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Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions

OBJECTIVES: Deviation from manufacturers’ pre-analytical sample handling recommendations necessitates extensive validation studies. This report uses plasma lactate testing, where a recommended 15 min room temperature sample handling limit cannot be met by the clinical laboratory, as an example for s...

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Autores principales: Hashim, Ibrahim A., Mohamed, Mishkat, Cox, Aileen, Fernandez, Fernabelle, Kutscher, Patricia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223191/
https://www.ncbi.nlm.nih.gov/pubmed/30426060
http://dx.doi.org/10.1016/j.plabm.2018.e00109
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author Hashim, Ibrahim A.
Mohamed, Mishkat
Cox, Aileen
Fernandez, Fernabelle
Kutscher, Patricia
author_facet Hashim, Ibrahim A.
Mohamed, Mishkat
Cox, Aileen
Fernandez, Fernabelle
Kutscher, Patricia
author_sort Hashim, Ibrahim A.
collection PubMed
description OBJECTIVES: Deviation from manufacturers’ pre-analytical sample handling recommendations necessitates extensive validation studies. This report uses plasma lactate testing, where a recommended 15 min room temperature sample handling limit cannot be met by the clinical laboratory, as an example for studies to bridge the gap with practice. DESIGN AND METHODS: Triplicate blood samples were collected from patients (n = 51) with lactate requests by clinicians and from normal volunteers (n = 50). One tube was transported on ice (4 °C), the others were maintained at room temperature (23 °C). Tubes stored at 4 °C were processed at 30 min from collection. Tubes stored at 23 °C were processed at 15 and at 30 min from collection. Lactate levels were measured using Roche Diagnostics Cobas 6000® analyzer. RESULTS: Lactate levels in normal subjects ranged from 0.6 to 3.1 mmol/L (median 1.1). Patient lactate levels ranged from 0.8 to 26.3 mmol/L (median 2.2). Bias in lactate levels following extended storage of samples from both normal subjects and patients ranged from − 1.3 to2.2 and from − 1.0–1.0 mmol/L when stored for 30 min at 23 °C or at 4 °C, respectively. The bias between lactate levels at 30 min at 23 °C and 4 °C was − 1.2 to − 0.5 mmol/L for both populations. Although the bias was not statistically significant for all variables, a clinically significant (>0.2 mmol/L) bias was observed in 28% of normal and 7.0% of patient samples. CONCLUSION: Extending the pre-analytical time to 30 min at 23 °C did not significantly impact clinical utility of lactate measurement in our patient population.
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spelling pubmed-62231912018-11-13 Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions Hashim, Ibrahim A. Mohamed, Mishkat Cox, Aileen Fernandez, Fernabelle Kutscher, Patricia Pract Lab Med Article OBJECTIVES: Deviation from manufacturers’ pre-analytical sample handling recommendations necessitates extensive validation studies. This report uses plasma lactate testing, where a recommended 15 min room temperature sample handling limit cannot be met by the clinical laboratory, as an example for studies to bridge the gap with practice. DESIGN AND METHODS: Triplicate blood samples were collected from patients (n = 51) with lactate requests by clinicians and from normal volunteers (n = 50). One tube was transported on ice (4 °C), the others were maintained at room temperature (23 °C). Tubes stored at 4 °C were processed at 30 min from collection. Tubes stored at 23 °C were processed at 15 and at 30 min from collection. Lactate levels were measured using Roche Diagnostics Cobas 6000® analyzer. RESULTS: Lactate levels in normal subjects ranged from 0.6 to 3.1 mmol/L (median 1.1). Patient lactate levels ranged from 0.8 to 26.3 mmol/L (median 2.2). Bias in lactate levels following extended storage of samples from both normal subjects and patients ranged from − 1.3 to2.2 and from − 1.0–1.0 mmol/L when stored for 30 min at 23 °C or at 4 °C, respectively. The bias between lactate levels at 30 min at 23 °C and 4 °C was − 1.2 to − 0.5 mmol/L for both populations. Although the bias was not statistically significant for all variables, a clinically significant (>0.2 mmol/L) bias was observed in 28% of normal and 7.0% of patient samples. CONCLUSION: Extending the pre-analytical time to 30 min at 23 °C did not significantly impact clinical utility of lactate measurement in our patient population. Elsevier 2018-10-24 /pmc/articles/PMC6223191/ /pubmed/30426060 http://dx.doi.org/10.1016/j.plabm.2018.e00109 Text en © 2018 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Hashim, Ibrahim A.
Mohamed, Mishkat
Cox, Aileen
Fernandez, Fernabelle
Kutscher, Patricia
Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions
title Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions
title_full Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions
title_fullStr Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions
title_full_unstemmed Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions
title_short Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions
title_sort plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223191/
https://www.ncbi.nlm.nih.gov/pubmed/30426060
http://dx.doi.org/10.1016/j.plabm.2018.e00109
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