Evaluation of the performance of systems for whole blood C-reactive protein detection: a multi-center study / 中华检验医学杂志

Objective:To explore the performance of the commonly used whole blood C-reactive protein (CRP) detection systems and give related recommendation on the performance requirements of detection systems.Methods:A total of 7 540 venous blood samples from 26 maternal, child and children′s hospitals were collected to conduct this multi-center study on the analytical performance of 5 commonly used whole blood CRP detection systems from March to April in 2019. The blank check, carryover, repeatability, intermediate precision, linearity, sample stability, influence of hematocrit/triglyceride/bilirubin, comparison with SIEMENS specific protein analyzer and trueness were evaluated. The 5 systems included BC-5390CRP autohematology analyzer, AstepPLUS specific protein analyzer, Ottoman-1000 Automated Specific Protein POCT Workstation, i-CHROMA Immunofluorometer equipment Reader and Orion QuikRead go detecting instrument. The 5 systems were labeled as a, b, c, d and e randomly.Results:Within the 5 systems, all values of blank check were less than 1.00 mg/L, the carryovers were lower than 1.00%. The repeatability of different ranges of CRP concentrations including 3.00-10.00, 10.00-30.00 and>30.00 mg/L were less than 10.00%, 6.00% and 5.00%, respectively, and the intermediate precision was less than 10.00%. The linearity correlation coefficients of the 5 systems were all above 0.975, while the slope was within 0.950-1.050. Whole blood samples were stable within 72 hours both at room temperature (18-25 ℃) and refrigerated temperature (2-8 ℃). The CRP results were rarely influenced by high triglyceride or bilirubin, except for the immmunoturbidimetric test based on microparticles coated with anti-human CRP F(ab) 2 fragments. When triglyceride was less than 15.46 mmol/L, the deviation of CRP was less than 10.00%. When bilirubin was less than 345.47 μmol/L, the deviation of CRP was less than 10.00%. CRP was more susceptible to Hct on the systems without Hct correction. The deviation of CRP between different Hct dilution concentration and 40% dilution concentration can reach as high as 67.48%. The correlation coefficients ( r) of 5 systems were all more than 0.975 in the range of 0-300.00 mg/L compared with Siemens specific protein analyzer. All systems passed the trueness verification using the samples with specified values of 12.89 and 30.60 mg/L. Conclusion:The performance of 5 systems can basically meet the clinical needs, but it is suggested that the whole blood CRP detection system without automatic Hct correction should be modified manually.

Association between cord blood IgE and toddler atopic diseases / 中华检验医学杂志

Objective@#To investigate the correlation between cord blood IgE level and allergic diseases (atopic dermatitis, food allergy, wheezing and allergic rhinitis) in 36 months old children and explore the susceptibility factors of allergy.@*Methods@#A cohort study was designed and Cord blood was collected during delivery of 779 women with full term, and the IgE level of the sample was detected by chemiluminescence immunoassay in Department of Laboratory Medicine, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine between October 1, 2012 and May 31, 2014. 638 children were followed up at the age of 36 months. The incidence of atopic dermatitis, food allergy, wheezing and allergic rhinitis were investigated by questionnaire, and the relationship between cord blood IgE level and allergic diseases in children was analyzed by multiple logistic regression.@*Results@#A total of 638 pregnant women and children were included in this study. The age of pregnant women was (29.7±3.3) years, and the IgE level in cord blood ranged from 0.1 to 8.43 IU/mL.In caesarean women, higher cord blood IgE was associated with increased risk of allergic dermatitis, wheezing and allergic rhinitis in children, OR=1.87, P<0.01; OR=1.86, P=0.01; OR=1.28, P=0.01; OR=1.98, P=0.01.@*Conclusion@#During cesarean section, the elevated IgE level of umbilical cord blood is correlated with the incidence of allergic diseases in children.

Association between cord blood IgE and toddler atopic diseases / 中华检验医学杂志

Objective To investigate the correlation between cord blood IgE level and allergic diseases (atopic dermatitis, food allergy, wheezing and allergic rhinitis) in 36 months old children and explore the susceptibility factors of allergy. Methods A cohort study was designed and Cord blood was collected during delivery of 779 women with full term, and the IgE level of the sample was detected by chemiluminescence immunoassay in Department of Laboratory Medicine, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine between October 1, 2012 and May 31, 2014. 638 children were followed up at the age of 36 months. The incidence of atopic dermatitis, food allergy, wheezing and allergic rhinitis were investigated by questionnaire, and the relationship between cord blood IgE level and allergic diseases in children was analyzed by multiple logistic regression. Results A total of 638 pregnant women and children were included in this study. The age of pregnant women was (29.7± 3.3) years, and the IgE level in cord blood ranged from 0.1 to 8.43 IU/mL.In caesarean women, higher cord blood IgE was associated with increased risk of allergic dermatitis, wheezing and allergic rhinitis in children, OR=1.87, P<0.01;OR=1.86, P=0.01;OR=1.28, P=0.01;OR=1.98, P=0.01. Conclusion During cesarean section, the elevated IgE level of umbilical cord blood is correlated with the incidence of allergic diseases in children.

Clonal dissemination of fluconazole-resistant Candida albicans strains isolated from vulvovaginal candidiasis / 中国感染与化疗杂志

Objective To investigate the distribution and molecular epidemiology of Candida strains isolated from vulvovaginal candidiasis in Shanghai,and conduct molecular phylogenetic analysis of the strains.Methods Candida pathogens were collected from the patients with vulvovaginal candidiasis during the period from August 2015 to February 2016 in Obstetrics and Gynecology Hospital of Fudan University,Shanghai First Maternity and Infant Hospital,and Intemational Peace Matemity and Child Health Hospital.All the strains were identified and statistically analyzed.ATB FUNGUS 3 kit was used to determine the minimum inhibitory concentration of antifungal agents against these strains in vitro.Molecular typing was conducted using multilocus sequence typing (MLST) method.Phylogenetic analysis was carried out by eBURST and MEGA 6 software.Results Of the 2 185 strains of Candida,1 988 were identified as Candida albicans,149 Candida glabrata,20 Candida tropicalis and 28 other Candida species.Overall,6.5％ of the Candida albicans strains were resistant to fluconazole.Twenty-six diploid sequence types (DSTs) were identified among the 93 strains of Candida albicans analyzed,including 50 fluconazole-susceptible strains with sporadic genotypes,but 43 fluconazole-resistant strains clustered as one clonal complex (CC 69) on the same branch (MLST Clade 1) of phylogenetic tree.Conclusions Candida albicans was the main pathogen of vulvovaginal candidiasis in the three obstetrics & gynecology hospitals in Shanghai,which showed slightly higher resistance to fluconazole.It is necessary to monitor the spread of fluconazole-resistant Candida albicans in these hospitals,especially clonal dissemination of CC 69 clone.

The application value of sinogram affirmed iterative reconstruction (SAFIRE) algorithm in the coronary computed tomography angiography(CCTA) with the tri-low scheme of dual source CT / 中华放射医学与防护杂志

Objective To investigate the application value of sinogram affirmed iterative reconstruction (SAFIRE) algorithm in the coronary computed tomography angiography(CCTA) with tri-low scheme (low tube voltage,low dose contrast agent,low flow rate injection) of the dual-source CT.Methods Totally 120 patients with body mass index (BMI) of 18.6 to 24.9 kg/m 2,heart rate ＜ 65 b/min were selected continuously and the contrast agent iohexol (350 mgI/ml) was used.The patients were divided equally into two groups:FBP group,using 120 kV tube voltages,contrast media dose of 0.9 ml/kg,and injection rate of 5.0 ml/s to carry out prospective ECG-trigger scanning,and image reconstruction based on filtered back projection (FBP) algorithm;SAFIRE group,using 80 kV tube voltage,contrast media dosage 0.7 ml/kg,injection rate of 3.5 ml/s to carry out prospective ECG-trigger high-pitch scanning,and iterative reconstruction technique.CT values of enhanced images and noise of two groups of arterial lumen and left ventricular bottom muscle were measured,and the signal-to-noise ratio (SNR) and contrast to noise ratio (CNR) were calculated.The method of double blind was used to evaluate coronary artery in 4-point scale (1 =non-diagnostic).The average volume CT dose index (CTDIvol) and the dose length product (DLP) for each patient were recorded and the effective radiation doses were calculated.Results The difference in the CT values,image noise,SNR,CNR between the two groups was not statistically significantly(P ＞ 0.05).The effective dose in SAFIRE group was (0.39 ± 0.02) mSv significantly lower than that in FBP group of (4.99 ± 1.36) mSv (t =26.31,P＜0.01).Conclusions For the patients with body mass index (BMI) 18.6 to 24.9 kg/m2,HR ＜ 65 b/min,the application of prospective ECG-trigger high pitch tri-low scheme combined with the iterative reconstruction algorithm in dual-source CT coronary angiography,can obtain the qualified image with lower radiation dose.

Preparation and Identification of A Peptide Monoclonal Antibody Against Human Papillomavirus 1 8E6 / 现代检验医学杂志

Objective To prepare a peptide monoclonal antibody (McAb)against human papillomavirus 18E6 separately,and identify its specificity and pathogenicity.Metheds The advantage epitope peptide was designed and synthesized by ABCpred and Bcepred,and then used to immunize BALB/c mice after coupling with bovine serum albumin (BSA).And the McAb was prepared by hybridoma technique.HPV18E6 gene was amplified from cervical swab specimen containing HPV18 and insert-ed into expression vector pET-28a.The constructed recombinant plasmid was transformed to E.coli BL21(DE3)for expres-sion under induction of isopropyl thio-β-D-galactoside.The expressed protein was used to identified the McAb had been pre-pared.Results The hybridoma cell lines could constantly produce MAbs against HPV18E6 peptides.Sequencing proved that recombinant plasmid pET-28a-HPV18E6 was constructed correctly.Western blotting showed that the anti-HPV18E6 pep-tides antibody could specifically recognize HPV18E6.Conclusion A monoclonal antibody against the advantage epitope pep-tide of human papillomavirus 18E6 prepared could specifically recognize HPV18E6 specifically.

SMN1 gene deletion analysis using mid-trimester amniotic fluid cells by real-time PCR / 中华检验医学杂志

Objectives To investigate the prenatal diagnosis method of spinal muscular atrophy with amniotic fluid sample.Methods Totally 1 064 amniotic fluid samples from mid-trimester pregnant women were enrolled during January 2015 and January 2016 in 4 hospitals.Genetic analysis was performed for detecting potential contamination of maternal tissue by a genetic technique based on short tandem repeat ( STR) markers.Deletion of SMN1 gene was detected in 1 062 uncontaminated amniotic fluid samples by real-time PCR and multiplex ligation-dependent probe amplification ( MLPA) respectively.Results Two contaminated amniotic fluid samples were detected within 1 064 mid-trimester pregnant women by STR genotyping.The other 1 062 uncontaminated amniotic fluid samples were tested by real-time PCR.There were 37 samples with heterozygous deletion of Exon 7 of SMN1 gene ( 3.67%) , 34 samples with heterozygous deletion of Exon 8 of SMN1 gene (3.2%) and two samples with homozygous deletion of Exon 7 and Exon8 of SMN1 gene ( 0.19%) respectively , while other samples observed with no deletion of Exon 7 and Exon8 in SMN1 gene.Totally 41 samples with heterozygous or homozygous deletion of SMN 1 gene and 55 samples with undetected deletion of SMN 1 gene were confirmed by MLPA and the results showed 100%consistence with that of real-time PCR.Conclusions Both real-time PCR and MLPA are suitable for detecting the deletion of SMN 1 gene with amniotic fluid sample . Real-time PCR exhibits less sample requirement and time compared with MLPA .

Application of the ratio of urine albumin to creatinine (ACR) in the urine samples at different time points in monitoring the early renal injury in patients with type 2 diabetes / 实用医学杂志

Objective To investigate the application of using urine ACR at different time points instead of 24-hour urinary albumin (24 h UA) for screening of early renal injury in patients with type 2 diabetes. Methods The 24-h urine samples at different time pointsfrom 89 hospitalized patients were collected. The correlations of the ACR of urine samples at different time points were compared with the 24-h UA. When the 24-h UA was taken as the standard,the receiver operating characteristic (ROC) curves of urine ACR at different time points were established and analized. Results No significant differences in urine ACR between the morning urine group [ACR 9.02 (5.69~ 11.64)mg/mmol] and the random urine group [ACR 8.65 (5.80 ~ 11.83) mg/mmol] (P > 0.05). A positive correlation was observed between the morning urine ACR and the random urine ACR (r = 0.951,P < 0.01), however, the ACR of the morning and the random urine group were all positively correlated with the 24-h UA (r=0.886, 0.859, P<0.01). There were no significant differences in the sensitivities and the specificities between the morning and the random urine specimens in screening for albuminuria (92.6%vs 90.1%, and 87.5%vs 87.5%, respectively). When the 24-h UA was taken as the standard,the area under the ROC curves of the ACR in the random urine specimens and the morning urine specimens were 0.954 ± 0.022 and 0.960 ± 0.021 , respectively. There were no statistical differences between these two groups. Conclusions The morning urine and the random urine ACR , instead of the 24-h UA , could be used for both the early screening and monitoring of the renal injury , and the random urine ACR detection is simple ,convenient and accurate for patients.

Reformation and evaluation of an operating procedure for detecting syphilitic anticardiolipin reagin / 中华皮肤科杂志

Objective To estimate the application value of a standard operating procedure (SOP) in the detection of syphilitic anticardiolipin reagin. Methods Clinical laboratories from 9 local hospitals in Shanghai participated the program. Quality control samples with unknown target value were qualitatively and quantitatively examined according to the uniform SOP in these laboratories with the same reagent and facility of horizontal reaction. External quality assessment (EQA) was carried out by using seven serum samples with no, or low (1∶ 128 dilution) to high (1∶1 dilution) concentrations of target before and after the implementation of SOP. The test results were statistically analyzed and the reasons for the detecting error were assessed. Results A total of 388 tests were performed in the 9 clinical laboratories. The total accuracy rate was 93.0%, including 40.2% in the detection of samples with 1 ∶ 8 dilution of target, 49.2% in the detection of samples with 1 ∶ 16 dilution of target, and 3.6% in the detection of samples with 1 ∶ 32 dilution of target. No forward bias was observed in these tests. There was a significant difference in the accuracy rate between the two times of EQA before and after the implementation of SOP (x2 = 4.17, P < 0.05). Conclusions The improved standard procedure for nontreponemal antigen test is beneficial to the decrease of testing error, and may provide a basis for the establishment of SOP and implementation of internal quality assessment.

Clinical distribution and drug resistance analysis of AmpC β-lactamase and ESBLs producing Enterobacter cloacae / 国际检验医学杂志

Objective To investigate the status of AmpC β-lactamase and extended spectrum β-lactamases (ESBLs) production and drug-resistance characteristic of Enterobacter cloacae.Methods Enterobacter cloacae was isolated and cultured from variety of specimens from April 2005 to July 2007. VITEK32 automatic microbial analytical system was applied to performing identification of bacteria and susceptibility test. ESBLs were confirmed by NCCLS double disc assay, and three-dimensional test was used to detect AmpC.Results A total of 63 strains of Enterobacter cloacae were isolated, including 13(20.6%) single AmpC producing strains, 24(31.8%) single ESBLs producing strains, 6(9.5%) both AmpC and ESBLs producing strains, and 20(38.1%) neither AmpC nor ESBLs producing strains. The resistance of lactamases producing strains was significantly higher than that of lactamases non-producing ones. Especially in both AmpC and ESBLs producing strains, the drug resistance was serous.Conclusion The prevalence of AmpC β-lactamases and/or ESBLs producing strains is a higher level in Fuyang area. The drug resistance of AmpC β-lactamases producing Enterobacter cloacae isn′t identical to that of ESBLs producing one. Different categories of antibacterials should be chosen according to the different types of producing lactamases.

Modified antegrade colonic lavage for left obstructing colorectal carcinoma / 中国普通外科杂志

Objective To analyze the outcome of patients with acute obstruction of left colorectal cancer treated by modified antegrade colonic lavage with primary tumor resection and anastomosis.Methods From April 2002 to April 2007,112 patients with acute obstruction of left colorectal cancer underwent surgery.During the operation the left colon was exteriorized and placed into a sterilized plastic bag to protect the surgical field from contamination,then a catheter was inserted via the appendix,and after antegrade colonic lavage,primary resection and anastomosis was performed.Results Tumor resection and primary anastomosis was successfully done in the 112 cases.Postoperatively,1 case had anastomotic leak which healed after reoperation with proximal colostomy,and one patient died.Conclusions Modified antegrade colonic lavage is a simple procedure,the bowel can be rapidly decompressed with essentially no contamination,and has a high level of bowel cleansing.It is possible to safely perform primary resection and anastomosis for left colon cancer after the modified antegrade lavage.