Comparison of three methods to detect antibody response to SARS-CoV-2 vaccine / 中华微生物学和免疫学杂志

Objective:To detect IgG and neutralizing antibodies response to SARS-CoV-2 vaccine by comparing enzyme-linked immunosorbent assay (ELISA), commercial magnetic particle chemiluminescence assay(CLIA) and neutralization test(NT).Methods:ELISA, CLIA and NT were used to detect 143 healthy people before and after 28 days immunization with 2 doses of SARS-CoV-2 vaccine, and calculate the positive conversion rate, quantitative results and analysis the consistency of the three methods.Results:The positive conversion rate of SARS-CoV-2 vaccine antibody detected by ELISA, CLIA and NT were respectively 97.9%, 98.6% and 85.3%. The geometric mean of the highest dilution of the serum quantitatively detected by ELISA was 586.6; The mean of CLIA S/CO value was 11.26; The geometric mean titer of the NT was 7.6. The correlation coefficient between ELISA, CLIA and NT were respectively 0.69( P<0.01) and 0.65( P<0.01), and the correlation coefficient between ELISA and CLIA was 0.79( P<0.01). Conclusions:The three methods all detected high levels of antibodies response to SARS-CoV-2 vaccine immunization. ELISA and CLIA are more consistent to detect IgG antibody, and have a good correlation with the quantitative detection results of the NT.

Analysis on diseases interfering treponema pallidum antibody detection by chemiluminescence / 国际检验医学杂志

Objective To explore the interference situation of several diseases in the detection of treponema pallidum antibody by chemiluminescence method.Methods One hundred and ten samples of 9 kinds of different infectious diseases and 200 clinical random samples were collected.Three hundreds and ten samples were simultaneously detected by using the Abbott ARCHITECT i2000 automatic chemiluminescence immunoassay analyzer and matched reagents,and the Roche E602 automatic chemiluminescence instrument and its matching reagent.The samples of inconsistent results were confirmed by the gelatin particle agglutination test (TPPA).Results There were 5 samples with inconsistent results detected by two instruments,5 samples confirmed by TPPA were negative,and 4 cases were the samples of multiple myelome.Conclusion (1)Abbott ARCHITECT i2000 and Roche E602 have a good consistency in detecting treponema pallidum antibody;(2)for the patients of multiple myeloma,the interference may exist in detecting treponema pallidum antibody by chemiluminescence method,which may cause false positive results and needs to be vigilant in our daily work.

Establishment of Detection Limit and Clinical Reportable Range for Detection of Anti-HBs by Chemiluminescence Method / 现代检验医学杂志

Objective To establish detection limit and clinical reportable range for detection of anti-HBs by chemiluminescence method and evaluate by clinical application.Methods Referring to the Clinical and Laboratory Standards Institute (CLSI) relevant documents,the programme of blank limit (LoB),detection limit (LoD),quantitative detection limit (LoQ),analytical range of measurement (AMR),clinical reportable range (CRR) for detection of anti-HBs by chemiluminescence method,were designed and measured.The established clinical reportable range and maximum dilution were used to predict the recovery stage of acute hepatitis B patients and to evaluate the effectiveness of different vaccines.Results LoB,LoD,LoQ,AMR and CRR for detection of anti-HBs by chemiluminescence method were 0.87,1.89,3.0,0～970.50 and 3.0 ～48 525 mIU/ml respectively,and the maximum dilution was 1 ∶ 50.The patient with acute hepatitis B showed elevated anti-HBs at fourth weeks after treatment (CRR).The anti-HBs mean was the highest in the B vaccine of the three vaccines.Conclusion The establishment of detection limit and clinical reportable range for detection of anti-HBs by chemiluminescence method was better meet the requirements of clinical laboratories,provide reliable results for clinical laboratories.

Evaluate Performance of the Self-made Quality Control Products for C Peptide by Mixed Serums / 现代检验医学杂志

Objective When detecting the blood C peptide by chemiluminescence method,used had confronted the lack of qual-ity control.This paper examines the feasibility of self-made C peptide quality control as indoor quality control products. Methods From the serum of diabetic patients and health examination,C peptide low values(concentration around the 1.20 ng/ml)and high value(concentration around the 12.0 ng/ml)were collected,excluding hemolysis,jaundice and tallow ser-um,preventing bacterial contamination,hepatitis B surface antigen,hepatitis C virus,human immunodeficiency virus indica-tors are negative;then these serum was mixed respectively,embalmed,packaged,-20 DEG preserved.The performance e-valuation of the C peptide mixed serum was carried out using SIEMENS’s C peptide reagent kit.Results Low value,high value of two levels of serum C peptide quality control in batch imprecision respectively were 4.46% and 4.15% respective-ly.Day not precision respectively were 6.00%,5.56%,-20 DEG saved stability for at least 6 months (P>0.05).Com-pared with six months by analysis of variance,F value of the low and high values were 0.665,0.602,P values were 0.471, 0.568 and the difference was not statistically significant (P>0.05),but the difference among bottles was no significant. Conclusion Two levels value of the C peptide in self-made preserved at -20 DEG can meet the requirements of internal quality control products.

Nucleic acid detection technology used in blood screening of blood donors / 国际检验医学杂志

Objective To evaluate the necessity and feasibility of nucleic acid test for donors blood screening .Methods From July 1 ,2011 to December 31 ,2014 ,a total of 170 316 blood samples which were negative in enzyme-linked immunosorbent assay (ELISA)and qualified in aianine aminotransferase detection ,were selected in this study stochastically .All the samples were detected hepatitis B virus(HBV) ,hepatitis C virus(HCV) ,human immunodeficiency virus(HIV) by nucleic acid amplification technology (NAT) .NAT positive samples were reconfirmed in National Center for Clinical Laboratories(NCCL) .Results A total of 160 cases of nucleic acid reactive samples were found out ,the total response rate was 0 .09% ,The response rate of Roche nucleic acid detec-tion system was 0 .10% ,response rate of David nucleic acid detection system was 0 .08% ,there was no significant difference be-tween the two methods(P>0 .05) .In 27 cases of specimens ,14 cases were confirmed as HBV DNA positive ,no HCV RNA and HIV RNA were detected ,the confirmed positive rate was 51 .85% .There were 2 samples detected by chemiluminescence HBsAg reactivity .Conclusion ELISA screening of blood donors has missing phenomenon ,nucleic acid detection method could be used as an effective supplement of the ELISA ,could improve the safety of blood for clinical use ,detection sensitivity is better than ELISA .

Methodological comparison on two kinds of method for detecting serum human epididymis protein 4 and bias evaluation / 国际检验医学杂志

Objective To compare the performance of 2 kinds of quantitative detection method the chemiluminescence immu-moassay and the enzyme-linked immunosorbent assay(ELISA)for detecting serum human epididymis geneproduct 4(HE4),and to explore the accuracy and practical value of the two methods.Methods In accordance to the document EP9-A2 of NCCLS,the Roche automatic electrochemical immunoassay system as the comparative method(X)and the ELISA as the testing method(Y )were per-formed according to the requirements of the detection kits.Results The serum HE4 level could be accurately reflected by the two methods.The correlation coefficient(r)in comparing these two kinds of method was ≥0.975,which showed that there was a high correlation between them.The detection results of the two methods were compared by paired sample t-test,and no statistically sig-nificant difference was found between them(P >0.05).Conclusion Because of CLIA′88 giving no specific medical decision level of HE4 and clinical acceptable level,therefore the expected bias of credibility interval can not be calculated or whether being clinically acceptable is unable to be judged.Based on the comparison of paired sample t test,these two kinds of detection methods can be used interchangeably to a certain extent.

A relação entre os níveis séricos de CA 125 e o grau de diferenciação em neoplasias ovarianas / The relationship between serum levels of CA 125 and the degree of differentiation in ovarian neoplasms

Introduction: Primary ovarian neoplasms exhibit a wide range of histopathological aspects, and tumors with epithelial differentiation are the most frequent. Among the malignant tumors, the most common histological type corresponds to serous adenocarcinoma, whose diagnosis is established in advanced stages of the disease in approximately 75% of the patients. Tumor marker CA 125 represents a glycoprotein synthesized mainly by neoplastic cells with epithelial differentiation, and its serum level seems to be associated with the biological potential of these lesions. Objective: To estimate the association between serum levels of CA 125 and the degree of differentiation in primary ovarian neoplasms. Method: Sixty distinct cases of primary ovarian tumors were selected, previously analyzed at the Laboratory of Pathology of the Hospital Complex of Universidade Luterana do Brasil (Ulbra), between 2005 and 2010, from patients undergoing concomitant analysis of CA 125. In each case, age, tumor size, histological type, degree of differentiation, presence of necrosis and tumor invasion of the albuginea or extraovarian tissues, pathological stage and serum CA 125 were determined. Results: A statistically significant relationship between CA 125 levels and histological grade (p = 0.001), age (p = 0.009), biological behavior of the tumor (malignant or benign - p = 0.002) and extraovarian invasion (p = 0.005) was found. No relationship between CA 125 levels and tumor size (p = 0.1006) and pathologic stage (p = 0.1) was determined. Histologic grade was associated with the presence of necrosis (p = 0.001), extraovarian invasion (p = 0.009) and tumor size (p = 0.008). Conclusion: In the present study, serum levels of CA 125 were associated with histological grade in primary ovarian neoplasms, especially in high-grade malignant tumors, suggesting that high levels of this glycoprotein are associated with lesions of more aggressive biological behavior...

Introdução: As neoplasias primárias de ovário apresentam uma ampla variação dos aspectos histomorfológicos; sendo os tumores com diferenciação epitelial os mais frequentes. Entre os tumores malignos, o tipo histológico mais comum é o adenocarcinoma seroso, cujo diagnóstico é determinado em estágios avançados de doença em aproximadamente 75% das pacientes. O marcador tumoral CA 125 corresponde a uma glicoproteína sintetizada pelas células neoplásicas com diferenciação epitelial principalmente, e seu nível sérico parece estar associado ao potencial biológico dessas lesões. Objetivo: Estimar a associação entre o nível sérico de CA 125 e o grau de diferenciação em neoplasias ovarianas primárias. Método: Foram selecionados 60 casos distintos de tumores ovarianos primários, previamente analisados entre 2005 e 2010, de pacientes submetidas à dosagem sérica concomitante do marcador CA 125. Em cada caso foram determinados tamanho tumoral, tipo histológico, grau de diferenciação, presença de necrose tumoral, invasão neoplásica da albugínea ou tecidos extraovarianos, estadiamento patológico e nível sérico de CA 125. Resultados: Foi encontrada uma relação estatisticamente significativa entre nível de CA 125 e grau histológico (p = 0,001), idade (p = 0,009), comportamento biológico da neoplasia (maligno ou benigno - p = 0,002) e invasão extraovariana (p = 0,005). Não foi observada relação do nível de CA 125 com o tamanho tumoral (p = 0,1006) e o estadiamento patológico (p = 0,1). O grau histológico esteve associado à presença de necrose (p = 0,001), invasão extraovariana (p = 0,009) e ao tamanho tumoral (p = 0,008).Conclusão: Os níveis séricos de CA 125 estiveram associados ao grau histológico em neoplasias primárias ovarianas, principalmente nos tumores malignos de alto grau, sugerindo que os níveis elevados dessa glicoproteína estejam associados a lesões de comportamento biológico mais agressivo...

Application of immunofluorescence measured troponin I / 国际检验医学杂志

Objective To explore the clinical application of determination of troponin I(cTnI) by enzyme linked fluorescent(EL-FA) method .Methods The concentration of cTnI in serum was detected by chemiluminescence immunoassay(CLIA) method and ELFA method .The precision test ,linear test ,recovery test and interference test were done on ELFA method .The correlation analy-sis was done on the results of cTnI detected by ELFA method and CLIA method .Results Determination of the concentration of cTnI by ELFA method ,the intraassay coefficient of variation(CV) of high(30 .00 μg/L cTnI) and low (0 .12 μg/L cTnI) values were 2 .81% and 1 .62% ,the interassay CV were 5 .67% and 3 .52% .Reliable detection range detection of ELFA method was 0 .00-30 .00 μg/L .When the total bilirubin concentration less than 450μmol/L ,hemoglobin concentration less than 1 .5 g/L ,three glycerol concentration less than 7 .0 mmol/L ,the ELFA method for the determination of cTnI was without interference .Determina-tion of the concentration of cTnI had a good correlation between ELFA method and CLIA method(r=0 .971) .Conclusion The EL-FA method has good precision ,recovery and linear range ,and has a good correlation with the CLIA method ,and the ELFA method is rapid and convenient ,suitable for the emergency inspection ,can satisfy the clinical requirements .

Investigation of in vitro antioxidant activity of ginkgo albumin by chemiluminescence method / 中草药

Objective To investigate the scavenging abilities of ginkgo albumin to reactive oxygen in vitro, as well as the protection and mechanism of ginkgo albumin on damaged DNA. Methods Lotus Seedpod Procyanidin (LSPC) and bovine serum albumin (BSA) were used as control sample, the effect of ginkgo albumin on removal of superoxide anion was determined by Pyrogallol-Luminol system. Scavenging ability of ginkgo albumin on hydroxide free radical was determined by CuSO4-Phen-Vc-H2O2, FeSO4-Luminol-H2O2, and FeSO4-Luminol systems. Luminol-H2O2 system was used to measure the scavenging effect on hydrogen peroxide. Preventive effect of ginkgo albumin on in vitro damaged DNA was determined by CuSO4-Phen-Vc-H2O2-DNA system. Results Ginkgo albumin possessed a good scavenging potency on reactive oxygen and protection on damaged DNA, but promoted oxidation in the FeSO4-Luminol-H2O2 and Luminol-H2O2 chemiluminescence systems. Conclusion Not every chemiluminescences system is suitable for investigating the antioxidant activity of ginkgo albumin.

DETERMINATION OF FLAVONOIDS IN HAWTHORN FRUITS AND THEIR ANTIOXIDATION EFFECT / 营养学报

Objective: To extract and determine the flavonoids of hawthorn fruits and their antioxidative effect. Method: The ultrasonic method was used for extracting flavonoids. The content of flavonoids was determined by spectrophotometry, and the antioxidation effect was determined by flow-injection chemiluminescence.. Results and Conclution: The recovery rate was 96%～105% and the coefficient of variation was 0.14 % by spectrophotometry. Hawthorn fruits had high antioxidative effect, showing dose-response relation.