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Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China

Background: China was certified malaria-free by the World Health Organization on 30 June 2021. However, due to imported malaria, maintaining a malaria-free status in China is an ongoing challenge. There are critical gaps in the detection of imported malaria through the currently available tools, esp...

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Autores principales: Lin, Kangming, Wang, Shuqi, Sui, Yuan, Zhang, Tao, Luo, Fei, Shi, Feng, Qian, Yingjun, Li, Jun, Lu, Shenning, Cotter, Chris, Wang, Duoquan, Li, Shizhu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10305131/
https://www.ncbi.nlm.nih.gov/pubmed/37368714
http://dx.doi.org/10.3390/tropicalmed8060296
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author Lin, Kangming
Wang, Shuqi
Sui, Yuan
Zhang, Tao
Luo, Fei
Shi, Feng
Qian, Yingjun
Li, Jun
Lu, Shenning
Cotter, Chris
Wang, Duoquan
Li, Shizhu
author_facet Lin, Kangming
Wang, Shuqi
Sui, Yuan
Zhang, Tao
Luo, Fei
Shi, Feng
Qian, Yingjun
Li, Jun
Lu, Shenning
Cotter, Chris
Wang, Duoquan
Li, Shizhu
author_sort Lin, Kangming
collection PubMed
description Background: China was certified malaria-free by the World Health Organization on 30 June 2021. However, due to imported malaria, maintaining a malaria-free status in China is an ongoing challenge. There are critical gaps in the detection of imported malaria through the currently available tools, especially for non-falciparum malaria. In the study, a novel point-of-care Rapid Diagnostic Test designed for the detection of imported malaria infections was evaluated in the field. Methods: Suspected imported malaria cases reported from Guangxi and Anhui Provinces of China during 2018–2019 were enrolled to evaluate the novel RDTs. Diagnostic performance of the novel RDTs was evaluated based on its sensitivity, specificity, positive and negative predictive values, and Cohen’s kappa coefficient, using polymerase chain reaction as the gold standard. The Additive and absolute Net Reclassification Index were calculated to compare the diagnostic performance between the novel RDTs and Wondfo RDTs (control group). Results: A total of 602 samples were tested using the novel RDTs. Compared to the results of PCR, the novel RDTs presented sensitivity, specificity, PPV, NPV, and diagnostic accuracy rates of 78.37%, 95.05%, 94.70%, 79.59%, and 86.21%, respectively. Among the positive samples, the novel RDTs found 87.01%, 71.31%, 81.82%, and 61.54% of P. falciparum, P. ovale, P. vivax, and P. malariae, respectively. The ability to detect non-falciparum malaria did not differ significantly between the novel and Wondfo RDTs (control group). However, Wondfo RDTs can detect more P. falciparum cases than the novel RDTs (96.10% vs. 87.01%, p < 0.001). After the introduction of the novel RDTs, the value of the additive and absolute Net Reclassification Index is 1.83% and 1.33%, respectively. Conclusions: The novel RDTs demonstrated the ability to distinguish P. ovale and P. malariae from P. vivax which may help to improve the malaria post-elimination surveillance tools in China.
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spelling pubmed-103051312023-06-29 Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China Lin, Kangming Wang, Shuqi Sui, Yuan Zhang, Tao Luo, Fei Shi, Feng Qian, Yingjun Li, Jun Lu, Shenning Cotter, Chris Wang, Duoquan Li, Shizhu Trop Med Infect Dis Article Background: China was certified malaria-free by the World Health Organization on 30 June 2021. However, due to imported malaria, maintaining a malaria-free status in China is an ongoing challenge. There are critical gaps in the detection of imported malaria through the currently available tools, especially for non-falciparum malaria. In the study, a novel point-of-care Rapid Diagnostic Test designed for the detection of imported malaria infections was evaluated in the field. Methods: Suspected imported malaria cases reported from Guangxi and Anhui Provinces of China during 2018–2019 were enrolled to evaluate the novel RDTs. Diagnostic performance of the novel RDTs was evaluated based on its sensitivity, specificity, positive and negative predictive values, and Cohen’s kappa coefficient, using polymerase chain reaction as the gold standard. The Additive and absolute Net Reclassification Index were calculated to compare the diagnostic performance between the novel RDTs and Wondfo RDTs (control group). Results: A total of 602 samples were tested using the novel RDTs. Compared to the results of PCR, the novel RDTs presented sensitivity, specificity, PPV, NPV, and diagnostic accuracy rates of 78.37%, 95.05%, 94.70%, 79.59%, and 86.21%, respectively. Among the positive samples, the novel RDTs found 87.01%, 71.31%, 81.82%, and 61.54% of P. falciparum, P. ovale, P. vivax, and P. malariae, respectively. The ability to detect non-falciparum malaria did not differ significantly between the novel and Wondfo RDTs (control group). However, Wondfo RDTs can detect more P. falciparum cases than the novel RDTs (96.10% vs. 87.01%, p < 0.001). After the introduction of the novel RDTs, the value of the additive and absolute Net Reclassification Index is 1.83% and 1.33%, respectively. Conclusions: The novel RDTs demonstrated the ability to distinguish P. ovale and P. malariae from P. vivax which may help to improve the malaria post-elimination surveillance tools in China. MDPI 2023-05-28 /pmc/articles/PMC10305131/ /pubmed/37368714 http://dx.doi.org/10.3390/tropicalmed8060296 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Lin, Kangming
Wang, Shuqi
Sui, Yuan
Zhang, Tao
Luo, Fei
Shi, Feng
Qian, Yingjun
Li, Jun
Lu, Shenning
Cotter, Chris
Wang, Duoquan
Li, Shizhu
Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China
title Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China
title_full Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China
title_fullStr Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China
title_full_unstemmed Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China
title_short Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China
title_sort evaluation of an innovative point-of-care rapid diagnostic test for the identification of imported malaria parasites in china
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10305131/
https://www.ncbi.nlm.nih.gov/pubmed/37368714
http://dx.doi.org/10.3390/tropicalmed8060296
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