Evaluation of inter-batch variability in the establishing and quality control of glucose

This research evaluated the inter-batch variability in the identification and quality control of glucose, according to international specifications detailed in the guide CLSI EP-15. Type of qualitative research, analytical, not experimental, prospective cross-sectional conducted at the Department of...

Descripción completa

Detalles Bibliográficos
Autores principales: Moya Salazar, J. J., Pio Dávila, L.
Formato: Artículo
Lenguaje:inglés
Publicado: UANL. Facultad de Medicina 2016
Materias:
Acceso en línea:http://eprints.uanl.mx/11722/1/S1665579616300515_S300_en.pdf
_version_ 1824413432225464320
author Moya Salazar, J. J.
Pio Dávila, L.
author_facet Moya Salazar, J. J.
Pio Dávila, L.
author_sort Moya Salazar, J. J.
collection Repositorio Institucional
description This research evaluated the inter-batch variability in the identification and quality control of glucose, according to international specifications detailed in the guide CLSI EP-15. Type of qualitative research, analytical, not experimental, prospective cross-sectional conducted at the Department of Clinical Laboratory at Polyclinic ‘‘La Fe’’ during January 2015 was performed. The inter-batch variability for glucose in the semi-automated biochemical analyzer URIT-810 with liquid enzyme glucose-LS reagent (GOD-PAP) Valtek® batch 140825 was evaluated. The calibrators (CS) were the lot CS-A: 140 428, CS-B: 120912 and CS-C: 131 202. Data analysis was performed in SPSS version 20.0 statistical analyzer and Microsoft Office Excel 2010 for Windows. The values found by calculating the sigma metric were: 2 (SE −0.35), 0 (SE 1.65) −0.9 (SE −0.75) to CS-A, CS-B and CS-C, respectively (p < 0.05). Only CS-A might be able to improve their performance, although with greater cost. Sub-optimal performance characteristics by using standard calibrators show high inter-lot variability, suggesting the choice and search for a new and better calibration method to ensure results that contain no medically important errors affecting patient health.
format Article
id eprints-11722
institution UANL
language English
publishDate 2016
publisher UANL. Facultad de Medicina
record_format eprints
spelling eprints-117222016-11-23T20:56:15Z http://eprints.uanl.mx/11722/ Evaluation of inter-batch variability in the establishing and quality control of glucose Moya Salazar, J. J. Pio Dávila, L. QP Fisiología This research evaluated the inter-batch variability in the identification and quality control of glucose, according to international specifications detailed in the guide CLSI EP-15. Type of qualitative research, analytical, not experimental, prospective cross-sectional conducted at the Department of Clinical Laboratory at Polyclinic ‘‘La Fe’’ during January 2015 was performed. The inter-batch variability for glucose in the semi-automated biochemical analyzer URIT-810 with liquid enzyme glucose-LS reagent (GOD-PAP) Valtek® batch 140825 was evaluated. The calibrators (CS) were the lot CS-A: 140 428, CS-B: 120912 and CS-C: 131 202. Data analysis was performed in SPSS version 20.0 statistical analyzer and Microsoft Office Excel 2010 for Windows. The values found by calculating the sigma metric were: 2 (SE −0.35), 0 (SE 1.65) −0.9 (SE −0.75) to CS-A, CS-B and CS-C, respectively (p < 0.05). Only CS-A might be able to improve their performance, although with greater cost. Sub-optimal performance characteristics by using standard calibrators show high inter-lot variability, suggesting the choice and search for a new and better calibration method to ensure results that contain no medically important errors affecting patient health. UANL. Facultad de Medicina 2016 Article PeerReviewed text en cc_by_nc_nd http://eprints.uanl.mx/11722/1/S1665579616300515_S300_en.pdf http://eprints.uanl.mx/11722/1.haspreviewThumbnailVersion/S1665579616300515_S300_en.pdf Moya Salazar, J. J. y Pio Dávila, L. (2016) Evaluation of inter-batch variability in the establishing and quality control of glucose. Medicina universitaria, 18 (71). pp. 85-90. ISSN 1665-5796
spellingShingle QP Fisiología
Moya Salazar, J. J.
Pio Dávila, L.
Evaluation of inter-batch variability in the establishing and quality control of glucose
thumbnail https://rediab.uanl.mx/themes/sandal5/images/online.png
title Evaluation of inter-batch variability in the establishing and quality control of glucose
title_full Evaluation of inter-batch variability in the establishing and quality control of glucose
title_fullStr Evaluation of inter-batch variability in the establishing and quality control of glucose
title_full_unstemmed Evaluation of inter-batch variability in the establishing and quality control of glucose
title_short Evaluation of inter-batch variability in the establishing and quality control of glucose
title_sort evaluation of inter batch variability in the establishing and quality control of glucose
topic QP Fisiología
url http://eprints.uanl.mx/11722/1/S1665579616300515_S300_en.pdf
work_keys_str_mv AT moyasalazarjj evaluationofinterbatchvariabilityintheestablishingandqualitycontrolofglucose
AT piodavilal evaluationofinterbatchvariabilityintheestablishingandqualitycontrolofglucose