AIM: To evaluate cortisolemia by using conventional electrochemiluminescence immunoassay(ECLIA) method compared to liquid chromatography-tandem mass spectrometry(LC-MS/MS) method in active ulcerative colitis(UC) patie...AIM: To evaluate cortisolemia by using conventional electrochemiluminescence immunoassay(ECLIA) method compared to liquid chromatography-tandem mass spectrometry(LC-MS/MS) method in active ulcerative colitis(UC) patients treated with oral prednisone(PD). METHODS: Twenty patients(12 males) with acute relapse of UC started oral PD at a dose of 40 mg once a day, tapered of 10 mg every 2 wk. When a stable 2-wk daily dose of 30 mg was reached, blood samples for cortisol levels' measurement were drawn in the morning in fasting conditions to determine circulating cortisol by LC-MS/MS and ECLIA assay. RESULTS: Median interquartile range cortisolemia with ECLIA and LC-MS/MS method was 54.1(185.8) nmol/L and 32.1(124.0) nmol/L, respectively(P < 0.001). The within-patient median differences between the two methods was 23.2(40.6) nmol/L, with higher cortisol levels for the ECLIA method. The estimated geomet-ric mean ratio between methods was 1.85(95%CI: 2.39-1.43) considering all data or 1.58(95%CI: 2.30-1.09) considering only data above the limit of quantification(n = 12). The 95%CIs of the geometric mean ratio between methods confirm a statistically significant difference.CONCLUSION: Blood cortisol levels detected with ECLIA method seems to be higher than the ones measured by LC-MS/MS, indicating a possible overestimation of them in patients treated with PD. Therefore, the cortisol suppression in patients under treatment with oral PD should not be measured using ECLIA method.展开更多
Chemiluminescence immunoassay(CLⅠA) has always been a great challenge in detecting cardiac troponin Ⅰ(c Tn Ⅰ) in whole blood samples without centrifugation because of the interference of red blood cells and low sen...Chemiluminescence immunoassay(CLⅠA) has always been a great challenge in detecting cardiac troponin Ⅰ(c Tn Ⅰ) in whole blood samples without centrifugation because of the interference of red blood cells and low sensitivity. Ⅰn this study, the antigens and erythrocytes in the blood were captured by the antibodies immobilized on the magnetic particles, recognized by another biotinconjugated c Tn Ⅰ antibody and detected by streptavidin/acridine aster-conjugated polychloromethylstyrene microspheres(PCMS). After magnetic separation, the supernatant was transferred and measured. No significant difference was noted between the c Tn Ⅰ concentrations of the serum samples,plasma samples and whole blood. The prepared PCMS provided more functional areas to conjugate streptavidin and acridinium ester, so the immunoassay has highly sensitive, the limits of blank at0.012 ng/mL, and functional sensitivity at 0.019 ng/mL with a CV of 20%, and 0.058 ng/mL with a CV of 10%. Total precision of any sample type ranged from 2.62%~5.67%. The assay was linear over the studied range of 0.01-50.00 ng/mL, and no hook effect was found when c Tn Ⅰ concentrations reached 1900 ng/mL. No significant interference was noted with the potential endogenous interfering substances. Compared with the commercial kit(Abbott assay kit), the correlation coefficient was 0.9859. A washing-free CLⅠA was established for the rapid detection of c Tn Ⅰ in human whole blood, using erythrocyte capture antibodies-conjugated magnetic nanoparticles for eliminating the influence of erythrocytes and PCMS for signal amplification, which showed great potential in clinical application.展开更多
A chemiluminescence enzyme immunoassay based on magnetic microparticles (MmPs-CLEIA) was developed to evaluate serum a-fetoprotein (AFP) in parallel with traditional colorimetric enzyme-linked immunosorbent assay (ELI...A chemiluminescence enzyme immunoassay based on magnetic microparticles (MmPs-CLEIA) was developed to evaluate serum a-fetoprotein (AFP) in parallel with traditional colorimetric enzyme-linked immunosorbent assay (ELISA).A systematic comparison between the MmPs-CLEIA and colorimetric ELISA concluded that the MPs-CLEIA exhibited fewer dosages of immunoreagents,less total assay time,and better linearity,recovery,precision,sensitivity and validity.AFP was detected in forty human serum samples by the proposed MPs-CLEIA and ELISA,and the results were compared with commercial electrochemiluminescence immunoassay (ECLIA) kit.The correlation coefficient between MPs-CLEIA and ELISA was obtained with R 2 0.6703;however,the correlation between MPs-CLEIA and ECLIA (R 2 0.9582) was obviously better than that between colorimetric ELISA and ECLIA (R 2 0.6866).展开更多
DNA methyltransferase 1(DNMT1)is a useful biomarker for lung cancer in early clinical diagnosis.A rapid magnetic chemiluminescence immunoassay(MCLIA)for DNMT1 in human serum has been developed.Horseradish peroxidase(H...DNA methyltransferase 1(DNMT1)is a useful biomarker for lung cancer in early clinical diagnosis.A rapid magnetic chemiluminescence immunoassay(MCLIA)for DNMT1 in human serum has been developed.Horseradish peroxidase(HRP)-second-Ab was used to labeled polyclonal antibodies of anti-DNMT1.DNMT1 in sample integrates with specific immunomagnetic beads and can constitute a supersandwiched immunoreaction.In magnetic field,nonspecific materials can be separated.After luminescent substrate luminol-H2O2-BIP was added,the relative light unit(RLU)of HRP was detected and was discovered to be directly proportional to the content of DNMT1 in sample.The correlative variables involved in the MCLIA value were optimized and the methodological evaluation was carried out.After optimization,in the range of0.5–128 ng/mL,the linear regression equation was y=0.5014 x+1.769(x was logCDNMT1,y was relative luminescence units(RLU)/RLU0),and the limit of detection was 0.01 ng/mL.The RSD of intra-and interassays were 15.8%–16.9%and 14.3%–18.1%,respectively.The recovery was from 70.0%to 106.2%.Furthermore,paralleled with purchasable enzyme-linked immunosorbent assay(ELISA)kits,MCLEIA had lower detection limit,wider linear range and shorter detection time.Therefore,the MCLEIA established in this study could be used for the sensitive detection of DNMT1 in serum sample.展开更多
A micro-plate magnetic chemiluminescence immunoassay was developed for rapid and high throughput detection of carcinoembryonic antigens (CEA) in human sera. This method was based on a sandwich immunoreaction of fluore...A micro-plate magnetic chemiluminescence immunoassay was developed for rapid and high throughput detection of carcinoembryonic antigens (CEA) in human sera. This method was based on a sandwich immunoreaction of fluorescein isothiocyanate (FITC)-labeled anti-CEA antibodies, CEA antigens, and horseradish peroxidase (HRP)-conjugated anti-CEA antibodies in mi- cro-plate. The immunomagnetic particles coated with anti-FITC antibodies were used as the solid phase for the immunoassay. The separation procedure was carried out by a magnetic plate adaptor and the luminol-hydrogen peroxide (H2O2)-HRP system was employed for the chemiluminescence detection. The proposed method combined the advantages of the micro-plate reactor and magnetic particle separation technology with the linear range of 5-250 ng mL·1. The detection limit of CEA was 0.61 ng mL·1. The coefficient of the variation was less than 7% and 13% for intra-assay and inter-assay precision, respectively. Compared with the commercial micro-plate chemiluminescent kit, the proposed method showed a good correlation.展开更多
This letter reports a chemiluminescene immunoassay method combined with immunomagnetic separation to rapidly detect Cyfra 21-1, in which bio-functionlized magnetic nanocomposites were used as mobile substrate for capt...This letter reports a chemiluminescene immunoassay method combined with immunomagnetic separation to rapidly detect Cyfra 21-1, in which bio-functionlized magnetic nanocomposites were used as mobile substrate for capturing and isolating the cyfra 21-1 proteins. After the captured Cyfra 21-1 further reacted with horseradish peroxidase-conjugated anti-Cyfra 21-1 antibody to form a sandwich immunocomplex, the chemiluminescence would be produced as a result of addition of the chemiluminescent substrate. A home-made optical biosensor was designed to detect the chemiluminescence instead of other large instruments. There is a good linear response between the chemiluminescence intensity and the concentration of Cyfra 21-1 in the range from 0.2 to 50 ng/mL. The whole detection process including incubation, washing and detection could be performed within 45 min. The proposed method offers a simple, noninvasive and reliable tool for detecting non-small cell lung cancer and has potential application for clinical testing.展开更多
Glypican-3 (GPC3) is reported as a great promising tumor marker for hepatocellular carcinoma (HCC) diagnosis.Highly sensitive and accurate analysis of serum GPC3 (sGPC3),in combination with or instead of traditional H...Glypican-3 (GPC3) is reported as a great promising tumor marker for hepatocellular carcinoma (HCC) diagnosis.Highly sensitive and accurate analysis of serum GPC3 (sGPC3),in combination with or instead of traditional HCC marker alpha-fetoprotein (AFP),is essential for early diagnosis of HCC.Biomaterial-functionalized magnetic particles have been utilized as solid supports with good biological compatibility for sensitive immunoassay.Here,the magnetic nanoparticles (MnPs) and magnetic microparticles (MmPs) with carboxyl groups were further modified with streptavidin,and applied for the development of chemiluminescence enzyme immunoassay (CLEIA).After comparing between MnPsand MmPs-based CLEIA,MnPs-based CLEIA was proved to be a better method with less assay time,greater sensitivity,better linearity and longer chemiluminescence platform.MnPs-based CLEIA was applied for detection of sGPC3 in normal liver,hepatocirrhosis,secondary liver cancer and HCC serum samples.The results indicated that sGPC3 was effective in diagnosis of HCC with high performance.展开更多
This paper described a new immunoassay method by capillary electrophoresis with enhanced chemiluminescence (CL) detection system based on luminol-hydrogen peroxide reaction catalyzed by horseradish peroxides (HRP). Us...This paper described a new immunoassay method by capillary electrophoresis with enhanced chemiluminescence (CL) detection system based on luminol-hydrogen peroxide reaction catalyzed by horseradish peroxides (HRP). Using para-iodophenol as a CL enhancer, the detection limit of about 1×10-12 mol/L for HRP was achieved, which corresponded to 1.32×10-5 U/mL. In optimal conditions, the free HRP-labeled CA125 antibody (Ab*) and the bound enzyme-labeled complex (Ab*-Ag) were well separated by capillary electrophoresis within 4 min. The assay was successfully used to determine the contents of CA125 in human sera, which were associated with ovarian cancer, and the recoveries of the standard addition experiments were 96 to 109 %.展开更多
BACKGROUND Antinuclear antibodies(ANAs)are crucial in diagnosing autoimmune diseases,mainly systemic lupus erythematosus(SLE).This study aimed to compare the performance of chemiluminescence assay(CLIA)and line immuno...BACKGROUND Antinuclear antibodies(ANAs)are crucial in diagnosing autoimmune diseases,mainly systemic lupus erythematosus(SLE).This study aimed to compare the performance of chemiluminescence assay(CLIA)and line immunoassay(LIA)in detecting ANAs in patients with autoimmune diseases,evaluate their diagnostic accuracy for SLE,and develop a novel diagnostic model using CLIA-detected antibodies for SLE.Specimens from patients with autoimmune diseases and physical examination specimens were collected to parallel detect specific antibodies.Individual antibodies'diagnostic performance and a model combining multiple antibodies were assessed.The findings provide valuable insights into improving the diagnosis of SLE through innovative approaches.AIM To compare the performance of CLIA and LIA in detecting ANAs in patients with autoimmune diseases,assess their accuracy for SLE,and develop a novel diagnostic model using CLIA-detected antibodies for SLE.METHODS Specimens have been obtained from 270 patients with clinically diagnosed autoimmune disorders,as well as 130 physical examination specimens.After that,parallel detection of anti-double-stranded DNA(dsDNA)antibody,anti-histone(Histone)antibody,anti-nucleosome(Nuc)antibody,anti-Smith(Sm)antibody,anti-ribosomal P protein(Rib-P)antibody,anti-sicca syndrome A(Ro60)antibody,anti-sicca syndrome A(Ro52)antibody,anti-sicca syndrome(SSB)antibody,anticentromere protein B(Cenp-B)antibody,anti-DNA topoisomerase 1(Scl-70)antibody,anti-histidyl tRNA synthetase(Jo-1)antibody,and anti-mitochondrial M2(AMA-M2)antibody was performed using CLIA and LIA.The detection rates,compliance rates,and diagnostic performance for SLE were compared between the two methodologies,followed by developing a novel diagnostic model for SLE.RESULTS CLIA and LIA exhibited essentially comparable detection rates for anti-dsDNA antibody,anti-Histone antibody,anti-Nuc antibody,anti-Sm antibody,anti-Rib-P antibody,anti-Ro60 antibody,anti-Ro52 antibody,anti-SSB antibody,anti-Cenp-B antibody,anti-DNAScl-70 antibody,anti-Jo-1 antibody and anti-AMA-M2 antibody(P>0.05).The two methods displayed identical results for the detection of anti-dsDNA antibody,anti-Histone antibody,anti-Nuc antibody,anti-Sm antibody,anti-Ro60 antibody,anti-Ro52 antibody,anti-SSB antibody,anti-Cenp-B antibody,anti-Scl-70 antibody,and anti-AMA-M2 antibody(Kappa>0.7,P<0.05),but showed a moderate agreement for the detection of anti-Rib-P antibody and anti-Jo-1 antibody(Kappa=0.671 and 0.665;P<0.05).In addition,the diagnostic performance of these antibodies detected by both methods was similar for SLE.The diagnostic model's area under the curve values,sensitivity,and specificity,including an anti-dsDNA antibody and an anti-Ro60 antibody detected by CLIA,were 0.997,0.962,and 0.978,respectively.These values were higher than the diagnostic performance of individual antibodies.CONCLUSION CLIA and LIA demonstrated excellent overall consistency in detecting ANA profiles.A diagnostic model based on CLIA-detected antibodies can successfully contribute to developing a novel technique for detecting SLE.展开更多
Background:This study was planned to assess the accuracy and comparability of two commercially available,laboratory-based SARS-CoV-2(severe acute respiratory syndrome)antigen(Ag)immunoassays.Methods:We studied a cohor...Background:This study was planned to assess the accuracy and comparability of two commercially available,laboratory-based SARS-CoV-2(severe acute respiratory syndrome)antigen(Ag)immunoassays.Methods:We studied a cohort of subjects with acute SARS-CoV-2 infection,from whom a nasopharyngeal swab was taken and tested with a molecular assay(Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit)and two laboratory-based,fully automated SARS-CoV-2 Ag immunoassays(Fujirebio Lumipulse G SARS-CoV-2 Ag and Roche Elecsys SARS-CoV-2 Ag).Results:The final population consisted in 93 subjects testing positive for SARS-CoV-2 RNA,34 with cycle threshold(Ct)values<29.5.The results of the two SARS-CoV-2 Ag immunoassays were significantly intercorrelated(r=0.77;P<0.001)in the entire cohort,though such correlation considerably improved in patients with high viral load(cycle threshold values<29.5:r=0.96;P<0.001).The accuracy for identifying samples with high viral load was excellent for both Lumipulse G SARS-CoV-2 Ag(AUC,0.99;P<0.001)and Elecsys SARS-CoV-2 Ag(AUC,0.99;P<0.001),with best cut-offs of 2.03 ng/mL for Lumipulse G SARS-CoV-2 Ag(1.00 sensitivity and 0.88 specificity)and 0.70 COI for Elecsys SARS-CoV-2 Ag(1.00 sensitivity and 0.80 specificity),respectively.Conclusion:The results of this study provide valuable support to usability of fully-automated,rapid,high throughput and accurate SARS-CoV-2 Ag immunoassays for complementing molecular assays.展开更多
文摘AIM: To evaluate cortisolemia by using conventional electrochemiluminescence immunoassay(ECLIA) method compared to liquid chromatography-tandem mass spectrometry(LC-MS/MS) method in active ulcerative colitis(UC) patients treated with oral prednisone(PD). METHODS: Twenty patients(12 males) with acute relapse of UC started oral PD at a dose of 40 mg once a day, tapered of 10 mg every 2 wk. When a stable 2-wk daily dose of 30 mg was reached, blood samples for cortisol levels' measurement were drawn in the morning in fasting conditions to determine circulating cortisol by LC-MS/MS and ECLIA assay. RESULTS: Median interquartile range cortisolemia with ECLIA and LC-MS/MS method was 54.1(185.8) nmol/L and 32.1(124.0) nmol/L, respectively(P < 0.001). The within-patient median differences between the two methods was 23.2(40.6) nmol/L, with higher cortisol levels for the ECLIA method. The estimated geomet-ric mean ratio between methods was 1.85(95%CI: 2.39-1.43) considering all data or 1.58(95%CI: 2.30-1.09) considering only data above the limit of quantification(n = 12). The 95%CIs of the geometric mean ratio between methods confirm a statistically significant difference.CONCLUSION: Blood cortisol levels detected with ECLIA method seems to be higher than the ones measured by LC-MS/MS, indicating a possible overestimation of them in patients treated with PD. Therefore, the cortisol suppression in patients under treatment with oral PD should not be measured using ECLIA method.
基金financially supported by National Natural Science Foundation of China (Nos.81902153,61871180,62071119 and 61971187)Jiangsu Provincial Key Research and Development Program (Nos.BA2020016 and BE 2018695)。
文摘Chemiluminescence immunoassay(CLⅠA) has always been a great challenge in detecting cardiac troponin Ⅰ(c Tn Ⅰ) in whole blood samples without centrifugation because of the interference of red blood cells and low sensitivity. Ⅰn this study, the antigens and erythrocytes in the blood were captured by the antibodies immobilized on the magnetic particles, recognized by another biotinconjugated c Tn Ⅰ antibody and detected by streptavidin/acridine aster-conjugated polychloromethylstyrene microspheres(PCMS). After magnetic separation, the supernatant was transferred and measured. No significant difference was noted between the c Tn Ⅰ concentrations of the serum samples,plasma samples and whole blood. The prepared PCMS provided more functional areas to conjugate streptavidin and acridinium ester, so the immunoassay has highly sensitive, the limits of blank at0.012 ng/mL, and functional sensitivity at 0.019 ng/mL with a CV of 20%, and 0.058 ng/mL with a CV of 10%. Total precision of any sample type ranged from 2.62%~5.67%. The assay was linear over the studied range of 0.01-50.00 ng/mL, and no hook effect was found when c Tn Ⅰ concentrations reached 1900 ng/mL. No significant interference was noted with the potential endogenous interfering substances. Compared with the commercial kit(Abbott assay kit), the correlation coefficient was 0.9859. A washing-free CLⅠA was established for the rapid detection of c Tn Ⅰ in human whole blood, using erythrocyte capture antibodies-conjugated magnetic nanoparticles for eliminating the influence of erythrocytes and PCMS for signal amplification, which showed great potential in clinical application.
基金supported by the National Basic Research Program of China (973 Program,no. 2007CB714507)National Nature Science Foundation of China (no. 90813015)
文摘A chemiluminescence enzyme immunoassay based on magnetic microparticles (MmPs-CLEIA) was developed to evaluate serum a-fetoprotein (AFP) in parallel with traditional colorimetric enzyme-linked immunosorbent assay (ELISA).A systematic comparison between the MmPs-CLEIA and colorimetric ELISA concluded that the MPs-CLEIA exhibited fewer dosages of immunoreagents,less total assay time,and better linearity,recovery,precision,sensitivity and validity.AFP was detected in forty human serum samples by the proposed MPs-CLEIA and ELISA,and the results were compared with commercial electrochemiluminescence immunoassay (ECLIA) kit.The correlation coefficient between MPs-CLEIA and ELISA was obtained with R 2 0.6703;however,the correlation between MPs-CLEIA and ECLIA (R 2 0.9582) was obviously better than that between colorimetric ELISA and ECLIA (R 2 0.6866).
基金supported by the National Natural Science Foundation of China(Nos.81402721,81573203,21605131)Science and Technology Department of Henan Province(No.22170004)
文摘DNA methyltransferase 1(DNMT1)is a useful biomarker for lung cancer in early clinical diagnosis.A rapid magnetic chemiluminescence immunoassay(MCLIA)for DNMT1 in human serum has been developed.Horseradish peroxidase(HRP)-second-Ab was used to labeled polyclonal antibodies of anti-DNMT1.DNMT1 in sample integrates with specific immunomagnetic beads and can constitute a supersandwiched immunoreaction.In magnetic field,nonspecific materials can be separated.After luminescent substrate luminol-H2O2-BIP was added,the relative light unit(RLU)of HRP was detected and was discovered to be directly proportional to the content of DNMT1 in sample.The correlative variables involved in the MCLIA value were optimized and the methodological evaluation was carried out.After optimization,in the range of0.5–128 ng/mL,the linear regression equation was y=0.5014 x+1.769(x was logCDNMT1,y was relative luminescence units(RLU)/RLU0),and the limit of detection was 0.01 ng/mL.The RSD of intra-and interassays were 15.8%–16.9%and 14.3%–18.1%,respectively.The recovery was from 70.0%to 106.2%.Furthermore,paralleled with purchasable enzyme-linked immunosorbent assay(ELISA)kits,MCLEIA had lower detection limit,wider linear range and shorter detection time.Therefore,the MCLEIA established in this study could be used for the sensitive detection of DNMT1 in serum sample.
基金support from the CAS Major Scientific Research and Equipment Development Projects (YZ-0632)the National Natural Science Founolation of China (Grant No. 20907060)+2 种基金the CAS Graduate Innovation Foundation (No. YXLW-3)the National key Technology R&D Program (Grant No. 2006BAF07B03-1-1)Shaanxi Province, China’s Scholarship Council (Grant No. 08JK482)
文摘A micro-plate magnetic chemiluminescence immunoassay was developed for rapid and high throughput detection of carcinoembryonic antigens (CEA) in human sera. This method was based on a sandwich immunoreaction of fluorescein isothiocyanate (FITC)-labeled anti-CEA antibodies, CEA antigens, and horseradish peroxidase (HRP)-conjugated anti-CEA antibodies in mi- cro-plate. The immunomagnetic particles coated with anti-FITC antibodies were used as the solid phase for the immunoassay. The separation procedure was carried out by a magnetic plate adaptor and the luminol-hydrogen peroxide (H2O2)-HRP system was employed for the chemiluminescence detection. The proposed method combined the advantages of the micro-plate reactor and magnetic particle separation technology with the linear range of 5-250 ng mL·1. The detection limit of CEA was 0.61 ng mL·1. The coefficient of the variation was less than 7% and 13% for intra-assay and inter-assay precision, respectively. Compared with the commercial micro-plate chemiluminescent kit, the proposed method showed a good correlation.
基金supported by the National Natural Science Foundation of China (61125105, 61101048, 61002037, 61027001)the Major National Scientific Research Plan (2011CB933202)the"Strategic Priority Research Program"of the Chinese Academy of Sciences (XDA06020101)
文摘This letter reports a chemiluminescene immunoassay method combined with immunomagnetic separation to rapidly detect Cyfra 21-1, in which bio-functionlized magnetic nanocomposites were used as mobile substrate for capturing and isolating the cyfra 21-1 proteins. After the captured Cyfra 21-1 further reacted with horseradish peroxidase-conjugated anti-Cyfra 21-1 antibody to form a sandwich immunocomplex, the chemiluminescence would be produced as a result of addition of the chemiluminescent substrate. A home-made optical biosensor was designed to detect the chemiluminescence instead of other large instruments. There is a good linear response between the chemiluminescence intensity and the concentration of Cyfra 21-1 in the range from 0.2 to 50 ng/mL. The whole detection process including incubation, washing and detection could be performed within 45 min. The proposed method offers a simple, noninvasive and reliable tool for detecting non-small cell lung cancer and has potential application for clinical testing.
基金supported by the National Basic Research Program of China (973 Program,No.2007CB714507)the National Natural Science Foundation of China (No.90813015)
文摘Glypican-3 (GPC3) is reported as a great promising tumor marker for hepatocellular carcinoma (HCC) diagnosis.Highly sensitive and accurate analysis of serum GPC3 (sGPC3),in combination with or instead of traditional HCC marker alpha-fetoprotein (AFP),is essential for early diagnosis of HCC.Biomaterial-functionalized magnetic particles have been utilized as solid supports with good biological compatibility for sensitive immunoassay.Here,the magnetic nanoparticles (MnPs) and magnetic microparticles (MmPs) with carboxyl groups were further modified with streptavidin,and applied for the development of chemiluminescence enzyme immunoassay (CLEIA).After comparing between MnPsand MmPs-based CLEIA,MnPs-based CLEIA was proved to be a better method with less assay time,greater sensitivity,better linearity and longer chemiluminescence platform.MnPs-based CLEIA was applied for detection of sGPC3 in normal liver,hepatocirrhosis,secondary liver cancer and HCC serum samples.The results indicated that sGPC3 was effective in diagnosis of HCC with high performance.
基金supported by the National Natural Science Foundation of China(No.20271033)the key project of National Natural Science Foundation of China(No.20335020)Natural Science Foundation of Shanghai(No.02ZA14057).
文摘This paper described a new immunoassay method by capillary electrophoresis with enhanced chemiluminescence (CL) detection system based on luminol-hydrogen peroxide reaction catalyzed by horseradish peroxides (HRP). Using para-iodophenol as a CL enhancer, the detection limit of about 1×10-12 mol/L for HRP was achieved, which corresponded to 1.32×10-5 U/mL. In optimal conditions, the free HRP-labeled CA125 antibody (Ab*) and the bound enzyme-labeled complex (Ab*-Ag) were well separated by capillary electrophoresis within 4 min. The assay was successfully used to determine the contents of CA125 in human sera, which were associated with ovarian cancer, and the recoveries of the standard addition experiments were 96 to 109 %.
文摘BACKGROUND Antinuclear antibodies(ANAs)are crucial in diagnosing autoimmune diseases,mainly systemic lupus erythematosus(SLE).This study aimed to compare the performance of chemiluminescence assay(CLIA)and line immunoassay(LIA)in detecting ANAs in patients with autoimmune diseases,evaluate their diagnostic accuracy for SLE,and develop a novel diagnostic model using CLIA-detected antibodies for SLE.Specimens from patients with autoimmune diseases and physical examination specimens were collected to parallel detect specific antibodies.Individual antibodies'diagnostic performance and a model combining multiple antibodies were assessed.The findings provide valuable insights into improving the diagnosis of SLE through innovative approaches.AIM To compare the performance of CLIA and LIA in detecting ANAs in patients with autoimmune diseases,assess their accuracy for SLE,and develop a novel diagnostic model using CLIA-detected antibodies for SLE.METHODS Specimens have been obtained from 270 patients with clinically diagnosed autoimmune disorders,as well as 130 physical examination specimens.After that,parallel detection of anti-double-stranded DNA(dsDNA)antibody,anti-histone(Histone)antibody,anti-nucleosome(Nuc)antibody,anti-Smith(Sm)antibody,anti-ribosomal P protein(Rib-P)antibody,anti-sicca syndrome A(Ro60)antibody,anti-sicca syndrome A(Ro52)antibody,anti-sicca syndrome(SSB)antibody,anticentromere protein B(Cenp-B)antibody,anti-DNA topoisomerase 1(Scl-70)antibody,anti-histidyl tRNA synthetase(Jo-1)antibody,and anti-mitochondrial M2(AMA-M2)antibody was performed using CLIA and LIA.The detection rates,compliance rates,and diagnostic performance for SLE were compared between the two methodologies,followed by developing a novel diagnostic model for SLE.RESULTS CLIA and LIA exhibited essentially comparable detection rates for anti-dsDNA antibody,anti-Histone antibody,anti-Nuc antibody,anti-Sm antibody,anti-Rib-P antibody,anti-Ro60 antibody,anti-Ro52 antibody,anti-SSB antibody,anti-Cenp-B antibody,anti-DNAScl-70 antibody,anti-Jo-1 antibody and anti-AMA-M2 antibody(P>0.05).The two methods displayed identical results for the detection of anti-dsDNA antibody,anti-Histone antibody,anti-Nuc antibody,anti-Sm antibody,anti-Ro60 antibody,anti-Ro52 antibody,anti-SSB antibody,anti-Cenp-B antibody,anti-Scl-70 antibody,and anti-AMA-M2 antibody(Kappa>0.7,P<0.05),but showed a moderate agreement for the detection of anti-Rib-P antibody and anti-Jo-1 antibody(Kappa=0.671 and 0.665;P<0.05).In addition,the diagnostic performance of these antibodies detected by both methods was similar for SLE.The diagnostic model's area under the curve values,sensitivity,and specificity,including an anti-dsDNA antibody and an anti-Ro60 antibody detected by CLIA,were 0.997,0.962,and 0.978,respectively.These values were higher than the diagnostic performance of individual antibodies.CONCLUSION CLIA and LIA demonstrated excellent overall consistency in detecting ANA profiles.A diagnostic model based on CLIA-detected antibodies can successfully contribute to developing a novel technique for detecting SLE.
文摘Background:This study was planned to assess the accuracy and comparability of two commercially available,laboratory-based SARS-CoV-2(severe acute respiratory syndrome)antigen(Ag)immunoassays.Methods:We studied a cohort of subjects with acute SARS-CoV-2 infection,from whom a nasopharyngeal swab was taken and tested with a molecular assay(Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit)and two laboratory-based,fully automated SARS-CoV-2 Ag immunoassays(Fujirebio Lumipulse G SARS-CoV-2 Ag and Roche Elecsys SARS-CoV-2 Ag).Results:The final population consisted in 93 subjects testing positive for SARS-CoV-2 RNA,34 with cycle threshold(Ct)values<29.5.The results of the two SARS-CoV-2 Ag immunoassays were significantly intercorrelated(r=0.77;P<0.001)in the entire cohort,though such correlation considerably improved in patients with high viral load(cycle threshold values<29.5:r=0.96;P<0.001).The accuracy for identifying samples with high viral load was excellent for both Lumipulse G SARS-CoV-2 Ag(AUC,0.99;P<0.001)and Elecsys SARS-CoV-2 Ag(AUC,0.99;P<0.001),with best cut-offs of 2.03 ng/mL for Lumipulse G SARS-CoV-2 Ag(1.00 sensitivity and 0.88 specificity)and 0.70 COI for Elecsys SARS-CoV-2 Ag(1.00 sensitivity and 0.80 specificity),respectively.Conclusion:The results of this study provide valuable support to usability of fully-automated,rapid,high throughput and accurate SARS-CoV-2 Ag immunoassays for complementing molecular assays.
