A rapid, inexpensive and disposable point-of-care blood test for sickle cell disease using novel, highly specific monoclonal antibodies.
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 HemoTypeSC™, based on novel monoclonal antibodies (MAbs) that differentiate normal adult haemoglobin (Hb A), sickle haemoglobin (Hb S) and haemoglobin C (Hb C). In competitive enzyme-linked immunosorbent assays, each MAb bound only its target with <0·1% cross-reactivity. With the HemoTypeSC™test procedure, the sensitivity for each variant was <5·0 g/l. The accuracy of HemoTypeSC™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 A2(0-5·6% of total Hb). HemoTypeSC™requires <1 μl of whole blood and no instruments or power sources. The total time-to-result is <20 min. HemoTypeSC™may be a practical solution for point-of-care testing for SCD and carrier status in low-resource settings.
Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Charles T
CT
Quinn
Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Mary C
MC
Paniagua
Silver Lake Research Corporation, Azusa, CA, USA.
Robert K
RK
DiNello
Silver Lake Research Corporation, Azusa, CA, USA.
Anand
A
Panchal
Silver Lake Research Corporation, Azusa, CA, USA.
Mark
M
Geisberg
D000755:Anemia, Sickle Cell / Q000097:blood* / Q000175:diagnosis*; D000818:Animals; D000911:Antibodies, Monoclonal; D003937:Diagnosis, Differential; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006403:Hematologic Tests / Q000379:methods* / Q000592:standards; D006801:Humans; D051379:Mice; D019095:Point-of-Care Systems; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012805:Sickle Cell Trait / Q000097:blood / Q000175:diagnosis
D000911:Antibodies, Monoclonal
haemoglobinopathy; lateral flow immunoassay; monoclonal antibody; point of care; sickle cell disease