Designing a Radioimmunometric Assay Kit for Prostate-Specific Antigen Measurement Using Polystyrene Tubes Coated By Immunochemical Method

ABSTRACT        Background and Objective: Prostate specific antigen (PSA) is considered as one of the most reliable biomarkers of cancer and other known prostate diseases. In the present study, solid phase sandwich immunoradiometric assay was used to measure the amount of PSA. In this type of measu...

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Main Authors: Haleh Foroutan, Marziyeh Khodabakhsh, Masoud Moharamzadeh
Format: Article
Language:English
Published: Golestan University of Medical Sciences 2016-07-01
Series:Medical Laboratory Journal
Subjects:
Online Access:http://mlj.goums.ac.ir/article-1-870-en.html
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spelling doaj-265de8b70fdb42aaae5ecebf15f82f382021-09-01T13:20:26ZengGolestan University of Medical SciencesMedical Laboratory Journal2538-44492016-07-0110418Designing a Radioimmunometric Assay Kit for Prostate-Specific Antigen Measurement Using Polystyrene Tubes Coated By Immunochemical MethodHaleh Foroutan0Marziyeh Khodabakhsh1Masoud Moharamzadeh2 Faculty member, Radiation Applications Research School, Nuclear Science and Technology Research Institute, Atomic Energy Organization of Iran, Tehran, Iran Radiation Applications Research School, Nuclear Science and Technology Research Institute, Atomic Energy Organization of Iran, Tehran, Iran Radiation Applications Research School, Nuclear Science and Technology Research Institute, Atomic Energy Organization of Iran, Tehran, Iran ABSTRACT        Background and Objective: Prostate specific antigen (PSA) is considered as one of the most reliable biomarkers of cancer and other known prostate diseases. In the present study, solid phase sandwich immunoradiometric assay was used to measure the amount of PSA. In this type of measurement, a pair of anti-PSA antibodies on the solid phase and labeled with Iodine-125, participate in forming a complex with two different epitopes of PSA.        Methods: Variables such as irradiation level, modification of polymer surfaces by alcohol washing, different concentrations and volumes of antibody, incubation temperature and drying conditions that influence the direct coating process were optimized. Finally, the stability, accuracy and precision of the laboratory kit were evaluated by comparison with a foreign kit.       Results: According to the obtained results, preliminary preparations such as irradiation, tube washing and specific temperature conditions are not required during the coating process. Drying by lyophilization method does not affect the quality of coating. Antibody concentration of 2.5 μg/ml and coating volume of 800 μl were determined as the optimum conditions for coating, which had good stability within a year. Alignment of results obtained from the domestic and foreign kits for accuracy of 30 samples from patients was confirmed by T-test (sig 2-tailed= 0.993 and 95% confidence interval). The short-term and long-term precision for three control ranges (low, medium, high) were less than 0.25 and 0.33 of allowable total error (TEa = 10%), respectively.        Conclusion: The produced domestic kit has acceptable precision according to the CLIA criteria.        Keywords: Biological testing, Radioimmunometric assay, monoclonal antibody, prostate specific antigen, prostate disease.http://mlj.goums.ac.ir/article-1-870-en.htmlbiological testingradioimmunometric assaymonoclonal antibodyprostate specific antigenprostate disease.
collection DOAJ
language English
format Article
sources DOAJ
author Haleh Foroutan
Marziyeh Khodabakhsh
Masoud Moharamzadeh
spellingShingle Haleh Foroutan
Marziyeh Khodabakhsh
Masoud Moharamzadeh
Designing a Radioimmunometric Assay Kit for Prostate-Specific Antigen Measurement Using Polystyrene Tubes Coated By Immunochemical Method
Medical Laboratory Journal
biological testing
radioimmunometric assay
monoclonal antibody
prostate specific antigen
prostate disease.
author_facet Haleh Foroutan
Marziyeh Khodabakhsh
Masoud Moharamzadeh
author_sort Haleh Foroutan
title Designing a Radioimmunometric Assay Kit for Prostate-Specific Antigen Measurement Using Polystyrene Tubes Coated By Immunochemical Method
title_short Designing a Radioimmunometric Assay Kit for Prostate-Specific Antigen Measurement Using Polystyrene Tubes Coated By Immunochemical Method
title_full Designing a Radioimmunometric Assay Kit for Prostate-Specific Antigen Measurement Using Polystyrene Tubes Coated By Immunochemical Method
title_fullStr Designing a Radioimmunometric Assay Kit for Prostate-Specific Antigen Measurement Using Polystyrene Tubes Coated By Immunochemical Method
title_full_unstemmed Designing a Radioimmunometric Assay Kit for Prostate-Specific Antigen Measurement Using Polystyrene Tubes Coated By Immunochemical Method
title_sort designing a radioimmunometric assay kit for prostate-specific antigen measurement using polystyrene tubes coated by immunochemical method
publisher Golestan University of Medical Sciences
series Medical Laboratory Journal
issn 2538-4449
publishDate 2016-07-01
description ABSTRACT        Background and Objective: Prostate specific antigen (PSA) is considered as one of the most reliable biomarkers of cancer and other known prostate diseases. In the present study, solid phase sandwich immunoradiometric assay was used to measure the amount of PSA. In this type of measurement, a pair of anti-PSA antibodies on the solid phase and labeled with Iodine-125, participate in forming a complex with two different epitopes of PSA.        Methods: Variables such as irradiation level, modification of polymer surfaces by alcohol washing, different concentrations and volumes of antibody, incubation temperature and drying conditions that influence the direct coating process were optimized. Finally, the stability, accuracy and precision of the laboratory kit were evaluated by comparison with a foreign kit.       Results: According to the obtained results, preliminary preparations such as irradiation, tube washing and specific temperature conditions are not required during the coating process. Drying by lyophilization method does not affect the quality of coating. Antibody concentration of 2.5 μg/ml and coating volume of 800 μl were determined as the optimum conditions for coating, which had good stability within a year. Alignment of results obtained from the domestic and foreign kits for accuracy of 30 samples from patients was confirmed by T-test (sig 2-tailed= 0.993 and 95% confidence interval). The short-term and long-term precision for three control ranges (low, medium, high) were less than 0.25 and 0.33 of allowable total error (TEa = 10%), respectively.        Conclusion: The produced domestic kit has acceptable precision according to the CLIA criteria.        Keywords: Biological testing, Radioimmunometric assay, monoclonal antibody, prostate specific antigen, prostate disease.
topic biological testing
radioimmunometric assay
monoclonal antibody
prostate specific antigen
prostate disease.
url http://mlj.goums.ac.ir/article-1-870-en.html
work_keys_str_mv AT halehforoutan designingaradioimmunometricassaykitforprostatespecificantigenmeasurementusingpolystyrenetubescoatedbyimmunochemicalmethod
AT marziyehkhodabakhsh designingaradioimmunometricassaykitforprostatespecificantigenmeasurementusingpolystyrenetubescoatedbyimmunochemicalmethod
AT masoudmoharamzadeh designingaradioimmunometricassaykitforprostatespecificantigenmeasurementusingpolystyrenetubescoatedbyimmunochemicalmethod
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