Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory

Background: This study aimed to create an in-house glucose quality control material for humans, addressing the challenge of obtaining high-cost commercially prepared quality control materials in developing countries. Methods: An in-house quality control material for glucose was prepared using a pool...

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Main Authors: Haymanot Tewabe, Asaye Mitiku, Abebe Yenesew
Format: Article
Language:English
Published: Elsevier 2024-03-01
Series:Practical Laboratory Medicine
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2352551724000234
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author Haymanot Tewabe
Asaye Mitiku
Abebe Yenesew
author_facet Haymanot Tewabe
Asaye Mitiku
Abebe Yenesew
author_sort Haymanot Tewabe
collection DOAJ
description Background: This study aimed to create an in-house glucose quality control material for humans, addressing the challenge of obtaining high-cost commercially prepared quality control materials in developing countries. Methods: An in-house quality control material for glucose was prepared using a pooled serum sample and analyzed using a fully automated chemistry analyzer following the ISO 80 guidelines. The mean, standard deviation (SD), and coefficient of variance were calculated from the first 30 days of measurement, and the variability was checked over eight months using SPSS software. The study used Pearson's correlation with a 95% confidence interval and a P-value less than 0.05, which was statistically significant. Results: The average mean ± SD of human serum glucose was 185.2 ± 8.4 mg/dL, indicating that the precision between each measurement was better. The prepared in-house quality control material was stable for approximately five months without any significant change in the serum glucose concentration (mg/dl) (p-value<0.05). Conclusions: The study suggests that room-temperature, 2–8 °C, and −20 °C to −30 °C storage of human serum samples for glucose analysis is a viable option, with stable glucose concentrations for up to 30 days. Pooled serum is a cost-effective method for in-house quality control, especially in resource-limited laboratories.
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spelling doaj.art-9bc59e8c476f479a967b7279906e881a2024-03-14T06:15:08ZengElsevierPractical Laboratory Medicine2352-55172024-03-0139e00377Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratoryHaymanot Tewabe0Asaye Mitiku1Abebe Yenesew2Department of Medical Laboratory Sciences, College of Medicine and Health Sciences, Debre Markos University, Debre Markos, Ethiopia; Corresponding author: P.O.Box 269, Ethiopia.Department of Medical Laboratory Sciences, College of Health Sciences, Dilla University, EthiopiaDepartment of Medical Laboratory Sciences, College of Medicine and Health Sciences, Debre Markos University, Debre Markos, EthiopiaBackground: This study aimed to create an in-house glucose quality control material for humans, addressing the challenge of obtaining high-cost commercially prepared quality control materials in developing countries. Methods: An in-house quality control material for glucose was prepared using a pooled serum sample and analyzed using a fully automated chemistry analyzer following the ISO 80 guidelines. The mean, standard deviation (SD), and coefficient of variance were calculated from the first 30 days of measurement, and the variability was checked over eight months using SPSS software. The study used Pearson's correlation with a 95% confidence interval and a P-value less than 0.05, which was statistically significant. Results: The average mean ± SD of human serum glucose was 185.2 ± 8.4 mg/dL, indicating that the precision between each measurement was better. The prepared in-house quality control material was stable for approximately five months without any significant change in the serum glucose concentration (mg/dl) (p-value<0.05). Conclusions: The study suggests that room-temperature, 2–8 °C, and −20 °C to −30 °C storage of human serum samples for glucose analysis is a viable option, with stable glucose concentrations for up to 30 days. Pooled serum is a cost-effective method for in-house quality control, especially in resource-limited laboratories.http://www.sciencedirect.com/science/article/pii/S2352551724000234Inhouse quality controlGlucoseValidation
spellingShingle Haymanot Tewabe
Asaye Mitiku
Abebe Yenesew
Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory
Practical Laboratory Medicine
Inhouse quality control
Glucose
Validation
title Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory
title_full Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory
title_fullStr Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory
title_full_unstemmed Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory
title_short Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory
title_sort validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory
topic Inhouse quality control
Glucose
Validation
url http://www.sciencedirect.com/science/article/pii/S2352551724000234
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AT asayemitiku validationoftheefficacyofpooledserumforserumglucoseinhousequalitycontrolmaterialincomparisonwithcommercialinternalqualitycontrolinclinicalchemistrylaboratory
AT abebeyenesew validationoftheefficacyofpooledserumforserumglucoseinhousequalitycontrolmaterialincomparisonwithcommercialinternalqualitycontrolinclinicalchemistrylaboratory