[Preparation and Release Properties of Recombinant Protein PLGA Microspheres and PLGA-Chitosan Microspheres].

Objective: To preparethe poly lactic-co-glycolic acid (PLGA) microspheres and PLGA-chitosan microspheres containing recombinant protein, namely the BIB protein, and to explore their optimal preparation parameters and release performance in gastric and intestinal fluids.

Methods: Double emulsions (water-in-oil-in-water, or W1/O/W2) solvent evaporation method was used to prepare the BIB-PLGA microspheres and the BIB-PLGA-chitosan microspheres. Univariate analysis was done to study the impact of the water-to-oil ratio (W1/O), PLGA mass fraction and PVA concentration on the morphology, particle size, polydispersity index (PDI), encapsulation efficiency (EE), and drug loading (DL) so as to identify the optimal parameters.

[Study on Dynamic Changes of Human Papillomavirus 16 Gene in the Occurrence of Cervical Cancer].

Objective: To explore the dynamic changes of human papillomavirus (HPV) type 16 5 gene in the development of cervical cancer and the significance of 5 mRNA in early screening of cervical cancer.

Methods: Paraffin specimens of cervical lesions were collected from 49 cases (HPV positive) during September 2015 to December 2017 According to the standard of FIGO, all cervical lesions were diagnosed as: 13 cases of cervicitis, cervical intraepithelial neoplasia disorders (CIN) Ⅰ in 5 cases, CIN Ⅱ in 18 cases, CIN Ⅲ in 5 cases, 8 cases of cervical cancer. Real-time fluorescence quantitative PCR was used to detect the integrity of 5 gene and the mRNA expression levels of 5, 6 and 7in cervical tissues.

Performance verification and comparison of TianLong automatic hypersensitive hepatitis B virus DNA quantification system with Roche CAP/CTM system.

Aim: To investigate and compare the analytical and clinical performance of TianLong automatic hypersensitive hepatitis B virus (HBV) DNA quantification system and Roche CAP/CTM system.

Methods: Two hundred blood samples for HBV DNA testing, HBV-DNA negative samples and high-titer HBV-DNA mixture samples were collected and prepared. National standard materials for serum HBV and a worldwide HBV DNA panel were employed for performance verification.

Autoantibodies in Chinese patients with chronic hepatitis B: prevalence and clinical associations.

Aim: To investigate the prevalence of autoantibodies and their associations with clinical features in Chinese patients with chronic hepatitis B (CHB).

Methods: A total of 325 Chinese patients with CHB were enrolled in this retrospective, hospital-based study. Patients with chronic hepatitis C (CHC), autoimmune hepatitis (AIH), or primary biliary cirrhosis (PBC) were included, with healthy donors acting as controls.

[Distribution of genotypes in ESBLs producing E. coli strains isolated from posthepatitic cirrhosis' patients with bloodstream infection].

Objective: To study the genotype distribution of extended-spectrum beta-lactamases (ESBLs) in ESBLs-producing Escherichia coli (E. coli) isolates from posthepatitic cirrhosis' patients with bloodstream infection.

Methods: E.

[Cloning and expressing of golgi protein73 gene fragment and preparation of monoclonal antibodies against the recombinant protein].

Objective: To clone and express human Golgi glycoprotein73 protein, and prepare the monoclonal antibody (mAb) against the protein.

Methods: GP73 gene was amplified from HepG2 cells by RT-PCR, then ligated with pQE31 to form recombinant plasmid pQE-GP73 and transformed into E. coli BL21.

[Cloning and expressing of tissue inhibitor of metalloproteinases I gene fragment and preparation of monoclonal antibodies against the recombinant protein].

Objective: To prepare the monoclonal antibody (mAb) against tissue inhibitor of metalloproteinases I (TIMP-I) fusion protein.

Methods: TIMP-I gene was amplified from fibrotic human liver tissue by RT-PCR, then ligated with pQE31 to form recombinant plasmid pQE-TIMP-I and transformed into E. coli BL21.

[Dynamic analysis of the lymphocyte subsets in HCV children with different genotypes during treatment].

Objective: To discuss the changes of lymphocyte subsets in HCV children with different genotypes during treatment with pegylated interferon alfa-2b and ribavirin.

Methods: The genotype of 45 HCV infected children were identified by real time PCR. The lymphocyte subsets were dynamically detected by BD FACSCalibur flow cytometer with four color MultiTEST IMK Kit during the treatment.

[Establishment of a purificatory method for alpha-fetoprotein variant by affinity adsorption].

Objective: To establish a purificatory method of alpha-fetoprotein variant (AFP-L3) based on microspincolumn with lens culinaris agglutinin (LCA).

Methods: LCA was isolated by ammonium sulfate precipitation method from lens culinaris. AFP-L3 affinity adsorption microspincolumns which were made from LCA coupled with activated Sepharose 4B were prepared.

[The investigantion of comparative experiments for different clinical laboratory instruments].

Objective: To estimate the consistency of two VITROS 3600 chemiluminescent analyzers according to the requirement of ISO15189.

Methods: Verification tests were made for precision and accuracy of anti-HCV in two instruments. While 40 serum samples including Anti-HCV negative (10 cases) , positive (10 cases) , and weakly positive (20 cases).

[Comparison of two different methods to detect HIV antibodies].

Objective: Evaluated the chemiluminescence and enzyme-linked immunosorbent assay (ELISA) to detect HIV antibodies, and compared the results, to provide a reference for the selection and clinical application of HIV screening.

Methods: 3000 cases of our hospital patients were measured by enzyme-linked immunosorbent assay and chemiluminescence immunoassay, using comfirmming experimental results as gold standards. Comparing sensitivity, specificity and other Indicators.

[Establishment of confirmatory test for suspicious hepatitis B surface antigen positive samples].

Objective: Establish a confirmatory test based on ELISA, and use to verify the authenticity of HBsAg weak positive samples, pick and get rid of the false result, and avoid the mistake diagnosis.

Method: The particles (reagent A) coated by streptavidin and biotinylated HBsAb (reagent B) were mixed in different proportions, then neutralized with serum whose the COI of HBsAg > 20 by ELISA in order to identify the activity of HBsAb in confirmatory reagent. 30 pieces of HBsAg weak positive serum neutralized with the confirmatory reagent, the serum were considered to be positive if rate of decline of HBsAg COI > 50%.

[Analysis of hemagglutination inhibition antibody level in patients with influenza A H1N1].

Objective: To understand the hemagglutination inhibition antibody level in patients with influenza A H1N1.

Methods: Sera from 28 patients with influenza A H1N1 at different time points after illness onset were collected and measured by hemagglutination inhibition assay.

Results: The serum hemagglutination inhibition antibody titers at 1, 5, 15, 22, 37, 49 and 58 days after illness onset were 5.

[Evaluation of the Helicobacter pylori stool antigen test].

Objective: To evaluate the clinical value of an enzyme-linked immunosorbent assay by the Helicobacter pylori stool antigen (HpSA) test for the detection of H. pylori infection.

Methods: 328 patients were measured upper gastrointestinal endoscopic examination which as gold standards and HpSA test in the meantime, comparing accuracy, sensitivity, specificity and other Indicators.

[Establishment of confirmatory test for HBsAb in serum of coexistence of hepatitis B surface antigen and antibodies to HBsAg].

Objective: Establish a kind of confirmation method based on ELISA, and use to verify authenticity of HBsAb + in HBsAg + HBsAb + serum, pick and get rid of the false masculine gender the result, and avoid the mistake diagnosis.

Method: Collect 60 pieces of serum whose thick degree of HBsAg at 1000 COI above tested by ECLIA as confirm serum, mixed the confirm serum of different dilution with HBsAb positive serum to screen and verify best thick degree of HBsAg. Collected 40 pieces of HBsAg + HBsAb + serum, ELISA tested the descend rate of HBsAb COI after neutralized with confirm serum in order to confirm authenticity of HBsAb + in pieces of HBsAg + HBsAb + serum.

[Quantitative analyses of intrahepatic HBV cccDNA and serum HBsAg in 54 patients with chronic hepatitis B].

Objective: To quantitatively detect intrahepatic HBV covalently closed circular DNA (cccDNA) and serum HBsAg; and to analyze the relationship between the two parameters and with serum HBV DNA level.

Methods: Intrahepatic cccDNA (copies/cell) was quantitated by plasmid-safe ATP-dependent Danes (PSAD) digestion in combination with rolling circle amplification and gap-spanning selective real-time PCR assay using formalin fixed paraffin-embedded liver biopsy samples. HBsAg was measured by chemiluminescence's reagent manufactured by Abbott Company using sera sampled at time-point of liver biopsy.

[The early diagnosis value of EV 71 IgM class antibodies in the hand, foot and mouth disease].

Objective: Assessment of detection of IgM antibodies for human enterovirus 71 (EV 71) in early diagnosis for the hand, foot and mouth disease (HFMD).

Method: The sera and throat swabs from 38 patients which were clinical diagnosis as HFMD, were continuous daily collected in our hospital in 2010. These specimens were detected by EV 71 IgM antibodies assay, real time RT-PCR methods for EV 71 and Enterovirus.

[The verification of a new DNA double-detection diagnostic kit for identifying novel influenza A (H1N1)].

Objective: To verify a new kit of "universal and novel influenza A (H1N1) virus nucleic acid double-detection methods (PCR-fluorescence probe)".

Methods: 150 cases of throat swab specimens were collected consecutively. After RNA was extracted, the specimens were detected by the verified kit.

[Analysis for post-transplant changes of peripheral lymphocyte subsets in liver transplant receptors with HBV infection].

Aim: To investigate the characters and changes of peripheral lymphocyte subsets and cytokines in liver transplant receptors with HBV infection in short phases after liver transplantation, and to provide evidences for monitoring post-transplant immune condition of liver transplant receptors.

Methods: Peripheral lymphocyte subsets and cytokine levels in pre- and post- transplant 12 h, 3 d, 10 d, 30 d, 60 d of 20 cases of patients with HBV-associated severe hepatic diseases were investigated and analyzed, and were compared respectively with those of 22 cases of healthy adults as control (HC) with flow cytometry (FCM) and ELISA.

Results: The patients' accounts of peripheral lymphocyte subsets before liver transplantation were lower than those of HC significantly, but the accounts decreased significantly after transplantation 12 h.

[Evaluation on clinical value of serum CA-125 level in hepatitis cirrhosis].

Objective: To determine the association between elevated levels of serum cancer antigen (CA) 125 and hepatitis cirrhosis in different stage, and also to explore the clinical application value of serum CA-125.

Methods: During June to December in 2008, 200 cases with hepatitis cirrhosis were random selected in our hospital. CA-125 levels were measured by electrochemiluminescence immunization assay in sera collected from these cases which were termed with Child-Paugh classification and analyzed by SAS.

[Changes and analysis of peripheral white blood cells and lymphocyte subsets for patients with pandemic influenza A virus (H1N1) infection].

Objective: To investigate the characters and changes of peripheral white blood cells and lymphocyte subsets of patients with pandemic influenza A virus (H1N1) infection and to provide evidences for diagnosis, treatment and prognosis of influenza A (H1N1) infection.

Methods: Peripheral white blood cell parameters and the percentages of lymphocyte subsets in acute and recovery phases of 59 cases of influenza A virus (H1N1) infectious patients (42 mild cases and 17 severe cases) were investigated and analyzed, and compared respectively with those of 43 cases of healthy adults as control (HC) and 24 cases of general influenza A virus (no-H1N1) infectious using whole blood cell analysis and flow cytometry.

Results: Peripheral white blood cell counts of mild cases decreased greatly but those of severe cases did not decrease significantly; the neutrophils of severe cases increased significantly in acute phase; similar to general influenza A virus (no-H1N1) infectious, the peripheral lymphocytes, CD3, CD4, CD8 and B cells of all patients with influenza A virus (H1N1) infection decreased greatly in acute phase and quickly recovered in recovery phase; NK and NKT cells absolute counts of severe cases decreased significantly in acute phase, and the decreasing extent of which were more than 20%.

[Clinical and laboratory characteristics of a new influenza A (HIN1) epidemic].

Objective: To analysis the clinical and laboratory characteristics of Patients infected with new influenza A (HIN1) virus.

Methods: All cases with new influenza A (H1N1) confirmed on polymerase chain reaction assay on throat swabs. There were included in a prospective evaluation of clinical characteristics, laboratory results, treatment and overcome of new influenza A (H1N1).

Multicentre evaluation of the Elecsys hepatitis B surface antigen II assay for detection of HBsAg in comparison with other commercially available assays.

Screening for hepatitis B surface antigen (HBsAg) demands highly sensitive and specific immunoassays with the ability to detect clinically relevant surface gene mutants-the presence of which is an increasing concern and can compromise test results. The objective of the study was to compare the clinical and technical performance of the fully automated Elecsys HBsAg II assay with other widely used HBsAg immunoassays in China. This was a multicentre study in which eight Chinese laboratories compared the Elecsys HBsAg II assay with the Architect HBsAg assay, AxSYM HBsAg assay, or generic microtitre plate (MTP) enzyme-linked immunosorbent assays (manufactured in China) against preselected samples, including recombinant surface gene mutants, and routine clinical samples.

[Evaluation of the ELISA and the enhanced chemiluminescence immunoassay in use to determine the serum markers for liver fibrosis].

Objective: To evaluate the detection method of ELISA and Enhanced Chemiluminescence Immunoassay (ECLIA) in use to determine serum hyaluronate acid (HA), laminin (LN), type IV collagen (IV-C) and type III procollagen (PC III).

Methods: 253 patients with chronic hepatitis B were determined the four liver fibrosis serum markers with both the ECLIA and ELISA, and then compared with pathology results separately.

Results: Both the detection results of ELISA and ECLIA can reflect that the patient's liver fibrosis from hepatitis to liver cirrhosis aggravated gradually.