[HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems].

Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.

[On detection of chromogranin A, synaptophysin, neuronspecific enolase and progastrin-releasing peptide in small cell lung cancer].

Lung cancer is one of the most common cancer, there is a significant difference between the treatment and prognosis of small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). SCLC tumor cells usually express neuroendocrine tumor (NET) markers, among which there are many studies on chromogranin A (CgA), synaptophysin (Syn), neuronspecific enolase (NSE) and pro-gastrin-releasing peptide (Pro-GRP) with SCLC. The levels of CgA, NSE and pro-GRP were related to the stage of SCLC, which were significantly higher in patients with extensive stage than in patients with limited stage, and their expression was significantly correlated with lower survival rate. Syn as an auxiliary diagnostic index of SCLC is more sensitive than CgA, and has high practical value in the differential diagnosis of SCLC and poorly differentiated squamous cell carcinoma; NSE is the most commonly used tumor marker in SCLC; Pro-GRP has stronger diagnostic advantages than CEA and NSE in distinguishing SCLC from NSCLC. Although these net markers are not specific markers of SCLC, their combined use with each others or combined with CT as an auxiliary diagnostic index may improve the level of differential diagnosis of SCLC, and they have a certain value in the staging of the disease, which is very important for the formulation of SCLC treatment strategy, their detection is conducive to the prevention and control of the disease.

[Progress in research of allergen detection methods].

Allergic diseases have continued to increase year by year causing serious physical and mental injury to patients, families and individuals. This increase has been driven by conventional environmental and nutritional changes but is also created by the continual introduction of food additives into the diet and novel interior decoration materials into the living space. The causes of allergic diseases are complex and diverse, and the medical laboratory often is not be able to identify the allergic trigger; this creates a difficult environment to identify the appropriate clinical treatment for disease prevention and control. Physicians must be able to identify these triggers to help patients avoid the underlying allergenic cause of their disease. This can only be done by actively knowing a patient's medical history, identifying the clinical manifestations of hypersensitivity and utilizing confirmatory testing as an important clinical tool in identifying the allergic source.

[Preliminary study of the antibody level in confirmed patients with COVID-19 after discharge].

Objective: To analyze the antibody levels and dynamic changes in patients infected with 2019-novel coronavirus(2019-nCoV). Methods: The average age of 72 corona virus disease 2019 (COVID-19) patients was (45.53±16.74)years(median age:47 year), including (44.88±17.09) years(median age:46 year) for 38 males and (46.32±16.52)years (median age:46 year) for 34 females in Loudi City, Hunan Province. There is no significant difference in genders between the severe and mild groups (χ²=0.916, P>0.05). There is a significant difference in the age between the severe and mild groups (F=3.315, P<0.05). The blood samples of 72 discharged patients were collected and the consistence of IgM and IgG antibodies were detected by chemiluminescence method. SPSS25.0 was used for gender, age, case type and antibody analysis of variance, χ2 test and other analysis. Results: The average time of the serum samples collection of 72 patients was (34.89±9.02)days (median time: 34 days) from onset of COVID-19, and (14.53±8.35) days (median time: 14 days) from discharge. The positive rate of IgM or IgG was 97.22% (70/72), and the positive rate of IgM and IgG was 48.61% (35/72) and 97.22% (70/72) respectively. Serum COVID-19 antibodies were detected in 72 patients from 1st to 40th days after discharge. The average concentration of IgM in 1-7 days, 8-14 days, 15-21 days, 22-28 days, above 29 days were 21.91(7.07-52.84)AU/ml, 14.16(6.19-32.88)AU/ml, 11.36(6.65-42.15)AU/ml, 8.15(3.66-30.12)AU/ml, 2.98(0.46-6.37)AU/ml. There was no significant difference in the time of IgM antibody concentration (H= 8.439, P>0.05). The average concentrations of IgG in 1-7 days, 8-14 days, 15-21 days, 22-28 days, 29 days and above were 169.90 (92.06-190.91) AU/ml, 163.89 (91.19-208.02) AU/ml, 173.31 (95.06-191.28) AU/ml, 122.84 (103.19-188.34) AU/ml, 101.98 (43.75-175.30) AU/ml, respectively, (H=2.232, P>0.05). The IgM becomes negative after the 3rd week of discharge and decreases rapidly with time. The IgG concentration higher than IgM during the same period, and keep at high level without any change, and decrease in the fourth week. Among them, 5 cases developed "re-infection" within 1-3 weeks after discharge, and the rate of "re-infection" was 6.94% (5/72 cases). Conclusions: After the COVID-19 patients are discharged from the hospital, the level of antibodies produced varies greatly among individuals, but the overall changes in antibodies have a certain pattern. It is recommended to strengthen the antibody monitoring during hospitalization and after discharge from the hospital to reduce the "re-infection" rate and potential risk of infection.

[Cytocompatibility of angiogenesis-promoting acidified silk protein sponge matrices and its effects on wound healing of full-thickness skin defects in rats].

Objective: To analyze the mechanism of acidified silk protein sponge matrices and methanolized silk protein sponge matrices in promoting wound healing. Methods: The experimental method was conducted. Acidified silk protein sponge matrices with vascularization ability and methanolized silk protein sponge matrices without vascularization ability were prepared by improved freeze-drying method. General observation was performed. Internal morphology was observed with scanning electron microscope. The secondary structure was observed with X-ray diffractometer (XRD) and infrared spectrometer. Compressive modulus was tested by tensile machine. Two 3-week-old male Sprague-Dawley (SD) rats were used to isolate bone marrow mesenchymal stem cells (BMSCs) cultured in above-mentioned two silk protein sponge matrices, the number of cells was counted under laser scanning confocal microscope after 1, 6 days of culture. Four full-thickness skin defect wounds were made on each one of twelve 8-week-old male SD rats, which were divided into methanolized silk group (24 wounds) and acidified silk group (24 wounds) covered with the corresponding silk protein sponge matrices. On post operation day (POD) 3, 7, 10, and 14, general observation was performed and the remaining wound area was recorded. On POD 3, 7, and 14, the wounds and marginal tissue were collected for hematoxylin-eosin staining (HE) staining and Masson staining to observe growth of new tissue and collagen deposition and CD34 immunohistochemical staining to observe vascularization. Sample number of each index of each group at every time point in animal experiment was 6. Data were statistically analyzed with analysis of variance of factorial design, analysis of variance for repeated measurement, independent-samples t test, and Bonferroni correction. Results: Methanolized silk protein sponge matrices and acidified silk protein sponge matrices had the same composition and similar porous structure, with pore size of 300-500 µm. XRD showed that methanolized silk protein sponge matrices showed a significant crystallization peak, while acidified silk protein sponge matrices was mainly composed of amorphous structure. Infrared spectrometer showed that acidified silk protein sponge matrices appeared a strong absorption peak at 1 650 cm(-1), and the methanolized silk protein sponge matrices appeared a strong absorption peak at 1 630 cm(-1). Compressive modulus of methanolized silk protein sponge matrices was (23.8±1.3) kPa, which was significantly higher than (6.1±0.9) kPa of acidified silk protein sponge matrices (t=19.550, P<0.01). After one day of culture, BMSCs successfully adhered to the two kinds of silk protein sponge matrices, and the cells were not spread. After six days of culture, BMSCs were spread on the two kinds of silk protein sponge matrices, and the number of cells on the acidified silk protein sponge matrices increased significantly. On POD 3, the wounds of the 2 groups did not shrink significantly. On POD 7, the wound area in acidified silk group was significantly smaller than that in methanolized silk group, and new epithelium growth occurred at the wound edge. On POD 14, the wounds of acidified silk group basically healed, and the wounds of methanolized silk group were dry and shrinked significantly. Remaining wound area of acidified silk group on POD 3, 7, 10, and 14 were significantly smaller compared with that in methanolized silk group ( t=7.782, 10.620, 3.707, 6.830, P<0.05 or P<0.01). HE staining, Masson staining, and CD34 immunohistochemical staining showed on POD 3, new tissue growing into silk protein sponge matrices of wounds of acidified silk group was more than that in methanolized silk group, the former group secreted a small amount of collagen, collagen formation was not observed in the latter group, the number of vascular endothelial cells migrated into the matrices were more in the former group than the latter group; on POD 7, the area of new tissue covering matrices hole of wounds of acidified silk group was larger than that in methanolized silk group, collagen in the former group was more than that in the latter group and was evenly distributed, the number of blood vessels in the former group was more than that on POD 3, and the new blood vessels in the latter group were scattered; on POD 14, the new tissue in acidified silk group was similar in structure to normal skin tissue and formed a certain thickness, the new tissue in methanolized silk group basically grew into the matrices, the former group had rich collagen deposition, the latter group had scattered collagen, and blood vessels in the former group distributed uniformly and density of blood vessels was significantly higher than that in the latter group ((55.7±6.0) and (34.1±1.0) pieces/mm(2), respectively, t=9.042, P<0.01). Conclusions: Angiogenesis-promoting acidified silk protein sponge matrices have good cytocompatibility, which can facilitate the rapid formation of vascular network in wound area, providing sufficient blood supply to accelerate the tissue regeneration and collagen deposition, thereby promoting wound healing and improving healing quality, these effects are better than methanolized silk protein sponge matrices.

[Comparison and reflection of standardization of public health management system both at home and abroad].

Objective: To better promote the standardization of public health management in China, and provide evidence for the development and improvement of the standardization strategy and management system in public health field in China. Methods: This paper summarizes and analyzes the information about the standardized management mechanism collected from international organizations related with standardization in public health. Results: The standards in public health varied in different management systems of the international organizations, and there were great differences in organization nature, standard types, application, release, organization structure, standard development principles, advantages, transformation, promotion and implementation, and evaluation. Conclusion: China can benefit from the studying of the working mechanism of the international organization related with standardization in public health to facilitate its own standardization in public health.