Startseite Medizin Detection of serum CC16 by a rapid and ultrasensitive magnetic chemiluminescence immunoassay for lung disease diagnosis
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Detection of serum CC16 by a rapid and ultrasensitive magnetic chemiluminescence immunoassay for lung disease diagnosis

  • Kaili Duan ORCID logo , Yu Xiang , Yilong Deng , Junman Chen EMAIL logo und Ping Liu EMAIL logo
Veröffentlicht/Copyright: 30. Juli 2024
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 63 Heft 1

Abstract

Objectives

It has been reported that serum Clara cell secreted protein 16 (CC16) is a potential biomarker for lung injury diseases, but currently, there is no other method that is faster, more accurate, or more sensitive being applied in clinical practice apart from ELISA. The current study was designed to established a magnetic nanoparticles chemiluminescence immunoassay (MNPs-CLIA) for highly sensitive automated detection of serum Clara cell secretory protein 16 (CC16), and validated its diagnostic performance for lung disease.

Methods

The study included the expression of CC16 recombinant protein, the preparation and screening of its monoclonal antibody (MAb), as well as the construction, optimization and analytical evaluation of the MNPs-CLIA method. The clinical application value of this method was investigated by detecting CC16 level in 296 serum samples.

Results

The linear range of the MNPs-CLIA assay system was 0.2–50 ng/mL, and the limit of detection was 0.037 ng/mL. Performance parameters such as specificity, recovery rate, and precision can meet the industry standards of in vitro diagnostic reagents. The established method reveals consistent results with ELISA (R2=0.9962) currently used clinically, and it also exhibits satisfactory diagnostic efficacy of silicosis, chronic obstructive pulmonary disease (COPD), and pulmonary sarcoidosis, with areas under the curve (AUC) of 0.9748, 0.8428 and 0.9128, respectively.

Conclusions

Our established MNPs-CLIA method has the advantages of automation, high throughput, rapidity, and simplicity, and can be promoted for widely popularized in clinical applications. MNPs-CLIA detection of serum CC16 has efficient diagnostic potentiality for predicting and diagnosing lung diseases.

Keywords: CC16; chemiluminescence; magnetic nanoparticle; monoclonal antibody; biomarkers
Corresponding authors: Junman Chen, PhD and Ping Liu, PhD, Key Laboratory of Clinical Laboratory Diagnostics (Ministry of Education), College of Laboratory Medicine, Chongqing Medical University, 1 Medical College Rd., Chongqing, 400016, China, E-mail: (J. Chen), (P. Liu)
Kaili Duan and Yu Xiang contributed equally to this work.

Funding source: Future Medical Youth Innovation Team Development Support Program Project of Chongqing Medical University

Award Identifier / Grant number: W0183

Funding source: Chongqing Technical Innovation and Application Development Special Project

Award Identifier / Grant number: CSTB2021TIAD-KPX0066

Funding source: National Natural Science Foundation of China

Award Identifier / Grant number: 82302621

Funding source: Science and Technology Research Program of Chongqing Municipal Education Commission

Award Identifier / Grant number: KJQN202300435

  1. Research ethics: Chongqing Medical University Ethical Review Committee, protocol number: 2024048.

  2. Informed consent: Not applicable.

  3. Author contributions: Kaili Duan and Yu Xiang: conceptualization, methodology, writing – original draft, formal analysis. Yilong Deng: software, investigation, validation. Junman Chen: data curation, supervision, writing – review & editing. Ping Liu: conceptualization, resources, writing – review & editing, project administration. The authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: The authors state no conflict of interest.

  5. Research funding: This work was supported by the Chongqing Technical Innovation and Application Development Special Project (CSTB2021TIAD-KPX0066), National Natural Science Foundation of China (82302621), Science and Technology Research Program of Chongqing Municipal Education Commission (Grant No. KJQN202300435), Future Medical Youth Innovation Team Development Support Program Project of Chongqing Medical University (Grant No. W0183).

  6. Data availability: The raw data can be obtained on request from the corresponding author.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0724).

Received: 2024-02-22
Accepted: 2024-07-22
Published Online: 2024-07-30
Published in Print: 2025-01-29

© 2024 Walter de Gruyter GmbH, Berlin/Boston

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Blood self-sampling: friend or foe?
  4. Reviews
  5. Blood self-sampling devices: innovation, interpretation and implementation in total lab automation
  6. Salivary fatty acids in humans: a comprehensive literature review
  7. Opinion Papers
  8. EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) recommendations for reinforcing cyber-security and managing cyber-attacks in medical laboratories
  9. Point-of-care testing: state-of-the art and perspectives
  10. A standard to report biological variation data studies – based on an expert opinion
  11. Ethical Checklists for Clinical Research Projects and Laboratory Medicine: two tools to evaluate compliance with bioethical principles in different settings
  12. Guidelines and Recommendations
  13. Assessment of cardiovascular risk and physical activity: the role of cardiac-specific biomarkers in the general population and athletes
  14. Genetics and Molecular Diagnostics
  15. Clinical utility of regions of homozygosity (ROH) identified in exome sequencing: when to pursue confirmatory uniparental disomy testing for imprinting disorders?
  16. An ultrasensitive DNA-enhanced amplification method for detecting cfDNA drug-resistant mutations in non-small cell lung cancer with selective FEN-assisted degradation of dominant somatic fragments
  17. General Clinical Chemistry and Laboratory Medicine
  18. The biological variation of insulin resistance markers: data from the European Biological Variation Study (EuBIVAS)
  19. The surveys on quality indicators for the total testing process in clinical laboratories of Fujian Province in China from 2018 to 2023
  20. Preservation of urine specimens for metabolic evaluation of recurrent urinary stone formers
  21. Performance evaluation of a smartphone-based home test for fecal calprotection
  22. Implications of monoclonal gammopathy and isoelectric focusing pattern 5 on the free light chain kappa diagnostics in cerebrospinal fluid
  23. Development and validation of a novel 7α-hydroxy-4-cholesten-3-one (C4) liquid chromatography tandem mass spectrometry method and its utility to assess pre-analytical stability
  24. Establishment of ELISA-comparable moderate and high thresholds for anticardiolipin and anti-β2 glycoprotein I chemiluminescent immunoassays according to the 2023 ACR/EULAR APS classification criteria and evaluation of their diagnostic performance
  25. Reference Values and Biological Variations
  26. Capillary blood parameters are gestational age, birthweight, delivery mode and gender dependent in healthy preterm and term infants
  27. Reference intervals and percentiles for soluble transferrin receptor and sTfR/log ferritin index in healthy children and adolescents
  28. Cancer Diagnostics
  29. Detection of serum CC16 by a rapid and ultrasensitive magnetic chemiluminescence immunoassay for lung disease diagnosis
  30. Cardiovascular Diseases
  31. The role of functional vitamin D deficiency and low vitamin D reservoirs in relation to cardiovascular health and mortality
  32. Annual Reviewer Acknowledgment
  33. Reviewer Acknowledgment
  34. Letters to the Editor
  35. EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) survey on cybersecurity
  36. Comment on Lippi et al.: EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) recommendations for reinforcing cyber-security and managing cyber-attacks in medical laboratories
  37. Six Sigma in laboratory medicine: the unfinished symphony
  38. Navigating complexities in vitamin D and cardiovascular health: a call for comprehensive analysis
  39. Simplified preanalytical laboratory procedures for therapeutic drug monitoring (TDM) in patients treated with high-dose methotrexate (HD-MTX) and glucarpidase
  40. New generation of Abbott enzyme assays: imprecision, methods comparison, and impact on patients’ results
  41. Correction of negative-interference from calcium dobesilate in the Roche sarcosine oxidase creatinine assay using CuO
  42. Two cases of MTHFR C677T polymorphism typing failure by Taqman system due to MTHFR 679 GA heterozygous mutation
  43. A falsely elevated blood alcohol concentration (BAC) related to an intravenous administration of phenytoin sodium
https://doi.org/10.1515/cclm-2024-0724
Schlagwörter für diesen Artikel
CC16; chemiluminescence; magnetic nanoparticle; monoclonal antibody; biomarkers

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Blood self-sampling: friend or foe?
  4. Reviews
  5. Blood self-sampling devices: innovation, interpretation and implementation in total lab automation
  6. Salivary fatty acids in humans: a comprehensive literature review
  7. Opinion Papers
  8. EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) recommendations for reinforcing cyber-security and managing cyber-attacks in medical laboratories
  9. Point-of-care testing: state-of-the art and perspectives
  10. A standard to report biological variation data studies – based on an expert opinion
  11. Ethical Checklists for Clinical Research Projects and Laboratory Medicine: two tools to evaluate compliance with bioethical principles in different settings
  12. Guidelines and Recommendations
  13. Assessment of cardiovascular risk and physical activity: the role of cardiac-specific biomarkers in the general population and athletes
  14. Genetics and Molecular Diagnostics
  15. Clinical utility of regions of homozygosity (ROH) identified in exome sequencing: when to pursue confirmatory uniparental disomy testing for imprinting disorders?
  16. An ultrasensitive DNA-enhanced amplification method for detecting cfDNA drug-resistant mutations in non-small cell lung cancer with selective FEN-assisted degradation of dominant somatic fragments
  17. General Clinical Chemistry and Laboratory Medicine
  18. The biological variation of insulin resistance markers: data from the European Biological Variation Study (EuBIVAS)
  19. The surveys on quality indicators for the total testing process in clinical laboratories of Fujian Province in China from 2018 to 2023
  20. Preservation of urine specimens for metabolic evaluation of recurrent urinary stone formers
  21. Performance evaluation of a smartphone-based home test for fecal calprotection
  22. Implications of monoclonal gammopathy and isoelectric focusing pattern 5 on the free light chain kappa diagnostics in cerebrospinal fluid
  23. Development and validation of a novel 7α-hydroxy-4-cholesten-3-one (C4) liquid chromatography tandem mass spectrometry method and its utility to assess pre-analytical stability
  24. Establishment of ELISA-comparable moderate and high thresholds for anticardiolipin and anti-β2 glycoprotein I chemiluminescent immunoassays according to the 2023 ACR/EULAR APS classification criteria and evaluation of their diagnostic performance
  25. Reference Values and Biological Variations
  26. Capillary blood parameters are gestational age, birthweight, delivery mode and gender dependent in healthy preterm and term infants
  27. Reference intervals and percentiles for soluble transferrin receptor and sTfR/log ferritin index in healthy children and adolescents
  28. Cancer Diagnostics
  29. Detection of serum CC16 by a rapid and ultrasensitive magnetic chemiluminescence immunoassay for lung disease diagnosis
  30. Cardiovascular Diseases
  31. The role of functional vitamin D deficiency and low vitamin D reservoirs in relation to cardiovascular health and mortality
  32. Annual Reviewer Acknowledgment
  33. Reviewer Acknowledgment
  34. Letters to the Editor
  35. EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) survey on cybersecurity
  36. Comment on Lippi et al.: EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) recommendations for reinforcing cyber-security and managing cyber-attacks in medical laboratories
  37. Six Sigma in laboratory medicine: the unfinished symphony
  38. Navigating complexities in vitamin D and cardiovascular health: a call for comprehensive analysis
  39. Simplified preanalytical laboratory procedures for therapeutic drug monitoring (TDM) in patients treated with high-dose methotrexate (HD-MTX) and glucarpidase
  40. New generation of Abbott enzyme assays: imprecision, methods comparison, and impact on patients’ results
  41. Correction of negative-interference from calcium dobesilate in the Roche sarcosine oxidase creatinine assay using CuO
  42. Two cases of MTHFR C677T polymorphism typing failure by Taqman system due to MTHFR 679 GA heterozygous mutation
  43. A falsely elevated blood alcohol concentration (BAC) related to an intravenous administration of phenytoin sodium
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