Development and evaluation of a rapid and sensitive POC chemiluminescent assay for β-human chorionic gonadotropin / 中国免疫学杂志

Objective:To develop and evaluate a rapid and sensitive point-of-care chemiluminescent assay(POC-CLIA)for β-human chorionic gonadotropin(β-HCG).Methods:POC-CLIA was constructed based on alkaline phosphatase(Alp)-AMPPD lumi-nescence system and magnetic particles(Mps)carrier.Performance of POC-CLIA,including sensitivity,precision,accuracy,linear dilution,specificity,stability,hook effect and clinical application were evaluated.Results:Detection limit of β-HCG was 0.71 mU/ml,linear detection range was 0.710～1.092×104 mU/ml,and was no hook effect up to 1.7×105 mU/ml.Intra and inter batch coefficients of variation were less than 10％,and could be stored stably at 37℃ for 10 days.Accuracy deviation was within±10％,so results were reliable.There was no cross-reactivity between interfering substances and anti-β-HCG antibdies.For detecting β-HCG in 100 clinical serum samples,results were highly correlated with those that were tested by clinical standard methods(R2=0.997 0).Turnaround time for single sample was less than 15 min and throughput could reach 200 T/h.Conclusion:This method is adequate that can be widely used in grassroots communities to help large-scale screening of pregnancy and related diseases.

Differential antibody response to COVID-19 disease and COVID-19 vaccines

Background: In our study, antibody positivity was evaluated by two methods in vaccinated and unvaccinated people according to their demographic characteristics and history of COVID-19. Methods: In this study, venous blood samples were taken from patients who were requested to have COVID-19 antibodies from our hospital's outpatient clinics between February 2022 and March 2022. Results: There was no statistically significant difference when IgG antibody positivity was compared according to the age ranges in chemiluminescence and immunochromatographic methods. When patients were evaluated according to antibody titers, it was found that 81% of the seronegative patients were unvaccinated and had not had Covid-19, and it was found that this group was statistically significant compared to other groups. Conclusions: It has been concluded that it will be of great importance for every country, even every region, to have a test and vaccine policy for diagnosis and follow-up in the fight against COVID-19.

Differential antibody response to COVID-19 disease and COVID-19 vaccines

Background: In our study, antibody positivity was evaluated by two methods in vaccinated and unvaccinated people according to their demographic characteristics and history of COVID-19. Methods: In this study, venous blood samples were taken from patients who were requested to have COVID-19 antibodies from our hospital's outpatient clinics between February 2022 and March 2022. Results: There was no statistically significant difference when IgG antibody positivity was compared according to the age ranges in chemiluminescence and immunochromatographic methods. When patients were evaluated according to antibody titers, it was found that 81% of the seronegative patients were unvaccinated and had not had Covid-19, and it was found that this group was statistically significant compared to other groups. Conclusions: It has been concluded that it will be of great importance for every country, even every region, to have a test and vaccine policy for diagnosis and follow-up in the fight against COVID-19.

A Case Control Study of Vitamin D Levels in Chronic Obstructive Pulmonary Disease Patients and Healthy Volunteers in South Gujarat, India

Introduction: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) programme states that COPD is a common, treatable, and preventable disease that is characterized by a persistent airflow restriction that usually progresses and is connected to an exaggerated chronic inflammatory response in the airways and the lung to harmful particles or gases. The combined severity of a patient's co-morbid illnesses and exacerbations increases. The purpose of the study was to assess the vitamin D status of COPD patients and healthy participants. Methodology: This case-control study was conducted among 75 cases and 75 control at the Surat Municipal Institute of Medical Education and Research General Medicine department. Result: The mean vitamin D of subjects in cases was 32.21 � 12.68 and it was 52.05 � 1.99 in controls. The difference in vitamin D between the two groups was statistically significant (P Value<0.001). Conclusion: COPD patients had lower amounts of vitamin D. As COPD severity increases, vitamin D levels decrease. Along with a rise in COPD exacerbations, vitamin D levels are also decreasing

Study on specific antibodies in patients infected with SARS-CoV-2 and recipients of inactivated vaccine / 中华微生物学和免疫学杂志

Objective:To detect the serum levels of SARS-CoV-2-specific IgM and IgG antibodies in patients infected with SARS-CoV-2 and recipients of inactivated vaccine in different periods for understanding their variation patterns in vivo. Methods:Chemiluminescence immunoassay was used to detect the levels of SARS-CoV-2-specific IgM and IgG antibodies in 144 serum samples of 44 COVID-19 patients, 381 serum samples of 118 asymptomatic infected cases and 398 serum samples of 273 inactivated vaccine recipients collected at different periods. The results were statistically analyzed together with basic characteristics and vaccination status.Results:The positive rates of IgM antibody in COVID-19 patients, asymptomatic infected cases and inactivated vaccine recipients were 52.27% (23/44), 23.73% (28/118) and 14.29% (39/273). The positive rate of IgM antibody was higher in COVID-19 patients than in asymptomatic infected cases and vaccine recipients (χ 2=12.106, P=0.001; χ 2=34.755, P<0.001). The positive rates of IgG antibody in the three populations were 100.00% (44/44), 97.46% (115/118) and 98.81% (166/168), and the differences were not statistically significant (χ 2=2.944, P=0.229). In COVID-19 patients, the concentration of IgM antibody in <40 years old group was lower than that in ≥40 years old group (Waldχ 2=6.609, P=0.010), and the concentration of IgG antibody in patients with vaccination was higher than that in patients without vaccination (Waldχ 2=12.402, P<0.001). In asymptomatic infected cases, the concentration of IgG antibody was higher in people with vaccination than in those without vaccination (Waldχ 2=4.530, P=0.033). In SARS-CoV-2 vaccine recipients, the concentration of IgG antibody in <40 years old group was higher than that in ≥40 years old group (Waldχ 2=9.565, P=0.002). Dynamic analysis of antibody levels showed that from week 1 to week 9, the concentrations of IgM and IgG antibodies in COVID-19 patients were higher than those in asymptomatic infected cases and vaccine recipients. Conclusions:The concentrations of IgM and IgG antibodies in COVID-19 patients were higher than those in asymptomatic infected cases and inactivated vaccine recipients. COVID-19 patients aged ≥40 years had higher level of IgM antibody. COVID-19 patients and asymptomatic infected cases who had received vaccination had higher concentration of IgG antibody. Inactivated vaccine showed good immunogenicity after whole course of immunization, and the IgG antibody level in <40 years old group was higher.

Value of urinary C-terminal agrin fragment in monitoring the progression of early kidney injury in type 2 diabetic patients / 中华检验医学杂志

Objective:This study aimed to explore the feasibility and clinical value of monitoring the progression of early kidney injury in type 2 diabetic patients by assessment of the urinary C-terminal agrin fragment (uCAF) with enzymatic chemiluminescence immunoassay.Methods:A total of 251 patients with type 2 diabetes, who attended the Second Affiliated Hospital of Wenzhou Medical University from October 2018 to March 2020, were included in this retrospective analysis. One hundred and fifty-six participants undergoing health check-up at the Second Affiliated Hospital of Zhejiang University School of Medicine in February 2021 served as controls. Basic clinical information, glycosylated hemoglobin type A 1c and serum creatinine values were recorded, and urine specimens were collected for urinary creatinine, urinary α 1 microglobulin(uα 1M), urinary immunoglobulin G (uIgG), urinary albumin, urinary N-Acetyl-B-D-glycosaminidase (uNAG) and uCAF measurements. Based on the estimated glomerular filtration rate (eGFR), 251 patients were classified into G1~G5 stage groups with 116, 22, 28, 55 and 30 patients in each group. One hundred and sixty-six patients with early diabetic kidney disease (stage G1-G3) were divided into subgroups A1 (79), A2 (48) and A3 (39) according to the urinary albumin/creatinine ratio (UACR), the uα1M levels were divided into uα1M subgroup 1 (83 cases), uα1M subgroup 2 (42 cases), and uα1M subgroup 3 (41 cases), and uIgG subgroup 1 (83 cases), uIgG subgroup 2 (42 cases), and uIgG subgroup 3 (41 cases) according to uIgG levels. The Spearman method was used to analyze the correlation between uCAF levels and eGFR, UACR, uα1M and uIgG levels. Results:(1) The linear range of the uCAF detected by enzymatic chemiluminescence immunoassay was 3.97-2 000.00 ng/ml, with a detection limit of 2.28 ng/ml, intra-batch coefficients of variation of 1.15% and 1.57%, inter-batch coefficients of variation of 1.63% and 5.78%, and a biological reference interval of <95.35 μg/g Cr. (2) The uCAF level and positive rate (UACR≥30 mg/g) increased with the decrease of eGFR from G1-G3, uCAF level was negatively correlated with eGFR value ( r=-0.543, P<0.000 1), and the positive rate increased from 24.14% (28/116) to 85.71% (24/28) from G1-G3. The uCAF level and positivity rate decreased with the decrease of eGFR from G4 to G5. uCAF level was positively correlated with eGFR value ( r=0.495, P<0.001), and the positivity rate decreased from 30.91% (17/55) to 23.33% (7/30) from G4 to G5. (3) In patients with early diabetic kidney disease, uCAF levels and positivity rates increased gradually with the increase of UACR. uCAF levels were positively correlated with UACR values ( r=0.602, P<0.001), and the uCAF positivity rate reached 21.52% (17/79) in the A1 subgroup. (4) uCAF level was positively correlated with uα1M and uIgG levels in patients with early diabetic kidney disease ( r=0.757, 0.596, both P<0.001). Conclusion:Analytical performance of enzyme chemiluminescence immunoassay for the detection of CAF is satisfactory and could be used a biomarker for monitoring damage and progression of early diabetic kidney disease in patients with type 2 diabetes.

Establishment and verification validation of plasma free metanephrines measurement by chemiluminescence immunoassay / 中华检验医学杂志

Objective:To establish a chemiluminescence immunoassay method for free metanephrines measurement in plasma, and verify its performance.Methods:The samples (calibrator, plasma, and quality control sample) were extracted and acylated, the processed analyte samples were then competed with the immobilized specific antigens of metanephrine (MN), normetanephrine (NMN) respectively, to combine specific antibodies marked by Horseradish Peroxidase (HRP), the immobilized antigens-antibody-HRP immune reaction product was then formed through the immune reaction, which could be detected through measurement of HRP catalytic substrate luminescence. Performance verification was performed using specificity, sensitivity,precision,thermally accelerated stability, and accuracy metrics.Results:The established detection methods for MN and NMN have no obvious cross-reactions when detecting multiple structural analogs; the limit of blank, limit of detection and functional sensitivity of the MN detection reagent was 10.51, 21.15 and 25.76 ng/L, and the performance of the NMN detection reagent was 11.54, 28.43 and 31.29 ng/L; the coefficients of variation of the detection reagents for MN and NMN were 2.41%-5.38% and 1.61%-3.22% respectively; the accelerated stability test of the two detection reagents showed that the reagents could be stored stably for 1 year at 2-8 ℃; and the measurement results of this method can be traced to the mass spectrometer.Conclusion:In this study, a chemiluminescence immunoassay detection method for free metanephrines in plasma is successfully established.

Evaluation of CLIA plus NAT for detecting HBsAg single-ELISA-reactive samples of blood donors / 中国输血杂志

【Objective】 To study the detection performance of HBsAg single-ELISA-reactive samples of blood donors. 【Methods】 Two kinds of ELISA reagents from different manufacturers (named as reagents A and B) were used for HBsAg screening. A total of 276 samples, from January 2017 to May 2021, with HBsAg single-ELISA-reactive results were collected for further nucleic acid detection technology (NAT) and chemiluminescence immunoassay (CLIA) testing, to undergo HBV-DNA and five hepatitis B tests, respectively. The relationship between HBsAg single-ELISA-reactivity, NAT and CLIA was statistically analyzed. 【Results】 Among the 276 HBsAg single-ELISA-reactive samples, 14 were NAT reactive, with the positive rate of 5.07% (14/276). Fisher′s exact test was used to compare the compliance of reagents A and B with NAT reactivity, and the difference was not statistically significant (P<0.05). Among 14 HBsAg+ /NAT+ samples retested by CLIA, 2 were HBsAg reactive(14.29%, 2/14), 13 were anti-HBc reactive (92.86%, 13/14), 9 had the quantitative value of anti-HBs <10 mIU/mL, 5 had the quantitative value of anti-HBs between 10 to 100mIU/ mL. A total of 5 serological patterns were detected, and anti-HBe+ /anti-HBc+ pattern was the dominant. There were 262 cases of HBsAg+ /NAT- samples, but only 1 (0.38%, , 1/262) case was HBsAg reactive by CLIA, 100 were anti-HBc reactive (38.17%, 100/262), 144 (54.96%, 144/262) were anti-HBs reactive, and 1 was HBeAg reactive. A total of 8 serological patterns were detected. 【Conclusion】 Most of HBsAg single-ELISA-reactive results are false, and NAT could effectively reduce the residual risk of transfusion transmitted diseases.

Molecular characteristics of hepatitis B infection with low level HBsAg and nucleic acid testing non-reactive results in blood donors / 中国输血杂志

【Objective】 To investigate HBV infection with low level of HBsAg and nucleic acid testing(NAT) non-reactive results in blood donors, and analyze molecular characteristics. 【Methods】 Low level HBsAg but NAT-nonreactive samples were collected and tested for HBsAg by Abbott chemiluminescent microparticle immunoassay (CMIA)., HBsAg, anti-HBs, HBeAg, anti-HBe and anti-HBc were further detected by Roche electrochemiluminescence immunoassay(ECLI). BCP/PC and S regions were also amplified by Nested-PCRs and qPCR for HBV DNA quantity were adopted simultaneously. 【Results】 Of 100 363 donations, 60(0.054%) low level HBsAg and NAT-nonreactive blood samples were enrolled the study. In which, 54/60(90%) and 57/60(95%) were WanTai HBsAg ELISA and DiaSorin HBsAg ELISA reactive respectively. Of 33 cases genotyped, genotype B were 87.9%( 29/33), including adw2 96.6%(28/29) and adw1 3.4%(1/29), C was observed in 4(12.1%) with sero-type adrq+. Mutations in S gene of genotype B such as Q101R, Q129H, T131I, M133L/T, F134L, G145R, V168A, L175S and V177A were observed as notable mutations, which can affect HBsAg diagnosis. A high frequency mutation C1799G(87.5%, 21/24)were detected in BCP/PC and would reduce the replication of virus. The median viral load measured by qPCR was 49.6(0~628)IU/mL. 【Conclusion】 A small part of donations with low-level HBsAg and NAT-nonreactive can not be deferred by one isolated ELISA screening assay. It is necessary to apply more sensitive and specific HBsAg assays and NAT in blood screening, and improve the ability to detected mutants.

Performance evaluation of two chemiluminescence immunoassay reagents for HCV antibody in blood donors screening / 中国输血杂志

【Objective】 Aim of this study was to evaluate performance of two chemiluminescence immunoassay (CLIA) reagents for hepatitis C virus antibodies (anti-HCV) detection, focusing on the feasibility of blood screening for blood donors. 【Methods】 The sero-panel samples from NCCL and the donor samples were tested with CLIA, ECLIA and two ELISA (A: double antigen sandwich method, B: indirect method) reagents synchronously to evaluate their performances respectively, and the sensitivity, specificity and CV of the four reagents were compared. 【Results】 CLIA, ECLIA, A and B reagents showed sensitivities of 99.06%(315/318), 99.69%(317/318), 99.06%(315/318) and 99.69%(317/318), and clinical specificities was 99.06%(315/318), 99.69%(317/318), 99.06%(315/318) and 99.69%(317/318), respectively. Between-run and within-run precision for ECLIA reagent ranged (both CV<8%) was better than two ELISA reagents (between-run: CV <15% and within-run: CV <20%), and the CLIA reagent also met the requirement in blood screening (CVs <14%). 【Conclusion】 This ECLIA reagent showed high sensitivity and good reproducibility together with acceptable specificity in routine sample screening, which proved its further application in blood screening. This CLIA reagent has high specificity and the same sensitivity as indirect ELISA reagent. This CLIA reagent could be used in combination with other reagents with high sensitivity to screen anti-HCV in blood donors.

Establishment of measurement threshold and comparison of results for detection of Treponema pallidum specific antibody by Siemens ADVIACentaur XP chemiluminescent immunoanalyzer / 生物工程学报

To investigate the detection threshold of Treponema pallidum specific antibody method by chemiluminescent immunoassay (CLIA) in Siemens ADVIA Centaur XP for Syphilis serological test, and compare with the results derived from CMIA, TP-WB and TPPA method. The result can serve as reference for the application of CLIA. In total 30 887 samples screened by Treponema pallidum specific antibody method were collected by Abbott architect i2000 CMIA from July 2018 to July 2019 in Yanda Hospital of Hebei Province. We selected 153 patients with the ratio of sample absorbance to critical value (S/CO) of 1-9 by CMIA screening of Treponema pallidum specific antibody as the research objects. The reverse sequence of syphilis serological detection was adopted, and TP-WB and TPPA were used as the confirmation methods respectively. MedCalc software was used to analyze the results of ROC curve, and the cut-off value was obtained. Chi square test was used to test the difference significance of counting data. The detection results of Treponema pallidum specific antibody in the same batch of serum samples were unequal by different methods. There was no significant difference between CLIA method and TPPA method, but significant difference between CLIA method with TP-WB method and CMIA method was found. TPPA test results and TP-WB test results were taken as gold standards, ROC curve analysis showed that the best diagnostic cutoff value of CLIA method was 4.01 and 16.06, respectively, and the area under the curve was 0.961 and 0.838. The suggested cutoff value of CLIA method is quite different when using different syphilis serological test methods as the gold standard, Therefore, when the S/CO value determined by CLIA is between 1.00 to 16.06, TP-WB method should be recommended as the first choice in laboratory serological test for recheck and confirmation to avoid clinical misdiagnosis.

Implementación del algoritmo reverso para el cribado de sífilis en un laboratorio clínico / Implementation of the reverse screening syphilis algorithm in a clinical laboratory

Resumen Introducción: La sífilis sigue siendo un problema de salud pública en todo el mundo; la precisión de las pruebas de diagnóstico es fundamental para el éxito de su control. Actualmente, hay dos enfoques para el diagnóstico serológico de la sífilis: el algoritmo tradicional y el algoritmo reverso. Objetivo: Analizar las ventajas y desventajas en la implementación del cribado para sífilis con el algoritmo reverso en un laboratorio clínico de pacientes ambulatorios. Materiales y Métodos: Se realizó un estudio de corte transversal analizando 246 sueros reactivos en el cribado sobre un total de 14.700 solicitudes de serología para sífilis. Se utilizaron los ensayos ARCHITECT SyphilisTP, V.D.R.L. y FTA-Abs. Resultados: De los 246 sueros reactivos por ARCHITECT Syphilis TP, 129 fueron reactivos y 117 no reactivos con V.D.R.L., éstos últimos resultaron 97 reactivos y 20 no reactivos por FTA-Abs, sugiriendo falsos positivos (0,13%). Se detectaron dos casos de infección primaria, no detectados con V.D.R.L y un caso de infección primaria en una gestante con un valor alto S/CO y V.D.R.L. de 1 dils. Conclusiones: Entre las ventajas de utilizar el algoritmo reverso se encontró mayor sensibilidad en la detección de sífilis primaria; automatización, trazabilidad, interpretación objetiva y resultados concluyentes.

Background: Syphilis remains a public health concern worldwide, the accuracy of diagnostic tests is critical for its successful control. Currently, there are two approaches to the diagnosis of syphilis using serological tests: the traditional algorithm and the reverse algorithm. Aim: The goal of this study was to analyse the advantages and disadvantages in the implementation of the syphilis reverse-screening algorithm in an outpatient clinical laboratory. Methods: An observational cross-sectional study was carried out analyzing 246 reactive sera from a total of 14700 requests for syphilis serology. Chemiluminescent assay ARCHITECT Syphilis TP, V.D.R.L. and FTA-Abs were performed. Results: Among 246 reactive sera by ARCHITECT Syphilis TP, 129 were reactive and 117 were non-reactive by V.D.R.L. the last mentioned resulted in 97 reactive and 20 non-reactive by FTA-Abs, suggesting false positives (0.13%). Two patients with primary infection were detected, that were not detected by V.D.R.L. and one pregnant woman with primary infection with a high value S/CO and V.D.R.L.:1 dils. Conclusions: Among the advantages of using a reverse algorithm were greater sensitivity in the detection of patients with primary syphilis; automation, complete traceability of the samples; objective interpretation and conclusive results.

Diagnosis of Toxoplasma gondii infection in pregnant women using automated chemiluminescence and quantitative real time PCR

Objective: To identify serodiagnosis and quantification of Toxoplasma gondii (T. gondii) infection among pregnant women in Salmas, northwest of Iran. Methods: In this cross-sectional study, 276 blood samples were collected from pregnant women referred to the health care centers in Salmas city. The demographic variables were also recorded. Titers of anti-Toxoplasma IgM and IgG antibodies (Ab) were determined using the chemiluminescence immunoassay. Quantitative real-time PCR targeting the T. gondii repeated element gene was also performed on the blood sample. Results: Out of all, 19.92% (55/276) and 2.17% (6/276) patients were seropositive for anti-Toxoplasma IgG and IgM Ab, respectively. Moreover, the presence of T. gondii DNA was observed in 12.31% (34/276) blood samples. A significant relationship was observed between the IgG Ab seropositivity and contact with the cat as a risk factor (P=0.022). Conclusions: The seroprevalence rate of T. gondii infection in pregnant women is relatively low. Consequently, the seronegative pregnant women are at risk, and a considerable rate of positive blood samples for the presence of parasite's DNA should not be ignored. Besides, quantitative real-time PCR could be considered as an accurate method for diagnosis of acute toxoplasmosis especially when the precise results are of the most importance in pregnancy. Limiting contact with cats is also suggested for pregnant women.

Diagnosis of Toxoplasma gondii infection in pregnant women using automated chemiluminescence and quantitative real time PCR

Objective: To identify serodiagnosis and quantification of Toxoplasma gondii (T. gondii) infection among pregnant women in Salmas, northwest of Iran. Methods: In this cross-sectional study, 276 blood samples were collected from pregnant women referred to the health care centers in Salmas city. The demographic variables were also recorded. Titers of anti-Toxoplasma IgM and IgG antibodies (Ab) were determined using the chemiluminescence immunoassay. Quantitative real-time PCR targeting the T. gondii repeated element gene was also performed on the blood sample. Results: Out of all, 19.92% (55/276) and 2.17% (6/276) patients were seropositive for anti-Toxoplasma IgG and IgM Ab, respectively. Moreover, the presence of T. gondii DNA was observed in 12.31% (34/276) blood samples. A significant relationship was observed between the IgG Ab seropositivity and contact with the cat as a risk factor (P=0.022). Conclusions: The seroprevalence rate of T. gondii infection in pregnant women is relatively low. Consequently, the seronegative pregnant women are at risk, and a considerable rate of positive blood samples for the presence of parasite's DNA should not be ignored. Besides, quantitative real-time PCR could be considered as an accurate method for diagnosis of acute toxoplasmosis especially when the precise results are of the most importance in pregnancy. Limiting contact with cats is also suggested for pregnant women.

Performance verification of LIAISON chemiluminescence immunity analyzer / 国际检验医学杂志

Objective To verify the performance of LIAISON chemiluminescence immunoassay analyzer in the prenatal screening for TORCH .Methods Reference to the US Institute of Clinical and Laboratory Stand-ards(NCCLS) series of documents and literature and combining with actual work ,we designed the verification program ,and tested and evaluated the LIAISON chemiluminescent immunoassay systems for the measurement precision ,accuracy ,linearity analysis ,clinical reportable range and biological reference intervals of Tox IgG , Tox IgM ,Rub IgG ,Rub IgM ,CMV IgG ,CMV IgM ,HSV IgG ,HSV IgM .We also compared the results with analysis performance provided by manufacturers (Italy LIAISON ) or recognized quality indicators .Results Intra-assay imprecision CV values were between 3 .58％ -7 .03％ ,which were less than the predetermined range;inter-assay imprecision CV values were between 3 .13％ -10 .73％ .Linear range validation regression coefficients a values were between 0 .97 -1 .03 and r2 >0 .95 .The linear relationship met the requirements . Both biological reference interval and reportable range meet the requirements .Conclusion The performance of LIAISON chemiluminescence immunoassay detection system satisfied the clinical requirements ,and the meas-urement results had advantages of high sensitivity ,specificity ,stability ,wide detection range ,good accuracy and repeatability ,which was suitable for clinical application .

Performance test and evaluation of ADVIA Centaur XP automatic chemiluminescence immunoassay system / 国际检验医学杂志

Objective The ADVIA Centaur XP automatic chemiluminescence immunoassay system detec-tion performance of the thyroid hormones and antibodies for validation and evaluation.Methods With refer-ence to the American association of clinical laboratory standardization guide and other related documents,the ADVIA Centaur XP automatic chemiluminescence immunoassay system test 7 items thyroid hormones and an-tibodies(T3,T4,FT3,FT4,TSH,anti-TG,anti-TPO)of precision,accuracy,linear range and carry pollution rate for validation.Results Within the seven thyroid hormones and antibodies batch testing precision of CV and CV between batch precision between 1.51% -6.17% and 1.86% -6.17%.Is the average accuracy of bias of the largest testing project FT3(8.47%),but in the acceptable range,good correlation,correlation coefficient R of 0.994 or higher,Average bias <1/2 CLIA′88 TEa(12.5%).T3,T4,FT3,FT4,TSH,anti-TG and anti-T PO in 1.24-5.59 nmol/L respectively,and 60.07 -195.10 nmol/L,3.40 -22.87 pmol/L,14.59 -40.54 pmol/L,1.63-74.13 μIU/mL,60.10 -381.30 μIU/mL and 180.10 -531.50 μIU/mL range is linear,Carry pollution rate is between 0.04% -0.97%.Conclusion ADVIA Centaur XP automatic chemiluminescence im-munoassay system detecting thyroid hormones and antibodies results consistent with the data provided by the manufacturer,the test results are accurate and reliable,and can be used for the detection of clinical samples.

Improve diagnostic performance of PCOS by measurements of testosterone and dehydcoepiandrosterone sulfate with ultra-performance liquid chromatography tandem mass spectrometry / 中华内分泌代谢杂志

Objective To compare ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) and chemiluminescence immunoassay(CLIA) measurement of human serum androgen levels in polycystic ovarian syndrome(PCOS). Methods 160 PCOS patients and 146 healthy subjects(control group) were recruited and their serum androgen levels——measurements of testosterone and dehydcoepiandrosterone sulfate (DHEA-S) were tested by UPLC-MS/MS and CLIA. The androgen results combined with body mass index(BMI) were analyzed by ROC curve. According to area under curve(AUC) calculated by SPSS, a better method will be selected to provide accurate test results for physicians. Results (1)AUC of DHEA-S tested by UPLC-MS/MS was significantly higher than the one tested by CLIA(P<0.01). There was no significant difference between the AUC of T tested by UPLC-MS/MS and the one tested by CLIA. (2)AUC of T combined with DHEA-S tested by HPLC was not only significantly higher than the AUC of two combined indicators tested by CLIA(P<0.01),but also significantly higher than the AUC of a single indicator——either T(P<0.01) or DHEA-S(P<0.01) tested by UPLC-MS/MS. (3)The AUC of T,DHEA-S combined with BMI tested by HPLC was not only significantly higher than the AUC of three combined indicators tested by CLIA(P<0.01),but also higher than the AUC of two combined indicators tested by UPLC-MS/MS(P<0.05). Conclusion T and DHEA-S tested by UPLC-MS/MS combined with BMI has a certain reference value in the diagnosis of PCOS.

Analysis on key contents for registration and application of automatic chemiluminescence immunoassay analyzer in new regulatory system / 医疗卫生装备

Objective To explore the key contents for the registration and application of the automatic chemiluminescence immunoassay analyzer in the new regulatory system to provide references to related enterprises and etc.Methods The requirements for review material,research material,product technical requirements,product specification and etc were analyzed based on the characteristics of the automatic chemiluminescence immunoassay analyzer,the requirements of newly published Provisions for Medical Device Registration as well as literature retrieval.Results Some suggestions were,put forward accordingly such as the working principle described based on reaction steps with emphases on the parts of immune reaction and optical detection.Conclusion References are provided to related enterprises when executing registration andapplication of medical devices.

Performance evaluation of the chemiluminescence immunoassay for mycoplasma pneumonia antibody detecting / 中华检验医学杂志

Objective Assessing the detection performance of testing mycoplasma pneumonia(MP) type-specific antibodies by Chemiluminescence immunoassay(CLIA), in order to evaluate the feasibility of screening MP infection by CLIA.Methods Total of 280 cases of respiratory disease patients,20 examples infected mycoplasma pneumonia and 20 cases health volunteers as the control group were enrolled in this study from August 2016 to October 2017 in the Nanfang Hospital,Southern Medical University,testing MP antibodies by CLIA,Enzyme linked immunosorbent assay(ELISA)and Passive agglutination method(PA) respectively.According to the performance evaluation scheme, we evaluate the performance indexs of detecting MP antibodies by CLIA, including lower limit of detection, intra-batch precision, inter-batch precision,linearity range,clinical coincidence rate and consistency compared with ELISA and PA,and the results were analyzed by EXCEL and SPSS version 22.0.Results MP-IgG CLIA reagent:Limit of blank, Limit of detection and Limit of quantitation were 1.9 AU/ml,4.5 AU/ml and 5.1 AU/ml respectively;Coefficient Variation(CV)of intra-batch precision in high and low concentration levels were 2.98% and 2.45%respectively; CV of inter-batch precision in high and low concentration levels were 6.44% and 6.83% respectively;both the Linear range and Clinical report range are from 2.0 AU/ml to 253.0 AU/ml;the linear regression equation R 2≥0.990 0,0.85≤b≤1.15.MP-IgM CLIA reagent: CV of intra-batch precision in high and low concentration levels were 2.55% and 2.86% respectively; CV of inter-batch precision in high and low concentration levels were 4.82% and 5.46% respectively.The total clinical coincidence rate of MP-IgG and MP-IgM detected by CLIA were 90.0%and 97.5%respectively.The kappa values of MP-IgG and MP-IgM detected by CLIA and ELISA were 0.763(P=0.000)and 0.804(P=0.023)respectively, with Consistent percentage of 88.9% and 91.4% respectively.The kappa value of CLIA and PA was 0.541(P=0.063)with a consistent percentage of 79.6%.Conclusions The results of study show that detecting MP type-specific antibodies by CLIA meet the prescribed performance indexes. Detecting MP type-specific antibodies by CLIA,which is precise, speedy and automated, could be applied to clinical and replace ELISA and PA, becoming the prior choice in clinical for MP infection screening.

A method of human serum folic acid dectetion by non-equilibrium competitive immunoassay using FITC detecting system / 重庆医学

Objective To prepare anti-folic acid (FA) polyclonal antibody and develop a new non-balanced competing chemiluminescence analysis for clinical detection of FA.Methods Established the detection method by added FITC-FA-analogs and FAHRP-antibody in the light emitting plate,which coated with anti-FITC antibody,to form the immune response complex of FITC/antibody-FITC-FA-analogs/FA-antibody-HRP.Then methodology evaluation was performed to evaluate the method performance;and further compared the detecting results with non-FITC system detection system and Electrochemiluminescence system (Roche Elecsys 2010).Results The ELISA results showed that the prepared anti-FA antibodies can recognize serum FA specificly.The methodology evaluation indicated that the linear correlation coefficient of the standard curve was 0.990 0;the analytical sensitivity was 1.21 ng/mL;the range of linear detection was 1.21～ 38.80 ng/mL;The coefficient variability of intra-assay was ＜5 ％,which was better than the results of non-FITC detection system;and the correlation coefficient was 0.908 1 compared with the Elecsys-2010 detection system.Conclusion The established chemiluminescence immunoassay for human serum FA has a good sensitivity and specificity,and suitable for clinical serum FA quantitativedetecting.