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PLoS One. 2014 Dec 9;9(12):e114540. doi: 10.1371/journal.pone.0114540. eCollection 2014.

Evaluation of a density-based rapid diagnostic test for sickle cell disease in a clinical setting in Zambia.

Author information

1
School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts, United States of America.
2
Department of Pediatrics, University Teaching Hospital, Lusaka, Zambia.
3
Department of Chemistry & Chemical Biology, Harvard University, Cambridge, Massachusetts, United States of America.
4
Department of Laboratory Medicine, Children's Hospital Boston, Boston, Massachusetts, United States of America.
5
Hematology Division, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.
6
Department of Chemistry & Chemical Biology, Harvard University, Cambridge, Massachusetts, United States of America; Wyss Institute for Biologically Inspired Engineering, Harvard University, Cambridge, Massachusetts, United States of America.

Abstract

Although simple and low-cost interventions for sickle cell disease (SCD) exist in many developing countries, child mortality associated with SCD remains high, in part, because of the lack of access to diagnostic tests for SCD. A density-based test using aqueous multiphase systems (SCD-AMPS) is a candidate for a low-cost, point-of-care diagnostic for SCD. In this paper, the field evaluation of SCD-AMPS in a large (n = 505) case-control study in Zambia is described. Of the two variations of the SCD-AMPS used, the best system (SCD-AMPS-2) demonstrated a sensitivity of 86% (82-90%) and a specificity of 60% (53-67%). Subsequent analysis identified potential sources of false positives that include clotting, variation between batches of SCD-AMPS, and shipping conditions. Importantly, SCD-AMPS-2 was 84% (62-94%) sensitive in detecting SCD in children between 6 months and 1 year old. In addition to an evaluation of performance, an assessment of end-user operability was done with health workers in rural clinics in Zambia. These health workers rated the SCD-AMPS tests to be as simple to use as lateral flow tests for malaria and HIV.

PMID:
25490722
PMCID:
PMC4260838
DOI:
10.1371/journal.pone.0114540
[Indexed for MEDLINE]
Free PMC Article

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