A multicenter study assessing the efficacy of various preoperative/pre-transfusion screening methods for blood transmitted disease / 中华检验医学杂志

Objective:This multi-centre study was conducted to assess the efficacy of various preoperative/pre-transfusion screening methods for blood transmitted disease.Methods:From July 2021 to December 2021, plasma samples of patients admitted to 10 hospitals were collected for screening preoperative/pre-transfusion blood transmitted disease. Nucleic acid detection technology was used to detect hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA and human immunodeficiency virus (HIV)(1+2) RNA, and the results were compared with the immuno-serological methods. χ 2 test and Kappa test were used to analyze the efficacy of these two methods. Results:A total of 8 655 valid specimens were collected from 10 hospitals. There was a statistically significant difference in the positive detection rate of HCV between the two methods ( P<0.001). There was no significant difference in the positive detection rate of HBV and HIV assessed by the two methods ( P>0.05), but the number of positive cases detected by HBV DNA and HIV RNA (218 and 4 cases) was significantly higher than the corresponding serological results (216 and 2 cases). At the same time, there were HBV, HCV and HIV immuno-serological omissions by the immuno-serological methods, among which 28 cases were HBsAg negative and HBV DNA positive, 2 cases were HCV antibody negative and HCV RNA positive, and 2 cases were HIV antigen/antibody negative and HIV RNA positive. In addition, in the 66 samples with inconsistent results from the two detection methods, 83.3% (55/66), 68.2% (45/66), 63.6% (42/66) and 62.1% (41/66) of patients aged was>45 years, tumor, surgery and male, respectively. Conclusions:Compared with immuno-serological tests, nucleic acid tests have the advantage in terms of sensitivity on detecting HBV, HCV and HIV infection and could reduce missed detection. The risk of transmission can be reduced by adding HBV, HCV, and HIV nucleic acid tests to preoperative/pre-transfusion immuno-serological tests screening for patients over 45 years of age and tumor patients.

Evaluación de la prueba Aspergillus Galactomannan Ag VircliaR Monotest como alternativa a kit Platelia ™ Aspergillus EIA / Evaluation of the Aspergillus Galactomannan ag VircliaR Monotest test as an alternative to Platelia™ Aspergillus EIA kit

INTRODUCCIÓN: La prueba Aspergillus galactomannan Ag Virclia® (GM-VClia) es una técnica de galactomanano monotest, auto-matizada, basada en inmunoensayo quimioluminiscente (CLIA). OBJETIVO: Evaluar el desempeño del test de GM-VClia en muestras de suero y lavado bronquioalveolar (LBA) procesadas previamente con el kit Platelia™ Aspergillus EIA (GM-Plat). MATERIALES Y MÉTODOS: Se estudiaron 56 muestras de suero y 40 de LBA, correspondientes a un total de 59 pacientes (algunos con determinación de galactomamano en ambas muestras) con enfermedades pulmonares, hematológicas, LES, Covid-19 y tumores, entre otros. Trece pacientes tuvieron aspergilosis invasora (1 probada y 12 probables). RESULTADOS: La correlación entre ambos métodos para suero y LBA fue r = 0,8861 p < 0,0001 y r = 0,6368 p < 0,001, respectivamente. Hubo una concordancia global de 67,7% (65/96), siendo de 85,7% (48/56) en sueros y 42,5,0% (14/49) en LBA. Al subir el punto de corte en LBA por GM-VClia la concordancia aumentó a 85,7%. CONCLUSIONES: Se observó una mayor correlación y concordancia en sueros que en LBA. El kit GM-VClia presentó una mayor sensibilidad y valor predictor negativo (VPN), que el kit GM-Plat. Las desventajas de GM-VClia, la constituyen la categoría "dudoso", que dificulta la interpretación y que, con los puntos de corte actuales en LBA, la correlación con GM-Plat es menor. Las ventajas son su mayor sensibilidad, facilidad de procesamiento y una mayor rapidez en los resultados.

BACKGROUND: The Aspergillus Galactomannan Ag Virclia® (GMVClia) test is a monotest and automated galactomannan technique based on chemiluminescent immunoassay (CLIA). AIM: To evaluate the performance of the GM-VClia test in serum and bronchioalveolar lavage (BAL) samples previously processed with the Platelia ™ Aspergillus EIA kit (GM-Plat). METHODS: 56 samples of serum 40 from BAL (some of them with galactomaman determination in both samples), from patients with pulmonary diseases, hematological diseases, SLE, Covid-19 and tumors, among others, were studied. Thirteen patients had invasive aspergillosis (1 proven and 12 probable). RESULTS: The correlation between both methods for serum and BAL was r = 0.8861 p < 0.0001 and r = 0.6368 p < 0.001, respectively. There was a global concordance of 67.7% (65/96), being 85.7% (48/56) in sera and 42.5.0% (14/49) in BAL. By raising the cut-off point in LBA by GM-VClia, the agreement increased to 85.7%. CONCLUSION: A greater correlation and concordance was observed in sera than in BAL. The GM-VClia kit had a higher sensitivity and NPV than the GM-Plat kit. The disadvantages of GM-VClia are the "doubtful" category, which makes interpretation difficult and that with the current cut-off points in LBA the correlation with GM-Plat is lower. The advantages are its greater sensitivity, ease of processing and faster results.

Determinación de anticuerpos anti-dsDNA: evaluación del desempeño de un inmunoensayo quimioluminiscente y correlación con el método de inmunofluorescencia indirecta / Detection of anti-dsDNA antibodies: evaluation of performance of a chemiluminescent immunoassay and correlation to the indirect immunofluorescence assay / Determinação de anticorpos anti-dsDNA: avaliação do desempenho de um imunoensaio quimioluminiscente e correlação com o método de imunoflourescência indireta

Resumen La determinación de anticuerpos anti-dsDNA es de utilidad para el diagnóstico y seguimiento clínico de pacientes con lupus eritematoso sistémico (LES) y es uno de los criterios de clasificación del SLICC-2012. El objetivo del estudio fue verificar el desempeño del inmunoensayo quimioluminiscente (CLIA) QUANTA Flash dsDNA y compararlo con el método en uso de inmunofluorescencia indirecta en Crithidia luciliae (CLIFT). Se analizaron con ambos métodos 195 pacientes con diagnóstico de enfermedades del tejido conectivo y solicitud de anticuerpos anti-dsDNA. Se obtuvieron 38 sueros positivos, 133 negativos y 24 (12,3%) discordantes. Entre estos resultados discordantes, hubo 17 que correspondieron a pacientes con LES y se agruparon en 16 CLIA+/CLIFT- y 1 CLIA-/CLIFT+. Se verificó el desempeño para precisión siguiendo el protocolo EP15-A2 y la linealidad. Se estudió la concordancia mediante el coeficiente Kappa y la correlación con el coeficiente Rho de Spearman. Se observó mayor sensibilidad diagnóstica para CLIA. El grado de acuerdo fue moderado y se obtuvo buena correlación entre los valores cuantitativos de CLIA y los títulos de CLIFT. De acuerdo al buen desempeño encontrado y a los resultados discordantes analizados, la mejor estrategia para la implementación de CLIA sería utilizarla en combinación con CLIFT, lo que aumentaría la sensibilidad diagnóstica sin perder especificidad.

Abstract The detection of anti-dsDNA antibodies is useful for diagnosis and clinical monitoring of patients with systemic lupus erythematosus (SLE) and it is part of the classification criteria according to SLICC 2012. The purpose of this study was to verify the performance of the chemiluminescent immunoassay (CLIA) QUANTA Flash dsDNA and to compare it with the method currently in use, i.e the indirect immunofluorescence in Crithidia luciliae (CLIFT). One hundred and ninety five patients, who presented connective tissue diseases and required the study of anti-dsDNA antibodies, were analyzed. Thirty eight positive serum samples were obtained, 133 were negative and 24 (12.3%) in disagreement. Within the discordant results, there were 17 that corresponded to patients with SLE and they were grouped in 16 CLIA+/CLIFT- and 1 CLIA-/CLIFT+. The accuracy performance was assessed according to the EP15-A2 protocol and linearity. Concordance and correlation were calculated with the Kappa and Spearman's Rho coefficient, respectively. Based on the good performance observed and the discordant results analyzed, the best strategy for CLIA implementation would be to combine it with CLIFT, which would increase the diagnostic sensitivity without losing specificity.

Resumo A determinação dos anticorpos anti-dsDNA é de utilidade para o diagnóstico e seguimento clinico de pacientes com lúpus eritematoso sistêmico (LES) e é um dos critérios de classificação do SLICC 2012. O objetivo do estudo foi verificar o desempenho do imunoensaio quimioluminescente (CLIA) QUANTA Flash dsDNA e compará-lo com o método em uso imunofluorescência indireta em Crithidia luciliae (CLIFT). Foram analisados com os dois métodos, 195 pacientes com diagnóstico de doenças do tecido conjuntivo e solicitude de anticorpos anti-dsDNA. Os resultados foram agrupados em 38 soros positivos, 133 negativos e 24 (12,3%) discordantes. Entre esses resultados discordantes, 17 corresponderam a pacientes com LES e se agruparam em 16 CLIA+/CLIFT- e 1 CLIA-/CLIFT+. Foi verificado o desempenho para precisão seguindo o protocolo EP15-A2 e a linearidade. Foi estudada a concordância mediante o coeficiente Kappa e correlação com o coeficiente Rho de Spearman. Observou-se maior sensibilidade diagnóstica para CLIA. O grau de acordo foi moderado e boa correlação foi observada entre os valores quantitativos de CLIA e os títulos de CLIFT. Com base no bom desempenho encontrado e nos resultados discordantes analisados, a melhor estratégia para implementar o CLIA seria utilizá-lo em combinação com o CLIFT, o que aumentaria a sensibilidade do diagnóstico sem perder a especificidade.

Analysis of syphilis antibody results in pregnant women and newborns detected by automatic chemiluminescent immunoassay / 中华检验医学杂志

Objective:To examine the distribution of syphilis antibody in pregnant women and newborns and to explore how to optimize the existing syphilis screening process by setting the diagnostic gray area.Methods:The results of syphilis testing obtained from 119 531 pregnant women and 21 275 newborns from 2015 to 2018 by automatic chemiluminescent immunoassay (CLIA) and the re-examination results determined by Treponema pallidum particle agglutination (TPPA) and the rapid plasma reagin test (RPR) were retrospective analyzed. Data analysis was performed by Chi-square, Fisher′s exact test and Chi-square test for trend. Results:The positive rates of Syphilis specific antibody (TPAb) in clinical specimens from pregnant women and newborns were 0.69% (825/119 531) and 1.24%(264/21 275). The total re-examination positive rates were 0.32% (380/119 531) and 0.90%(191/21 275), and the suspicious syphilis prevalence rates in these specimens were 0.13% (161/119 531) and 0.31%(67/21 275), respectively. The suspicious syphilis prevalence rates in specimens of pregnant women from 2015 to 2018 and newborns increased year by year (χ 2=9.860, P=0.002; χ 2=5.311, P=0.021). With the elevation of the optical density value of samples to cut-off ratio (S/CO) value, positive coincidence rate of TPPA and TPAb in pregnant women and newborns increased significantly (χ 2=614.833, P<0.001; P<0.001). When the S/CO value in newborns exceeded 7.00 or the S/CO value in pregnant women exceeded 15.00, the effectiveness of TPAb results is equivalent to TPPA. The prevalence of suspected syphilis in pregnant women and newborns also increased with the increase of S/CO value (χ 2=323.059, P<0.001; P<0.001). When the S/CO value in newborns bellowed 3.00 or the S/CO value in pregnant women bellowed 5.00, the prevalence rate of suspected syphilis was 0%, which could preliminarily exclude syphilis infection. Conclusions:The prevalence rates of suspected syphilis in pregnant women was increasing during the recent years. It is necessary to further strengthen syphilis screening and intervention treatment in early pregnancy to improve the rate of eugenics. Being a primary screening method for syphilis in pregnant women and newborns, CLIA has high false positive rate. According to the gray area established in this study, the syphilis screening process can be optimized to prevent missed detection, which may reduce the false positive rate and avoid clinical misdiagnosis.

Niveles de vitamina D en pacientes asistidos en Centros de Salud Pública de la provincia de La Pampa (Argentina)

RESUMEN El objetivo fue evaluar el estatus de vitamina D (VD) en relación con la estación del año en pacientes asistidos en Centros de Salud Pública de la provincia de La Pampa mediante un estudio retrospectivo al período 01/01/17-31/12/17. Se determinó la concentración de VD por Quimioluminiscencia en 1333 pacientes, (1148 mujeres y 185 hombres) entre 18-94 años de edad. Se clasificó la concentración de VD en Deficiencia (<20 ng/ml); Insuficiencia (20-29 ng/ml) y Suficiencia (>30 ng/ml) de acuerdo a los criterios de Endocrine Society y guías de FASEN) y se lo relacionó con estación del año, género, edad y Zona Sanitaria. Se empleó un programa estadístico InfoStat versión 2017 considerando relación estadística significativa p<0.05. El 79% de los pedidos provinieron de Centros de Atención Primaria de la Salud y 21% de especialistas. Del 43.8 a 62.5% del género femenino y 36 a 63.6% del Masculino presentaban Deficiencia de VD en las Zonas Sanitarias. Se encontró diferencia significativa en la concentración de VD entre las estaciones climáticas (ANOVA Masculino FC: 9.80; Femenino FC: 31.81, ambos p<0.0001). Se observó menor concentración de VD en ambos géneros en invierno-primavera (43.8 a 62.5 % de las mujeres y 36 a 63.6% de los hombres). No hubo diferencia significativa en la Deficiencia de VD entre grupos de edad y género. Se encontró que un mayor número de pacientes del género femenino menores de 65 años tenían valores menores de 20 ng/ml de VD en invierno y primavera (p< 0.01). No hubo diferencia significativa en las de mayor edad. El médico de atención primaria es el principal prescriptor de VD en centros Asistenciales de Salud Pública de la provincia. Es necesario determinar los criterios de solicitud para disminuir el elevado retesteo debido al impacto socioeconómico que genera al sistema público.

ABSTRACT We set out to evalúate the state ofVitamin D (VD) in our context (La Pampa, Argentina) to determine the link between its deficit and the season of the year. A Retrospective study corresponding to the period of 01/01/17 to 12/31/17 was developed. The concentration of VD by Chemiluminescent Immunoassay was determined in the Central Laboratory of the Dr. Lucio Molas Hospital, Santa Rosa, La Pampa, Argentina in 1333 patients (1148 female and 185 male) between 18-94 years old. The vitamin D value was classified as deficiency less than 20 ng/ml, insufficiency between 20 and 29 ng/ml and Sufficiency >30 ng/ml (Endocrinology Society of the USA. Variables studied: gender, age, place of residence, medical speciality/Service or Primary Health Care Centers that requested VD's dosing; date of the year in which it was made. We used a program called InfoStat version 2017 considering a statistically significant relationship at p <0.05. The 79% of the orders came from Health Primary Attention Centers and 21% where from specialists. 43.8% to 62.5% women and 36% to 63.6% men had Vitamin D deficiency. There was no statistically difference in Vitamin D between groups of age and gender. Differences between seasons were found (ANOVA Male FC: 9.80; Female FC: 31.81, p<0.0001). There was a less concentration of Vitamin D in both genders in Winter-Spring. We found that 37% to 60% of male and female had defficiency of VD in Winter-Spring. Primary Health Care Physician is the main prescriptor of VD in Public Health Care Centers of La Pampa. It is necessary to determine the criteria to request. Vitamin D, to diminish the high socio-economic impact that carries to the Public Health System.

Comparison of the ratio of plasma aldosterone to renin concentrationmeasured by two chemiluminescent immunoassays in screening for primary aldosteronism / 中华内分泌外科杂志

Objective@#To compare the detection efficiency of the ratio of plasma aldosterone concentration to renin concentration (ARR) measured by imported and domestic chemiluminescent immunoassay kits for screening primary aldosteronism (PA) .@*Methods@#A total of 164 patients with essential hypertension and 64 patients with PA were recruited in this study. Plasma aldosterone concentration (PAC) and renin concentration (PRC) were measured concurrently by imported chemiluminescent immunoassay kit (Diasorin, Italy) and domestic kit (Mindray, Shenzhen, China) , and then ARR were calculated. A ROC curve analysis was performed to compare the screening efficacy of the two kits and the optimal ARR cut-offs for PA screening were recommended according to Youden’s index.@*Results@#The areas under the ROC curves (AUCROC) of ARR were 0.937 (95% CI 0.897-0.965, P<0.0001) detected by imported kit and 0.942 (95% CI 0.903-0.968, P<0.0001) detected by domestic kit. The difference of AUCROC of ARR detected by two kits was 0.00457 (95% CI -0.0210-0.0302, P<0.7263) .The highest Youden’s indexes of ARR were 0.749 (detected by imported kit) with the cut-off value of 12.8 (pg/ml) / (μIU/ml) (sensitivity 96.87%, specificity 78.05%) and 0.756 (detected by domestic kit) with the cut-off value of 12.5 (pg/ml) / (μIU/ml) (sensitivity 89.06%, specificity 86.59%) .@*Conclusions@#There was no significant difference between domestic and imported chemiluminescent immunoassays in the screening efficiency of ARR for PA.

Comparison of the ratio of plasma aldosterone to renin concentrationmeasured by two chemiluminescent immunoassays in screening for primary aldosteronism / 中华内分泌外科杂志

Objective To compare the detection efficiency of the ratio of plasma aldosterone concentra-tion to renin concentration (ARR) measured by imported and domestic chemiluminescent immunoassay kits for screening primary aldosteronism (PA). Methods A total of 164 patients with essential hypertension and 64 pa-tients with PA were recruited in this study. Plasma aldosterone concentration (PAC) and renin concentration (PRC) were measured concurrently by imported chemiluminescent immunoassay kit(Diasorin, Italy) and domestic kit (Mindray, Shenzhen, China), and then ARR were calculated. A ROC curve analysis was performed to compare the screening efficacy of the two kits and the optimal ARR cut-offs for PA screening were recommended according to Youden's index. Results The areas under the ROC curves (AUCROC) of ARR were 0.937 (95％ CI 0.897-0.965, P<0.0001) detected by imported kit and 0.942 (95％ CI 0.903-0.968, P<0.0001) detected by domestic kit. The difference of AUCROC of ARR detected by two kits was 0.00457 (95％ CI -0.0210-0.0302, P<0.7263).The highest Youden's indexes of ARR were 0.749 (detected by imported kit) with the cut-off value of 12.8(pg/ml)/(μIU/ml)(sensitivity 96.87％, specificity 78.05％) and 0.756 (detected by domestic kit) with the cut-off value of 12.5 (pg/ml)/(μIU/ml)(sensitivity 89.06％, specificity 86.59％). Conclusions There was no significant difference between domestic and imported chemiluminescent immunoassays in the screening efficiency of ARR for PA.

The Role of the Signal-to-Cutoff Ratio in Automated Anti-HCV Chemiluminescent Immunoassays by Referring to the Nucleic Acid Amplification Test and the Recombinant Immunoblot Assay

BACKGROUND: Following discontinuation of the recombinant immunoblot assay (RIBA), the only available supplementary test for the detection of hepatitis C virus (HCV) is the nucleic acid amplification test (NAAT). However, the NAAT does not adequately detect past HCV. Consequently, it is hard to distinguish between past HCV infection and biological false positivity with an anti-HCV result alone. We assessed the diagnostic performance of two immunoassays: the ARCHITECT anti-HCV chemiluminescent microparticle immunoassay (CMIA; Abbott Diagnostics, Wiesbaden, Germany) and the Access HCV Ab PLUS chemiluminescent immunoassay (CIA; Bio-Rad, Marnes-la-Coquette, France). We also explored an optimized algorithm to determine the anti-HCV results. METHODS: We tested 126,919 patients and 44,556 individuals who underwent a medical checkup. RIBA and NAAT were conducted for samples that tested anti-HCV-positive using CMIA and CIA. We assessed the optimal signal-to-cutoff (S/CO) ratio in HCV-positive samples. RESULTS: In total, 1,035 blood samples tested anti-HCV-positive. Of these, RIBA was positive in 512, indeterminate in 160, and negative in 363 samples. One hundred sixty-five samples were NAAT-positive. Diagnostic sensitivity and positive predictive value (PPV) were 96.7% and 52.1%, respectively, for CMIA, and 94.7% and 72.3%, respectively, for CIA. The optimal S/CO ratio was 5.2 for CMIA and 2.6 for CIA at 95% PPV. In total, 286 samples tested positive in CMIA and 444 in CIA, while 443 samples tested positive in both assays. CONCLUSIONS: It is hard to determine anti-HCV positivity based on the S/CO ratio alone. However, this study elucidated the role of the S/CO ratio by using the NAAT and RIBA.

Preparation of polyclonal antibody and establishment of chemiluminescence immunoassay for aldosterone / 中国免疫学杂志

Objective:The polyclonal antibody of aldosterone (ALD) for immunoassay was developed.And a chemiluminescence immunoassay (CLIA) for the determination of ALD in human blood was established.Methods:Aldosterone oxime was prepared by chemical modification and then conjugated with BSA to prepare immunogen.Rabbit anti ALD polyclonal antibody was prepared by immunizing rabbits with the ALD-BSA.The CLIA of ALD was performed using biotin streptavidin amplification system and competition method.Results:After identification,rabbit No.3 received the highest sensitivity to ALD antibody,and the 50％ binding inhibition (IC50) value for ALD concentration was 268 pg/ml.The measuring range of CLIA method using the antibody was 62.5-2 000 pg/ml.The assay sensitivity was 23.7 pg/ml.The intra-and inter-assay coefficients of variation were 6.9％-9.5％ and 8.5％-12.7％,respectively.Analytical recovery rate was in the range of 93.1％-104.1％.The correlation coefficient between measured and expected values were 0.996 after serial dilution.Compared with radioimmunoassay kit,the correlative equation was y =0.932x+4.596,the correlation coefficient was 0.948 (n =95).Conclusion:The result of methodological identification shows that it was in line with the basic requirements of clinical application.

Investigation and Analysis of Hepatitis C Screened by Chemiluminescent Immu-noassay / 现代检验医学杂志

Objective The purpose of this study is to explore the applicability of chemiluminescent immunoassay in screening hepatitis C infection,and to find the infection status of heptitis C virus in Ningxia,and to provide scientific basis for its pre vention and control.Methods A total of 209 889 hepatitis C antibody (anti-HCV) data detected by chemiluminescent immu noassay (CIA) were collected from the General Hospital of Ningxia Medical University during 2011～2015.According to the 《Laboratory Hepatitis C Antibody Detection and Results Report Guide of 2003 CDC》of the United States,Cases were divid ed into weak positive (0.9≤S/CO value≤8.0) and positive (S/CO value＞8.0) two groups.According to the clinical diag nostic criteria of 《 Hepatitis C Prevention Guide》 of 2015 version to complete the diagnosis of acute and chronic hepatitis C.The chi square test and curve estimation of regression analysis was used to analyze the diagnosis rate of hepatitis C and the distribution characteristics of the patients with hepatitis C.Results In the S/CO value＞8.0 group,the diagnosis rate of hepatitis C was 97.57％.In the 0.9≤S/CO value≤8.0 group,the diagnosis rate of hepatitis C was only 2.05％.Among the people infected with HCV,there was no significant difference between male and female (x2 =1.432,P＞0.05).The infection rate was high in the individuals of ages between 21～60 years old,the infection rate of children and the elderly was low (x2 254.901,P＜0.01),almost all Departments of the hospital were distributed.The majority of false positive groups were elderly,children,pregnant women and tumor patients.The main departments were obstetrics,oncology,pediatrics and oral and maxillofacial surgery.Conclusion The method of Chemiluminescent immunoassay to detect anti-HCV is suitable for clinical screening of hepatitis C.but it is necessary to pay attention to the treatment of false positives.It is necessary to improve the detection of hepatitis C in the population with high prevalence in Ningxia,and pay attention to the prevention and treatment of nosoco-mial infection,and constantly improve the screening and monitoring system for hepatitis C.

The comparison of different immunoassays for the detection on autoantibodies specific to primary biliary cholangitis / 中华检验医学杂志

Objective To compare the test performance of different immunoassays for the detection on autoantibodies specific to primary biliary cholangitis,including anti-mitochondrial type 2 antibody(AMA-M2),anti-glycoprotein 210(anti-gp210)and anti-nuclear body protein sp100(anti-sp100).Methods Serum samples from Primary Biliary Cholangitis(PBC, n=91), liver disease control(including viral hepatitis,autoimmune hepatitis and liver cirrhosis,n=67)and healthy individual(n=40)were collected from Beijing Youan Hospital during the period between April 2014 and April 2017.All samples were tested with chemiluminescent immunoassay(CLIA)and enzyme linked immunosorbent assay(ELISA)for AMA-M2, meanwhile the detection on anti-gp210 and anti-sp100 were compared between CLIA and Line Immunoassay(LIA).The Kappa coefficient were used to measure the level of qualitative agreement between different assays.The diagnostic accuracy of AMA-M2 detected with CLIA and ELISA were compared by receiver operating characteristic curve(ROC).Results The overall qualitative agreement between CLIA and ELISA for the detection to AMA-M2 is 88.4%(Kappa =0.765, P<0.01).Excellent qualitative agreement between CLIA and LIA for the detection to anti-gp210 and anti-sp100 was also found with overall agreement as 96.5%(Kappa=0.852,P<0.01)and 98%(Kappa=0.884,P<0.01), respectively.The ROC analysis also showed similar area under the curve(AUC)for CLIA(0.965, P<0.01)and ELISA (0.928,P<0.01)on detection to AMA-M2.Conclusions CLIA and ELISA showed excellent agreement for the detection to AMA-M2.High qualitative agreement between CLIA and LIA was also found when testing anti-gp210 and anti-sp100.

Comparison of results of two immunoassays for detection of hepatitis B surface antigen in pregnant women / 中华流行病学杂志

Objective To evaluate and compare the detection consistency of hepatitis B surface antigen (HBsAg) by two immunoassays: enzyme-linked immunosorbent assay (ELISA) and electrochemiluminescent immunoassay (ECLIA). Methods A prospective study was conducted among 2296 pregnant women recruited consecutively from January 1, 2014 to January 31, 2015 in a hospital. Blood samples were collected from them for the detection of HBsAg by using ELISA and ECLIA, Ka ppa test was performed on the results. Nested polymerase chain reaction and sequencing of HBV S gene were also performed in all samples. Phylogenetic analysis was performed using Mega 6.0 software. Results The two methods had high detection consistence of HBsAg ( Ka ppa=0.71). There were significant differences in detection result of B genotype and adw2 serotype HBV strains between two methods. Among 123 identified HBV strains, 113 belonged to genotype B and available for further analysis. The difference in detection of substitution rates between two methods or different positive groups were not significant. Compared with ELISA single positive group, the ECLIA single positive group had completely different substitution sites. Conclusion The two methods had high detection consistence of HBsAg, but there were still 32.4% HBV DNA positive cases in ELISA/ECLIA single positive group, and complete complementary substitution sites between ELISA single positive group and ECLIA single positive group. Our results suggested that more effective detection procedure should be considered for the possible impact of the HBV silent transmission and infection.

Comparison of results of two immunoassays for detection of hepatitis B surface antigen in pregnant women / 中华流行病学杂志

Objective To evaluate and compare the detection consistency of hepatitis B surface antigen (HBsAg) by two immunoassays: enzyme-linked immunosorbent assay (ELISA) and electrochemiluminescent immunoassay (ECLIA). Methods A prospective study was conducted among 2296 pregnant women recruited consecutively from January 1, 2014 to January 31, 2015 in a hospital. Blood samples were collected from them for the detection of HBsAg by using ELISA and ECLIA, Ka ppa test was performed on the results. Nested polymerase chain reaction and sequencing of HBV S gene were also performed in all samples. Phylogenetic analysis was performed using Mega 6.0 software. Results The two methods had high detection consistence of HBsAg ( Ka ppa=0.71). There were significant differences in detection result of B genotype and adw2 serotype HBV strains between two methods. Among 123 identified HBV strains, 113 belonged to genotype B and available for further analysis. The difference in detection of substitution rates between two methods or different positive groups were not significant. Compared with ELISA single positive group, the ECLIA single positive group had completely different substitution sites. Conclusion The two methods had high detection consistence of HBsAg, but there were still 32.4% HBV DNA positive cases in ELISA/ECLIA single positive group, and complete complementary substitution sites between ELISA single positive group and ECLIA single positive group. Our results suggested that more effective detection procedure should be considered for the possible impact of the HBV silent transmission and infection.

Performance evaluation of Mindray TSH assay on CL2000i system-pre-requisite for IFCC standardization and harmonization of thyroid function tests / 国际检验医学杂志

Objective To evaluate the performance of Mindray TSH chemiluminescence immunoassay ,including imprecision , limit of detection ,functional sensitivity ,interference ,cross-reaction ,and calibration consistency .The purpose was to confirm Mind-ray TSH assay meets the criteria of IFCC standardization and harmonization of thyroid functional tests .Methods The CLSI guide-lines defined in EP documents have been followed to measure the limit of detection ,functional sensitivity ,specificity ,imprecision and calibration consistency of Mindray TSH immunoassay on CL2000i system .Results Limit of detection was 0 .001 5 μIU/mL ,func-tional sensitivity was 0 .013 μIU/mL ,the correlation coefficient of linearity was 0 .999 in the range of 0-98 .95 μIU/mL .Mindray TSH calibrator C0 spiked with luteinizing hormone (LH) up to 500 mIU/mL ,follicle stimulating hormone (FSH) up to 500 mIU/mL ,or human chorionic gonadotropin (HCG) up to 200 000 mIU/mL detected no cross reactivity (detected TSH was less than 0 .2μIU/mL) .Hemoglobin up to 500 mg/dL ,bilirubin up to 10 mg/dL ,triglycerides up to 1 800 mg/dL ,and protein up to 10 g/dL showed -6 .91% ~8 .60% bias in TSH measurement .The total imprecision of two controls (high and low levels) and three serum specimens were in the range of 3 .24% and 5 .34% .Calibration consistency which had been demonstrated with high and low controls were measured between -6 .58% and 5 .26% .Conclusion The performance of Mindray thyroid-stimulating hormone assay meets the criteria for IFCC standardization and harmonization of thyroid function tests .

Serial research of traceability and harmonization of thyroid-stimulating hormone detection approved by IFCC / 国际检验医学杂志

Objective To implement the harmonization of thyroid-stimulating hormone(TSH) of Mindray assay system by par-ticipating in harmonization research program of International Federation of Clinical Chemistry (IFCC)-Standardization of Thyroid Function Tests(C-STFT ) .Methods A total of three combinations of TSH reagents and calibrators were used to measure 20 serum samples of healthy human .Within-run precision and batch-to-batch variation were assessed .The concept of harmonization was dem-onstrated by comparing our test results with All Procedure Trimmed Mean (APTM ) provided by IFCC and recalibrating with Mater Calibrators .Results The within-run precision was 1 .96% ,batch-to-batch variation was 0 .47% - 1 .15% ,depending on the level of TSH analyte .There existed a positive bias compared to APTM values .After recalibration with Mater Calibrators and Passing &Bablok regression ,the slope of method comparison was 1 .0 ,and correlation coefficient was more than 0 .975 .Conclusion By using a panel of real human specimen and recalibration based on APTM ,the test results of Mindray assay system could be harmonized with mainstream manufacturers globally .

Chemiluminescent immunoassay method for determination of cathelicidin-BF in rat serum / 国际药学研究杂志

Objective To establish a chemiluminescent immunoassay method for the determination of cathelicidin-BF (BF-30) in rat serum, to provide a fast and simple analytical method for its pharmacokinetic studies, then to investigate the pharmacokinetic characteristics of BF-30 in vivo. Methods A chemiluminescent immunoassay method was developed and the matrix effect, precision, accuracy, stability and the dilution effect were evaluated, then the method was used to determine the concentration of BF-30 in rat serum. Results The linear range of BF-30 in rat serum was 0.5-40 ng/ml, and the lowest limit of determination was 0.5 ng/ml. No matrix effect was observed. The RSD of inter-and intra-day precisions were 8.76%-14.15% and 4.91%-11.11%, respectively, and accuracy was-1.27%--7.71%. The stability of samples for 13 days and stock solution for 30 days at-20°C were good, and the stability of serum samples after 2 cycles of freeze-thaw met the requirements. There was no dilution effect noted after 40 times sample dilution. Conclusion We heve developed a simple, accurate and reliable method which can be applied to the determination of BF-30 in rat serum and following pharmacokinetic study.

Chemiluminescent immunoassay method for determination of cathelicidin-BF in rat serum / 国际药学研究杂志

Objective To establish a chemiluminescent immunoassay method for the determination of cathelicidin-BF(BF-30)in rat serum,to provide a fast and simple analytical method for its pharmacokinetic studies,then to investigate the pharmacokinet?ic characteristics of BF-30 in vivo. Methods A chemiluminescent immunoassay method was developed and the matrix effect,preci?sion,accuracy,stability and the dilution effect were evaluated,then the method was used to determine the concentration of BF-30 in rat serum. Results The linear range of BF-30 in rat serum was 0.5-40 ng/ml,and the lowest limit of determination was 0.5 ng/ml. No matrix effect was observed. The RSD of inter-and intra-day precisions were 8.76%-14.15%and 4.91%-11.11%,respectively,and ac?curacy was-1.27%--7.71%. The stability of samples for 13 days and stock solution for 30 days at-20℃were good,and the stability of serum samples after 2 cycles of freeze-thaw met the requirements. There was no dilution effect noted after 40 times sample dilution. Conclusion We heve developed a simple,accurate and reliable method which can be applied to the determination of BF-30 in rat se?rum and following pharmacokinetic study.

Analysis of the Results of ELISA by Detecting Low Quantitative HBsAg(CMIA)in Serums / 现代检验医学杂志

Objective To evaluate the performance of ELISA by detecting low quantitative HBsAg in serums.Methods 305 serum samples that the quantitation range was from 0.05 IU/ml to 9.99 IU/ml were collected,and then detected by ELISA. Results The rate of patients with low quantitation of HBsAg was 18.12% in patients with positive HBsAg.The total de-tected rate of ELISA was 87.87%,and the rate of 0.05~0.11,0.12~0.20,0.21 ~0.50,0.51 ~ 1.00,1.01~5.00 IU/ml and 5.01~9.99IU/ml were 36.00%,61.11%,78.38%,84.62%,99.11% and 100.00%,respectively.The differences were statistically significant between the detected rates of each group(χ2 =99.84,P =0.000).There was high correlation coeffi-cient between the results detected by ELISA and by CMIA(r = 0.874,P = 0.000).Conclusion The clinical laboratory should be careful to apply the method of ELISA to detect HBsAg for its missing detection in samples with low quantitation of HBsAg.

An initial investigation of the serum thyroid hormone reference range in the apparently healthy individuals of Beijing and Shanghai area of China / 中华检验医学杂志

ObjectiveTo establish the reference intervals of serum triiodothyronine (TT3),the thyroxine ( TT4 ),free triiodothyronine ( FT3 ),free thyroxine ( FT4 ) and thyroid-stimulating hormone (TSH)in the apparently healthy individuals of Beijing and Shanghai.Methods According to the requirement for laboratory support for the diagnosis and monitoring of thyroid diseases in the National Academy ofClinicalBiochemistry(NACB)laboratorymedicinepracticeguidelines, therewere 390 apparently healthy individuals tested (221 male,169 female,18 -65 years old) from Beijing and Shanghai for serum TT3,TT4,FT3,FT4 and TSH on American Beckman UniCel DXI 800 Automatic Chemiluminescent Analyzer.All markers were analyzed between gender,region,age group using t test and ANOVA.The reference intervals of all markers were determined by P2.5 - P97.5.ResultsTT3,TT4,FT3,FT4,TSH levels in the male group were ( 1.90 ± 0.32) nmol/L,( 116.77 ± 18.02) nmol/L,( 5.28 ±0.67) pmol/L,( 11.54 ± 1.97) pmol/L,( 1.92 ± 1.12 ) mIU/L,respectively,while the above indicators in the female group were ( 1.82 ± 0.32) nmol/L,( 115.73 ± 14.39 ) nmol/L,(5.04 ± 0.59 ) pmol/L,( 10.94 ± 1.45) pmol/L,( 2.37 ± 1.86 ) mIU/L,respectively.When comparing the results in genders,statistical significance was shown in TF3,FT3,FT4 and TSH of two gender groups( t =2.377,3.642,3.471,2.520,all P ＜ 0.05 ).When comparing different regions,statistical significance was only shown in FT3 ( t =6.410,P ＜ 0.05 ),in which Beijing group was (5.01 ± 0.63) pmol/L,and Shanghai group was (5.41 ±0.61 ) pmol/L,and no significant difference were shown in other four markers.Correlation analysis showed that TT4 was positively correlated with age (r =0.22,P ＜ 0.001 ) while TSH was negatively correlated with age ( r =- 0.12,P ＜ 0.05 ).TT3,TT4,FT3,FT4,TSH reference intervals were ( 1.22 - 2.50 ) nmol/L,(83.37 - 149.37 ) nmol/L,( 3.88 - 6.48 ) pmol/L,( 7.70 - 14.86) pmol/L,( 0.38 - 5.58 ) mIU/L,respectively.ConclusionDifferences of serum thyroid hormones were observed in different areas of China,It is important to establish reference intervals of the serum thyroid hormones in Chinese population.

Evaluation of Two Beta2-microglobulin Reagents by Turbidimetric Immunoassay / 대한진단검사의학회지

BACKGROUND: An increased level of beta2-microglobulin (beta2M) is seen in diseases such as lymphoproliferative diseases, renal diseases, solid tumors, liver diseases, certain viral infection, or chronic inflammatory diseases, etc. In this study, we evaluated a quantitative beta2M assay for precision and linearity using an automated turbidimetric immunoassay (TIA) by Hitachi 7600-110 (Hitachi High Technologies Co., Japan). The TIA of beta2M was compared with a chemiluminescent immunoassay (CLIA) by Immulite 2000 (Diagnostic Products Corporation, USA). METHODS: Two TIAs, the Hitachi 7600-110 with Roche reagent (Roche-TIA) and the Hitachi 7600- 110 with HBI reagent (HBI-TIA), were evaluated for within-run precision, within-day precision, betweendays precision, and linearity. With 68 serum samples, two TIAs were compared with Immulite 2000 using DPC reagent (DPC-CLIA). These data were analyzed by Passing-Bablok analysis and Bland- Altman analysis. RESULTS: The coefficients of variation (CVs) of within-run precision, within-day precision, and between- days precision were less than 7% in all groups. The linearity tests of the two TIAs were maintained well (Roche-TIA: R2=0.9952; HBI-TIA: R2=0.9946). The comparison study indicated good correlations (Roche-TIA/DPC-CLIA: r=0.9738, y=0.9625x-0.0375; HBI-TIA/DPC-CLIA: r=0.9725, y= 1.1000x-0.3100). In Bland-Altman analysis, less than 2SD differences were observed between the two groups. CONCLUSIONS: Both Roche-TIA and HBI-TIA showed a good precision and excellent correlations with DPC-CLIA; therefore, TIA could be used in the routine laboratory to determine a quantitative analysis of beta2M.