Evaluation of Locally Established Reference Intervals for Hematology and Biochemistry Parameters in Western Kenya
Identifieur interne : 000223 ( Ncbi/Checkpoint ); précédent : 000222; suivant : 000224Evaluation of Locally Established Reference Intervals for Hematology and Biochemistry Parameters in Western Kenya
Auteurs : Collins Odhiambo [Kenya] ; Boaz Oyaro [Kenya] ; Richard Odipo [Kenya] ; Fredrick Otieno [Kenya] ; George Alemnji [Barbade] ; John Williamson [Kenya] ; Clement Zeh [Kenya]Source :
- PLoS ONE [ 1932-6203 ] ; 2015.
Abstract
Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities.
An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya. Laboratory values generated from the KICoS were compared to published region-specific reference intervals and the 2004 NIH DAIDS toxicity tables used for the trial.
About 1106 participants were screened for the KICoS between January 2007 and June 2010. Nine hundred and fifty-three participants aged 16 to 34 years, HIV-seronegative, clinically healthy, and non-pregnant were selected for this analysis. Median and 95% reference intervals were calculated for hematological and biochemistry parameters. When compared with both published region-specific reference values and the 2004 NIH DAIDS toxicity table, it was shown that the use of locally established reference intervals would have resulted in fewer participants classified as having abnormal hematological or biochemistry values compared to US derived reference intervals from DAIDS (10% classified as abnormal by local parameters vs. >40% by US DAIDS). Blood urea nitrogen was most often out of range if US based intervals were used: <10% abnormal by local intervals compared to >83% by US based reference intervals.
Differences in reference intervals for hematological and biochemical parameters between western and African populations highlight importance of developing local reference intervals for clinical care and trials in Africa.
Url:
DOI: 10.1371/journal.pone.0123140
PubMed: 25874714
PubMed Central: 4395286
Affiliations:
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type="wicri:Area/Ncbi/Curation">000223</idno><idno type="wicri:Area/Ncbi/Checkpoint">000223</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Evaluation of Locally Established Reference Intervals for Hematology and Biochemistry Parameters in Western Kenya</title><author><name sortKey="Odhiambo, Collins" sort="Odhiambo, Collins" uniqKey="Odhiambo C" first="Collins" last="Odhiambo">Collins Odhiambo</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Kenya Medical Research Institute, Kisumu, Kenya</addr-line></nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>Kenya Medical Research Institute, Kisumu</wicri:regionArea><wicri:noRegion>Kisumu</wicri:noRegion></affiliation></author><author><name sortKey="Oyaro, Boaz" sort="Oyaro, Boaz" uniqKey="Oyaro B" first="Boaz" last="Oyaro">Boaz Oyaro</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Kenya Medical Research Institute, Kisumu, Kenya</addr-line></nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>Kenya Medical Research Institute, Kisumu</wicri:regionArea><wicri:noRegion>Kisumu</wicri:noRegion></affiliation></author><author><name sortKey="Odipo, Richard" sort="Odipo, Richard" uniqKey="Odipo R" first="Richard" last="Odipo">Richard Odipo</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Kenya Medical Research Institute, Kisumu, Kenya</addr-line></nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>Kenya Medical Research Institute, Kisumu</wicri:regionArea><wicri:noRegion>Kisumu</wicri:noRegion></affiliation></author><author><name sortKey="Otieno, Fredrick" sort="Otieno, Fredrick" uniqKey="Otieno F" first="Fredrick" last="Otieno">Fredrick Otieno</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Kenya Medical Research Institute, Kisumu, Kenya</addr-line></nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>Kenya Medical Research Institute, Kisumu</wicri:regionArea><wicri:noRegion>Kisumu</wicri:noRegion></affiliation></author><author><name sortKey="Alemnji, George" sort="Alemnji, George" uniqKey="Alemnji G" first="George" last="Alemnji">George Alemnji</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>U.S. Centers for Disease Control and Prevention (CDC), Bridgetown, Barbados</addr-line></nlm:aff><country xml:lang="fr">Barbade</country><wicri:regionArea>U.S. Centers for Disease Control and Prevention (CDC), Bridgetown</wicri:regionArea><wicri:noRegion>Bridgetown</wicri:noRegion></affiliation></author><author><name sortKey="Williamson, John" sort="Williamson, John" uniqKey="Williamson J" first="John" last="Williamson">John Williamson</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>U.S. Centers for Disease Control and Prevention (CDC), Kisumu, Kenya</addr-line></nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>U.S. Centers for Disease Control and Prevention (CDC), Kisumu</wicri:regionArea><wicri:noRegion>Kisumu</wicri:noRegion></affiliation></author><author><name sortKey="Zeh, Clement" sort="Zeh, Clement" uniqKey="Zeh C" first="Clement" last="Zeh">Clement Zeh</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>U.S. Centers for Disease Control and Prevention (CDC), Kisumu, Kenya</addr-line></nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>U.S. Centers for Disease Control and Prevention (CDC), Kisumu</wicri:regionArea><wicri:noRegion>Kisumu</wicri:noRegion></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="sec001"><title>Background</title><p>Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities.</p></sec><sec id="sec002"><title>Methods</title><p>An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya. Laboratory values generated from the KICoS were compared to published region-specific reference intervals and the 2004 NIH DAIDS toxicity tables used for the trial.</p></sec><sec id="sec003"><title>Results</title><p>About 1106 participants were screened for the KICoS between January 2007 and June 2010. Nine hundred and fifty-three participants aged 16 to 34 years, HIV-seronegative, clinically healthy, and non-pregnant were selected for this analysis. Median and 95% reference intervals were calculated for hematological and biochemistry parameters. When compared with both published region-specific reference values and the 2004 NIH DAIDS toxicity table, it was shown that the use of locally established reference intervals would have resulted in fewer participants classified as having abnormal hematological or biochemistry values compared to US derived reference intervals from DAIDS (10% classified as abnormal by local parameters vs. >40% by US DAIDS). Blood urea nitrogen was most often out of range if US based intervals were used: <10% abnormal by local intervals compared to >83% by US based reference intervals.</p></sec><sec id="sec004"><title>Conclusion</title><p>Differences in reference intervals for hematological and biochemical parameters between western and African populations highlight importance of developing local reference intervals for clinical care and trials in Africa.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Esparza, J" uniqKey="Esparza J">J Esparza</name></author><author><name sortKey="Osmanov, S" uniqKey="Osmanov S">S Osmanov</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jaoko, W" uniqKey="Jaoko W">W Jaoko</name></author><author><name sortKey="Nakwagala, Fn" uniqKey="Nakwagala F">FN 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first="Clement" last="Zeh">Clement Zeh</name></country><country name="Barbade"><noRegion><name sortKey="Alemnji, George" sort="Alemnji, George" uniqKey="Alemnji G" first="George" last="Alemnji">George Alemnji</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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