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Evaluation of chemiluminescent immunoassay quantitative detection for pro-gastrin-releasing peptide (ProGRP) in serum and plasma

OBJECTIVE: To evaluate a newly developed Hybiome ProGRP chemiluminescent assay. METHODS: Analytical sensitivity, precision, recovery, and equivalency of serum and plasma, serum stability, and complement interference of the Hybiome ProGRP assay were evaluated. Serum specimens from 318 individuals inc...

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Autores principales: Cheng, Yizhuang, He, Jing, Zhang, Liping, Chen, Xiufa, Ou, Saiying
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607052/
https://www.ncbi.nlm.nih.gov/pubmed/31856626
http://dx.doi.org/10.1177/0300060519882802
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author Cheng, Yizhuang
He, Jing
Zhang, Liping
Chen, Xiufa
Ou, Saiying
author_facet Cheng, Yizhuang
He, Jing
Zhang, Liping
Chen, Xiufa
Ou, Saiying
author_sort Cheng, Yizhuang
collection PubMed
description OBJECTIVE: To evaluate a newly developed Hybiome ProGRP chemiluminescent assay. METHODS: Analytical sensitivity, precision, recovery, and equivalency of serum and plasma, serum stability, and complement interference of the Hybiome ProGRP assay were evaluated. Serum specimens from 318 individuals including 38 small cell lung cancer (SCLC), 65 non-small cell lung cancer (NSCLC), 53 benign lung diseases, and 162 healthy controls were assessed using the Hybiome ProGRP assay and Roche Elecsys ProGRP assay, and the results were compared. RESULTS: The Hybiome ProGRP assay showed good analytical sensitivity, precision, and accuracy, and it showed equivalence between serum and plasma and serum stability. The methodological comparison results showed good correlation between the Hybiome and Roche assays (slope, 0.9889; intercept, 1.28). Both the Hybiome and Roche assays showed good ability to distinguish between SCLC and NSCLC. Based on 95% specificity in the NSCLC cohort, a clinical differentiation cut-off for separating SCLC from NSCLC patients was 114 pg/mL for the Hybiome assay and 117 pg/mL for the Roche assay; the AUC was 0.9166 and the sensitivity was 71.05% for Hybiome and 0.9045 and 76.32% for Roche, respectively. CONCLUSION: The Hybiome ProGRP chemiluminescent assay shows good analytical performance and good correlation with the Roche Elecsys ProGRP assay.
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spelling pubmed-76070522020-11-12 Evaluation of chemiluminescent immunoassay quantitative detection for pro-gastrin-releasing peptide (ProGRP) in serum and plasma Cheng, Yizhuang He, Jing Zhang, Liping Chen, Xiufa Ou, Saiying J Int Med Res Clinical Research Report OBJECTIVE: To evaluate a newly developed Hybiome ProGRP chemiluminescent assay. METHODS: Analytical sensitivity, precision, recovery, and equivalency of serum and plasma, serum stability, and complement interference of the Hybiome ProGRP assay were evaluated. Serum specimens from 318 individuals including 38 small cell lung cancer (SCLC), 65 non-small cell lung cancer (NSCLC), 53 benign lung diseases, and 162 healthy controls were assessed using the Hybiome ProGRP assay and Roche Elecsys ProGRP assay, and the results were compared. RESULTS: The Hybiome ProGRP assay showed good analytical sensitivity, precision, and accuracy, and it showed equivalence between serum and plasma and serum stability. The methodological comparison results showed good correlation between the Hybiome and Roche assays (slope, 0.9889; intercept, 1.28). Both the Hybiome and Roche assays showed good ability to distinguish between SCLC and NSCLC. Based on 95% specificity in the NSCLC cohort, a clinical differentiation cut-off for separating SCLC from NSCLC patients was 114 pg/mL for the Hybiome assay and 117 pg/mL for the Roche assay; the AUC was 0.9166 and the sensitivity was 71.05% for Hybiome and 0.9045 and 76.32% for Roche, respectively. CONCLUSION: The Hybiome ProGRP chemiluminescent assay shows good analytical performance and good correlation with the Roche Elecsys ProGRP assay. SAGE Publications 2019-12-19 /pmc/articles/PMC7607052/ /pubmed/31856626 http://dx.doi.org/10.1177/0300060519882802 Text en © The Author(s) 2019 https://creativecommons.org/licenses/by-nc/4.0/ Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Clinical Research Report
Cheng, Yizhuang
He, Jing
Zhang, Liping
Chen, Xiufa
Ou, Saiying
Evaluation of chemiluminescent immunoassay quantitative detection for pro-gastrin-releasing peptide (ProGRP) in serum and plasma
title Evaluation of chemiluminescent immunoassay quantitative detection for pro-gastrin-releasing peptide (ProGRP) in serum and plasma
title_full Evaluation of chemiluminescent immunoassay quantitative detection for pro-gastrin-releasing peptide (ProGRP) in serum and plasma
title_fullStr Evaluation of chemiluminescent immunoassay quantitative detection for pro-gastrin-releasing peptide (ProGRP) in serum and plasma
title_full_unstemmed Evaluation of chemiluminescent immunoassay quantitative detection for pro-gastrin-releasing peptide (ProGRP) in serum and plasma
title_short Evaluation of chemiluminescent immunoassay quantitative detection for pro-gastrin-releasing peptide (ProGRP) in serum and plasma
title_sort evaluation of chemiluminescent immunoassay quantitative detection for pro-gastrin-releasing peptide (progrp) in serum and plasma
topic Clinical Research Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607052/
https://www.ncbi.nlm.nih.gov/pubmed/31856626
http://dx.doi.org/10.1177/0300060519882802
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