Objective:This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV.Methods:Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020.Results:The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55); and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15); and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits.Conclusion:The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents.

The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020.The current edition was officially implemented on December 30,2020.The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines,which are the common re-quirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia.Owing to adherence to the principles of scientificity,versatility,operability,and sustainable development,there is an improvement in the general chapters of the 2020 edition over those of the previous editions.Further,the application of advanced and mature analytical techniques has expanded,the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened,and technical requirements are now better harmonized with international standards.The updated edition provides technical and methodological support to ensure safety,effectiveness,and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technolo-gies,improving the quality control of medicines,and strengthening the means of drug regulation in China.This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.

Objective:To develop an age-appropriate and disease-specific social adaptation measurement tool for adolescents infected with HIV in the context of Chinese culture, and to test its reliability and validity.Methods:Through literature review and consultation with 8 experts, this study constructed the conceptual framework of social adaptation of adolescents infected with HIV and formulated the dimensions and items of the scale. The convenient sampling method was adopted, and questionnaires were distributed online and offline at Beijing Ditan Hospital, Xuzhou Center for Disease Control and Prevention and Yunnan Provincial Infectious Disease Hospital from October 2020 to February 2021 for questionnaire validity testing. A preliminary age-specific and disease-adaptable Social Adaptation Scale for HIV Infected Adolescents was prepared using methods such as project analysis and reliability and validity testing.Results:The scale consisted of 3 dimensions of cognition, emotion and will, 5 variables, and a total of 23 items. The Cronbach's α coefficient of the scale was 0.856, and the split reliability was 0.836. The item-level content validity index ( I- CVI) of the scale was 0.750-1.000, the scale-level content validity index ( S- CVI) was 0.940, and the scale score and subjective well-being scale score were positivelycorrelated ( P<0.05) . Factor analysis extracted 5 common factors, and the cumulative explanatory variable was 61.156%. Conclusions:The scale has good reliability, validity and feasibility, which can be used as an evaluation tool for social adjustment of HIV-infected adolescents in China.

Objective To evaluate the clinical outcomes and prognosis of older human immunodeficiency virus (HIV )-infected patients under antiretroviral therapy (ART ) in China .Methods This study was carried out in a retrospective cohort of HIV-infected patients initiated ART between January 2004 and December 2012 at The First Affiliated Hospital ,China Medical University .The patients were enrolled and divided into two groups ,including <50 years group (young and middle-aged group) and≥50 years group (older group) .Immunological and virological responses and mortality were analyzed . Data were analyzed by t test ,chi-square test ,two-way analysis of variance and log-rank test .Results Totally 291 subjects were included ,among whom 97 subjects were older patients and 194 subjects were young and middle-aged patients .Male was predominate in both groups ,which accounted for 91 .8％ and 87 .6％ ,respectively .The CD4+ T lymphocyte count in the older group before treatment was (151 .9 ±96 .2) cells /μL ,which was significantly lower than that in the young and middle-aged group (183 .4 ± 93 . 5) cells/μL (t= 2 .657 , P=0 .009) .At month 12 of treatment ,the CD4+ T lymphocyte count in the older group was significantly lower than that in the young and middle-aged groups (t= 2 .120 , P=0 .035) ,while there was no statistically significant difference between the two groups at month 24 (t=1 .025 ,P=0 .299) .The percentage of CD4+ T lymphocyte count increasing to 500 cells/μL in the older and youth groups during follow-up were 11 .3％ and 16 .0％ ,respectively (χ2=1 .127 ,P =0 .376) .Log-rank analysis showed that the mean times of virus inhibition in older group and young and middle-aged group were 7 .9 (95％ CI:6 .8-8 .5) and 7 .6 (95％ CI:6 .5 -9 .3) ,respectively ,with no statistically significant difference (χ2 =0 .002 , P=0 .961) .Virological failure was reported in 4 patients (4 .1％ ) in older group and 11 patients (5 .7％ ) in young and middle-aged group . Chi-square test showed no statistically significant difference between the two groups (χ2 = 0 .15 , P= 0 .78) .During follow-up , 19 .6％ (19/97) in older group and 3 .6％ (7/194) in young and middle-aged group died .The former was significantly higher than the latter (χ2 = 21 .113 , P< 0 .01 ) .Conclusions Older patients show a poor immunologic response ,similar viral suppression and higher risk of mortality compared with young and middle-aged patients . Future research should be aimed at the feasible and specific strategy for early diagnosis and timely treatment for older patients to improve treatment efficacy and reduce mortality .

Objective To evaluate the detectability of HIV antigen-antibody in the window period of acute infection by three HIV antigen-antibody assays.Methods Twenty-two samples of HIV seroconversion serum panels and thirty-seven HIV acute infected plasm samples from our laboratory collected from cohort study of men who have sex with men between 2009 and 2011,were assayed by ECLIA,CLIA and ELISA methods.All assays were evaluated for the ability to detect HIV in the window period,and the sensitivity of each assay for acute samples was analyzed.Chi square test was used for statistical analysis.Results The ability of detecting HIV in the window period of each assay was different.For HIV seroconversion serum panels,the results of ECLIA and CLIA assays were consistent,and the window period was shortened at least 1 to 5 days compared with ELISA assay.For HIV acute samples,all were HIV positive by ECLIA or CLIA assay,but for ELISA assay,94.6％ was positive.For samples before seroconversion,ECLIA and CLIA assay had the same sensitivity (93.5％),which is superior to ELISA assay (71.0％) (x2 =5.14,P ＜0.05).Conclusion The ability of detecting HIV in the window period was different for each assay.The results of ECLIA and CLIA assay are consistent,superior to ELISA assay.

Objective To compare the performance of fourth generation HIV antigen/antibody combined detection reagents for HIV early infection samples,international HIV seroconversion panel samples and routine clinical screening samples.Methods Thirty seven early HIV infected samples from the followup gays in Shen Yang between 2009 and 2011,66 seroconversion panel samples from BBI company (U.S.A),NABI company(U.S.A) and NIBSC company(U.K) and 703 routine HIV screening samples in the first hospital of China medical university in October 2010 were collected.All kinds of samples were tested by three diagnostic reagents based on chemiluminescence assay (CLIA),electrochemiluminescence assay (ECLIA) and enzyme-linked immunosorbent assay (ELISA) respectively.The detection sensitivity and specificity of these assays were analyzed.Results For 59 early infected and seroconversion samples,the sensitivities of both ECLIA and CLIA reagent were 96.61％ (95％ CI 91.5％-100.0％),higher than that of the ELISA kit (95％ CI 75.0％-92.9％) (x2 =5.341,P ＜ 0.05),which is 83.93％ ; Comparison among the three reagents for different subtypes of the antibody seroconversion samples showed that ECLIA had the highest sensitivity while CLIA was the lowest ; Detection sensitivity of the three reagents for the P24 antigen is CLIA ＞ ECLIA ＞ ELISA; With detection of 703 clinical routine screening samples,the specificities of three reagents were 100％ (CLIA),99.86％ (ECLIA) and 99.71％ (ELISA) respectively.Conclusions For the sensitivity of the fourth HIV diagnostic reagents CLIA and ECLIA are better than ELISA.The former two reagents are more suitable for identifying earlier HIV infection in clinic.

Objective To evaluate the performance of the third generation ELISA and the fourth generation ELISA for HIV-1 diagnosis assays on acute and early HIV-1 infected samples.Methods Sixtyseven acute/early HIV-1 infected samples were collected from the follow-up gays with seroconversion in Shen Yang city and from clinical patients in the First Affiliated Hospital of China Medical University with incomplete HIV-1 specific bands in western blot between 2008 and 2010.Third generation ELISA,fourth generation ELISA,western blot and HIV-1 viral load detecting were used for detecting these samples.The sensitivity,consistency were compared between third generation ELISA and fourth generation ELISA to detect the seroconversion samples and the window periods were abserved.Chi square test was used for statistical analysis.Results In the 67 acute/early HIV-1 infected samples,56 were HIV positive and 11 were HIV negative by the third generation ELISA.The sensitivity of the third generation ELISA was 83.6％ (95％ CI:72.5％ -91.5％); 63 were HIV positive,1 was at gray zone and 3 were HIV negative by the fourth generation ELISA.The sensitivity of the fourth generation ELISA was 94.0％ (95％ CI:85.4％ -98.3％),higher than the third generation ELISA(x2 =16.1,P ＜0.01).The consistency of the third generation ELISA and the fourth generation ELISA was 86.6％ ( 95％ CI:76.0％ - 93.7％).The earliest third generation ELISA positive sample was the sample collected 16 days after HIV infection and the earliest fourth generation ELISA positive sample was the sample collected 9 days after HIV infection.There was significantly different on the window periods between the third generation ELISA and the fourth generation ELLSA Conclusion The fourth generation ELISA had a higher sensitivity and shorter window period on acute/early HIV infected samples than the third generation ELISA,which is more suitable for the HIV early infection screening on high risk populations.

ObjectiveTo screen mimetic HIV-1 neutralizing epitopes from plasma with high level neutralizing antibody,and to provide useful information for further study of the interaction between antigen and antibody.MethodsIn order to gain neutralizing antibody recognized mimotopes, we detected neutralizing antibodieslevelsof 11HIV-1infectedslowprogressorsbyPBMC-basedneutralization assays.High-titer HIV-neutralizing antibodies from plasma of SPs was used as the ligand for biopanning by phage-displayed random peptide library.Positive phage clones was evaluated by ELISA,sequenced,and analyzed for homology to HIV-1 env by local BLAST to deduce the neutralizing peptide.ResultsTwenty-two clones were obtained consistent with requirement through three rounds biopanning.After comparison analysis,twelve clones include C8 were obtained as mimotopes of neutralizing antibody,C40 located in gp41Ⅱ cluster with the highest titer by inhibition ratio may be as neutralizing epitope.Conclusion By the use of IgG antibodies from SPs to screen the phage random polypeptide library,one can acquire multiple phage mimetic peptides of HIV related antigen epitope.(Chin J Lab Med,2012,35:838-842 )

ObjectiveTo investigate the influence of Mycobacterium tuberculosis (MTB) co-infection and other factors on the HIV replication level in antiretroviral treatment na(i)ve patients.MethodsSix hundred TB patients and 465 HIV infectors were recruited between April 2010 and September 2010.TB coinfections were diagnosed in HIV infected cases with chest X-ray,checking TB in sputum with anti-acid staining and culture of the sputum,histopatholo diagnosis and clinical diagnosis.HIV infections were screened in TB patients with the 3rd generation ELISA antibody test.Sixty-one antiretroviral treatment na(i)ve HIV/TB co-infectors and 34 HIV infectors with CD4 T cell count below 350 cells/μl were included in this study.Information about the demography,epidemiology and results of clinical diagnostic tests of HIV and TB was collected through pathography and questionnaires from all participants.HIV viral load were detected with COBAS AmpliPrep/COBAS TaqMan(R) System of Roche Company.ResultsThe viral load of HIV/TB co-infectors was (5.05±0.93) lg copies/ml,while the viral load of HIV infectors was (5.06±0.76) lg copies/ml,after control of age,race,marital status,education,route of HIV infection,HIV clade and CD4 T cell count,there was no significant difference between the two groups (P=0.94).CRF01_AE HIV-1 infection was associated with higher HIV viral load compared with non CRF01_AE (OR=8.07,95％ CI 1.07-61.20,P=0.04).ConclusionNo obvious effect of MTB co-infection on HIV replication level of HIV infected cases with relatively low CD4 T cell count in Guangxi region,while the CRF01_AE HIV infected individuals showed higher viral load,we should raise concern on the monitoring and treatment on this population.

Objective To investigate the level of B7-H1 and its counter-receptor PD-1 expression in mDC and different subsets of T lymphocytes in HIV infected individuals in China and to analyze the correlation between the level of B7-H1/PD-1 and disease progression, and to demonstrate that PD-1/PD-L1-dependent inhibition is operating in HIV infected patients.Methods Percentage of B7-H1 and PD-1 expression in mDC, CD+4 T cells and CD+8 T cells from thirty-six untreated HIV infected patients and 20 health controls were selected and detected by flow-cytometry, its correlations with CD+4 T cell absolute counts and plasma viral loads were analyzed.Results The percentage of B7-H1 expression in mDC, CD+4 T cells and CD+8 T cells (mean 15.21, mean 20.63, mean 13.5)were higher than that of health controls (all P<0.05).The percentage of PD-1 expression in CD+4 T cells and CD+8 T cells (mean 17.91, mean 19.21)were higher than that of health controls (P<0.05, P<0.05). The level of B7-H1 and PD-1 expression were inversely correlated with CD+4 T-cell counts(mDC+B7-H1+:r=-0.647, P<0.01;CD+4B7-H1+:r=-0.489, P=0.002;CD+8B7-H1+:r=-0.372, P=0.026;CD+4PD-1+:r=-0.374, P=0.025;CD+8PD-1+:r=-0.455, P=0.005) and positively correlated with HIV viral load(mDC+B7-H1+:r=0.662, P<0.01;CD+4B7-H1+: r=0.426, P=0.01;CD+8B7-H1+:r=0.531, P=0.001;CD+4PD-1+:r=0.362, P=0.03;CD+8PD-1+:r=0.380, P=0.022).Conclusion The level of B7-H1 and PD-1 expression was associated with HIV disease progression, which provides a useful marker to define disease progression of HIV infection.