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Assessment of the Diagnostic Performance of Truehb Point-Of Journal of Blood Medicine Dovepress open access to scientific and medical research Open Access Full Text Article ORIGINAL RESEARCH Assessment of the diagnostic performance of TrueHb® point-of-care hemometer compared with Sysmex i3 analyzer among patients at International Hospital Kampala, Uganda This article was published in the following Dove Press journal: Journal of Blood Medicine Ivan Mugisha Taremwa1 Aim/Objective: To assess the diagnostic performance of TrueHb® point-of-care (POC) Ivan Ndeze1 hemometer compared with Sysmex i3 analyzer at International Hospital Kampala, Uganda. Bashir Mwambi1 Materials and methods: We analyzed ethylenediaminetetraacetic acid blood samples to ® Christine Atuhairwe2 estimate hemoglobin (Hb) levels using parallel testing with TrueHb hemometer and Sysmex DianaIndaAchieng3 i3 analyzer. Data were analyzed to ascertain the diagnostic performance of the test assays fi Bernard Natukunda4 using the Bland and Altman method. Sensitivity, speci city, positive and negative predictive values were calculated. 1Department of Medical Laboratory For personal use only. Results: The study enrolled 402 patients; of these, 156 (38.8%) were males. The average Hb Sciences, Institute of Allied Health Sciences, Clarke International University, levels were 8.7±1.8 and 13.3±2.6 g/dL for the anemic and nonanemic patients, respectively. Kampala, Uganda; 2Institute of Public One hundred and fifty-five participants were anemic, giving anemia prevalence of 38.56% Health and Management, Clarke (95% CI: 35.17–40.38). The mean difference of the TrueHb® and Sysmex i3 assays was International University, Kampala, Uganda; 3Lancet Laboratories, Kampala, 2.2219 (SD 1.07915), and the two devices did not show a difference in their measurements Uganda; 4Department of Medical (t=−2.407, p-value 0.017, 95% CI: −0.095–0.010). Further, they showed a significant level of Laboratory Sciences, Faculty of Medicine, – fi Mbarara University of Science and agreement (t=41.281; 95% CI: 2.1161 2.3277) and intraclass correlation coef cients Technology, Mbarara, Uganda (ICC=0.793). The sensitivity, specificity, positive and negative predictive values were 100.00%, 51.01%, 55.16% and 100.00%, respectively. The average performance turnaround time (TAT) for the TrueHb® hemometer was 2.46 mins (95% CI: 2.37–2.55). Conclusion: TrueHb® POC hemometer is an accurate POC for Hb estimation with a good Journal of Blood Medicine downloaded from https://www.dovepress.com/ by 81.199.139.20 on 09-Jul-2019 performance agreement with the Sysmex i3 analyzer. This, coupled with its utility aspects, makes it a good diagnostic tool in a high anemia burden and low-resource setting. Keywords: anemia, hemoglobin estimation, point-of-care testing, TrueHb®, Sysmex i3, Uganda Background The burden of anemia remains unacceptably high in sub-Saharan Africa.1–3 It is linked to numerous life-threatening consequences like poor cognitive ability, dimin- ished immunity and aggravated mortality.3 To avert its effect, timely and accurate determination of hemoglobin concentration has been recognized.4,5 This has taken varied determination methods such as cyanmethemoglobin, use of copper II sulfate, Correspondence: Ivan Mugisha Taremwa automated hematology analyzers and point-of-care (POC) devices as the latest Institute of Allied Health Sciences, Clarke invention.6–10 International University, P.O Box 7782, Kampala, Uganda While the automated analyzers are considered the gold standard assay, it is Tel +25 677 434 6368 Email [email protected] greatly limited by poor electricity connections in most areas, prohibitive purchase submit your manuscript | www.dovepress.com Journal of Blood Medicine 2019:10 85–92 85 DovePress © 2019 Taremwa et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms. php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the http://doi.org/10.2147/JBM.S188302 work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Powered by TCPDF (www.tcpdf.org) 1 / 1 Taremwa et al Dovepress prices, installation, trainings as well as daily maintenance scientific evidence and feasibility for use at International costs.9–11 This phenomenon agitates the need for cheap, Hospital Kampala (IHK) in Uganda. easy-to-use and accurate methods.5,9,10 Due to limited electricity supply in most parts of developing countries, Materials and methods the cyanmethemoglobin, gravimetric copper II sulfate and Study site, design and duration color code hemoglobin estimation methods are commonly This was a cross-sectional laboratory-based study used;7–9,12 however, these are inaccurate and are conducted during the period of March to April 2018 in subjective to a high observer error.13 Cognizant to these, the Hematology Laboratory at IHK, located on plot 4686 efforts to find affordable, sensitive, specific, user-friendly, Kisugu, Namuwongo, a Kampala suburb. The facility rapid and robust, equipment-free and deliverable to end started in 1999 as a private hospital offering extended users (ASSURED) have proven ideal leading to invention medical services for an array of patients, and it runs of POC devices for resource-limited settings that are easy about 100 blood samples daily from both inpatients and to use, are fieldable, use microvolume of blood, are fast, outpatients. Hb estimation is routinely performed as part have shortened turnaround time(TAT), have high accuracy of the complete blood count (CBC) using the Sysmex i3 and are well-interpreted.6,7,11,14 Consequently, this has led analyzer. The laboratory participates in the external to the invention of varied POC devices with diverse proficiency of National Health Laboratory Scheme, South performance. They include hemoglobin color scale that Africa. rely on color comparison of blood absorbed on chromato- graphy paper with a standard red-based color scale, a battery-operated photometer branded as the Hemocue® Study population, sample size estimation (Hemocue AB, Angelholm, Sweden) that is based on and recruitment criteria modified azide methemoglobin measurement, DiaSpect Our study comprised both pediatric and adult patients hemoglobin T system (DiaSpect Medical GmbH, Sailauf, seeking medical services at IHK whose clinical condition For personal use only. Germany) that utilizes multichromatic sensor to measure (s) required laboratory hematological investigations and its absorbance over a wide spectral range and the latest who consented/assented to participate. being TrueHb® (Wrig Nanosystems Pvt. Ltd, New Delhi, Being a validation study, we conveniently considered India). 402 blood samples, basing on the available logistics. TrueHb® hemometer is an in vitro diagnostic device Venous blood samples were collected by venipuncture that utilizes fresh capillary whole blood samples to according to the WHO-recommended standard operating 16 screen for anemia.15 It is based on the principle of procedures and were analyzed within 1 hr of collection. reflectance photometry following the conversion of In situations of anticipated delays, the samples were kept hemoglobin in the sample to a complex with the help refrigerated at 2–8°C and allowed to equilibrate at room of proprietary set of reagents present in the strip (Wrig temperature before analysis. Journal of Blood Medicine downloaded from https://www.dovepress.com/ by 81.199.139.20 on 09-Jul-2019 Nanosystems Pvt. Ltd). A previous study to validate The samples were investigated for CBC using Sysmex TrueHb® has indicated a strong positive correlation i3 analyzer as requested by the attending clinician who with the Sysmex hematology analyzer and a better was independent of the study. We excluded clotted blood POC device for screening anemia.4 samples, those from neonates patients with a known Despite the availability of numerous POC devices to bleeding diathesis. screen anemia, none has become widely utilized in our settings where they are desired. They are limited by low Laboratory analyses reliability, being affected by humid environments and are Samples were assayed to estimate the hemoglobin very expensive to suit the requirements of a limited concentration using the TrueHb® hemometer (Wrig resource setting.10 Further, the availability of numerous Nanosystems Pvt. Ltd) and Sysmex i3 hematology POC devices has posed an impasse in the choice of an analyzer (Sysmex Corporation Kobe, Japan) according appropriate device for clinical care, research and blood to the manufacturers’ instructions. banking. This study assessed the diagnostic performance The Hb levels performed by the Sysmex i3 analyzer of a new invention, TrueHb® POC hemometer, in were considered as the gold standard. Assessment of the comparison with Sysmex i3 analyzer to elucidate its degree of anemia was based on the cutoff values for age 86 submit your manuscript | www.dovepress.com Journal of Blood Medicine 2019:10 DovePress Powered by TCPDF (www.tcpdf.org) 1 / 1 Dovepress Taremwa et al and gender as defined by the WHO criteria. Anemia was agreement and 0.81–1.00: almost perfect agreement.18 defined as Hb levels less than 11.0 g/dL, 11.5 g/dL and Performance evaluation was based on measurement of: 12.0 g/dL for children aged 6–59 months, 5–11 years and sensitivity=true positives (TP)/[TP+false negatives (FN)]; 12–14 years, respectively. For adults, anemia was specificity=TN/[false positives (FP)+TN]; positive predic- considered as Hb concentration less than 12.0 g/dL in tive value (PPV)=TP/(TP+FP); negative predictive value nonpregnant women, 11.0 g/dL in pregnant women and (NPV)=TN/(TN+FN). 13.0 g/dL in males.17 Ethical approval Quality control Ethical approval was obtained from the research and ethics The performance of the TrueHb® hemometer and the committee of Clarke International University, Kampala, Sysmex i3 hematology analyzer was standardized based Uganda.
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