Evaluation of the performance of the ABON™ Plus Malaria® and I-test® tests in the diagnosis of imported malaria in Tunisia

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Dorsaf Aloui
Oumaima Khemis
Mariem Bouchakoua
Sonia Trabelsi

Abstract

Background: Imported malaria remains a public health challenge in malaria-free countries. Rapid diagnostic tests (RDTs) are used alongside microscopy, but their performance varies with clinical presentation and epidemiological context.
Methods: We conducted a retrospective study (2020–2023) at the Parasitology-Mycology Laboratory of Charles Nicolle Hospital, Tunisia, including 25 symptomatic patients and 246 asymptomatic non-permanent resident students from sub-Saharan Africa. Microscopy (thick and thin smears)
served as the reference standard. Sensitivity, specificity, positive and negative predictive values (PPV, NPV), and Cohen’s kappa (κ) were calculated to assess the performance of the ABON™ PLUS Malaria (Abon biopharm, China) et I-test® (Bacterovir laboratoire) RDTs.
Results: Malaria was diagnosed in 35 individuals (13%), comprising 12 symptomatic patients (48%) and 23 asymptomatic patients (9.35%). Plasmodium falciparum was the most common species (95%). In symptomatic subjects, parasitemia ranged from 0.5% to 20%, and both tests demonstrated excellent agreement with the thick blood smear
(κ=0.91 for ABON™ Plus; κ=1 for I-test®). In contrast, parasitemia was low (<0.1%) in asymptomatic students. For this group, the ABON™ Plus test showed a sensitivity of 48% and a specificity of 100% (PPV: 100%; NPV: 95%), while the I-test® had a sensitivity of 23.8% and a specificity of 100%
(PPV: 100%; NPV: 90%). Consequently, agreement with the reference smear was good for the ABON™ Plus test (κ=0.62) but poor for the I-test®(κ=0.35).
Conclusion: Both RDTs performed well in symptomatic cases, but low sensitivity in asymptomatic individuals highlights the importance of microscopy and targeted screening to prevent malaria reintroduction in malaria-free countries.

Keywords:

Imported malaria, Rapid diagnostic tests, screening, Tunisia

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