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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2024年8月23日

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  • Ayodele Alabi,
  • Fungai P. Musangomunei,
  • Fabrice Lotola-Mougeni,
  • Juste C. Bie-Ondo,
  • Kristin Murphy,
  • Paulin N. Essone,
  • Anita L. Kabwende,
  • Saidou Mahmoudou,
  • Aurélien Macé,
  • Victoria Harris,
  • Michael Ramharter,
  • Martin P. Grobusch,
  • Maria Yazdanbakhsh,
  • B. Leticia Fernandez-Carballo,
  • Camille Escadafal,
  • Peter G. Kremsner,
  • Sabine Dittrich,
  • Selidji T. Agnandji

摘要

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 99·1% (95·2–100%) and 72·7% (64·3–80·1%); and for CRP detection (20 mg/L and above) 86·9% (80–92%) and 87% (79·2–92·7%), respectively. The difference in CRP levels between bacterial infection (mean = 41·2 mg/L) and other causes of fever, measured from our study population using the Nycocard device, was statistically significant (p < 0·01); CRP precision-recall AUC to distinguish bacterial infection class vs. non-bacterial classifications was 0·79.

Conclusion

S-DUO RDT is suitable for malaria detection in moderate-to-high malaria transmission settings such as in Lambaréné; however, a CRP band detection limit > 40 mg/L is more adequate for indication of antibiotic prescription for AFI cases in Gabon.