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Author Notes:

Patrick T. McGann, Email: patrick.mcgann@cchmc.org

M.P.-P. and P.T.M designed the research, collected and analyzed data, and wrote the manuscript; E.A.T. and W.A.L. optimized and contributed the reagents and edited the manuscript; L.R.S. and R.E.W. assisted in the design of the research, analysis of the data, and writing of the manuscript.

T.A.H. and A.P. collected and analyzed the data and edited the manuscript.

The authors read and approved the final manuscript.

The authors would like to thank the students, physicians, research staff, administrative personnel, and laboratory technicians who participated in the study as readers of the point-of-care tests.

Two authors on the manuscript (E.A.T. And W.A.L.), as developers of the original test, hold equity in Sanguina, LLC, the company currently responsible for developing the POC hemoglobin assay described in the study. These authors supplied the testing reagents and collaborated to modify the detection range of the test, but did not direct study design or data analysis.

All other authors report no conflict of interest.

Subject:

Research Funding:

This work was supported by the National Heart, Lung, and Blood Institute (PTM, Award #1K23HL128885).

Keywords:

  • Anemia
  • Global health
  • Hematology
  • Point-of-care diagnostics

AnemoCheck-LRS: an optimized, color-based point-of-care test to identify severe anemia in limited-resource settings

Tools:

Journal Title:

BMC Medicine

Volume:

Volume 18, Number 1

Publisher:

, Pages 337-337

Type of Work:

Article | Final Publisher PDF

Abstract:

Background: Severe anemia is common and frequently fatal for hospitalized patients in limited-resource settings. Lack of access to low-cost, accurate, and rapid diagnosis of anemia impedes the delivery of life-saving care and appropriate use of the limited blood supply. The WHO Haemoglobin Colour Scale (HCS) is a simple low-cost test but frequently inaccurate. AnemoCheck-LRS (limited-resource settings) is a rapid, inexpensive, color-based point-of-care (POC) test optimized to diagnose severe anemia. Methods: Deidentified whole blood samples were diluted with plasma to create variable hemoglobin (Hb) concentrations, with most in the severe (≤ 7 g/dL) or profound (≤ 5 g/dL) anemia range. Each sample was tested with AnemoCheck-LRS and WHO HCS independently by three readers and compared to Hb measured by an electronic POC test (HemoCue 201+) and commercial hematology analyzer. Results: For 570 evaluations within the limits of detection of AnemoCheck-LRS (Hb ≤ 8 g/dL), the average difference between AnemoCheck-LRS and measured Hb was 0.5 ± 0.4 g/dL. In contrast, the WHO HCS overestimated Hb with an absolute difference of 4.9 ± 1.3 g/dL for samples within its detection range (Hb 4–14 g/dL, n = 405). AnemoCheck-LRS was much more sensitive (92%) for the diagnosis of profound anemia than WHO HCS (22%). Conclusions: AnemoCheck-LRS is a rapid, inexpensive, and accurate POC test for anemia. AnemoCheck-LRS is more accurate than WHO HCS for detection of low Hb levels, severe anemia that may require blood transfusion. AnemoCheck-LRS should be tested prospectively in limited-resource settings where severe anemia is common, to determine its utility as a screening tool to identify patients who may require transfusion.

Copyright information:

© 2020, The Author(s).

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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