Method evaluation of pepsinogen I/II assay based on chemiluminescent immunoassays and comparison with other test methods

Eun Jung Cho; Hyun Ki Kim; Tae Dong Jeong; Dae Hyun Ko; Suh Eun Bae; Jong Soo Lee; Woochang Lee; Jae Won Choe; Sail Chun; Hwoon Yong Jung; Won Ki Min

doi:10.1016/j.cca.2015.11.015

Method evaluation of pepsinogen I/II assay based on chemiluminescent immunoassays and comparison with other test methods

Eun Jung Cho, Hyun Ki Kim, Tae Dong Jeong, Dae Hyun Ko, Suh Eun Bae, Jong Soo Lee, Woochang Lee, Jae Won Choe, Sail Chun, Hwoon Yong Jung, Won Ki Min

Department of Laboratory Medicine

Research output: Contribution to journal › Article › peer-review

14 Scopus citations

Abstract

Background: Serum pepsinogen (PG) I and the PG I/PG II ratio have been used for atrophic gastritis (AG) diagnosis for decades. Low levels of PG I and/or PG I/PG II are closely related to AG and predict the risk of gastric cancer. We evaluated the performance of the chemiluminescent immunoassay-based Architect Pepsinogen I/II assay. Methods: The evaluation consisted of determination of the precision, linearity, limit of blank (LoB), limit of detection (LoD) and method comparison with Eiken and Biohit assays. Results: The total CVs were below 5% for both PG I and PG II. Acceptable linearity was observed for PG I and PG II in their respective reportable ranges. The PG I LoB was 0.317 ng/mL and the PG II LoB was 0.418 ng/mL, and LoDs were 0.412 ng/mL and 0.497 ng/mL, respectively. Correlation analysis indicated that results of the Architect assay were comparable to those of the Eiken and Biohit assays, but the three methods lead to different estimations of the cancer risk. Conclusion: The overall analytical performance of Architect Pepsinogen I/II assay is acceptable for the detection of patients with suspected AG. The categorization results of gastric cancer risk showed some difference among test methods suggesting the need for harmonization among the methods from vendors.

Original language	English
Pages (from-to)	149-154
Number of pages	6
Journal	Clinica Chimica Acta
Volume	452
DOIs	https://doi.org/10.1016/j.cca.2015.11.015
State	Published - 15 Jan 2016

Bibliographical note

Publisher Copyright:
© 2015 Published by Elsevier B.V.

Keywords

Atrophic gastritis
Chemiluminescent immunoassay
Gastric cancer
Method evaluation
Pepsinogen

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.cca.2015.11.015

Cite this

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title = "Method evaluation of pepsinogen I/II assay based on chemiluminescent immunoassays and comparison with other test methods",

abstract = "Background: Serum pepsinogen (PG) I and the PG I/PG II ratio have been used for atrophic gastritis (AG) diagnosis for decades. Low levels of PG I and/or PG I/PG II are closely related to AG and predict the risk of gastric cancer. We evaluated the performance of the chemiluminescent immunoassay-based Architect Pepsinogen I/II assay. Methods: The evaluation consisted of determination of the precision, linearity, limit of blank (LoB), limit of detection (LoD) and method comparison with Eiken and Biohit assays. Results: The total CVs were below 5% for both PG I and PG II. Acceptable linearity was observed for PG I and PG II in their respective reportable ranges. The PG I LoB was 0.317 ng/mL and the PG II LoB was 0.418 ng/mL, and LoDs were 0.412 ng/mL and 0.497 ng/mL, respectively. Correlation analysis indicated that results of the Architect assay were comparable to those of the Eiken and Biohit assays, but the three methods lead to different estimations of the cancer risk. Conclusion: The overall analytical performance of Architect Pepsinogen I/II assay is acceptable for the detection of patients with suspected AG. The categorization results of gastric cancer risk showed some difference among test methods suggesting the need for harmonization among the methods from vendors.",

keywords = "Atrophic gastritis, Chemiluminescent immunoassay, Gastric cancer, Method evaluation, Pepsinogen",

author = "Cho, {Eun Jung} and Kim, {Hyun Ki} and Jeong, {Tae Dong} and Ko, {Dae Hyun} and Bae, {Suh Eun} and Lee, {Jong Soo} and Woochang Lee and Choe, {Jae Won} and Sail Chun and Jung, {Hwoon Yong} and Min, {Won Ki}",

note = "Publisher Copyright: {\textcopyright} 2015 Published by Elsevier B.V.",

year = "2016",

month = jan,

day = "15",

doi = "10.1016/j.cca.2015.11.015",

language = "English",

volume = "452",

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journal = "Clinica Chimica Acta",

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T1 - Method evaluation of pepsinogen I/II assay based on chemiluminescent immunoassays and comparison with other test methods

AU - Cho, Eun Jung

AU - Kim, Hyun Ki

AU - Jeong, Tae Dong

AU - Ko, Dae Hyun

AU - Bae, Suh Eun

AU - Lee, Jong Soo

AU - Lee, Woochang

AU - Choe, Jae Won

AU - Chun, Sail

AU - Jung, Hwoon Yong

AU - Min, Won Ki

PY - 2016/1/15

Y1 - 2016/1/15

N2 - Background: Serum pepsinogen (PG) I and the PG I/PG II ratio have been used for atrophic gastritis (AG) diagnosis for decades. Low levels of PG I and/or PG I/PG II are closely related to AG and predict the risk of gastric cancer. We evaluated the performance of the chemiluminescent immunoassay-based Architect Pepsinogen I/II assay. Methods: The evaluation consisted of determination of the precision, linearity, limit of blank (LoB), limit of detection (LoD) and method comparison with Eiken and Biohit assays. Results: The total CVs were below 5% for both PG I and PG II. Acceptable linearity was observed for PG I and PG II in their respective reportable ranges. The PG I LoB was 0.317 ng/mL and the PG II LoB was 0.418 ng/mL, and LoDs were 0.412 ng/mL and 0.497 ng/mL, respectively. Correlation analysis indicated that results of the Architect assay were comparable to those of the Eiken and Biohit assays, but the three methods lead to different estimations of the cancer risk. Conclusion: The overall analytical performance of Architect Pepsinogen I/II assay is acceptable for the detection of patients with suspected AG. The categorization results of gastric cancer risk showed some difference among test methods suggesting the need for harmonization among the methods from vendors.

AB - Background: Serum pepsinogen (PG) I and the PG I/PG II ratio have been used for atrophic gastritis (AG) diagnosis for decades. Low levels of PG I and/or PG I/PG II are closely related to AG and predict the risk of gastric cancer. We evaluated the performance of the chemiluminescent immunoassay-based Architect Pepsinogen I/II assay. Methods: The evaluation consisted of determination of the precision, linearity, limit of blank (LoB), limit of detection (LoD) and method comparison with Eiken and Biohit assays. Results: The total CVs were below 5% for both PG I and PG II. Acceptable linearity was observed for PG I and PG II in their respective reportable ranges. The PG I LoB was 0.317 ng/mL and the PG II LoB was 0.418 ng/mL, and LoDs were 0.412 ng/mL and 0.497 ng/mL, respectively. Correlation analysis indicated that results of the Architect assay were comparable to those of the Eiken and Biohit assays, but the three methods lead to different estimations of the cancer risk. Conclusion: The overall analytical performance of Architect Pepsinogen I/II assay is acceptable for the detection of patients with suspected AG. The categorization results of gastric cancer risk showed some difference among test methods suggesting the need for harmonization among the methods from vendors.

KW - Atrophic gastritis

KW - Chemiluminescent immunoassay

KW - Gastric cancer

KW - Method evaluation

KW - Pepsinogen

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SN - 0009-8981

VL - 452

SP - 149

EP - 154

JO - Clinica Chimica Acta

JF - Clinica Chimica Acta

ER -

Method evaluation of pepsinogen I/II assay based on chemiluminescent immunoassays and comparison with other test methods

Abstract

Bibliographical note

Keywords

UN SDGs

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