Establishing and validating of an laboratory information system-based auto-verification system for biochemical test results in cancer patients.

BACKGROUND: To establish and validate an laboratory information system (LIS)-based auto-verification (AV) system by using large amounts of biochemical test results in cancer patients. METHODS: An algorithm of the AV process was designed for pre-analysis, analysis, and post-analysis. The limit range check was adjusted three times, while the delta check criteria were first replaced by the same patients' historical extremum results. AV rules of 51 biochemical test items were tested by using data of 121 123 samples (6 177 273 tests) in 2016 that were manually reviewed through the simulative i-Vertification software of Roche. The improved and optimal AV rules were programed into our LIS and validated by using 140 113 clinical specimens in 2018. RESULTS: The AV passing rate for samples tested in our laboratory increased from 15.57% to the current overall passing rate of 49.70%. The passing rate of each item for rule 3 was between 71.16% and 99.91%. Different cancer groups had different passing rate, while the disease group of liver, gallbladder, and pancreas always had the lowest passing rate. A total of 9420 reports (6.72%) were not verified by AV but could be verified by MV in 2018, while there were no reports that were verified by AV but not by MV. The TAT of March 2018 decreased with increase in sample size compared with the same time in 2017. CONCLUSION: We have firstly established an LIS-based AV system and implemented it in actual clinical care for cancer patients.

Diagnostic value of CYFRA 21-1 and CEA for predicting lymph node metastasis in operable lung cancer.

Tumour markers are used extensively for the management of lung cancer, including diagnosis, evaluating effectiveness of treatments, monitoring recurrence after therapy and for predicting prognosis. However, there exists a knowledge gap regarding potential quantitative correlations between tumour marker levels and the extents of lymph node involvement in primary lung cancer. The current study is comprised of 139 lung cancer patients scheduled to undergo surgical operation. Of the 139 patients, 107 were subsequently diagnosed with lung cancer without lymph node involvement and 32 were diagnosed with malignant disease with lymph node involvement by histological examination. Preoperative tumour marker levels were quantified in each patient. The median tumour marker levels were statistically higher in lung cancer patients with malignant lymph nodes than in those who suffered either benign lung disease or carcinoma in situ (Kruskal-Wallistest; P = 0.001). Tumour marker levels were significantly correlated with clinical stage (ANOVA; P = 0.009). When examined as a dichotomous variable (CYFRA 21-1 ≤ 5.0 and CEA ≤ 5.0 group and CYFRA 21-1 > 5.0 or CEA > 5.0 group), elevated tumour marker levels correlated strongly with the presence of positive lymph nodes (χ(2) test; P = 0.000). This correlation suggests that the tumour marker levels are clinical predictors for the malignant involvement of lymph nodes in operable lung cancer patients.

Plasma D-dimer value as a predictor of malignant lymph node involvement in operable non-small cell lung cancer.

Fibrin deposition and remodelling of the extracellular matrix are important early steps in tumour metastasis. The D-dimer value is an indicator of intravascular fibrin formation and degradation. Thus, the D-dimer value may be a predictor of the malignant involvement of lymph nodes in operable non-small cell lung cancer (NSCLC) patients. The study comprised 142 highly suspected lung cancer patients scheduled to undergo pneumonectomy, lobectomy or wedge resection. Of the 142 patients, 124 were subsequently diagnosed as NSCLC, and 18 were subsequently diagnosed as benign lung disease by histological examination. Preoperative plasma D-dimer values were quantified, and the relationship between plasma D-dimer and clinical variables including tumour size, involvement of lymph nodes and clinical stage was examined using Spearman correlation coefficients and χ (2) tests. The median plasma D-dimer values were statistically higher in NSCLC patients with malignant lymph nodes than in those who suffered either benign lung disease or carcinoma in situ (Kruskal-Wallis test; P = 0.001). Plasma D-dimer values were significantly correlated with clinical stage (ANOVA; P = 0.009). An obvious relationship was observed between elevated D-dimer (>0.475 mg/L fibrinogen equivalent units) and malignant lymph node involvement (χ (2) test; P = 0.0000). This correlation suggests that the plasma D-dimer value is a clinically important predictor for the malignant involvement of lymph nodes in operable NSCLC.

Postoperative dynamic changes in the concentration of CK19-2G2 in lung cancer patients and the clinical value of this marker.

CK19-2G2, a newly identified fragment of cytokeratin 19, is a candidate marker for the diagnosis of lung cancer and for monitoring a patient's response to lung cancer treatment. This study investigated the postoperative dynamic changes in serum CK19-2G2 concentration and the clinical value of this marker in lung cancer patients. Preoperative and postoperative concentrations of CK19-2G2 were measured in 352 lung cancer patients who had undergone pulmonary resection. Stratified analyses based on pathologic types and lymph node involvement were performed to determine their possible impacts on postoperative CK19-2G2 concentration. CK19-2G2 concentration was significantly lower after tumor resection than before tumor resection. For squamous cell carcinoma patients, the postoperative CK19-2G2 concentration had decreased significantly at 1 week after surgery and had decreased further at 1 month after surgery. For adenocarcinoma patients, there were little changes in the CK19-2G2 concentration during 1 week to 1 month after surgery. At 1 week after surgery, the CK19-2G2 concentration was slightly higher in patients with N2 stage disease than in those with N0 and N1 stage disease, and this difference increased at 1 month after surgery. Postoperative CK19-2G2 concentration may be an indicator of prognosis. An increase after the initial drop in CK19-2G2 concentration after surgery may indicate a poor prognosis.