Article
Possibilities and limitations of Point-of-Care real-time-PCR Truelab® on hospitalized acute febrile children at Bugando Medical Centre in Mwanza, Tanzania
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Authors
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Johannes Plett
- Center of Pediatric & Adolescent Medicine, University Medical Center, Mainz, Germany
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Britta Gröndahl
- Center of Pediatric & Adolescent Medicine, University Medical Center, Mainz, Germany
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Neema Kayange
- Department of Pediatric & Adolescent Medicine, Bugando Medical Centre (BMC), Mwanza, Tanzania
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Philip Koliopoulos
- Center of Pediatric & Adolescent Medicine, University Medical Center, Mainz, Germany
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Christian Jensen
- Center of Pediatric & Adolescent Medicine, University Medical Center, Mainz, Germany
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Steven E. Mshana
- Department of Microbiology & Immunology, Catholic University of Health and Allied Sciences, Mwanza, Tanzania
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Stephan Gehring
- Center of Pediatric & Adolescent Medicine, University Medical Center, Mainz, Germany
| Published: | November 4, 2024 |
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Outline
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Research question: Acute febrile diseases are a serious threat for children in Sub-Saharan-Africa. Malaria and mosquito-borne viruses are common etiologies. Little epidemiological data and few diagnostic tools distinguishing various pathogens lead to inadequate treatment decisions. Precise Point-of-Care (PoC) diagnostic tools are considered helpful to optimize diagnostic procedures and to reduce unnecessary prescription of anti-infectives. The aim of the project was to evaluate the possibilities and limitations of the Truelab® PCR analyzer by molbio®, a PoC-real-time-PCR (PoC-rt-PCR) diagnostic tool.
Methods: In May-September 2022 pediatric participants presenting with fever were enrolled in the study at BMC at Mwanza, Tanzania. Clinical measurements, medical history and prescribed medication were recorded. All participants were tested on-site with Malaria Rapid-Diagnostic-Tests (MRDT) and Dengue-NS1-Rapid-Tests (DRT) as well as with PoC-rt-PCR for Plasmodium falciparum or vivax, Dengue or Chikungunya virus. A multiplex-PCR-ELISA (MPCR) for the differentiation between the pathogens was conducted off-site at University Hospital Mainz, Germany.
Results: The total number of patients was 112. 73/112 (65%) were under the age of five. The test results showed no evidence for the presence of arboviral pathogens in either the DRT, the PoC-rt-PCR or the MPCR. The test results for the detection of malaria showed 23/112 (21%) positive MRDT results, 19/105 (18%) positive PoC-rt-PCR results. 21/112 (19%) samples showed positive results in the MPCR. There were two false negative PoC-rt-PCR results and two false positive MRDT results. Sensitivity of MRDT was 21/21 (100%), specificity was 89/91 (98%). Sensitivity of PoC-rt-PCR for Plasmodia was 19/21 (90%), specificity was 91/91 (100%). PoC-rt-PCR showed invalid test results for 86/303 (28%). In the repetition some tests showed valid results. 108/112 (96%) patients received antibiotics. 35/112 (31%) patients received anti-malarials while 10/112 (9%) patients did not show malaria infection by local diagnostic methods.
Discussion: 21/112 (19%) of acute febrile patients were tested positive for mosquito-transmittable pathogens by MPCR as gold standard. MRDT and PoC-rt-PCR showed different sensitivities and specificities in the detection of malaria infection which must be validated by literature references. The targeted use of PoC diagnostic devices like MRDT as screening and PoC-rt-PCR as confirmation tests can help to avoid unnecessary treatment for patients and reduce the occurrence of resistance to anti-malarial drugs. Invalid PoC-rt-PCR-tests result into higher financial costs. The fraction of invalid test runs needs to be lowered tremendously to consider establishment at endemic low resource settings.
