Performance of a novel hematology analyzer in the detection of Plasmodium infections in clinical settings: Systematic review

Abstract

Background: Early and accurate diagnosis is crucial for malaria disease effective management. In the current context of global malaria control and elimination, there is a dire need for innovative, easy-to-use, highly sensitive, and automated malaria diagnostic methods. Against this backdrop, this review scrutinized the available data on the diagnostic performance of the hematology analyzer XN-31 compared to other diagnostic methods currently used in malaria diagnosis. Methods: The published articles on the diagnostic performance of the hematology analyzer XN‑31 in detecting Plasmodium infections in clinical settings were systematically searched on major medical databases. The data were reported following the Preferred Reporting Items for Systematic and Meta-analyses (PRISMA) guidelines. Results: In total, 279 articles were identified, of which 7 met the inclusion criteria. The overall concordance of XN-31 compared with microscopy and/or rapid diagnostic test (RDT), polymerase chain reaction (PCR), and quantitative buffy coat (QBC) was high (≥ 85%). The overall sensitivity, specificity, positive and negative predictive values of XN-31 were also high (> 80%) regardless of the malaria diagnostic method used. Finally, the parasitemia values of XN-31 showed an excellent correlation with the current malaria clinical diagnostic gold standard (> 0.99). Thus, this latter performance makes the XN-31 as accurate as expert microscopy in the biological diagnosis of malaria. Conclusion: This systematic review showed that the XN-31 is an automated rapid, robust, and accurate malaria diagnostic method. However, data on its performance in real conditions of use, especially in malaria endemic countries, should be collected to consolidate its use.