Analysis of nucleic acids extracted from rapid diagnostic tests reveals a significant proportion of false positive test results associated with recent malaria treatment

Autor: Tobias Schindler, Maximillian Mpina, Jean-Pierre Dangy, C. A. Yoboue, Marcel Tanner, Wonder P. Phiri, Olivier Tresor Donfack, Carlos A. Guerra, Elizabeth Nyakurungu, Koranan Blöchliger, Mitoha Ondo’o Ayekaba, Salome Hosch, Guillermo A. García, Claudia Daubenberger, Etienne A. Guirou
Jazyk: angličtina
Rok vydání: 2022
Předmět:
medicine.medical_specialty
media_common.quotation_subject
PfHRP2 persistence
Plasmodium falciparum
Plasmodium ovale
Population
RC955-962
Protozoan Proteins
Antigens
Protozoan
Infectious and parasitic diseases
RC109-216
Molecular malaria surveillance
Plasmodium malariae
Hygiene
Informed consent
Nucleic Acids
Environmental health
Arctic medicine. Tropical medicine
parasitic diseases
medicine
False Positive Reactions
Positive test
Malaria
Falciparum
education
Retrospective Studies
media_common
education.field_of_study
Coinfection
Diagnostic Tests
Routine
business.industry
Incidence
Research
Ethics committee
Diagnostic test
medicine.disease
equipment and supplies
False-positive malaria rapid diagnostic test
Malaria
Infectious Diseases
pfhrp2 gene deletion
Population Surveillance
Equatorial Guinea
Tropical medicine
Parasitology
business
Zdroj: Malaria Journal, Vol 21, Iss 1, Pp 1-12 (2022)
Malaria Journal
Popis: Background: Surveillance programs often use malaria rapid diagnostic tests (RDTs) to determine the proportion of the population carrying parasites in their peripheral blood to assess the malaria transmission intensity. Despite an increasing number of reports on false-negative and false-positive RDT results, there is a lack of systematic quality control activities for RDTs deployed in malaria surveillance programs. Methods: The diagnostic performance of field-deployed RDTs used for malaria surveys was assessed by retrospective molecular analysis of the blood retained on the tests. Findings: Of the 2,865 RDTs that were collected in 2018 on Bioko Island and analysed in our study, 4·7% had a false-negative result. These false-negative RDTs were associated with low parasite density infections. In a substantial proportion of samples, we identified masked pfhrp2 and pfhrp3 gene deletions in which at least one P. falciparum strain carried a gene deletion. Among all positive RDTs analysed, 28·4% were tested negative by qPCR and therefore considered to be false-positive. Analysing the questionnaire data collected from the participants, this high proportion of false-positive RDTs could be explained by PfHRP2 antigen persistence after recent malaria treatment. Interpretation: We conclude that malaria surveillance depending solely on RDTs needs well-integrated quality control procedures assessing the extend and impact of reduced sensitivity and specificity of RDTs on malaria control programs. Funding: Bioko Island Malaria Elimination Project (BIMEP). Declaration of Interests: The authors declare no conflicts of interest. Ethics Approval Statement: The Ministry of Health and Social Welfare of Equatorial Guinea and the Ethics Committee of the London School of Hygiene & Tropical Medicine (Ref. No. LSHTM: 5556) approved the 2018 malaria indicator survey. Written informed consent was obtained from all adults and from parents or guardians of children who agreed to participate. Only samples for which an additional consent for molecular analysis was obtained were included in this study. We confirm that all experiments were performed in accordance with relevant national and international guidelines and regulations.
Databáze: OpenAIRE
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