Use of Schistosoma mansoni soluble egg antigen (SEA) for antibody detection and diagnosis of schistosomiasis: The need for improved accuracy evaluations of diagnostic tools.

• Many studies of SEA ELISA fail to comply with guidelines for accuracy estimations. • Wide variation of sensitivity (71–99%) and specificity (6–100%). • Better evaluation studies are as important as searching for new antigens. Many antigens for use in antibody-detection systems for schistosomiasis have been investigated over the past 40 years. In particular, soluble egg antigens (SEA) are still widely used in enzyme-linked immunosorbent assays (ELISAs) for detection of immunoglobulin classes and subclasses. Here, we conducted a literature review to examine accuracy evaluations of SEA-Immunoglobulin G (IgG)-ELISAs performed to detect Schistosoma mansoni infections and published between 1979 and 2019. S. mansoni is the main causative agent for intestinal schistosomiasis in many countries in Africa and Central and South America. After retrieving 214 relevant abstracts from the PubMed database, we selected 15 publications to undergo a full review. Sensitivity and specificity values varied from 71 to 99%, and from 6 to 100%, respectively. In addition, 11/15 studies did not state confidence intervals. Therefore, the findings from this review indicate that after four decades, we still do not have consistent evaluation estimates of SEA-IgG-ELISAs. Antigen mass per well and dilution of test sera in these articles varied from 0.018 µg to 1.5 µg, and from 1:50 to 1:500, respectively. Most of the reported accuracy evaluations used control sera which were selected based on parasitological examinations for egg detection, although ill-defined criteria were also noted. The number and composition of control serum panels was considered not adequate in approximately half of the studies. It is also noteworthy that among more than 30 diagnostic antigen preparations under development since the 1970s, most were not validated in the field and they failed to reach populations in need. Thus, attention to guidelines for standardization, estimations of accuracy, and reporting of results is needed to facilitate coordinated efforts aimed at schistosomiasis control and elimination. Large variability of sensitivity (A) and specificity (B) estimates for SEA-ELISA suggests better controlled evaluation studies are needed. Image, graphical abstract [ABSTRACT FROM AUTHOR]