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Performance evaluation of a prototype rapid diagnostic test for combined detection of gambiense human African trypanosomiasis and malaria.
PLoS Negl Trop Dis. 2020 04; 14(4):e0008168.PN

Abstract

BACKGROUND

Malaria is endemic in all regions where gambiense or rhodesiense human African trypanosomiasis (HAT) is reported, and both diseases have similarities in their symptomatology. A combined test could be useful for both diseases and would facilitate integration of the screening for gambiense HAT (gHAT) and malaria diagnosis. This study aimed to evaluate a combined prototype rapid diagnostic test (RDT) for gHAT and malaria.

METHODS

Blood samples were collected in the Democratic Republic of the Congo and in Uganda to evaluate the performance of a prototype HAT/Malaria Combined RDT in comparison to an individual malaria RDT based on Plasmodium falciparum (P.f.) Histidine Rich Protein II (HRP-II or HRP2) antigen (SD BIOLINE Malaria Ag P.f. RDT) for malaria detection and an individual gHAT RDT based on recombinant antigens, the SD BIOLINE HAT 2.0 RDT for HAT screening. Due to the current low prevalence of gHAT in endemic regions, the set of blood samples that were collected was used to evaluate the specificity of the RDTs for gHAT, and additional archived plasma samples were used to complete the evaluation of the HAT/Malaria Combined RDT in comparison to the HAT 2.0 RDT.

RESULTS

Frozen whole blood samples from a total of 486 malaria cases and 239 non-malaria controls, as well as archived plasma samples from 246 gHAT positive and 246 gHAT negative individuals were tested. For malaria, the sensitivity and specificity of the malaria band in the HAT/Malaria Combined RDT were 96.9% (95% CI: 95.0-98.3) and 97.1% (95% CI: 94.1-98.8) respectively. The sensitivity and specificity of the SD BIOLINE malaria Ag P.f. RDT were 97.3% (95% CI: 95.5-98.6) and 97.1% (95% CI: 94.1-98.8) respectively. For gHAT, using archived plasma samples, the sensitivity and specificity were respectively 89% (95% CI: 84.4-92.6) and 93.5% (95% CI: 89.7-96.2) with the HAT/Malaria Combined RDT, and 88.2% (95% CI: 83.5-92) and 94.7% (95% CI: 91.1-97.2) with the HAT 2.0 RDT. Using the whole blood samples that were collected during the study, the specificity of the HAT/Malaria Combined RDT for gHAT was 95.8% (95% CI: 94.3-97.0).

CONCLUSION

The HAT/Malaria Combined prototype RDT was as accurate as the individual malaria or gHAT RDTs. The HAT/Malaria Combined prototype RDT is therefore suitable for both malaria diagnosis and gHAT screening. However, there is a need to assess its accuracy using fresh samples in prospective clinical trials.

Links

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Authors+Show Affiliations

Lumbala C
Disease Control Directorate, Ministry of Public Health, Democratic Republic of the Congo. Global Health Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Matovu E
College of Veterinary Medicine, Animal Resources and Biosecurity, Makerere University, Kampala, Uganda.
Sendagire H
College of Health Sciences, Makerere University, Kampala, Uganda.
Kazibwe AJN
College of Veterinary Medicine, Animal Resources and Biosecurity, Makerere University, Kampala, Uganda.
Likwela JL
Public Health Department, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo.
Muhindo Mavoko H
Kinshasa University, Kinshasa, Democratic Republic of the Congo.
Kayembe S
Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
Lutumba P
Kinshasa University, Kinshasa, Democratic Republic of the Congo.
Biéler S
Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
Van Geertruyden JP
Global Health Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Ndung'u JM
Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.

MeSH

AdolescentAdultAntigens, ProtozoanDemocratic Republic of the CongoDiagnostic Tests, RoutineFemaleHumansMalariaMalePlasmodium falciparumProspective StudiesProtozoan ProteinsSensitivity and SpecificityTrypanosoma brucei gambienseTrypanosomiasis, AfricanUgandaYoung Adult

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32251426

Citation

Lumbala, Crispin, et al. "Performance Evaluation of a Prototype Rapid Diagnostic Test for Combined Detection of Gambiense Human African Trypanosomiasis and Malaria." PLoS Neglected Tropical Diseases, vol. 14, no. 4, 2020, pp. e0008168.
Lumbala C, Matovu E, Sendagire H, et al. Performance evaluation of a prototype rapid diagnostic test for combined detection of gambiense human African trypanosomiasis and malaria. PLoS Negl Trop Dis. 2020;14(4):e0008168.
Lumbala, C., Matovu, E., Sendagire, H., Kazibwe, A. J. N., Likwela, J. L., Muhindo Mavoko, H., Kayembe, S., Lutumba, P., Biéler, S., Van Geertruyden, J. P., & Ndung'u, J. M. (2020). Performance evaluation of a prototype rapid diagnostic test for combined detection of gambiense human African trypanosomiasis and malaria. PLoS Neglected Tropical Diseases, 14(4), e0008168. https://doi.org/10.1371/journal.pntd.0008168
Lumbala C, et al. Performance Evaluation of a Prototype Rapid Diagnostic Test for Combined Detection of Gambiense Human African Trypanosomiasis and Malaria. PLoS Negl Trop Dis. 2020;14(4):e0008168. PubMed PMID: 32251426.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance evaluation of a prototype rapid diagnostic test for combined detection of gambiense human African trypanosomiasis and malaria. AU - Lumbala,Crispin, AU - Matovu,Enock, AU - Sendagire,Hakim, AU - Kazibwe,Anne J N, AU - Likwela,Joris L, AU - Muhindo Mavoko,Hypolite, AU - Kayembe,Simon, AU - Lutumba,Pascal, AU - Biéler,Sylvain, AU - Van Geertruyden,Jean-Pierre, AU - Ndung'u,Joseph M, Y1 - 2020/04/06/ PY - 2019/05/24/received PY - 2020/02/24/accepted PY - 2020/04/16/revised PY - 2020/4/7/pubmed PY - 2020/7/7/medline PY - 2020/4/7/entrez SP - e0008168 EP - e0008168 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 14 IS - 4 N2 - BACKGROUND: Malaria is endemic in all regions where gambiense or rhodesiense human African trypanosomiasis (HAT) is reported, and both diseases have similarities in their symptomatology. A combined test could be useful for both diseases and would facilitate integration of the screening for gambiense HAT (gHAT) and malaria diagnosis. This study aimed to evaluate a combined prototype rapid diagnostic test (RDT) for gHAT and malaria. METHODS: Blood samples were collected in the Democratic Republic of the Congo and in Uganda to evaluate the performance of a prototype HAT/Malaria Combined RDT in comparison to an individual malaria RDT based on Plasmodium falciparum (P.f.) Histidine Rich Protein II (HRP-II or HRP2) antigen (SD BIOLINE Malaria Ag P.f. RDT) for malaria detection and an individual gHAT RDT based on recombinant antigens, the SD BIOLINE HAT 2.0 RDT for HAT screening. Due to the current low prevalence of gHAT in endemic regions, the set of blood samples that were collected was used to evaluate the specificity of the RDTs for gHAT, and additional archived plasma samples were used to complete the evaluation of the HAT/Malaria Combined RDT in comparison to the HAT 2.0 RDT. RESULTS: Frozen whole blood samples from a total of 486 malaria cases and 239 non-malaria controls, as well as archived plasma samples from 246 gHAT positive and 246 gHAT negative individuals were tested. For malaria, the sensitivity and specificity of the malaria band in the HAT/Malaria Combined RDT were 96.9% (95% CI: 95.0-98.3) and 97.1% (95% CI: 94.1-98.8) respectively. The sensitivity and specificity of the SD BIOLINE malaria Ag P.f. RDT were 97.3% (95% CI: 95.5-98.6) and 97.1% (95% CI: 94.1-98.8) respectively. For gHAT, using archived plasma samples, the sensitivity and specificity were respectively 89% (95% CI: 84.4-92.6) and 93.5% (95% CI: 89.7-96.2) with the HAT/Malaria Combined RDT, and 88.2% (95% CI: 83.5-92) and 94.7% (95% CI: 91.1-97.2) with the HAT 2.0 RDT. Using the whole blood samples that were collected during the study, the specificity of the HAT/Malaria Combined RDT for gHAT was 95.8% (95% CI: 94.3-97.0). CONCLUSION: The HAT/Malaria Combined prototype RDT was as accurate as the individual malaria or gHAT RDTs. The HAT/Malaria Combined prototype RDT is therefore suitable for both malaria diagnosis and gHAT screening. However, there is a need to assess its accuracy using fresh samples in prospective clinical trials. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/32251426/Performance_evaluation_of_a_prototype_rapid_diagnostic_test_for_combined_detection_of_gambiense_human_African_trypanosomiasis_and_malaria_ DB - PRIME DP - Unbound Medicine ER -