Simultaneous point-of-care detection of anemia and sickle cell disease in Tanzania: the RAPID study

• Type of Material: Article
• Authors: Luke R. Smart, Cincinnati Childrens Hospital Medical Center; Emmanuela E. Ambrose, Catholic University of Health & Allied Sciences; Kevin C. Raphael, Catholic University of Health & Allied Sciences; Adolfine Hokororo, Catholic University of Health & Allied Sciences; Erasmus Kamugisha, Catholic University of Health & Allied Sciences; Erika A. Tyburski, Emory University; Wilbur Lam, Emory University; Russell E. Ware, Cincinnati Childrens Hospital Medical Center; Patrick T. McGann, Cincinnati Childrens Hospital Medical Center
• Language: English
• Date: 2018-02-01
• Publisher: Springer (part of Springer Nature): Springer Open Choice Hybrid Journals
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017, Springer-Verlag GmbH Germany, part of Springer Nature.
• Final Published Version (URL): http://dx.doi.org/10.1007/s00277-017-3182-8
• Title of Journal or Parent Work: Annals of Hematology
• ISSN: 0939-5555
• Volume: 97
• Issue: 2
• Start Page: 239
• End Page: 246
• Grant/Funding Information: This work was supported by a grant from the National Heart, Lung and Blood Institute, National Institutes of Health (K23 HL128885 to P.T.M.) and the Cincinnati Children’s Research Foundation.
• Keywords: TESTING DEVICE; CHILDREN; Science & Technology; BLOOD-TRANSFUSION; Point-of-care testing; CHILDHOOD MORTALITY; DIAGNOSIS; HEMOGLOBIN; Diagnostics; GLOBAL EPIDEMIOLOGY; Anemia; PROVIDES; Global health; Hematology; BURDEN; Sickle cell anemia; AFRICA; Life Sciences & Biomedicine
• Research Categories: Health Sciences, Public Health; Health Sciences, Epidemiology

Abstract

Both anemia and sickle cell disease (SCD) are highly prevalent across sub-Saharan Africa, and limited resources exist to diagnose these conditions quickly and accurately. The development of simple, inexpensive, and accurate point-of-care (POC) assays represents an important advance for global hematology, one that could facilitate timely and life-saving medical interventions. In this prospective study, Robust Assays for Point-of-care Identification of Disease (RAPID), we simultaneously evaluated a POC immunoassay (Sickle SCAN™) to diagnose SCD and a first-generation POC color-based assay to detect anemia. Performed at Bugando Medical Center in Mwanza, Tanzania, RAPID tested 752 participants (age 1 day to 20 years) in four busy clinical locations. With minimally trained medical staff, the SCD POC assay diagnosed SCD with 98.1% sensitivity and 91.1% specificity. The hemoglobin POC assay had 83.2% sensitivity and 74.5% specificity for detection of severe anemia (Hb ≤ 7 g/dL). Interobserver agreement was excellent for both POC assays (r = 0.95–0.96). Results for the hemoglobin POC assay have informed the second-generation assay design to be more suitable for low-resource settings. RAPID provides practical feasibility data regarding two novel POC assays for the diagnosis of anemia and SCD in real-world field evaluations and documents the utility and potential impact of these POC assays for sub-Saharan Africa.