Abstract
BackgroundIron deficiency (ID) and anaemia are major health concerns, particularly in young children. Screening for ID based on haemoglobin (Hb) concentration alone has been shown to lack sensitivity and specificity. The American Academy of Pediatrics (AAP) recommends soluble transferrin receptor (sTfR) as a promising approach to screen for iron deficiency. However, in most settings, assessment of iron status requires access to centralized laboratories. There is an urgent need for rapid, sensitive, and affordable diagnostics for sTfR at the point-of-care.MethodsAn immunochromatographic assay-based point-of-care screening device was developed for rapid quantification of sTfR from a drop of serum within a few minutes. Performance optimization of the assay was done in sTfR-spiked buffer and commercially available sTfR calibrator, followed by a small-scale proof-of-concept validation with archived serum samples.FindingsOn preliminary testing with archived serum samples and comparison with Ramco ELISA, a correlation of 0.93 (P < 0.0001) was observed, demonstrating its potential for point-of-care assessment of iron status.InterpretationThe analytical performance of the point-of-care sTfR screening device indicates the potential for application in home-use test kits and field settings, especially in low- and middle-income settings. An added advantage of sTfR quantification in combination with our previously reported serum ferritin diagnostics is in integration of Cook's equation as a quantitative and minimally-invasive indicator of total body iron stores.FundThrasher Research Fund (Early Career Award #13379), NIH R03 EB 023190, NSF grant #1343058, and Nutrition International (project #10-8007-CORNE-01).
Highlights
Iron is the most common nutritional deficiency among infants and children, with an estimated prevalence of 3–80% [1], and is associated with long-term detrimental effects on neurodevelopment [2,3] which may be irreversible
Among the biomarkers recommended by the World Health Organization (WHO) for assessment of iron status, a combination of ferritin and soluble transferrin receptor levels reflects the full spectrum of iron status from normal iron stores to tissue iron deficiency [5,6]
Quantification of soluble transferrin receptor (sTfR) and serum ferritin enables the use of Cook's equation [5,14] to calculate total body iron stores, a minimally-invasive proxy measure of the gold standard [5] definition of total body stores using bone marrow aspirate [15,16]
Summary
Iron deficiency (ID) and anaemia are major health concerns, in young children. There is an urgent need for rapid, sensitive, and affordable diagnostics for sTfR at the point-of-care. Methods: An immunochromatographic assay-based point-of-care screening device was developed for rapid quantification of sTfR from a drop of serum within a few minutes. Findings: On preliminary testing with archived serum samples and comparison with Ramco ELISA, a correlation of 0.93 (P b 0.0001) was observed, demonstrating its potential for point-of-care assessment of iron status. Interpretation: The analytical performance of the point-of-care sTfR screening device indicates the potential for application in home-use test kits and field settings, especially in low- and middle-income settings. An added advantage of sTfR quantification in combination with our previously reported serum ferritin diagnostics is in integration of Cook's equation as a quantitative and minimally-invasive indicator of total body iron stores. Fund: Thrasher Research Fund (Early Career Award #13379), NIH R03 EB 023190, NSF grant #1343058, and Nutrition International (project #10-8007-CORNE-01)
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