Estimation of the uncertainty of values assigned to calibration materials prepared in-house: An example for hydroxychloroquine calibrators in blood-hemolysate-based matrix.
Identifieur interne : 000475 ( Main/Corpus ); précédent : 000474; suivant : 000476Estimation of the uncertainty of values assigned to calibration materials prepared in-house: An example for hydroxychloroquine calibrators in blood-hemolysate-based matrix.
Auteurs : Raúl Rigo-Bonnin ; Francesca CanaliasSource :
- Clinical biochemistry [ 1873-2933 ] ; 2021.
English descriptors
- KwdEn :
- Antimalarials (administration & dosage), Antimalarials (blood), COVID-19 (blood), COVID-19 (drug therapy), COVID-19 (pathology), COVID-19 (virology), Calibration (MeSH), Chromatography, High Pressure Liquid (methods), Chromatography, High Pressure Liquid (standards), Hemolysis (MeSH), Humans (MeSH), Hydroxychloroquine (administration & dosage), Hydroxychloroquine (blood), Quality Control (MeSH), Reference Standards (MeSH), SARS-CoV-2 (isolation & purification), Uncertainty (MeSH).
- MESH :
- chemical , administration & dosage : Antimalarials, Hydroxychloroquine.
- chemical , blood : Antimalarials, Hydroxychloroquine.
- blood : COVID-19.
- drug therapy : COVID-19.
- isolation & purification : SARS-CoV-2.
- methods : Chromatography, High Pressure Liquid.
- pathology : COVID-19.
- standards : Chromatography, High Pressure Liquid.
- virology : COVID-19.
- Calibration, Hemolysis, Humans, Quality Control, Reference Standards, Uncertainty.
Abstract
BACKGROUND
Hydroxychloroquine is an antimalarial drug that has been prescribed for the treatment of patients with COVID-19 infection. To assist in clinician decision-making, several clinical laboratories have developed and validated measurement procedures in-house based on HPLC or HPLC-MS/MS to measure the mass concentration of hydroxychloroquine in different biological fluids. In these cases, laboratories produce their calibration materials but rarely estimate the measurement uncertainty of their assigned values. Thus, we aimed to show how this uncertainty can be calculated, using the preparation of hydroxychloroquine calibrators in blood-hemolysate-based matrix as an example.
METHODS
A bottom-up approach was used to estimate the uncertainty related to the values assigned to end-user calibration materials prepared in-house. First, a specification of the measurand and a measurement equation were proposed. Then, different sources of uncertainty related to the preparation of hydroxychloroquine calibration materials were identified and quantified. Afterwards, the combined uncertainty was calculated using the law for the propagation of uncertainty resulting in the final expanded uncertainty.
RESULTS
In this study, the most significant source of uncertainty was that associated with the hydroxychloroquine's reference material mass obtained via balance, while the smallest contribution was from the uncertainty associated with the hydroxychloroquine reference material purity.
CONCLUSIONS
A simple procedure to estimate the measurement uncertainty of values assigned to calibration materials is presented here, which would be easy to implement in clinical laboratories. Also, it could be put into practice for other pharmacological quantities measured by in-house HPLC or HPLC-MS/MS procedures commonly used in clinical laboratories.
DOI: 10.1016/j.clinbiochem.2021.01.005
PubMed: 33453194
PubMed Central: PMC7833999
Links to Exploration step
pubmed:33453194Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Estimation of the uncertainty of values assigned to calibration materials prepared in-house: An example for hydroxychloroquine calibrators in blood-hemolysate-based matrix.</title><author><name sortKey="Rigo Bonnin, Raul" sort="Rigo Bonnin, Raul" uniqKey="Rigo Bonnin R" first="Raúl" last="Rigo-Bonnin">Raúl Rigo-Bonnin</name><affiliation><nlm:affiliation>Laboratori Clínic, IDIBELL, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: raulr@bellvitgehospital.cat.</nlm:affiliation></affiliation></author><author><name sortKey="Canalias, Francesca" sort="Canalias, Francesca" uniqKey="Canalias F" first="Francesca" last="Canalias">Francesca Canalias</name><affiliation><nlm:affiliation>Laboratori de Referència d'Enzimologia Clínica, Departament de Bioquímica i Biologia Molecular, Universitat Autònoma de Barcelona, Bellaterra, Spain.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:33453194</idno><idno type="pmid">33453194</idno><idno type="doi">10.1016/j.clinbiochem.2021.01.005</idno><idno type="pmc">PMC7833999</idno><idno type="wicri:Area/Main/Corpus">000475</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000475</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Estimation of the uncertainty of values assigned to calibration materials prepared in-house: An example for hydroxychloroquine calibrators in blood-hemolysate-based matrix.</title><author><name sortKey="Rigo Bonnin, Raul" sort="Rigo Bonnin, Raul" uniqKey="Rigo Bonnin R" first="Raúl" last="Rigo-Bonnin">Raúl Rigo-Bonnin</name><affiliation><nlm:affiliation>Laboratori Clínic, IDIBELL, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: raulr@bellvitgehospital.cat.</nlm:affiliation></affiliation></author><author><name sortKey="Canalias, Francesca" sort="Canalias, Francesca" uniqKey="Canalias F" first="Francesca" last="Canalias">Francesca Canalias</name><affiliation><nlm:affiliation>Laboratori de Referència d'Enzimologia Clínica, Departament de Bioquímica i Biologia Molecular, Universitat Autònoma de Barcelona, Bellaterra, Spain.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Clinical biochemistry</title><idno type="eISSN">1873-2933</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antimalarials (administration & dosage)</term><term>Antimalarials (blood)</term><term>COVID-19 (blood)</term><term>COVID-19 (drug therapy)</term><term>COVID-19 (pathology)</term><term>COVID-19 (virology)</term><term>Calibration (MeSH)</term><term>Chromatography, High Pressure Liquid (methods)</term><term>Chromatography, High Pressure Liquid (standards)</term><term>Hemolysis (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (administration & dosage)</term><term>Hydroxychloroquine (blood)</term><term>Quality Control (MeSH)</term><term>Reference Standards (MeSH)</term><term>SARS-CoV-2 (isolation & purification)</term><term>Uncertainty (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antimalarials</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antimalarials</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en"><term>SARS-CoV-2</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Chromatography, High Pressure Liquid</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Chromatography, High Pressure Liquid</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Calibration</term><term>Hemolysis</term><term>Humans</term><term>Quality Control</term><term>Reference Standards</term><term>Uncertainty</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Hydroxychloroquine is an antimalarial drug that has been prescribed for the treatment of patients with COVID-19 infection. To assist in clinician decision-making, several clinical laboratories have developed and validated measurement procedures in-house based on HPLC or HPLC-MS/MS to measure the mass concentration of hydroxychloroquine in different biological fluids. In these cases, laboratories produce their calibration materials but rarely estimate the measurement uncertainty of their assigned values. Thus, we aimed to show how this uncertainty can be calculated, using the preparation of hydroxychloroquine calibrators in blood-hemolysate-based matrix as an example.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>A bottom-up approach was used to estimate the uncertainty related to the values assigned to end-user calibration materials prepared in-house. First, a specification of the measurand and a measurement equation were proposed. Then, different sources of uncertainty related to the preparation of hydroxychloroquine calibration materials were identified and quantified. Afterwards, the combined uncertainty was calculated using the law for the propagation of uncertainty resulting in the final expanded uncertainty.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>In this study, the most significant source of uncertainty was that associated with the hydroxychloroquine's reference material mass obtained via balance, while the smallest contribution was from the uncertainty associated with the hydroxychloroquine reference material purity.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>A simple procedure to estimate the measurement uncertainty of values assigned to calibration materials is presented here, which would be easy to implement in clinical laboratories. Also, it could be put into practice for other pharmacological quantities measured by in-house HPLC or HPLC-MS/MS procedures commonly used in clinical laboratories.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33453194</PMID><DateCompleted><Year>2021</Year><Month>03</Month><Day>03</Day></DateCompleted><DateRevised><Year>2021</Year><Month>03</Month><Day>03</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2933</ISSN><JournalIssue CitedMedium="Internet"><Volume>89</Volume><PubDate><Year>2021</Year><Month>Mar</Month></PubDate></JournalIssue><Title>Clinical biochemistry</Title><ISOAbbreviation>Clin Biochem</ISOAbbreviation></Journal><ArticleTitle>Estimation of the uncertainty of values assigned to calibration materials prepared in-house: An example for hydroxychloroquine calibrators in blood-hemolysate-based matrix.</ArticleTitle><Pagination><MedlinePgn>70-76</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0009-9120(21)00019-9</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.clinbiochem.2021.01.005</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Hydroxychloroquine is an antimalarial drug that has been prescribed for the treatment of patients with COVID-19 infection. To assist in clinician decision-making, several clinical laboratories have developed and validated measurement procedures in-house based on HPLC or HPLC-MS/MS to measure the mass concentration of hydroxychloroquine in different biological fluids. In these cases, laboratories produce their calibration materials but rarely estimate the measurement uncertainty of their assigned values. Thus, we aimed to show how this uncertainty can be calculated, using the preparation of hydroxychloroquine calibrators in blood-hemolysate-based matrix as an example.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A bottom-up approach was used to estimate the uncertainty related to the values assigned to end-user calibration materials prepared in-house. First, a specification of the measurand and a measurement equation were proposed. Then, different sources of uncertainty related to the preparation of hydroxychloroquine calibration materials were identified and quantified. Afterwards, the combined uncertainty was calculated using the law for the propagation of uncertainty resulting in the final expanded uncertainty.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">In this study, the most significant source of uncertainty was that associated with the hydroxychloroquine's reference material mass obtained via balance, while the smallest contribution was from the uncertainty associated with the hydroxychloroquine reference material purity.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">A simple procedure to estimate the measurement uncertainty of values assigned to calibration materials is presented here, which would be easy to implement in clinical laboratories. 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