Objective:To investigate the clinical values of progastrin-releasing peptide (Pro-GRP), neuron-specific enolase (NSE), cytokeratin 19 fragment antigen 21-1 (CYFRA21-1), squamous cell carcinoma antigen (SCCA) and human human epididymis protein 4 (HE4) detections in the diagnosis of lung cancer patients.Methods:The clinical data of 200 lung cancer patients who were admitted to the Second Affiliated Hospital of Xuzhou Medical University from January 2020 to December 2021 were retrospectively analyzed. According to the pathological type, the patients were divided into lung adenocarcinoma group (80 cases), lung squamous cell carcinoma group (75 cases) and small cell lung cancer group (45 cases). Fifty patients with benign lung diseases and 50 healthy physical examiners who were admitted to the hospital during the same period were selected. All the subjects were tested for the levels of Pro-GRP, NSE, CYFRA21-1, SCCA and HE4, and the differences of each index level in the subjects of different subgroups were compared. The receiver operating characteristic (ROC) curve was drawn, and using pathological diagnosis result as the gold standard, the diagnostic efficacy of each index alone and in combination for lung cancer was compared.Results:The serum levels of Pro-GRP, NSE, CYFRA21-1, SCCA and HE4 in lung cancer group were higher than those in the benign lung diseases group and the healthy control group (all P < 0.001). There were no statistical differences in the levels of serum Pro-GRP, NSE, CYFRA21-1, SCCA and HE4 between the benign lung diseases group and the healthy control group (all P > 0.05). The levels of Pro-GRP, NSE and HE4 in the small cell lung cancer group were higher than those in the lung adenocarcinoma group and the lung squamous cell carcinoma group (all P < 0.05). NSE and HE4 levels in the lung adenocarcinoma group were higher than those in the lung squamous carcinoma group (both P < 0.05), while CYFRA21-1 and SCCA levels were lower than those in the lung squamous carcinoma group (both P < 0.05). The AUC of lung cancer diagnosed by HE4 was the largest (0.813), the AUC of lung adenocarcinoma diagnosed by HE4 was the largest (0.824), the AUC of lung squamous carcinoma diagnosed by CYFRA21-1 was the largest (0.884), and the AUC of small cell lung cancer diagnosed by NSE was the largest (0.959). The AUC of lung cancer diagnosed by combined detection of 5 indicators was 0.951, the AUC of lung adenocarcinoma and small cell lung cancer diagnosed by combined detection of 5 indicators was 0.975 and 0.996, and the AUC of lung squamous cell carcinoma diagnosed by combined detection of CYFRA21-1, SCCA and HE4 was 0.967. Conclusions:The levels of Pro-GRP, NSE, CYFRA21-1, SCCA, HE4 and other indicators have certain clinical values in the diagnosis of lung cancer and its pathological types, and the combined detection of each index is more valuable than a single index.

Objective:To investigate the clinical application of free/total prostate-specific antigen (f/tPSA), peripheral blood neutrophil-to-lymphocyte ratio (NLR), interleukin-6 (IL-6) and prostate health index density (PHID) detection in the early diagnosis of prostate cancer.Methods:The clinical data of 160 patients with abnormal prostate specific antigen (PSA) who were admitted to the Second Affiliated Hospital of Xuzhou Medical University from January 2020 to January 2022 were retrospectively analyzed. According to the pathological results of prostate biopsy or electrical resection, the patients were divided into prostate cancer group (68 cases) and benign prostatic hyperplasia group (92 cases), and 50 male healthy physical examiners in the Second Affiliated Hospital of Xuzhou Medical University during the same period were selected as healthy control group. All enrolled members were tested for total prostate-specific antigen (tPSA), free prostate-specific antigen (fPSA), and prostate specific antigen isoform 2 (p2PSA), IL-6 and other indicators, and the f/tPSA, prostate health index (PHI), PHID and NLR were calculated. Receiver operating characteristic (ROC) curve was plotted to compare the efficacy of each index in diagnosing and differentially diagnosing prostate cancer and benign prostatic hyperplasia.Results:The serum levels of tPSA, fPSA, p2PSA, PHI and PHID in the prostate cancer group were higher than those in the benign prostatic hyperplasia group and the healthy control group (all P < 0.05), and the serum f/tPSA was lower than that in the benign prostatic hyperplasia group and the healthy control group ( P < 0.05). The area under the curve (AUC) of PHID for the diagnosis of early stage prostate cancer was the largest [0.915 (95% CI 0.864-0.966)], followed by PHI [0.884 (95% CI 0.823-0.944)]. The sensitivity of both f/tPSA and PHI in diagnosing early stage prostate cancer was 86.80%, which was higher than other indicators; the specificity of PHID in diagnosing early stage prostate cancer was 94.00%, which was higher than other indicators. The AUC of f/tPSA for the diagnosis of benign prostatic hyperplasia was the largest [0.828 (95% CI 0.739-0.917)], followed by PHID [0.826 (95% CI 0.760-0.892)]. The sensitivity of f/tPSA in diagnosing benign prostatic hyperplasia (85.90%) was higher than other indicators, and the specificity of PHI in diagnosing benign prostatic hyperplasia (94.00%) was higher than other indicators. The AUC of fPSA, PHID, f/tPSA and p2PSA in differentiating early stage prostate cancer and benign prostatic hyperplasia were 0.752 (95% CI 0.663-0.841), 0.730 (95% CI 0.647-0.812), 0.713 (95% CI 0.623-0.803), 0.710 (95% CI 0.629-0.791), respectively, and there was no significant difference in each pairwise comparison (all P > 0.05). The sensitivity of NLR in differentiating early stage prostate cancer and benign prostatic hyperplasia was 91.20%, which was higher than other indicators, and the specificity of fPSA in differentiating early stage prostate cancer and benign prostatic hyperplasia was 94.00%, which was higher than other indicators. Conclusions:The f/tPSA, PHI and PHID detection have certain clinical values in the early diagnosis of prostate cancer, and can provide references for early diagnosis, early treatment and prognosis evaluation of high-risk population of prostate cancer.

Objective:To learn about the detection quality and external quality control assessment of fluoride and arsenic in laboratories at all levels in Qinghai Province.Methods:The Z-score method was used to analyze and evaluate the evaluation results of 1 provincial, 8 municipal and 43 county level laboratories of disease prevention and control institutions participating in the external quality control assessment of water fluoride and brick tea fluoride in Qinghai Province in 2021, as well as 1 provincial, 1 municipal and 2 county level laboratories of disease prevention and control institutions participating in the external quality control assessment of water arsenic and urine arsenic. The feedback rate and qualification rate of external quality control of each assessment laboratory were calculated.Results:In 2021, the feedback rate of external quality control of water fluoride, brick tea fluoride, water arsenic and urine arsenic in provincial and municipal level laboratories of Qinghai Province were 100.00%; except that the qualified rate of water fluoride was 7/9, the qualified rate of external quality control of other projects was 100.00%. The feedback rate of external quality control of water fluoride, brick tea fluoride, water arsenic and urine arsenic in county level laboratories was 100.00%; except that the qualified rate of water fluoride was 86.05% (37/43), the qualified rate of external quality control of other projects was 100.00%. In the specific assessment results of the laboratory, the assessment results of water fluoride sample FS20210101 from 1 provincial, 1 municipal and 2 county level laboratories, and FS20210102 from 1 county level laboratory were suspicious; the assessment results of water fluoride sample FS20210101 from 3 county level laboratories were not satisfactory; the assessment results of fluoride and arsenic sample in other laboratories were satisfactory.Conclusions:The qualified rate of external quality control of fluoride and arsenic in laboratories at all levels in Qinghai Province is relatively high, but some county level laboratories are still dissatisfied with the assessment results of water fluoride. Therefore, it is necessary to strengthen the detection level of water fluoride in laboratories.

Objective:To analyze the external quality control assessment results of urinary iodine, salt iodine and water iodine in iodine deficiency disorders laboratories in Qinghai Province, to evaluate the testing capacity of provincial, municipal and county-level laboratories and the operation of external quality control network, so as to provide quality assurance for consolidating and eliminating iodine deficiency disorders.Methods:In 2021, 1 provincial, 8 municipal, and 43 county-level laboratories in Qinghai Province had participated in the assessment of urinary iodine and salt iodine, while 1 provincial and 8 municipal-level laboratories had participated in the assessment of water iodine. The assessment results were evaluated using the method of reference value ± uncertainty of external quality control samples.Results:All laboratories that participated in the assessment had provided feedback. One provincial-level laboratory passed the assessment of urinary iodine, salt iodine, and water iodine. Among 8 municipal-level laboratories, 2 laboratories failed the urinary iodine assessment, with a pass rate of 6/8; the assessment of salt iodine and water iodine in 8 laboratories were all qualified. Among 43 county-level laboratories, 7 laboratories failed the urinary iodine assessment, with a pass rate of 83.7% (36/43); the assessment of salt iodine in 43 laboratories were all qualified.Conclusions:The external quality control network of iodine deficiency disorders laboratories in Qinghai Province has fully covered all municipal and county-level laboratories. The testing capability of provincial-level laboratory is stable and maintains a high level; the testing quality of some municipal and county-level laboratories is still unstable and needs to be further strengthened.

【Objective】 To establish gas chromatography for the determination of tributyl phosphate(TBP) residues in human prothrombin complex and then verify it. 【Methods】 Acid modified polyethylene glycol(PEG)(20M) capillary column was used with n-hexane as solvent. The chromatographic parameters were as follows: gasification chamber temperature at 220 ℃, column temperature at 155 ℃, detector temperature at 220 ℃, column flow rate at 2.0 mL/min, carrier gas as N2, detector as FID, and collection time for 10min. The accuracy, repeatability, linearity, specificity, intermediate precision, detection limit, quantitative limit, range and durability were verified. 【Results】 The verification results showed that the method had good specificity. The linear regression correlation coefficient of standard curve was 0.999 90. The recovery rate were 98.4%, 97.5% and 95.7% when the concentration at 50%, 100%(30μg/mL) and 150%, respectively, with an average recovery of 97.2% and a relative deviation of 2.15%. When the concentration was 100%, the repeatability was 2.08%, and the relative deviation of intermediate precision was 1.63%. The detection limit was 0.255 μg/mL, and the quantitative limit was 0.511 μg/mL. After changing capillary chromatographic columns with different batch numbers but the same types and manufacturer, the applicability test of the system met the requirements, and the method had good durability. 【Conclusion】 This method can be used for the determination of TBP residues of human prothrombin complex in laboratory.

Objective:To evaluate the water fluoride detection ability of county (city, district) level (referred to as the county-level) laboratories in Qinghai Province.Methods:During the "13th Five-Year Plan" period (2016 - 2020), 4, 4, 4, 43, 43 county-level laboratories in Qinghai Province were organized to participate in the national water fluoride external quality control assessment, and the assessment results were evaluated by Z-ratio scoring method.Results:The response rate of county-level laboratories was 86.05% (37/43) in 2019, and 100.00% in other years. The qualified rate of county-level laboratories was 100.00% from 2016 to 2018; in 2019 and 2020, the assessment was fully covered, and the qualified rate was 81.40% (35/43) and 95.35% (41/43), respectively. Compared with 2019, the response rate and qualified rate in 2020 increased significantly, and the differences were statistically significant (χ 2 = 6.450, 4.074, P < 0.05). In the past 5 years, two assessment samples│Z│ < 1 in each laboratory were the most common, but with two assessment samples 2≤│Z│ < 3 in some qualified laboratories. Conclusion:The consistency of water fluoride determination in Qinghai Province is not very ideal, and the detection ability of county-level laboratories still needs to be strengthened.

Objective:To analyze the external quality control assessment results of fluoride in brick tea in the provincial, city (prefecture) and county (city, district)-level endemic fluorosis laboratories in Qinghai Province, and to evaluate the testing capabilities of laboratories at all levels.Methods:The Z-score method was used to analyze and evaluate the results of provincial, city (prefecture) and county (city, district)-level laboratories that participated in the external quality control assessment of fluoride in brick tea in Qinghai Province from 2014 to 2020, and│Z│≤2 was qualified; 2 <│Z│ < 3 was basic qualified; │Z│≥3 was unqualified.Results:From the feedback, the feedback rate of external quality control of fluoride in brick tea in provincial and city (prefecture)-level laboratories in Qinghai Province from 2014 to 2020 was 100.00%; the feedback rate of county (city, district)-level laboratories from 2014 to 2018 was 100.00%, and there were no feedback units in 2019 and 2020. From the assessment of qualification, the qualification rate of provincial, city (prefecture)-level laboratories was 100.00% in all other years except one unit failed in 2017; the qualification rate of county (city, district)-level laboratories was 100.00% in 2014, 2015, 2016 and 2019, and there were 6 unqualified units in other years.Conclusions:From 2014 to 2020, some endemic fluorosis laboratories in Qinghai Province still fail to pass the external quality control assessment of fluoride in brick tea. In the future, it will be the focus of work to strengthen personnel training and improve the detection ability.

【Objective】 To study the application effect of gel adsorbent tank in the production of human prothrombin complex concentrate(PCC). 【Methods】 Six batches of PCC were produced from 1000 L cryoprecipitated plasma, using the same gel twice for adsorption within the tank.The number of gel repeated application was examined by retrospective confirmation, and the adsorption rate, specific activity and residue of finished virus inactivation reagent were determined before and after adsorption. 【Results】 All 6 batches of PPC, produced by the same gel, satisfied quality criteria. Both PPC solution and the gel presented good color. The average activities of coagulation Factors Ⅱ, Ⅶ, Ⅸ and Ⅹ of six batches of PCC were 118.2%, 157.0%, 140.5% and 176.8%, respectively. The The adsorption capacity of coagulation factor Ⅱ, Ⅸ and Ⅹ were both 100% in the first and second adsorption, while coagulation factor Ⅶ were 75% and 81%, respectively. The average specific activity of coagulation factor Ⅸ was 0.7 IU/mg. The average residues of polysorbate 80 and tributyl phosphate products were 0 μg/mL and 33 μg/mL, respectively. The same batch of gel can be repeatedly used up to 6 times during the PCC process. 【Conclusion】 The gel adsorption tank presents good application value in the production of PCC, which can realize process amplification and automatic control.

【Objective】 To establish a microbial limit test method for diatomite and pearlite, and verify its applicability. 【Methods】 According to the requirements of general rule 1105, Microbial Limit Test for Non Sterile Products of Pharmacopoeia of the People′s Republic of China (2020 Edition), the applicability test of microbial counting methods for three batches of perlite and diatomite was conducted before the microbial limit test of samples. The microbial growth of filter aid was analyzed and the recovery rate of each test bacterium was calculated. 【Results】 The ratio of the colony number of the test group minus the colony number of the test sample control group to the bacterial liquid control group was in the range of 0.5~2.0. 【Conclusion】 The method is accurate, reliable and can be used for microbial limit test of diatomite and perlite.

【Objective】 To study the quality control of human albumin intermediates content in production process using High Performance Liquid chromatography (HPLC) method. 【Methods】 In accordance with the general principles of The Chinese Pharmacopoeia (2015 edition), 3121 human albumin polymer was used to determine the component V precipitation solution, human albumin stock solution, human albumin semi-finished products and human albumin products in the production process of human albumin. The chromatographic retention time and the chromatographic peak area percentage corresponding to the retention time were analyzed. 【Results】 The polymer content of component V precipitation solution, human albumin stock solution, human albumin semi-finished products, and human albumin products were was 0.2% vs 0.0% vs 1.9% vs 1.7%, 0.2% vs 0.0% vs1.8% vs1.5% and 0.1% vs 0.0% vs 1.6% vs 1.5%, respectively. 【Conclusion】 HPLC can be used as a monitoring method for human albumin production.