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Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4

BACKGROUND: Clinical laboratory reference intervals (RIs) are essential for diagnosing and managing patients in routine clinical care as well as establishing eligibility criteria and defining adverse events in clinical trials, but may vary by age, gender, genetics, nutrition and geographic location....

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Autores principales: Sing’oei, Valentine, Ochola, Jew, Owuoth, John, Otieno, June, Rono, Eric, Andagalu, Ben, Otieno, Lucas, Nwoga, Chiaka, Copeland, Nathanial K., Lawlor, John, Yates, Adam, Imbach, Michelle, Crowell, Trevor A., Eller, Leigh Anne, Kamau, Edwin, Modjarrad, Kayvon, Cowden, Jessica, Ake, Julie, Robb, Merlin L., Polyak, Christina S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8009432/
https://www.ncbi.nlm.nih.gov/pubmed/33784358
http://dx.doi.org/10.1371/journal.pone.0249259
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author Sing’oei, Valentine
Ochola, Jew
Owuoth, John
Otieno, June
Rono, Eric
Andagalu, Ben
Otieno, Lucas
Nwoga, Chiaka
Copeland, Nathanial K.
Lawlor, John
Yates, Adam
Imbach, Michelle
Crowell, Trevor A.
Eller, Leigh Anne
Kamau, Edwin
Modjarrad, Kayvon
Cowden, Jessica
Ake, Julie
Robb, Merlin L.
Polyak, Christina S.
author_facet Sing’oei, Valentine
Ochola, Jew
Owuoth, John
Otieno, June
Rono, Eric
Andagalu, Ben
Otieno, Lucas
Nwoga, Chiaka
Copeland, Nathanial K.
Lawlor, John
Yates, Adam
Imbach, Michelle
Crowell, Trevor A.
Eller, Leigh Anne
Kamau, Edwin
Modjarrad, Kayvon
Cowden, Jessica
Ake, Julie
Robb, Merlin L.
Polyak, Christina S.
author_sort Sing’oei, Valentine
collection PubMed
description BACKGROUND: Clinical laboratory reference intervals (RIs) are essential for diagnosing and managing patients in routine clinical care as well as establishing eligibility criteria and defining adverse events in clinical trials, but may vary by age, gender, genetics, nutrition and geographic location. It is, therefore, critical to establish region-specific reference values in order to inform clinical decision-making. METHODS: We analyzed data from a prospective observational HIV incidence cohort study in Kombewa, Kenya. Study participants were healthy males and females, aged 18–35 years, without HIV. Median and 95% reference values (2.5(th) percentile to 97.5(th) percentile) were calculated for laboratory parameters including hematology, chemistry studies, and CD4 T cell count. Standard Deviation Ratios (SDR) and Bias Ratios (BR) are presented as measures of effect magnitude. Findings were compared with those from the United States and other Kenyan studies. RESULTS: A total of 299 participants were analyzed with a median age of 24 years (interquartile range: 21–28). Ratio of males to females was 0.9:1. Hemoglobin range (2.5(th)—97.5(th) percentiles) was 12.0–17.9 g/dL and 9.5–15.3 g/dL in men and women respectively. In the cohort, MCV range was 59-95fL, WBC 3.7–9.2×10(3)/μL, and platelet 154–401×10(3)/μL. Chemistry values were higher in males; the creatinine RI was 59–103 μmol/L in males vs. 46–76 μmol/L in females (BRUL>.3); and the alanine transferase range was 8.8–45.3 U/L in males vs. 7.5–36.8 U/L in females (SDR>.3). The overall CD4 T cell count RI was 491–1381 cells/μL. Some parameters including hemoglobin, neutrophil, creatinine and ALT varied with that from prior studies in Kenya and the US. CONCLUSION: This study not only provides clinical reference intervals for a population in Kisumu County but also highlights the variations in comparable settings, accentuating the requirement for region-specific reference values to improve patient care, scientific validity, and quality of clinical trials in Africa.
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spelling pubmed-80094322021-04-07 Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4 Sing’oei, Valentine Ochola, Jew Owuoth, John Otieno, June Rono, Eric Andagalu, Ben Otieno, Lucas Nwoga, Chiaka Copeland, Nathanial K. Lawlor, John Yates, Adam Imbach, Michelle Crowell, Trevor A. Eller, Leigh Anne Kamau, Edwin Modjarrad, Kayvon Cowden, Jessica Ake, Julie Robb, Merlin L. Polyak, Christina S. PLoS One Research Article BACKGROUND: Clinical laboratory reference intervals (RIs) are essential for diagnosing and managing patients in routine clinical care as well as establishing eligibility criteria and defining adverse events in clinical trials, but may vary by age, gender, genetics, nutrition and geographic location. It is, therefore, critical to establish region-specific reference values in order to inform clinical decision-making. METHODS: We analyzed data from a prospective observational HIV incidence cohort study in Kombewa, Kenya. Study participants were healthy males and females, aged 18–35 years, without HIV. Median and 95% reference values (2.5(th) percentile to 97.5(th) percentile) were calculated for laboratory parameters including hematology, chemistry studies, and CD4 T cell count. Standard Deviation Ratios (SDR) and Bias Ratios (BR) are presented as measures of effect magnitude. Findings were compared with those from the United States and other Kenyan studies. RESULTS: A total of 299 participants were analyzed with a median age of 24 years (interquartile range: 21–28). Ratio of males to females was 0.9:1. Hemoglobin range (2.5(th)—97.5(th) percentiles) was 12.0–17.9 g/dL and 9.5–15.3 g/dL in men and women respectively. In the cohort, MCV range was 59-95fL, WBC 3.7–9.2×10(3)/μL, and platelet 154–401×10(3)/μL. Chemistry values were higher in males; the creatinine RI was 59–103 μmol/L in males vs. 46–76 μmol/L in females (BRUL>.3); and the alanine transferase range was 8.8–45.3 U/L in males vs. 7.5–36.8 U/L in females (SDR>.3). The overall CD4 T cell count RI was 491–1381 cells/μL. Some parameters including hemoglobin, neutrophil, creatinine and ALT varied with that from prior studies in Kenya and the US. CONCLUSION: This study not only provides clinical reference intervals for a population in Kisumu County but also highlights the variations in comparable settings, accentuating the requirement for region-specific reference values to improve patient care, scientific validity, and quality of clinical trials in Africa. Public Library of Science 2021-03-30 /pmc/articles/PMC8009432/ /pubmed/33784358 http://dx.doi.org/10.1371/journal.pone.0249259 Text en https://creativecommons.org/publicdomain/zero/1.0/ This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 (https://creativecommons.org/publicdomain/zero/1.0/) public domain dedication.
spellingShingle Research Article
Sing’oei, Valentine
Ochola, Jew
Owuoth, John
Otieno, June
Rono, Eric
Andagalu, Ben
Otieno, Lucas
Nwoga, Chiaka
Copeland, Nathanial K.
Lawlor, John
Yates, Adam
Imbach, Michelle
Crowell, Trevor A.
Eller, Leigh Anne
Kamau, Edwin
Modjarrad, Kayvon
Cowden, Jessica
Ake, Julie
Robb, Merlin L.
Polyak, Christina S.
Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4
title Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4
title_full Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4
title_fullStr Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4
title_full_unstemmed Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4
title_short Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4
title_sort clinical laboratory reference values in adults in kisumu county, western kenya; hematology, chemistry and cd4
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8009432/
https://www.ncbi.nlm.nih.gov/pubmed/33784358
http://dx.doi.org/10.1371/journal.pone.0249259
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