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Analytical And Clinical Evaluation Of A Chemiluminescent Immunoassay To Detect Serum Chitinase-3-like Protein 1 In Hbv-related Liver Diseases.

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Analytical And Clinical Evaluation Of A Chemiluminescent Immunoassay To Detect Serum Chitinase-3-like Protein 1 In Hbv-related Liver Diseases.

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Analytical and Clinical Evaluation of a Chemiluminescent Immunoassay to Detect Serum Chitinase-3-like Protein 1 in

Yanqiang Liao¹, Se Peng², Lesheng Huang³

¹Department of Laboratory Medicine, Doumen Qiaoli Hospital of Traditional Chinese Medicine, Zhuhai 519125, China.

International Journal of Analytical Chemistry

|February 2, 2024

View abstract on PubMed

Summary

This summary is machine-generated.

A new chemiluminescent immunoassay (CLIA) accurately detects serum chitinase-3-like protein 1 (CHI3L1). This assay shows promise for diagnosing hepatitis B virus (HBV)-related liver cancer (HCC).

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Area of Science:

Biochemistry
Clinical Chemistry
Hepatology

Background:

Serum chitinase-3-like protein 1 (CHI3L1) is a recognized biomarker for liver diseases, including hepatocellular carcinoma (HCC).
Accurate and sensitive detection methods are crucial for diagnosing and managing HBV-related liver conditions.

Purpose of the Study:

To evaluate the analytical performance of a novel chemiluminescent immunoassay (CLIA) for quantifying serum CHI3L1.
To assess the clinical utility of this CLIA in diagnosing hepatitis B virus (HBV)-related liver diseases, particularly HCC.

Main Methods:

Analytical validation of the CHI3L1 CLIA, including linearity and detection limit assessment.
Measurement of serum CHI3L1 levels in patients with chronic hepatitis B (CHB) and healthy controls.

Correlation analysis with established biomarkers like alpha-fetoprotein (AFP), FIB-4, and APRI.

Main Results:

The CHI3L1 CLIA demonstrated excellent analytical performance with a wide linear range (1.50–2000.00 ng/mL) and low detection limit (0.98 ng/mL).
Elevated serum CHI3L1 levels were observed in patients with CHB and HCC compared to healthy controls.
The assay showed moderate diagnostic value for HBV-related HCC (AUC = 0.808) and significant correlations with AFP, FIB-4, and APRI.

Conclusions:

The developed CLIA offers a sensitive, accurate, and precise method for CHI3L1 detection with acceptable reference intervals.
This assay is valuable for the diagnosis of HBV-related HCC, complementing existing diagnostic tools.