%, and 86.4%, respectively; the positive predictive values were 55.3%, 59.3%, and 58.2%, respectively; the ruled-in rates were 22.6% (157/696), 19.5% (209/1 070), and 27.0% (239/884), respectively. With a requirement of sensitivity and negative predictive value >99%, the ruled-out cutoff for the subgroup of patients aged >70 years in the derivation group was established as 0 h hs-cTnT <6 ng/L or 0 h hs-cTnT<22 ng/L and 0-2 h Δhs-cTnT <5 ng/L, which increased the ruled-out rate of the subgroup aged >70 years to 45.6% (403/884). In the validation group, 42.2% (196/465) patients could be ruled-out. The incidence of MACE within 30 days for ruled-out patients aged >70 years using the established cutoff was 0.Conclusion:The diagnostic performance for the ruled-out and ruled-in diagnosis using the guideline-recommended 0-2 h hs-cTnT cutoff are relatively consistent across different age groups, but the ruled-out rate for patients aged >70 years is lower than for those aged ≤60 and >60-70 years. The ruled-out cutoff established in this study can be used to improve diagnostic performance of thus indicator on suspected NSTEMI patients.

Objective:To compare the distribution differences of serum protein electrophoresis (SPE) among different gender and age individuals, and to explore the clinical application of SPE screening monoclonal gammopathy.Methods:A retrospective analysis was conducted based on the SPE results obtained from 533 989 cases enrolled from January 2018 to December 2019 at Zhongshan Hospital Affiliated to Fudan University. Among these patients, 435 479 inpatients were from departments of hematology, nephrology, spinal surgery, endocrinology, and rheumatology and immunology; and 98 510 were apparently healthy individuals. The distributions of albumin, α1 globulin, α2 globulin, β1 globulin, β2 globulin and γ globulin in different gender and age groups (≤20, 21-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, ≥91 years old) were compared. A total of 10 014 cases were selected by immunofixation electrophoresis (IFE). The positive detection rates of different SPE bands and IFE bands were analyzed. The sensitivity and specificity of SPE methods were determined according to IFE results as the gold standard.Results:No significant difference was examined in the proportion of SPE bands between different genders ( P>0.05). There were statistically significant differences in the proportion of albumin bands between apparently healthy individuals and hospitalized patients at different ages (apparently healthy individuals: F=5.12, P<0.05, inpatients: F=4.18, P<0.05), and all of them decreased with the increase of age. The proportion of γ globulin bands increased with age (apparently healthy individuals: F=1.34, P<0.05; inpatients: F=1.24, P<0.05). The sensitivity of SPE was 69% (2 098/3 051), and the specificity was 97% (6 721/6 963). Compared with IFE method, the positive detection rate of monoclonal gammopathy was significantly different (χ2=5 049.94, P<0.05). The positive rate of monoclonal gammopathy in γ globulin region (21.11%, 2 114/10 014) was higher than that in β globulin region (3.28%, 328/10 014) (χ2=90.74, P<0.05) and β-γ globulin region (1.63%, 163/10 014) (χ2=44.34, P<0.05). IgG and IgM bands are common in γ globulin region. Among them, IgG-κ type accounted for 94.1% (995/1 058), IgG-λ type accounted for 94.8% (690/728), IgM-κ type accounted for 89.2% (222/249), IgM-λ accounted for 83.8% (62/74). IgA bands are common in β region, of which IgA-κ accounted for 49.8% (103/207) and IgA-λ accounted for 51.6% (149/289). The positive rate of monoclonal gammopathy of IgG-κ type was the highest (10.57%, 1 058/10 014), and the positive rate of monoclonal gammopathy of IgM-λ type was the lowest (0.74%, 74/10 014). Conclusions:With increasing age, the proportion of albumin band in SPE decreased and the proportion of γ globulin band increased. IgG and IgM type monoclonal gammopathy is mostly found in the gamma region, with a higher detection rate in IgG type. IgA type monoclonal gammopathy is mostly found in the β region, with a lower detection rate.