Analytic Characteristics and Performance of Novel Immunoassay Point-of-Care Tests for Early Diagnosis of Sickle Cell Disease

Abstract Microtechnology point-of-care tests (POCTs), which are accurate and easy to use, are needed for the diagnosis of infants with sickle cell disease (SCD) to facilitate linkage to early care and management in resource-constrained public health centers in sub-Saharan Africa. We systematically reviewed the evidence of 2 novel POCTs' characteristics, performance, and clinical utility compared with standard laboratory-based methods. Studies evaluating the use of POCTs for SCD screening were identified by a search of PubMed and CINAHL. Eighty-four abstracts were screened, and 68 full-text articles were assessed, of which 12 met the inclusion criteria. Twelve studies conducted in 10 countries evaluated performance and diagnostic accuracy of 2 qualitative immunoassay POCTs (Sickle SCAN and HemoTypeSC). Eight studies were field reviews that compared the performance of the POCTs to extant laboratory methods, and one study reported on clinical management of SCD. The studies of diagnostic accuracy showed excellent performance for immunoassay POCTs. The reported correlation between criterion standard comparator laboratory-based assays was high across the 2 POCTs. Specificity for both POCTs was excellent among newborns and infants even in the presence of high fetal hemoglobin levels. The POCTs were deemed easy to use and had rapid turnaround times. The performance of immunoassay SCD-POCTs is comparable to reference assays, and the SCD-POCTs have the potential to improve patient outcomes. Additional studies on clinical utility, implementation, and accessibility are needed. Future research should focus on understanding and mapping the barriers to implementation within the context of resource-constrained settings.