Objective: To analyze the nucleic acid load of human parvovirus B19 in major commercially available blood products in China, including human albumin, human intravenous immunoglobulin, human rabies immunoglobulin and various coagulation factor products, aiming to provide evidence for improving blood product manufacturing processes and quality control of source plasma. Methods: A total of 98 batches of coagulation factor products were tested for human parvovirus B19 nucleic acid using real-time fluorescent quantitative PCR, including 42 batches of human prothrombin complex, 35 batches of human coagulation factor Ⅷ, and 21 batches of human fibrinogen. Additionally, 6 batches of human albumin, 6 batches of human intravenous immunoglobulin, and 38 batches of human rabies immunoglobulin were tested for human parvovirus B19 nucleic acid. Results: Human parvovirus B19 nucleic acid were undetectable in human albumin, human intravenous immunoglobulin and human rabies immunoglobulin. Among the 98 batches of coagulation factor products tested for human parvovirus B19 nucleic acid, B19 nucleic acid reactivity rate was 69.0% (29/42) for human prothrombin complex batches, but nucleic acid concentration were all significantly lower than 10 IU/mL. The reactivity rate of B19 nucleic acid in 35 batches of human coagulation factor Ⅷ was 48.6% (17/35), with nucleic acid concentration all below 10 IU/mL. The reactivity rate of B19 nucleic acid in 21 batches of human fibrinogen was 61.9% (13/21), with nucleic acid concentration all below 10 IU/mL. Conclusion: No human parvovirus B19 has been detected in human albumin, human intravenous immunoglobulin, or human rabies immunoglobulin. Human parvovirus B19 nucleic acid may exist in commercially available coagulation factor products, highlighting the need for enhanced screening of human parvovirus B19 nucleic acid in these products. It is also recommended that B19 viral nucleic acid testing be conducted on source plasma, particularly for coagulation factor products.

Objective: To analyze the nucleic acid load of human parvovirus B19 in major commercially available blood products in China, including human albumin, human intravenous immunoglobulin, human rabies immunoglobulin and various coagulation factor products, aiming to provide evidence for improving blood product manufacturing processes and quality control of source plasma. Methods: A total of 98 batches of coagulation factor products were tested for human parvovirus B19 nucleic acid using real-time fluorescent quantitative PCR, including 42 batches of human prothrombin complex, 35 batches of human coagulation factor Ⅷ, and 21 batches of human fibrinogen. Additionally, 6 batches of human albumin, 6 batches of human intravenous immunoglobulin, and 38 batches of human rabies immunoglobulin were tested for human parvovirus B19 nucleic acid. Results: Human parvovirus B19 nucleic acid were undetectable in human albumin, human intravenous immunoglobulin and human rabies immunoglobulin. Among the 98 batches of coagulation factor products tested for human parvovirus B19 nucleic acid, B19 nucleic acid reactivity rate was 69.0% (29/42) for human prothrombin complex batches, but nucleic acid concentration were all significantly lower than 10 IU/mL. The reactivity rate of B19 nucleic acid in 35 batches of human coagulation factor Ⅷ was 48.6% (17/35), with nucleic acid concentration all below 10 IU/mL. The reactivity rate of B19 nucleic acid in 21 batches of human fibrinogen was 61.9% (13/21), with nucleic acid concentration all below 10 IU/mL. Conclusion: No human parvovirus B19 has been detected in human albumin, human intravenous immunoglobulin, or human rabies immunoglobulin. Human parvovirus B19 nucleic acid may exist in commercially available coagulation factor products, highlighting the need for enhanced screening of human parvovirus B19 nucleic acid in these products. It is also recommended that B19 viral nucleic acid testing be conducted on source plasma, particularly for coagulation factor products.

Objective:To revise the quality standards of purified siliceous earth in the Chinese Pharmacopoeia 2020 Vol Ⅳ.Methods:Referring to USP2024 and GB 14936-2012 food additive purified siliceous earth and related ref-erences,the current quality standards for pharmaceutical excipient purified siliceous earth were revised,including description,dissolved substances in water,dissolved substances in acid,and content determination.The soluble a-luminum content was also investigated.Results:Revised the description of characteristic items,methods for deter-mining dissolved substances in water and acid,and limits for content determination;Through the investigation of soluble aluminum before and after filtration of human serum albumin(HSA)samples using purified siliceous earth as a filter aid,it is shown that purified siliceous earth has a certain degree of adsorption effect on aluminum ele-ment.At present,the use of low-temperature ethanol ultrafiltration process does not increase the residual aluminum content in biological products,so an aluminum element determination item is not added to the standard.Conclusion:The comprehensive quality standards for purified siliceous earth will be included in the Chinese Phar-macopoeia 2025 edition,providing strong technical support for the quality and safety supervision of this product.

Amide proton transfer-weighted (APTw) imaging is a kind of new magnetic resonance molecular imaging that rapidly developed in recent years. APTw imaging reflects the protein concentration and acid-base changes in tissues by detecting amide protons in free proteins and peptides in tissues. APTw imaging is a complementary technique to the existing magnetic resonance techniques, which can provide new molecular biological information for central nervous system diseases. In this article, the basic principle of APTw imaging and its application in common central nervous system diseases such as brain tumor, ischemic stroke, and neurodegenerative diseases are reviewed to provide new methods for promoting the transformation of APTw imaging from the research stage to routine clinical application, and facilitating the precise diagnosis and treatment of central nervous system diseases.

Objective:To revise the quality standards of purified siliceous earth in the Chinese Pharmacopoeia 2020 Vol Ⅳ.Methods:Referring to USP2024 and GB 14936-2012 food additive purified siliceous earth and related ref-erences,the current quality standards for pharmaceutical excipient purified siliceous earth were revised,including description,dissolved substances in water,dissolved substances in acid,and content determination.The soluble a-luminum content was also investigated.Results:Revised the description of characteristic items,methods for deter-mining dissolved substances in water and acid,and limits for content determination;Through the investigation of soluble aluminum before and after filtration of human serum albumin(HSA)samples using purified siliceous earth as a filter aid,it is shown that purified siliceous earth has a certain degree of adsorption effect on aluminum ele-ment.At present,the use of low-temperature ethanol ultrafiltration process does not increase the residual aluminum content in biological products,so an aluminum element determination item is not added to the standard.Conclusion:The comprehensive quality standards for purified siliceous earth will be included in the Chinese Phar-macopoeia 2025 edition,providing strong technical support for the quality and safety supervision of this product.

Amide proton transfer-weighted (APTw) imaging is a kind of new magnetic resonance molecular imaging that rapidly developed in recent years. APTw imaging reflects the protein concentration and acid-base changes in tissues by detecting amide protons in free proteins and peptides in tissues. APTw imaging is a complementary technique to the existing magnetic resonance techniques, which can provide new molecular biological information for central nervous system diseases. In this article, the basic principle of APTw imaging and its application in common central nervous system diseases such as brain tumor, ischemic stroke, and neurodegenerative diseases are reviewed to provide new methods for promoting the transformation of APTw imaging from the research stage to routine clinical application, and facilitating the precise diagnosis and treatment of central nervous system diseases.

[Objective] To establish a real-time fluorescence quantitative PCR nucleic acid detection method of human parvovirus B19 and validate the method systematically. [Methods] Specific primers and probes for the highly conserved regions of the three genotypes of B19 virus were designed, and B19 quantitative amplification standard curves were established. The accuracy, precision (repeatability and intermediate precision), linear range, quantification limit, detection limit, specificity, anti cross contamination, genotyping and anti-interference ability of this method were verified. [Results] When the quantitative reference range for B19 virus was 2.0×10¹ to 1.0×10⁸ IU/mL, a double logarithmic regression analysis was performed between the measured values and the theoretical values, and the regression equation R²≥0.98 showed good linear correlation. The quantification limit was 20 IU/mL, with a detection rate of 100%. The detection limit was 10 IU/mL, and the detection rate is 95.23%. Three genotypes of B19 virus samples can be effectively detected. The plasma of seven non B19 pathogens, including hepatitis A virus, hepatitis B virus, hepatitis C virus, human immuno-deficiency virus, human cytomegalovirus, hepatitis E virus and Treponema pallidum, was non reactive and has good species specificity. Simultaneously, in the presence of seven other concurrent pathogens, positive samples with a weak positive concentration of E3 IU/mL could be stably detected, and the B19 nucleic acid testing method was not interfered with. When the hemoglobin concentration was 431 mg/dL, triglycerides (1 269 turbidity) and unconjugated bilirubin concentration was 20 mg/dL, this method was non reactive for all three common plasma interfering substances. In the presence of three common plasma interfering substances, positive samples with a weak positive concentration of E3 IU/mL could be stably detected, and the B19 nucleic acid testing method was not interfered with. The deviation between the detection values of standard substances at two concentration levels of S1 (E5 IU/mL) and S2 (E4 IU/mL) and the target values were≤±0.5 log value. The CV values of positive sample 1 (concentration level E5 IU/mL) and positive sample 2 (concentration level E4 IU/mL) for daily precision confirmation and continuous 5-day intra-day precision confirmation were both≤5%. [Conclusion] This method has strong specificity, high sensitivity, wide linear range, stability, reliability and high accuracy, and can be used for the detection of human parvovirus B19 nucleic acid in plasma.

Objective To explore the pH conditions for human immunodeficiency virus(HIV) detection(ELISA) in the finished products of human immunoglobulin(pH 4) for intravenous injection(IVIG), in order to control the residual HIV risk of IVIG and ensure the safety of blood products.Methods The HIV antibody reference materials and antigen reference materials were diluted to the detection limit level using different pH buffer solutions. The detection of HIV reference materials at different pH and detection limit levels by the reagent kit were observed to determine the appropriate pH detection range of the reagent kit. The pH range of the finished product was adjusted to the appropriate range of the reagent kit by using different concentrations of Tris-HCl solutions, and then the HIV antibody reference materials and HIV antigen reference materials were diluted to the detection limit level to obtain the appropriate pH detection range of the product.Results The A450/630 values of the HIV antibody reference materials and HIV antigen reference materials with detection buffer at pH 7. 0-9. 0 were similar to those of the normal saline(NS) group, and the suitable pH range for the HIV kit used was pH 7. 0-9. 0. IVIG 4. 0 was diluted with0. 1 mol/L Tris-HCl solution to the appropriate pH range of the reagent kit as the diluent. The A450/630 value of antibody 0. 25 NCU/mL in IVIG pH 7. 0-8. 0 group was higher than the cutoff value and significantly higher than that in the IVIG pH 4. 0 group.The amount of 0. 1 mol/L Tris-HCl solution added accounted for more than 1/5 of the IVIG volume. IVIG 4. 0 was diluted with 1 mol/L Tris-HCl solution to the appropriate pH range of the reagent kit as the diluent. The A450/630value of antibody 0. 25 NCU/mL and antigen 1. 5 U/mL levels was higher than the cutoff value in the IVIG pH 7. 0-9. 0 group. The amount of 1 mol/L Tris-HCl solution added was only 1/28-1/37 of the total detection volume, and had little effect on the effective detection content of the test sample.Conclusion Compared to the detection conditions of pH 4. 0, pH 7. 5-8. 0 is more suitable for HIV detection in IVIG. 1 mol/L Tris-HCl solution was used to adjust the pH of IVIG to 7. 5-8. 0 for HIV detection(ELISA)in IVIG, which effectively solves the problem that the pH bias in IVIG finished product is not conducive to HIV detection, with no effect on the detection volume of the finished product, thus significantly improving the accuracy and reliability of the detection results.

Objective:To compare the clinical efficacy of endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) in the treatment of elderly patients with early gastric cancer.Methods:Ninety-two elderly patients with early gastric cancer admitted to the 923th Hospital of the Joint Service Support Force of PLA from June 2019 to February 2022 were enrolled, and they were divided into ESD group (60 cases) and EMR group (32 cases) according to different surgical methods. The ESD group was treated with ESD surgery, while the EMR group was treated with EMR surgery. The short-term clinical efficacy of the two groups was compared. The gastric function including pepsinogen Ⅰ(PGⅠ), pepsinogenⅡ(PGⅡ), PGⅠ /PGⅡ ratio and the tumor markers including carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 125 (CA125), and invasion genes within the lesion including vascular endothelial growth factor C (VEGF-C), E-cadherin, microtubule depolymerin (Stathmin), Krüppel like factor 4 (KLF4) were detected before and 3 d after surgery. Followed up for 1 year, the recurrence rate and complications between the two groups were compared.Results:All of 92 patients successfully removed the diseased tissue as a whole, and the R0 and R1 resection rate between the two groups had no statistical differences ( P>0.05). At 3 d after surgery, the levels of PG Ⅰand PGⅠ/PG Ⅱin the both groups were higher than those before surgery, and the level of PG Ⅱ in the both groups was lower than that before surgery; the levels of PG Ⅰand PGⅠ/PG Ⅱ in the ESD group were higher than those in the EMR group: (86.50 ± 8.23) μg/L vs. (77.47 ± 7.40) μg/L, 5.29 ± 0.54 vs. 3.65 ± 0.50; the level of PG Ⅱ ratio in the ESD group was lower than that in the EMR group: (16.34 ± 3.05) μg/L vs. (21.20 ± 3.27) μg/L, there were statistical differences ( P<0.05). At 3 d after surgery, the levels of CEA, CA19-9 and CA125 in the two groups were decreased, and the levels of the above indicators in the ESD group were lower than those in the EMR group: (2.42 ± 0.45) μg/L vs. (3.29 ± 0.40) μg/L, (8.55 ± 2.10) kU/L vs. (10.62 ± 2.76) kU/L, (13.75 ± 4.28) kU/L vs. (17.20 ± 4.90) kU/L, there were statistical differences ( P<0.05). At 3 d after surgery, the mRNA expression of E-cadherin and KLF4 in the two groups were increased, and the mRNA expression of VEGF-C, Stathmin in the two groups were decreased, and the mRNA expression of E-cadherin and KLF4 in the ESD group were lower than those in the EMR group: 2.89 ± 0.31 vs. 3.03 ± 0.21, 2.90 ± 0.28 vs. 3.12 ± 0.37, and the mRNA expression of VEGF-C, Stathmin in the ESD group were higher than those in the EMR group: 0.45 ± 0.11 vs. 0.41 ± 0.07, 0.52 ± 0.23 vs. 0.43 ± 0.09, there were statistical differences ( P<0.05). The complication rate in the ESD group was lower than that in the EMR group: 5.00%(3/60) vs. 23.33% (14/60) , there was statistical difference ( χ2 = 8.32, P<0.01). The recurrence rate in the 1-year between the two groups had no statistical difference ( P>0.05). Conclusions:Compared with EMR, ESD is effective in the treatment of elderly early gastric cancer, which can better correct the abnormal secretion of pepsinogen, promote the functional recovery of gastric cells and glands, reduce the level of serum tumor markers, inhibit the metastasis and proliferation of tumor cells, and has good safety.

Objective:To investigate the characteristics of subtype diversity and transmission on HIV-1 among 12 to 30 years old student MSM in Zhejiang province.Methods:A total of 290 newly diagnosed HIV infected student MSM were selected as the research objects for molecular studies on HIV, in Zhejiang province during 2013 to 2015. Data on epidemiology and plasma samples of these people were collected. HIV-1 nucleotide sequences of pol gene regions were amplified using the RT-PCR/nested PCR method and sequenced. Phylogenetic analysis was performed to determine the HIV-1 genotypes. Characteristics of transmission mode among these cases were also analyzed. Results:A total of 290 cases, 50.3 % were diagnosed in Hangzhou and 81.0 % had college or above degrees. 178 sequences including 10 subtypes, were obtained, with the main subtypes as CRF01_AE (49.4 %, 88/178) and CRF07_BC (39.3 %, 70/178). A total of 18 molecular transmission clusters were formed (42 cases, cluster size from 2 to 4), with the proportions of clusters as 23.6 % (42/178). 61.9 % (26/42) of student MSM with their schools located in the same district within the transmission clusters. Their sexual partners would include both student MSM and non-student MSM. The proportion of clusters among middle school students was 38.2 % (13/34), higher than that of college students (20.1 %, 29/144) ( χ2=4.996, P<0.05). Conclusions:The HIV-1 subtypes of student MSM in Zhejiang province appeared diversity, which indicated with the diversity of sources of infection. The geographical distribution of cluster cases is relatively centralized. In order to effectively control the spread of AIDS, more attention should be paid to the sexual partners involved and to specific programs on intervention.