Publications

" Our main objective is to develop and maintain over time a good expertise and infrastructure ensuring high quality training and clinical research."
Prof Halidou TINTO, PharmD, Msc, PhD Head of the CRUN

2024
Journal Articles
	Irene Molina–de Fuente, Marc Christian Tahita, Kabore Bérenger, Thuy Huong Ta Tang, Luz García, Vicenta González, Agustín Benito, Judith M. Hübschen, Halidou Tinto, Pedro Berzosa Malaria diagnosis challenges and pfhrp2 and pfhrp3 gene deletions using pregnant women as sentinel population in Nanoro region, Burkina Faso Journal Article In: Pathogens and global health, vol. 118, iss. 6, 2024, ISSN: 2047-7732. Abstract \| BibTeX \| Tags: Adolescent, Adult, Antigens, Burkina Faso / epidemiology, Diagnostic Tests, doi:10.1080/20477724.2024.2388489, Falciparum* / diagnosis, Falciparum* / epidemiology, Falciparum* / parasitology, Female, Gene Deletion, Humans, Irene Molina-de la Fuente, Malaria, Marc Christian Tahita, MEDLINE, Microscopy, National Center for Biotechnology Information, National Institutes of Health, National Library of Medicine, NCBI, NIH, NLM, Non-U.S. Gov't, Parasitic / diagnosis, Parasitic / epidemiology, Pedro Berzosa, Plasmodium falciparum / genetics, Plasmodium falciparum* / isolation & purification, PMC11441055, pmid:39140699, Pregnancy, Pregnancy Complications, Protozoan Proteins* / genetics, Protozoan* / genetics, PubMed Abstract, Research Support, Routine* / methods, Sensitivity and Specificity, Young Adult \| Links: Close Close @article{nokey, title = {Malaria diagnosis challenges and pfhrp2 and pfhrp3 gene deletions using pregnant women as sentinel population in Nanoro region, Burkina Faso}, author = {Irene Molina\textendashde Fuente and Marc Christian Tahita and Kabore B\'{e}renger and Thuy Huong Ta Tang and Luz Garc\'{i}a and Vicenta Gonz\'{a}lez and Agust\'{i}n Benito and Judith M. H\"{u}bschen and Halidou Tinto and Pedro Berzosa}, url = {https://pubmed.ncbi.nlm.nih.gov/39140699/}, doi = {10.1080/20477724.2024.2388489}, issn = {2047-7732}, year = {2024}, date = {2024-01-01}, journal = {Pathogens and global health}, volume = {118}, issue = {6}, publisher = {Pathog Glob Health}, abstract = {Malaria in pregnancy causes adverse consequences and prompt and accurate diagnosis is essential for case management. In malaria endemic countries, diagnosis is mainly based on rapid diagnostic tests (RDT) and microscopy. However, increasing reports of false negatives caused by low parasitemia and pfhrp2/3 deletions raise concerns about HRP2-based RDT usefulness. This study aimed to assess RDT and microscopy performance and to describe pfhrp2/3 deletions in a cohort of 418 pregnant women in Burkina Faso. Malaria was diagnosed using RDT and microscopy and blood samples were collected during antenatal care visits. Diagnostic results were compared to PCR as gold standard. Pfhrp2 and pfhrp3 deletions were characterized for patients with confirmed P. falciparum infection. RDT had better sensitivity (76%) but lower specificity (83%) than microscopy (sensitivity = 57%; specificity = 98%). Low parasitemia (\<150 parasites/µL), especially in multigravidae, was the principal factor causing false negatives by both methods. Moreover, pfhrp2 deletion frequency among overall false negatives by RDT was 21.43%. Higher frequency of deletions was found among all samples, independently of RDT result, for example around 2% of samples had double deletions meaning that the majority of deletions had no effect on RDT testing. Finally, it was found higher pfhrp2 deletion in women with lower uterine height during the first trimester. Wider and National surveillance study of deletions is recommended among pregnant women and in Burkina Faso.}, keywords = {Adolescent, Adult, Antigens, Burkina Faso / epidemiology, Diagnostic Tests, doi:10.1080/20477724.2024.2388489, Falciparum / diagnosis, Falciparum* / epidemiology, Falciparum* / parasitology, Female, Gene Deletion, Humans, Irene Molina-de la Fuente, Malaria, Marc Christian Tahita, MEDLINE, Microscopy, National Center for Biotechnology Information, National Institutes of Health, National Library of Medicine, NCBI, NIH, NLM, Non-U.S. Gov't, Parasitic / diagnosis, Parasitic / epidemiology, Pedro Berzosa, Plasmodium falciparum / genetics, Plasmodium falciparum* / isolation \& purification, PMC11441055, pmid:39140699, Pregnancy, Pregnancy Complications, Protozoan Proteins* / genetics, Protozoan* / genetics, PubMed Abstract, Research Support, Routine* / methods, Sensitivity and Specificity*, Young Adult}, pubstate = {published}, tppubtype = {article} } Close Malaria in pregnancy causes adverse consequences and prompt and accurate diagnosis is essential for case management. In malaria endemic countries, diagnosis is mainly based on rapid diagnostic tests (RDT) and microscopy. However, increasing reports of false negatives caused by low parasitemia and pfhrp2/3 deletions raise concerns about HRP2-based RDT usefulness. This study aimed to assess RDT and microscopy performance and to describe pfhrp2/3 deletions in a cohort of 418 pregnant women in Burkina Faso. Malaria was diagnosed using RDT and microscopy and blood samples were collected during antenatal care visits. Diagnostic results were compared to PCR as gold standard. Pfhrp2 and pfhrp3 deletions were characterized for patients with confirmed P. falciparum infection. RDT had better sensitivity (76%) but lower specificity (83%) than microscopy (sensitivity = 57%; specificity = 98%). Low parasitemia (<150 parasites/µL), especially in multigravidae, was the principal factor causing false negatives by both methods. Moreover, pfhrp2 deletion frequency among overall false negatives by RDT was 21.43%. Higher frequency of deletions was found among all samples, independently of RDT result, for example around 2% of samples had double deletions meaning that the majority of deletions had no effect on RDT testing. Finally, it was found higher pfhrp2 deletion in women with lower uterine height during the first trimester. Wider and National surveillance study of deletions is recommended among pregnant women and in Burkina Faso. Close
2023
Journal Articles
	Oumou Camara, Mamadou Camara, Laura Cristina Falzon, Hamidou Ilboudo, Jacques Kaboré, Charlie Franck Alfred Compaoré, Eric Maurice Fèvre, Philippe Büscher, Bruno Bucheton, Veerle Lejon Performance of clinical signs and symptoms, rapid and reference laboratory diagnostic tests for diagnosis of human African trypanosomiasis by passive screening in Guinea: a prospective diagnostic accuracy study Journal Article In: Infectious diseases of poverty, vol. 12, iss. 1, 2023, ISSN: 2049-9957. Abstract \| BibTeX \| Tags: African, Animals, Clinical Trial, Diagnostic Tests, doi:10.1186/s40249-023-01076-1, Guinea, Humans, Mamadou Camara, MEDLINE, National Center for Biotechnology Information, National Institutes of Health, National Library of Medicine, NCBI, NIH, NLM, Oumou Camara, PMC10026442, pmid:36941656, Prospective Studies, PubMed Abstract, Routine, Sensitivity and Specificity, Trypanosomiasis, Veerle Lejon \| Links: Close Close @article{Camara2023, title = {Performance of clinical signs and symptoms, rapid and reference laboratory diagnostic tests for diagnosis of human African trypanosomiasis by passive screening in Guinea: a prospective diagnostic accuracy study}, author = {Oumou Camara and Mamadou Camara and Laura Cristina Falzon and Hamidou Ilboudo and Jacques Kabor\'{e} and Charlie Franck Alfred Compaor\'{e} and Eric Maurice F\`{e}vre and Philippe B\"{u}scher and Bruno Bucheton and Veerle Lejon}, url = {https://pubmed.ncbi.nlm.nih.gov/36941656/}, doi = {10.1186/S40249-023-01076-1}, issn = {2049-9957}, year = {2023}, date = {2023-01-01}, journal = {Infectious diseases of poverty}, volume = {12}, issue = {1}, publisher = {Infect Dis Poverty}, abstract = {Background: Passive diagnosis of human African trypanosomiasis (HAT) at the health facility level is a major component of HAT control in Guinea. We examined which clinical signs and symptoms are associated with HAT, and assessed the performance of selected clinical presentations, of rapid diagnostic tests (RDT), and of reference laboratory tests on dried blood spots (DBS) for diagnosing HAT in Guinea. Method: The study took place in 14 health facilities in Guinea, where 2345 clinical suspects were tested with RDTs (HAT Sero-K-Set, rHAT Sero-Strip, and SD Bioline HAT). Seropositives underwent parasitological examination (reference test) to confirm HAT and their DBS were tested in indirect enzyme-linked immunoassay (ELISA)/Trypanosoma brucei gambiense, trypanolysis, Loopamp Trypanosoma brucei Detection kit (LAMP) and m18S quantitative PCR (qPCR). Multivariable regression analysis assessed association of clinical presentation with HAT. Sensitivity, specificity, positive and negative predictive values of key clinical presentations, of the RDTs and of the DBS tests for HAT diagnosis were determined. Results: The HAT prevalence, as confirmed parasitologically, was 2.0% (48/2345, 95% CI: 1.5\textendash2.7%). Odds ratios (OR) for HAT were increased for participants with swollen lymph nodes (OR = 96.7, 95% CI: 20.7\textendash452.0), important weight loss (OR = 20.4, 95% CI: 7.05\textendash58.9), severe itching (OR = 45.9, 95% CI: 7.3\textendash288.7) or motor disorders (OR = 4.5, 95% CI: 0.89\textendash22.5). Presence of at least one of these clinical presentations was 75.6% (95% CI: 73.8\textendash77.4%) specific and 97.9% (95% CI: 88.9\textendash99.9%) sensitive for HAT. HAT Sero-K-Set, rHAT Sero-Strip, and SD Bioline HAT were respectively 97.5% (95% CI: 96.8\textendash98.1%), 99.4% (95% CI: 99.0\textendash99.7%) and 97.9% (95% CI: 97.2\textendash98.4%) specific, and 100% (95% CI: 92.5\textendash100.0%), 59.6% (95% CI: 44.3\textendash73.3%) and 93.8% (95% CI: 82.8\textendash98.7%) sensitive for HAT. The RDT’s positive and negative predictive values ranged from 45.2\textendash66.7% and 99.2\textendash100% respectively. All DBS tests had specificities ≥ 92.9%. While LAMP and m18S qPCR sensitivities were below 50%, trypanolysis and ELISA/T.b. gambiense had sensitivities of 85.3% (95% CI: 68.9\textendash95.0%) and 67.6% (95% CI: 49.5\textendash82.6%). Conclusions: Presence of swollen lymph nodes, important weight loss, severe itching or motor disorders are simple but accurate clinical criteria for HAT referral in HAT endemic areas in Guinea. Diagnostic performances of HAT Sero-K-Set and SD Bioline HAT are sufficient for referring positives to microscopy. Trypanolysis on DBS may discriminate HAT patients from false RDT positives. Trial registration The trial was registered under NCT03356665 in clinicaltrials.gov (November 29, 2017, retrospectively registered https://clinicaltrials.gov/ct2/show/NCT03356665) Graphical Abstract: [Figure not available: see fulltext.].}, keywords = {African, Animals, Clinical Trial, Diagnostic Tests, doi:10.1186/s40249-023-01076-1, Guinea, Humans, Mamadou Camara, MEDLINE, National Center for Biotechnology Information, National Institutes of Health, National Library of Medicine, NCBI, NIH, NLM, Oumou Camara, PMC10026442, pmid:36941656, Prospective Studies, PubMed Abstract, Routine, Sensitivity and Specificity, Trypanosomiasis, Veerle Lejon}, pubstate = {published}, tppubtype = {article} } Close Background: Passive diagnosis of human African trypanosomiasis (HAT) at the health facility level is a major component of HAT control in Guinea. We examined which clinical signs and symptoms are associated with HAT, and assessed the performance of selected clinical presentations, of rapid diagnostic tests (RDT), and of reference laboratory tests on dried blood spots (DBS) for diagnosing HAT in Guinea. Method: The study took place in 14 health facilities in Guinea, where 2345 clinical suspects were tested with RDTs (HAT Sero-K-Set, rHAT Sero-Strip, and SD Bioline HAT). Seropositives underwent parasitological examination (reference test) to confirm HAT and their DBS were tested in indirect enzyme-linked immunoassay (ELISA)/Trypanosoma brucei gambiense, trypanolysis, Loopamp Trypanosoma brucei Detection kit (LAMP) and m18S quantitative PCR (qPCR). Multivariable regression analysis assessed association of clinical presentation with HAT. Sensitivity, specificity, positive and negative predictive values of key clinical presentations, of the RDTs and of the DBS tests for HAT diagnosis were determined. Results: The HAT prevalence, as confirmed parasitologically, was 2.0% (48/2345, 95% CI: 1.5–2.7%). Odds ratios (OR) for HAT were increased for participants with swollen lymph nodes (OR = 96.7, 95% CI: 20.7–452.0), important weight loss (OR = 20.4, 95% CI: 7.05–58.9), severe itching (OR = 45.9, 95% CI: 7.3–288.7) or motor disorders (OR = 4.5, 95% CI: 0.89–22.5). Presence of at least one of these clinical presentations was 75.6% (95% CI: 73.8–77.4%) specific and 97.9% (95% CI: 88.9–99.9%) sensitive for HAT. HAT Sero-K-Set, rHAT Sero-Strip, and SD Bioline HAT were respectively 97.5% (95% CI: 96.8–98.1%), 99.4% (95% CI: 99.0–99.7%) and 97.9% (95% CI: 97.2–98.4%) specific, and 100% (95% CI: 92.5–100.0%), 59.6% (95% CI: 44.3–73.3%) and 93.8% (95% CI: 82.8–98.7%) sensitive for HAT. The RDT’s positive and negative predictive values ranged from 45.2–66.7% and 99.2–100% respectively. All DBS tests had specificities ≥ 92.9%. While LAMP and m18S qPCR sensitivities were below 50%, trypanolysis and ELISA/T.b. gambiense had sensitivities of 85.3% (95% CI: 68.9–95.0%) and 67.6% (95% CI: 49.5–82.6%). Conclusions: Presence of swollen lymph nodes, important weight loss, severe itching or motor disorders are simple but accurate clinical criteria for HAT referral in HAT endemic areas in Guinea. Diagnostic performances of HAT Sero-K-Set and SD Bioline HAT are sufficient for referring positives to microscopy. Trypanolysis on DBS may discriminate HAT patients from false RDT positives. Trial registration The trial was registered under NCT03356665 in clinicaltrials.gov (November 29, 2017, retrospectively registered https://clinicaltrials.gov/ct2/show/NCT03356665) Graphical Abstract: [Figure not available: see fulltext.]. Close
	Piero Olliaro, Juvenal Nkeramahame, Philip Horgan, Halidou Tinto, François Kiemde, Rita Baiden, Alexander Adjei, James Kapisi, Heidi Hopkins, Olawale Salami, Catrin E. Moore, Sabine Dittrich, Stephan Weber, Stefano Ongarello Synthesis and Meta-analysis of 3 Randomized Trials Conducted in Burkina Faso, Ghana, and Uganda Comparing the Effects of Point-of-Care Tests and Diagnostic Algorithms Versus Routine Care on Antibiotic Prescriptions and Clinical Outcomes in Ambulatory Patients <18 Years of Age With Acute Febrile Illness Journal Article In: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, vol. 77, iss. Suppl 2, pp. S199-S205, 2023, ISSN: 1537-6591. BibTeX \| Tags: {Algorithms, Anti-Bacterial Agents* / therapeutic use, Author(firstnames='Adélaïde', Author(firstnames='Alexander', Author(firstnames='Asadu', Author(firstnames='Daniel', Author(firstnames='David', Author(firstnames='Deborah', Author(firstnames='Elizeus', Author(firstnames='François', Author(firstnames='Freddy Eric', Author(firstnames='Halidou', Author(firstnames='Heidi', Author(firstnames='James', Author(firstnames='Rita', Author(firstnames='Vida', Burkina Faso, CollabAuthor(name='ADIP study group', Diagnostic Tests, Ghana, Humans, Juvenal Nkeramahame, MEDLINE, Meta-Analysis, National Center for Biotechnology Information, National Institutes of Health, National Library of Medicine, NCBI, NIH, NLM, Non-U.S. Gov't, Piero Olliaro, PMC10368413, Point-of-Care Testing, Prescriptions, PubMed Abstract, Randomized Controlled Trials as Topic, Research Support \| Links: Close Close @article{Olliaro2023, title = {Synthesis and Meta-analysis of 3 Randomized Trials Conducted in Burkina Faso, Ghana, and Uganda Comparing the Effects of Point-of-Care Tests and Diagnostic Algorithms Versus Routine Care on Antibiotic Prescriptions and Clinical Outcomes in Ambulatory Patients \<18 Years of Age With Acute Febrile Illness}, author = {Piero Olliaro and Juvenal Nkeramahame and Philip Horgan and Halidou Tinto and Fran\c{c}ois Kiemde and Rita Baiden and Alexander Adjei and James Kapisi and Heidi Hopkins and Olawale Salami and Catrin E. Moore and Sabine Dittrich and Stephan Weber and Stefano Ongarello}, url = {https://pubmed.ncbi.nlm.nih.gov/37490743/}, doi = {10.1093/CID/CIAD324}, issn = {1537-6591}, year = {2023}, date = {2023-01-01}, journal = {Clinical infectious diseases : an official publication of the Infectious Diseases Society of America}, volume = {77}, issue = {Suppl 2}, pages = {S199-S205}, publisher = {Clin Infect Dis}, keywords = {{Algorithms, Anti-Bacterial Agents / therapeutic use, Author(firstnames='Ad\'{e}la\"{i}de', Author(firstnames='Alexander', Author(firstnames='Asadu', Author(firstnames='Daniel', Author(firstnames='David', Author(firstnames='Deborah', Author(firstnames='Elizeus', Author(firstnames='Fran\c{c}ois', Author(firstnames='Freddy Eric', Author(firstnames='Halidou', Author(firstnames='Heidi', Author(firstnames='James', Author(firstnames='Rita', Author(firstnames='Vida', Burkina Faso, CollabAuthor(name='ADIP study group', Diagnostic Tests, Ghana, Humans, Juvenal Nkeramahame, MEDLINE, Meta-Analysis, National Center for Biotechnology Information, National Institutes of Health, National Library of Medicine, NCBI, NIH, NLM, Non-U.S. Gov't, Piero Olliaro, PMC10368413, Point-of-Care Testing*, Prescriptions, PubMed Abstract, Randomized Controlled Trials as Topic, Research Support}, pubstate = {published}, tppubtype = {article} } Close
	Japhet Kabalu Tshiongo, Flory Luzolo, Melissa Kabena, Lise Kuseke, Moussa Djimde, Patrick Mitashi, Crispin Lumbala, Kassoum Kayentao, Sandra Menting, Petra F. Mens, Henk D. F. H. Schallig, Pascal Lutumba, Halidou Tinto, Hypolite Muhindo Mavoko, Vivi Maketa Performance of ultra-sensitive malaria rapid diagnostic test to detect Plasmodium falciparum infection in pregnant women in Kinshasa, the Democratic Republic of the Congo Journal Article In: Malaria journal, vol. 22, iss. 1, 2023, ISSN: 1475-2875. Abstract \| BibTeX \| Tags: Antigens, Democratic Republic of the Congo, Diagnostic Tests, doi:10.1186/s12936-023-04749-2, Falciparum* / epidemiology, Female, Flory Luzolo, Humans, Japhet Kabalu Tshiongo, Malaria, Malaria, MEDLINE, National Center for Biotechnology Information, National Institutes of Health, National Library of Medicine, NCBI, NIH, NLM, Plasmodium falciparum, PMC10594769, pmid:37872634, Pregnancy, Pregnant Women, Protozoan, PubMed Abstract, Rapid diagnostic tests, Routine / methods, Sensitivity and Specificity, Vivi Maketa \| Links: Close Close @article{nokey, title = {Performance of ultra-sensitive malaria rapid diagnostic test to detect Plasmodium falciparum infection in pregnant women in Kinshasa, the Democratic Republic of the Congo}, author = {Japhet Kabalu Tshiongo and Flory Luzolo and Melissa Kabena and Lise Kuseke and Moussa Djimde and Patrick Mitashi and Crispin Lumbala and Kassoum Kayentao and Sandra Menting and Petra F. Mens and Henk D. F. H. Schallig and Pascal Lutumba and Halidou Tinto and Hypolite Muhindo Mavoko and Vivi Maketa}, url = {https://pubmed.ncbi.nlm.nih.gov/37872634/}, doi = {10.1186/S12936-023-04749-2}, issn = {1475-2875}, year = {2023}, date = {2023-01-01}, journal = {Malaria journal}, volume = {22}, issue = {1}, publisher = {Malar J}, abstract = {Background: Low peripheral parasitaemia caused by sequestration of Plasmodium falciparum in the placenta hampers the diagnosis of malaria in pregnant women, leading to microscopy or conventional rapid diagnostic tests (RDTs) false-negative results. Although mainly asymptomatic, maternal malaria remains harmful to pregnant women and their offspring in endemic settings and must be adequately diagnosed. Ultra-sensitive RDTs (uRDTs) are thought to be more sensitive than RDTs, and their diagnostic performance was assessed in the current study in pregnant women living in Kinshasa, a stable malaria transmission area in the Democratic Republic of the Congo. Methods: To assess and compare the diagnostic performances of both RDTs and uRDTs, 497 peripheral blood samples were tested using microscopy and quantitative polymerase chain reaction (qPCR) as the index and the reference tests, respectively. The agreement between the different diagnostic tests assessed was estimated by Cohen's Kappa test. Results: The median parasite density by qPCR was 292 p/μL of blood [IQR (49.7\textendash1137)]. Using qPCR as the reference diagnostic test, the sensitivities of microscopy, RDT and uRDT were respectively [55.7% (95% CI 47.6\textendash63.6)], [81.7% (95%CI 74.7\textendash87.3)] and [88% (95% CI 81.9\textendash92.6)]. The specificities of the tests were calculated at 98.5% (95% CI 96.6\textendash99.5), 95.2% (95% CI 92.5\textendash97.2) and 94.4% (95% CI 91.4\textendash96.6) for microscopy, RDT and uRDT, respectively. The agreement between qPCR and uRDT was almost perfect (Kappa = 0.82). For parasite density (qPCR) below 100 p/µL, the sensitivity of RDT was 62% (95% CI 47.1\textendash75.3) compared to 68% (95% CI 53.3\textendash80.4) for uRDT. Between 100 and 200 p/µL, the sensitivity of RDT was higher, but still lower compared to uRDT: 89.4% (95% CI 66.8\textendash98.7) for RDT versus 100% (95% CI 82.3\textendash100) for uRDT. In both cases, microscopy was lower, with 20% (95% CI 10\textendash33.7) and 47.3% (95% CI 24.4\textendash71.1) respectively. Conclusions: uRDT has the potential to improve malaria management in pregnant women as it has been found to be slightly more sensitive than RDT in the detection of malaria in pregnant women but the difference was not significant. Microscopy has a more limited value for the diagnosis of malaria during the pregnancy, because of its lower sensitivity.}, keywords = {Antigens, Democratic Republic of the Congo, Diagnostic Tests, doi:10.1186/s12936-023-04749-2, Falciparum / epidemiology, Female, Flory Luzolo, Humans, Japhet Kabalu Tshiongo, Malaria, Malaria*, MEDLINE, National Center for Biotechnology Information, National Institutes of Health, National Library of Medicine, NCBI, NIH, NLM, Plasmodium falciparum, PMC10594769, pmid:37872634, Pregnancy, Pregnant Women, Protozoan, PubMed Abstract, Rapid diagnostic tests, Routine / methods, Sensitivity and Specificity, Vivi Maketa}, pubstate = {published}, tppubtype = {article} } Close Background: Low peripheral parasitaemia caused by sequestration of Plasmodium falciparum in the placenta hampers the diagnosis of malaria in pregnant women, leading to microscopy or conventional rapid diagnostic tests (RDTs) false-negative results. Although mainly asymptomatic, maternal malaria remains harmful to pregnant women and their offspring in endemic settings and must be adequately diagnosed. Ultra-sensitive RDTs (uRDTs) are thought to be more sensitive than RDTs, and their diagnostic performance was assessed in the current study in pregnant women living in Kinshasa, a stable malaria transmission area in the Democratic Republic of the Congo. Methods: To assess and compare the diagnostic performances of both RDTs and uRDTs, 497 peripheral blood samples were tested using microscopy and quantitative polymerase chain reaction (qPCR) as the index and the reference tests, respectively. The agreement between the different diagnostic tests assessed was estimated by Cohen's Kappa test. Results: The median parasite density by qPCR was 292 p/μL of blood [IQR (49.7–1137)]. Using qPCR as the reference diagnostic test, the sensitivities of microscopy, RDT and uRDT were respectively [55.7% (95% CI 47.6–63.6)], [81.7% (95%CI 74.7–87.3)] and [88% (95% CI 81.9–92.6)]. The specificities of the tests were calculated at 98.5% (95% CI 96.6–99.5), 95.2% (95% CI 92.5–97.2) and 94.4% (95% CI 91.4–96.6) for microscopy, RDT and uRDT, respectively. The agreement between qPCR and uRDT was almost perfect (Kappa = 0.82). For parasite density (qPCR) below 100 p/µL, the sensitivity of RDT was 62% (95% CI 47.1–75.3) compared to 68% (95% CI 53.3–80.4) for uRDT. Between 100 and 200 p/µL, the sensitivity of RDT was higher, but still lower compared to uRDT: 89.4% (95% CI 66.8–98.7) for RDT versus 100% (95% CI 82.3–100) for uRDT. In both cases, microscopy was lower, with 20% (95% CI 10–33.7) and 47.3% (95% CI 24.4–71.1) respectively. Conclusions: uRDT has the potential to improve malaria management in pregnant women as it has been found to be slightly more sensitive than RDT in the detection of malaria in pregnant women but the difference was not significant. Microscopy has a more limited value for the diagnosis of malaria during the pregnancy, because of its lower sensitivity. Close