Performance evaluation of a combination Plasmodium dual-antigen CRP rapid diagnostic test in Lambaréné, Gabon

Purpose The consequent use of malaria rapid diagnostic tests (RDTs) preceding a treatment decision has improved the global management of malaria. A combination RDT, including an inflammation marker to potentially guide antibiotic prescription, could improve the management of acute febrile illness (AFI). Methods We performed a prospective, cross-sectional study in Gabon evaluating the STANDARD Malaria/CRP DUO (S-DUO) RDT. Participants aged 2 to 17 years with fever at presentation and/or a history of fever < 7 days were enrolled. Expert microscopy, SD Bioline Malaria Ag P.f/Pan test for malaria detection, and NycoCard CRP device for CRP were used as comparators. AFI cases were classified on a spectrum encompassing bacterial vs. non-bacterial infection. Results 415 participants with AFI were enrolled. S-DUO RDT sensitivity and specificity for malaria detection vs. microscopy were 99<middle dot>1% (95<middle dot>2-100%) and 72<middle dot>7% (64<middle dot>3-80<middle dot>1%); and for CRP detection (20 mg/L and above) 86<middle dot>9% (80-92%) and 87% (79<middle dot>2-92<middle dot>7%), respectively. The difference in CRP levels between bacterial infection (mean = 41<middle dot>2 mg/L) and other causes of fever, measured from our study population using the Nycocard device, was statistically significant (p < 0<middle dot>01); CRP precision-recall AUC to distinguish bacterial infection class vs. non-bacterial classifications was 0<middle dot>79. Conclusion S-DUO RDT is suitable for malaria detection in moderate-to-high malaria transmission settings such as in Lambar & eacute;n & eacute;; however, a CRP band detection limit > 40 mg/L is more adequate for indication of antibiotic prescription for AFI cases in Gabon.