Performance evaluation of a chemiluminescence microparticle immunoassay for <scp>CK</scp>‐<scp>MB</scp>

Lin, Zhenxu; Fang, Yizhen; Jin, Hongwei; Lin, Hongxin; Zhang, Dai; Luo, Qin; Li, Hongwei; Yan-Ling, Lin; Huang, Shui‐zhen; Gao, Lei; Xu, Fang; Zhang, Zhongying

doi:10.1002/jcla.22426

Cited by 4 publications

(6 citation statements)

References 8 publications

(10 reference statements)

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“…The PC detection system established in this study has the following advantages: (i) Compared with the detection kit based on the coagulation method, the chromogenic substrate method is not easily affected by some interfering enzymes and anticoagulant drugs in vivo , and has higher stability and precision. 13 , 15 (ii) The reaction time is moderate, and the entire detection process only takes 15 min. (iii) The reagent production cost is lower, which can effectively reduce the burden on patients and facilitate the development of PC activity testing in the clinic.…”

Section: Discussionmentioning

confidence: 99%

“…The correlation equation and correlation coefficient were determined, and the consistency of the two detection systems was presented with the Bland‐Altman plot. In addition, receiver operating characteristic (ROC) curves were used to analyze and compare the diagnostic efficiency of the two detection systems for DVT 13,14 …”

Section: Methodsmentioning

confidence: 99%

“…In addition, receiver operating characteristic (ROC) curves were used to analyze and compare the diagnostic efficiency of the two detection systems for DVT. 13 , 14 …”

Section: Methodsmentioning

confidence: 99%

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Establishment of a new protein C detection system based on chromogenic substrate assay and its clinical diagnostic value for deep vein thrombosis

Ge²,

Zhao

et al. 2021

Clinical Laboratory Analysis

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Background Deficiency of protein C (PC) affects the balance between blood coagulation and fibrinolysis in the human body. Chromogenic‐based assay is recommended as the preferred screening method for detecting PC deficiency. We established a PC detection system based on the chromogenic substrate assay. Methods First, a kit for the determination of PC activity in plasma was elaborately developed and its reaction parameters on XL‐3200c were explored. Then, we evaluated its performance and collected specimens to compare the test results obtained with those of the Siemens detection system. Finally, the clinical diagnostic efficacy of this detection system for deep vein thrombosis (DVT) was assessed. Results Optimum conditions for PC detection were 0.25–0.1 U/ml protein C activator Protac® and 2.5–1 mM Pefachrome®PCa5297. The composition and concentration ranges of buffer substances and stabilizers in the kit were also explored. Satisfactory results were observed in performance evaluation. The test results of the newly built detection system were highly correlated with those of the Siemens detection system (R2 = 0.9771 in the control group and R2 = 0.9776 in the DVT group), and Bland‐Altman plots also showed high consistency between the two detection systems. In addition, the area under the curve (AUC) of the newly built PC detection system for DVT was 0.888, indicating this system could effectively improve the diagnostic sensitivity and specificity for DVT. Conclusion In this study, a sensitive, wide linear range and reliable PC activity detection system were established.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Establishment of a new protein C detection system based on chromogenic substrate assay and its clinical diagnostic value for deep vein thrombosis

Ge²,

Zhao

et al. 2021

Clinical Laboratory Analysis

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“…Therefore, the three different cytosolic isoenzymes formed by the various combinations of M (muscle) and B (brain) subunits in the cytosol are-CK-MM, CK-MB and CK-BB. [1][2][3][4][5][6] The CK-MM is mainly found in all kinds of muscle cells, CK-MB mainly in the myocardial cells and CK-BB exists mainly in the brain cells. 3 The distribution of various isoenzymes in the serum of healthy individuals is:-CK-MM (96-100%), CK-MB (0-6%) and CK-BB is almost undetectable.…”

Section: Introductionmentioning

confidence: 99%

“…[1][2][3][4][5][6] The CK-MM is mainly found in all kinds of muscle cells, CK-MB mainly in the myocardial cells and CK-BB exists mainly in the brain cells. 3 The distribution of various isoenzymes in the serum of healthy individuals is:-CK-MM (96-100%), CK-MB (0-6%) and CK-BB is almost undetectable. 6 Apart from these cytosolic enzymes, a mitochondrial isoenzyme of CK (CKm) is found in muscle, brain and cerebrospinal fluid.…”

Section: Introductionmentioning

confidence: 99%

Creatine Kinase-MB measurement using Immunoinhibition methodology. How much is the interference?

Gulia¹,

Goswami²

2020

PJMS

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Creatine kinase-MB (CK-MB) is considered as sensitive and specific indicator for myocardial infarction. Various methods are available for CK-MB measurement but are associated with inherent shortcomings. The routinely used Immunoinhibition method is evaluated for the various interferents and their impact on the estimated CK-MB value. Materials and Methods: The CK-MB values were analyzed for 500 patient samples whose total CK values were within the normal reference interval. Immunoinhibition method (INH) & N-Acetylcysteine (NAC) methods were used for CK-MB and total CK estimation respectively. Results: The observed mean ± S.D. for CK was 90.15 ± 48.9 U/L and for CK-MB was 33.29 ± 20.47 U/L. The box and whisker plots were used to represent the data of CK & CK-MB. The CK-MB levels were observed to exceed the total CK under certain circumstances owing to interferents. The CK-MB values were observed to exceed the total CK in 8.6% of the cases. Conclusion:The utility of CK-MB has ever been questioned. It has been categorized as over-used test. The conventional immunoassay methodology for CK-MB measurement is not free from interferences, awareness about these is important while interpreting the results so as to exclude method related artifactual values.

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On the Challenges for the Diagnosis of SARS-CoV-2 Based on a Review of Current Methodologies

et al. 2020

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Diagnosis of COVID-19 has been challenging owing to the need for mass testing and for combining distinct types of detection to cover the different stages of the infection. In this review, we have surveyed the most used methodologies for diagnosis of COVID-19, which can be basically categorized into genetic-material detection and immunoassays. Detection of genetic material with real-time polymerase chain reaction (RT-PCR) and similar techniques has been achieved with high accuracy, but these methods are expensive and require time-consuming protocols which are not widely available, especially in less developed countries. Immunoassays for detecting a few antibodies, on the other hand, have been used for rapid, less expensive tests, but their accuracy in diagnosing infected individuals has been limited. We have therefore discussed the strengths and limitations of all of these methodologies, particularly in light of the required combination of tests owing to the long incubation periods. We identified the bottlenecks that prevented mass testing in many countries, and proposed strategies for further action, which are mostly associated with materials science and chemistry. Of special relevance are the methodologies which can be integrated into point-of-care (POC) devices and the use of artificial intelligence that do not require products from a well-developed biotech industry.

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Performance evaluation of a chemiluminescence microparticle immunoassay for CK‐MB

Abstract: Overall the results of the verification study indicated the performance of kit is met the requirements of the clinical test.

Cited by 4 publications

References 8 publications

Establishment of a new protein C detection system based on chromogenic substrate assay and its clinical diagnostic value for deep vein thrombosis

Establishment of a new protein C detection system based on chromogenic substrate assay and its clinical diagnostic value for deep vein thrombosis

Creatine Kinase-MB measurement using Immunoinhibition methodology. How much is the interference?

On the Challenges for the Diagnosis of SARS-CoV-2 Based on a Review of Current Methodologies

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