JOURNAL OF CLINICAL LABORATORY ANALYSIS
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2018
·Vol. 32
·期 6
·e22426
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IF 1.303
Zhi-yuan Lin,Yi-zhen Fang,Hong-wei Jin,Hua-yue Lin,Zhang Dai,Qing Luo,Hong-wei Li,Yan-ling Lin,Shui-zhen Huang,Lei Gao,Fei-hai Xu,Zhong-ying Zhang
Background To verify and evaluate the performance characteristics of a creatine kinase phosphokinase isoenzymes MB (CK-MB) assay kit, which produced by Xiamen Innodx Biotech Co. Ltd. Methods Evaluation was carried out according to “Guidelines for principle of analysis performance evaluation of in vitro diagnostic reagent.” The performance parameters included detection limit, linearity range, reportable range, recovery test, precision verification, interference test, cross-reactivity, matrix effect, and method comparison. Results The detection limit was 0.1 ng/mL. The assay had clinical linearity over range of 0.1 ng/mL-500 ng/mL. Reportable range was from 0.1 ng/mL to 1000 ng/mL. The average percent of recovery was 99.66%. The coefficient of variation (CV) for within-run and between-run of low CK-MB sample was 5.55% and 6.16%, respectively. As for high-level sample, it was 7.88% and 7.80%. In medical decision level, the relative deviation (Bias) of all interference tests was lower than 15%. When the sample had mild-hemolysis; hemoglobin ≤15 g/L; triglyceride ≤17 mmol/L; bilirubin ≤427.5 μmol/L; rheumatoid factor ≤206U/mL, there was no significant interference to be found. Moreover, assay kit had no cross-reaction with CK-MM and CK-BB. At last, total diagnostic accuracy of kit was 93.24%, when compared with refer kit. Conclusion Overall the results of the verification study indicated the performance of kit is met the requirements of the clinical test.
研究领域:
医学检验
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生物化学
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产品关联
DOI
PubMed
高影响因子
COLLOIDS AND SURFACES A-PHYSICOCHEMICAL AND ENGINEERING ASPECTS
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2025
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IF 5.4
Shihong Zhu,Daohang Du,Shuli Yu,Ting Tao,Xianfeng Chu,Yunhua Jiang,Jia Yang,Jiefu Li,Zhifei Wang
Chemiluminescent immunoassays utilizing magnetic nanoparticles exhibit critical importance in in vitro diagnostics, attributed to their remarkable superparamagnetic properties, high specificity, and uniform monodispersity. Current surface functionalization strategies for antibody conjugation predominantly rely on carboxyl or amino groups, requiring pre-activation steps for both amino- and carboxyl-modified nanoparticles prior to antibody labeling. However, the complex activation protocols and persistent challenges in developing efficient chemiluminescent detection methods highlight significant technical obstacles. To address these limitations, we developed vinyl sulfone-functionalized magnetic beads (VSF-GMP), enabling rapid antibody conjugation via specific reactions between vinyl sulfone groups and lysine residues exposed on the surface of creatine kinase MB isoenzyme antibodies (CK-MB). This approach facilitates highly efficient chemiluminescent immunoassays. The engineered VSF-GMP magnetic beads demonstrated molecular weight-dependent adsorption profiles, achieving maximal binding capacity (86.32 μg/mg) for mouse IgG (150 kDa) compared to β-lactoglobulin (18.2 kDa) and bovine serum albumin (66.4 kDa). Moreover, compared with the protein coupling method using EDC/NHS-activated carboxylated magnetic beads, our VSF-GMP beads exhibited superior coupling efficiency. Additionally, bis-functionalized poly(ethylene glycol) (NH 2 -PEG-NH 2 ) was employed as a blocking agent to optimize the reactivity and stability of antibody conjugation, reducing non-specific protein labeling on the magnetic beads by 97.8 %. The analytical performance of the proposed chemiluminescent immunoassay (CLIA) was rigorously evaluated. Finally, the practical utility of VSF-GMP magnetic beads for CK-MB determination in plasma samples was investigated. These engineered magnetic beads showcase exceptional analytical sensitivity, specificity, and operational simplicity, establishing a robust platform for advanced chemiluminescent diagnostics with enhanced throughput capabilities.
研究领域:
生物医学工程
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分析化学
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免疫学
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产品关联
DOI
高影响因子
BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS
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2020
·
IF 2.985
Gen Liu,Bo-fang Zhang,Qi Hu,Xiao-pei Liu,Jing Chen
Syringic acid is an abundant phenolic acid compound that possesses anti-oxidant, anti-microbial, anti-inflammatory, and anti-endotoxic properties. However, the research of pretreatment with syringic acid against myocardial ischemia reperfusion is still limited. Thus, our research revealed the protective effect of syringic acid in the rat model with myocardial ischemia reperfusion injury. Histological analysis was performed by hematoxylin and eosin (H&E). The myocardial systolic function was detected by echocardiographic. Myocardial infarct size was measured by Evans blue and 2,3,5-triphenyltetrazolium chloride (TTC) double staining. The apoptosis index was recorded by Terminal deoxynucleotidyl transferase dUTP nick end labeling staining (TUNEL). The contents of creatine kinase MB (CK-MB) and lactate dehydrogenase (LDH) in the serum were determined by a commercial kit. The expression of the PI3K/Akt/GSK-3β signaling pathway-related molecules and apoptosis-associated indicators was detected by western blotting or real-time PCR. We found that pretreatment with syringic acid obviously increased the myocardial systolic function (LVEF and LVFS) and decreased the infarct size, the apoptosis index as well as the serum level of CK-MB and LDH. Meanwhile, syringic acid also remarkably augmented the contents of p-PI3K, p-Akt, p-GSK-3β, Bcl-2 and mitochondria cytochrome c . However, the expression of caspase-3, -9 and Bax significantly reduced. Interestingly, co-treatment with PI3K inhibitor of LY294002 counteracted those effects induced by syringic acid. In conclusion, pretreatment with syringic acid can mitigate myocardial ischemia reperfusion injury by inhibiting mitochondria-induced apoptosis which is regulated by the PI3K/Akt/GSK-3β signaling pathway .
研究领域:
药理学
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心脏病学
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分子生物学
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产品关联
DOI
PubMed
高影响因子
BIOSENSORS & BIOELECTRONICS
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2018
·
IF 8.173
Kaige Zhao,Min Tang,Huaisheng Wang,Zhenxian Zhou,Yafeng Wu,Songqin Liu
An immunosensing biochip for simultaneous detection of three biomarkers related to acute myocardial infarction (AMI) was developed based on anionic soybean peroxidase (SBP) functionalized nanoprobe and chemiluminescent imaging. The nanoprobes (Ab2-SiO 2 -SBP) were fabricated by co-immobilization of SBP and one of the detection polyclonal antibodies , anti-cardiac troponin I antigen (anti-cTnI), anti-creatine kinase-MB (anti-CK-MB) and anti-myoglobin (anti-Myo), on the silica nanoparticle surface. The detection sensitivity was enhanced since the large surface area of silica carriers increased the loading of SBP for per sandwiched immunoreaction. The immunosensing biochip designed as 3 × 8 wells array was constructed by simultaneously immobilizing three capture monoclonal antibodies on the same one microtiter well with 2 × 3 active spots. In the presence of target protein, the nanoprobes will be attached onto the spots with high specificity through the sandwiched immunoreactions, which triggered the chemiluminescence (CL) signals on each sensing site of the microtiter plates and allowed to CL imaging of three biomarkers in one well at the same time. Therefore, the proposed biochip was a promising convenient strategy for simultaneous detection of cTnI, CK-MB and Myo, which showed potential application for multianalyte determination in clinical diagnostics.
研究领域:
生物医学工程
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临床诊断
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纳米技术
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免疫学
✓ 已验证
产品关联
DOI
PubMed
高影响因子
MICROCHEMICAL JOURNAL
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2021
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IF 4.821
Junjie Wang,Chunxiang Xu,Milan Lei,Yi Ma,Xiaoxuan Wang,Ru Wang,Jianli Sun,Ru Wang
The detection of cardiac markers with high sensitivity and specificity is exceedingly essential for the early diagnosis and warning of cardiovascular disease. In this work, we developed a microcavity-based sandwich immune chip to realize the ultrasensitive detection of cardiac troponin I (cTnI) and creatine kinase isoenzyme MB (CK-MB) by surface-enhanced Raman spectroscopy (SERS) method. Herein, polystyrene microspheres modified with gold nanoparticles (Au NPs) were fixed on the substrate via polydopamine, which was used as an immune capture chip. 5,5′-Dithio bis-(2-nitrobenzoic acid) (DTNB) and 4-mercaptobenzoic acid (4MBA) labelled Au NPs served as immune signal probes for cTnI and CK-MB, respectively. Light confinement effect of polystyrene (PS) microcavities and localized surface plasmon resonance (LSPR) near the Au NPs synergistically strengthened the electromagnetic field and promoted the interaction between light and matter, which enhanced SERS performance with an enhancement factor of 1.95 × 10 12 for SERS sensing. The immunoassay results demonstrated the sensitive quantitative detection with the limit of detection (LOD) of 3.16 pg/mL and 4.27 pg/mL for cTnI and CK-MB, separately. The method also had good specificity, reproducibility and stability. It could be expected that our proposed microcavity-based SERS chip immunoassay technique would be considered as an effective diagnostic tool for ultrasensitive detection of cardiac biomarkers.
研究领域:
心脏病学
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纳米技术
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分析化学
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生物医学工程
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DOI
高影响因子
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