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...
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Formato: | Artículo |
Lenguaje: | inglés |
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UANL. Facultad de Medicina
2016
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Materias: | |
Acceso en línea: | http://eprints.uanl.mx/11722/1/S1665579616300515_S300_en.pdf |
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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 |