ABSTRACT
Objective To verify the analytical performance of Hitachi 7600-210automatic biochemical analyzer detection system.Methods The precision, accuracy, linearity and clinical reportable range, limit of quantitative detection and anti-interference capability were validated according to Clinical and Laboratory Standards Institute (CLSI) documents (EP15-A3and EP17-A2) and Clinical Laboratory Improvement Amendment 1988 (CLIA′88) standards.Results The within precisions of high and low two concentrations were both less than1/4CLIA′88TEa (laboratory permissible total error), the day precisions were less than 1/3CLIA′88TEa, the pass rates of three external quality assessments in 2017 were all not less than 80％and range from 0.02mmol/L to 401.80mmol/L.The clinical reportable was ranged from 0.02to 401.80mmol/L with a linear relationship.The LoB, LoD and LoQ of glucose (GLU) detection were 0.01 mmol/L, 0.03 mmol/L and 0.08mmol/L respectively.The anti-interference capability to hemoglobin (Hb), vitamin C (VitC), bilirubin (BIL) and triglyceride (TG) in the detection system to GLU measurement were in accordance with the manufacturer′s statement.Conclusion Performance verification of Hitachi 7600-210automatic biochemical analyzer detection system to GLU detection is consistent with the manufacturer statement also in accordance with CLIA′88standards, which can meet the expectant use of clinical test.
ABSTRACT
Objective To analyze the syphilis epidemic characteristics and trends of Yongchuan District during 2010? 2015 to provide a basis for formulating the prevention and control strategy of syphilis.Methods The data of syphilis cases reported in Yongchuan District of Chongqing City during 2010-2015 were arranged,checked anal statisticallyanalyzed.Results The incidence rate of syphilis showed a reverse U type change trend from rising to declining,latent syphilis accounted for the highest proportion,congenital syphilis cases were decreased year by year.The analysis results showed that the constituent ratio of latent syphilis and congenital syphilis had statistical difference between 2010-2013 and 2014-2015(P＜0.05);syphilis high prevalent area was concentrated at the city and town area,while prevalence rate was slower in rural area.Most of syphilis patients were concentrated in the age group of 25-45 years old.There was no difference between women and men;syphilis cases generally had lower educational level,majority concentrated at the population of junior high school or below;the occupations in the syphilis patients were concentrated at the entertainment personnel,followed by migrant workers.Conclusion The incidence rate of syphilis is changed from rising to smoothly and steady decreased.It is necessary to adopt the pertinent prevention and control measures for the high-risk population.
ABSTRACT
Objective To explore the reason of negative HBeAg result detected by ELISA in the specimen with both positive HBV DNA and positive PreS1 in order to provide objective analysis of HBV replication.Methods Senty-six sera with negative HBeAg,but positive PreS1 and HBVDNA were included in this study.(1) HBeAg was detected again by ELISA after the specimen was diluted at a ratio of 1:100.(2) HBeAg/IC was detected by solid ELISA using monoclonal antibody against HBeAg.(3) The gene mutation of Pre C region was detected by oligonucleotide hybridization.Results HBeAg was positive in 5 specimen which were detected in dilution of 1:100 and HBeAg/IC was detectable in 38 specimen.The gene mutation of Pre C region was found in 24 specimen.Conclusion Hook effect of post-zone,formation of HBeAg/IC and gene mutation of Pre C region were the main reasons of negative HBeAg result by ELISA in the specimen with positive HBV DNA.The specimen with positive HBV DNA and negative HBeAg were presented in the patients who were mostly infected by wild type of HBV.Formation of HBeAg/IC result in the undetectable HBeAg in serum by routine ELISA.