Potential new tool for anemia screening: An evaluation of the performance and usability of the TrueHb Hemometer

In low- and middle-income countries, many women experience anemia during pregnancy due to insufficient dietary intake of key micronutrients, parasitic infections, hemoglobinopathies, and chronic infections. Maternal anemia increases perinatal risks for both mothers and infants, and slow progress to reduce the prevalence may be due in part to the lack of affordable tools to quantify hemoglobin levels in antenatal care (ANC) clinics. A simple, inexpensive, accurate, and robust diagnostic is needed to measure hemoglobin in ANC. This study evaluated the performance and usability of the TrueHb Hemometer. A cross-sectional diagnostic accuracy study was conducted to compare the accuracy of the TrueHb and the HemoCue® 201+ using capillary samples. Next, analytical performance (precision, coefficient of variation, R2) of the TrueHb was evaluated in varying environmental conditions using linearity panels with serial dilutions of venous blood samples. Lastly, the usability of the TrueHb Hemometer was assessed across three domains (effectiveness, efficiency, and satisfaction) by 20 ANC providers in Ghana. Capillary blood test results were not well correlated (R2 = 0.35) between the TrueHB and HemoCue201+, but 80% of TrueHb measurements were within +/-1.0 g/dl of the HemoCue® 201+ hemoglobin values. Precision tests indicated similar mean values across the three environmental conditions (CV<6%). At 21°C, the TrueHb follows a linear relationship (R2≥0.96) but does not generate accurate readings below 4.0 g/dl. At 30°C and 37°C, the TrueHb follows a linear relationship (R2 > 0.90) but begins to underestimate the hemoglobin concentration below 7.0 g/dl. The usability study identified potential failure modes due to inadequate instructions and device feedback. With some modifications, both to the product and to the instructions for use, the TrueHb may be suitable for use in ANC settings to help fill the diagnostic gap for anemia screening during pregnancy. Further testing is required with anemic populations in LMIC settings.

[1]  S. Hess,et al.  Measurement and interpretation of hemoglobin concentration in clinical and field settings: a narrative review , 2019, Annals of the New York Academy of Sciences.

[2]  F. Mekonnen,et al.  Compliance to iron and folic acid supplementation in pregnancy, Northwest Ethiopia , 2018, BMC Research Notes.

[3]  M. G. Pereira,et al.  Maternal Anemia and Low Birth Weight: A Systematic Review and Meta-Analysis , 2018, Nutrients.

[4]  P. Lumbiganon,et al.  Risk of maternal mortality in women with severe anaemia during pregnancy and post partum: a multilevel analysis. , 2018, The Lancet. Global health.

[5]  E. Rogozińska,et al.  Accuracy of on‐site tests to detect anemia during prenatal care , 2017, International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics.

[6]  Zhang Yang,et al.  Aplastic anemia associated with pregnancy: maternal and fetal complications , 2016, The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians.

[7]  N. Kassebaum.  The Global Burden of Anemia. , 2016, Hematology/oncology clinics of North America.

[8]  J. Critchley,et al.  Accuracy of the WHO Haemoglobin Colour Scale for the diagnosis of anaemia in primary health care settings in low-income countries: a systematic review and meta-analysis. , 2016, The Lancet. Global health.

[9]  Md. Mizanur Rahman,et al.  Maternal anemia and risk of adverse birth and health outcomes in low- and middle-income countries: systematic review and meta-analysis. , 2016, The American journal of clinical nutrition.

[10]  S. Zodpey,et al.  Diagnostic accuracy of haemoglobin colour strip (HCS-HLL), a digital haemoglobinometer (TrueHb) and a non-invasive device (TouchHb) for screening patients with anaemia , 2015, Journal of Clinical Pathology.

[11]  R. Saxena,et al.  Performance analysis of newly developed point‐of‐care hemoglobinometer (TrueHb) against an automated hematology analyzer (Sysmex XT 1800i) in terms of precision in hemoglobin measurement , 2015, International journal of laboratory hematology.

[12]  L. Caulfield,et al.  The Impact of Anemia on Child Mortality: An Updated Review , 2014, Nutrients.

[13]  Michael R. Kramer,et al.  Adverse perinatal outcomes associated with moderate or severe maternal anaemia based on parity in Finland during 2006-10. , 2014, Paediatric and perinatal epidemiology.

[14]  W. Fawzi,et al.  Anaemia, prenatal iron use, and risk of adverse pregnancy outcomes: systematic review and meta-analysis , 2013, BMJ.

[15]  I. Adam,et al.  Comparison of HemoCue® hemoglobin-meter and automated hematology analyzer in measurement of hemoglobin levels in pregnant women at Khartoum hospital, Sudan , 2012, Diagnostic Pathology.

[16]  Joanne Katz,et al.  Moderate to severe, but not mild, maternal anemia is associated with increased risk of small-for-gestational-age outcomes. , 2012, The Journal of nutrition.

[17]  F. Viteri,et al.  Daily oral iron supplementation during pregnancy. , 2012, The Cochrane database of systematic reviews.

[18]  Ritch Macefield,et al.  How to specify the participant group size for usability studies: a practitioner's guide , 2009 .

[19]  D. Pelletier,et al.  An analysis of anemia and pregnancy-related maternal mortality. , 2001, The Journal of nutrition.

[20]  R. Stoltzfus,et al.  Clinical pallor is useful to detect severe anemia in populations where anemia is prevalent and severe. , 1999, The Journal of nutrition.