Premium
A rapid, inexpensive and disposable point‐of‐care blood test for sickle cell disease using novel, highly specific monoclonal antibodies
Author(s) -
Quinn Charles T.,
Paniagua Mary C.,
DiNello Robert K.,
Panchal Anand,
Geisberg Mark
Publication year - 2016
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.14298
Subject(s) - medicine , monoclonal antibody , antibody , immunology , sickle cell trait , monoclonal , disease , hemoglobin
Sickle cell disease ( SCD ) is a significant healthcare burden worldwide, but most affected individuals reside in low‐resource areas where access to diagnostic testing may be limited. We developed and validated a rapid, inexpensive, disposable diagnostic test, the HemoType SC ™ , based on novel monoclonal antibodies ( MA bs) that differentiate normal adult haemoglobin (Hb A), sickle haemoglobin (Hb S) and haemoglobin C (Hb C). In competitive enzyme‐linked immunosorbent assays, each MA b bound only its target with <0·1% cross‐reactivity. With the HemoType SC ™ test procedure, the sensitivity for each variant was <5·0 g/l. The accuracy of HemoType SC ™ was evaluated on 100 whole blood samples from individuals with common relevant haemoglobin phenotypes, including normal (Hb AA , N = 20), carrier or trait (Hb AS , N = 22; Hb AC , N = 20), SCD (Hb SS , N = 22; Hb SC , N = 13), and Hb C disease (Hb CC , N = 3). The correct haemoglobin phenotype was identified in 100% of these samples. The accuracy of the test was not affected by Hb F (0–94·8% of total Hb) or Hb A 2 (0–5·6% of total Hb). HemoType SC ™ requires <1 μl of whole blood and no instruments or power sources. The total time‐to‐result is <20 min. HemoType SC ™ may be a practical solution for point‐of‐care testing for SCD and carrier status in low‐resource settings.