Title |
Analytical sensitivity of current best-in-class malaria rapid diagnostic tests
|
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Published in |
Malaria Journal, March 2017
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DOI | 10.1186/s12936-017-1780-5 |
Pubmed ID | |
Authors |
Alfons Jimenez, Roxanne R. Rees-Channer, Rushini Perera, Dionicia Gamboa, Peter L. Chiodini, Iveth J. González, Alfredo Mayor, Xavier C. Ding |
Abstract |
Rapid diagnostic tests (RDTs) are today the most widely used method for malaria diagnosis and are recommended, alongside microscopy, for the confirmation of suspected cases before the administration of anti-malarial treatment. The diagnostic performance of RDTs, as compared to microscopy or PCR is well described but the actual analytical sensitivity of current best-in-class tests is poorly documented. This value is however a key performance indicator and a benchmark value needed to developed new RDTs of improved sensitivity. Thirteen RDTs detecting either the Plasmodium falciparum histidine rich protein 2 (HRP2) or the plasmodial lactate dehydrogenase (pLDH) antigens were selected from the best performing RDTs according to the WHO-FIND product testing programme. The analytical sensitivity of these products was evaluated using a range of reference materials including P. falciparum and Plasmodium vivax whole parasite samples as well as recombinant proteins. The best performing HRP2-based RDTs could detect all P. falciparum cultured samples at concentrations as low as 0.8 ng/mL of HRP2. The limit of detection of the best performing pLDH-based RDT specifically detecting P. vivax was 25 ng/mL of pLDH. The analytical sensitivity of P. vivax and Pan pLDH-based RDTs appears to vary considerably from product to product, and improvement of the limit-of-detection for P. vivax detecting RDTs is needed to match the performance of HRP2 and Pf pLDH-based RDTs for P. falciparum. Different assays using different reference materials produce different values for antigen concentration in a given specimen, highlighting the need to establish universal reference assays. |
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Geographical breakdown
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Congo, The Democratic Republic of the | 1 | 14% |
United States | 1 | 14% |
Portugal | 1 | 14% |
Unknown | 4 | 57% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 3 | 43% |
Science communicators (journalists, bloggers, editors) | 3 | 43% |
Practitioners (doctors, other healthcare professionals) | 1 | 14% |
Mendeley readers
Geographical breakdown
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Spain | 1 | <1% |
Unknown | 168 | 99% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 32 | 19% |
Student > Ph. D. Student | 26 | 15% |
Researcher | 20 | 12% |
Other | 13 | 8% |
Student > Bachelor | 12 | 7% |
Other | 28 | 17% |
Unknown | 38 | 22% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 33 | 20% |
Biochemistry, Genetics and Molecular Biology | 17 | 10% |
Agricultural and Biological Sciences | 15 | 9% |
Engineering | 14 | 8% |
Nursing and Health Professions | 9 | 5% |
Other | 36 | 21% |
Unknown | 45 | 27% |