Establishing hemolysis and lipemia acceptance thresholds for clinical chemistry tests.
Hemolysis
Indices
Interferent
Lipemia
Specimen quality
Journal
Clinica chimica acta; international journal of clinical chemistry
ISSN: 1873-3492
Titre abrégé: Clin Chim Acta
Pays: Netherlands
ID NLM: 1302422
Informations de publication
Date de publication:
Nov 2020
Nov 2020
Historique:
received:
08
06
2020
revised:
27
07
2020
accepted:
04
08
2020
pubmed:
11
8
2020
medline:
22
6
2021
entrez:
11
8
2020
Statut:
ppublish
Résumé
A key component of laboratory medicine is the evaluation of specimen suitability for downstream analytical testing. Accurate identification and characterization of the impact of interferents on clinical chemistry analytes is important for patient care. To empirically assess the influence of hemolysis and lipemia on clinical chemistry tests analyzed on a Roche cobas® c701 system, we evaluated serum pools spiked with increasing concentrations of hemolysate and Intralipid®. Using an interferent acceptance threshold of within ± 10% of the non-hemolyzed or non-lipemic results, 31 routine chemistry analytes were evaluated. The majority of analytes were determined to have the same or very similar acceptability thresholds as those listed in the vendor package insert. However, several analytes resulted in new thresholds that deviated from manufacturer recommendations (9 higher and 2 lower for lipemia, 7 higher and 6 lower for hemolysis). Samples with high enzyme activities (LDH, ALT, AST, ALP, and CK) were observed to tolerate higher levels of hemolysis, and tiered hemolysis thresholds were established for these enzymes. Independent evaluation of indices is recommended to enable thoughtful implementation of specimen quality criteria and to provide guidance to laboratorians and providers on the nature of these interferences.
Sections du résumé
BACKGROUND
BACKGROUND
A key component of laboratory medicine is the evaluation of specimen suitability for downstream analytical testing. Accurate identification and characterization of the impact of interferents on clinical chemistry analytes is important for patient care. To empirically assess the influence of hemolysis and lipemia on clinical chemistry tests analyzed on a Roche cobas® c701 system, we evaluated serum pools spiked with increasing concentrations of hemolysate and Intralipid®.
METHODS
METHODS
Using an interferent acceptance threshold of within ± 10% of the non-hemolyzed or non-lipemic results, 31 routine chemistry analytes were evaluated.
RESULTS
RESULTS
The majority of analytes were determined to have the same or very similar acceptability thresholds as those listed in the vendor package insert. However, several analytes resulted in new thresholds that deviated from manufacturer recommendations (9 higher and 2 lower for lipemia, 7 higher and 6 lower for hemolysis). Samples with high enzyme activities (LDH, ALT, AST, ALP, and CK) were observed to tolerate higher levels of hemolysis, and tiered hemolysis thresholds were established for these enzymes. Independent evaluation of indices is recommended to enable thoughtful implementation of specimen quality criteria and to provide guidance to laboratorians and providers on the nature of these interferences.
Identifiants
pubmed: 32771484
pii: S0009-8981(20)30386-7
doi: 10.1016/j.cca.2020.08.004
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
459-465Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.