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Rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or Plasmodium vivax malaria in endemic countries
BACKGROUND: In settings where both Plasmodium vivax and Plasmodium falciparum infection cause malaria, rapid diagnostic tests (RDTs) need to distinguish which species is causing the patients' symptoms, as different treatments are required. Older RDTs incorporated two test lines to distinguish m...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Ltd
2014
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4453861/ https://www.ncbi.nlm.nih.gov/pubmed/25519857 http://dx.doi.org/10.1002/14651858.CD011431 |
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author | Abba, Katharine Kirkham, Amanda J Olliaro, Piero L Deeks, Jonathan J Donegan, Sarah Garner, Paul Takwoingi, Yemisi |
author_facet | Abba, Katharine Kirkham, Amanda J Olliaro, Piero L Deeks, Jonathan J Donegan, Sarah Garner, Paul Takwoingi, Yemisi |
author_sort | Abba, Katharine |
collection | PubMed |
description | BACKGROUND: In settings where both Plasmodium vivax and Plasmodium falciparum infection cause malaria, rapid diagnostic tests (RDTs) need to distinguish which species is causing the patients' symptoms, as different treatments are required. Older RDTs incorporated two test lines to distinguish malaria due to P. falciparum, from malaria due to any other Plasmodium species (non‐falciparum). These RDTs can be classified according to which antibodies they use: Type 2 RDTs use HRP‐2 (for P. falciparum) and aldolase (all species); Type 3 RDTs use HRP‐2 (for P. falciparum) and pLDH (all species); Type 4 use pLDH (fromP. falciparum) and pLDH (all species). More recently, RDTs have been developed to distinguish P. vivax parasitaemia by utilizing a pLDH antibody specific to P. vivax. OBJECTIVES: To assess the diagnostic accuracy of RDTs for detecting non‐falciparum or P. vivax parasitaemia in people living in malaria‐endemic areas who present to ambulatory healthcare facilities with symptoms suggestive of malaria, and to identify which types and brands of commercial test best detect non‐falciparum and P. vivax malaria. SEARCH METHODS: We undertook a comprehensive search of the following databases up to 31 December 2013: Cochrane Infectious Diseases Group Specialized Register; MEDLINE; EMBASE; MEDION; Science Citation Index; Web of Knowledge; African Index Medicus; LILACS; and IndMED. SELECTION CRITERIA: Studies comparing RDTs with a reference standard (microscopy or polymerase chain reaction) in blood samples from a random or consecutive series of patients attending ambulatory health facilities with symptoms suggestive of malaria in non‐falciparum endemic areas. DATA COLLECTION AND ANALYSIS: For each study, two review authors independently extracted a standard set of data using a tailored data extraction form. We grouped comparisons by type of RDT (defined by the combinations of antibodies used), and combined in meta‐analysis where appropriate. Average sensitivities and specificities are presented alongside 95% confidence intervals (95% CI). MAIN RESULTS: We included 47 studies enrolling 22,862 participants. Patient characteristics, sampling methods and reference standard methods were poorly reported in most studies. RDTs detecting 'non‐falciparum' parasitaemia Eleven studies evaluated Type 2 tests compared with microscopy, 25 evaluated Type 3 tests, and 11 evaluated Type 4 tests. In meta‐analyses, average sensitivities and specificities were 78% (95% CI 73% to 82%) and 99% (95% CI 97% to 99%) for Type 2 tests, 78% (95% CI 69% to 84%) and 99% (95% CI 98% to 99%) for Type 3 tests, and 89% (95% CI 79% to 95%) and 98% (95% CI 97% to 99%) for Type 4 tests, respectively. Type 4 tests were more sensitive than both Type 2 (P = 0.01) and Type 3 tests (P = 0.03). Five studies compared Type 3 tests with PCR; in meta‐analysis, the average sensitivity and specificity were 81% (95% CI 72% to 88%) and 99% (95% CI 97% to 99%) respectively. RDTs detecting P.vivax parasitaemia Eight studies compared pLDH tests to microscopy; the average sensitivity and specificity were 95% (95% CI 86% to 99%) and 99% (95% CI 99% to 100%), respectively. AUTHORS' CONCLUSIONS: RDTs designed to detect P. vivax specifically, whether alone or as part of a mixed infection, appear to be more accurate than older tests designed to distinguish P. falciparum malaria from non‐falciparum malaria. Compared to microscopy, these tests fail to detect around 5% ofP. vivax cases. This Cochrane Review, in combination with other published information about in vitro test performance and stability in the field, can assist policy‐makers to choose between the available RDTs. 12 April 2019 No update planned Review superseded This Cochrane Review has been superseded by Choi 2019 https://doi.org/10.1002/14651858.CD013218 |
format | Online Article Text |
id | pubmed-4453861 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | John Wiley & Sons, Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-44538612015-06-10 Rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or Plasmodium vivax malaria in endemic countries Abba, Katharine Kirkham, Amanda J Olliaro, Piero L Deeks, Jonathan J Donegan, Sarah Garner, Paul Takwoingi, Yemisi Cochrane Database Syst Rev BACKGROUND: In settings where both Plasmodium vivax and Plasmodium falciparum infection cause malaria, rapid diagnostic tests (RDTs) need to distinguish which species is causing the patients' symptoms, as different treatments are required. Older RDTs incorporated two test lines to distinguish malaria due to P. falciparum, from malaria due to any other Plasmodium species (non‐falciparum). These RDTs can be classified according to which antibodies they use: Type 2 RDTs use HRP‐2 (for P. falciparum) and aldolase (all species); Type 3 RDTs use HRP‐2 (for P. falciparum) and pLDH (all species); Type 4 use pLDH (fromP. falciparum) and pLDH (all species). More recently, RDTs have been developed to distinguish P. vivax parasitaemia by utilizing a pLDH antibody specific to P. vivax. OBJECTIVES: To assess the diagnostic accuracy of RDTs for detecting non‐falciparum or P. vivax parasitaemia in people living in malaria‐endemic areas who present to ambulatory healthcare facilities with symptoms suggestive of malaria, and to identify which types and brands of commercial test best detect non‐falciparum and P. vivax malaria. SEARCH METHODS: We undertook a comprehensive search of the following databases up to 31 December 2013: Cochrane Infectious Diseases Group Specialized Register; MEDLINE; EMBASE; MEDION; Science Citation Index; Web of Knowledge; African Index Medicus; LILACS; and IndMED. SELECTION CRITERIA: Studies comparing RDTs with a reference standard (microscopy or polymerase chain reaction) in blood samples from a random or consecutive series of patients attending ambulatory health facilities with symptoms suggestive of malaria in non‐falciparum endemic areas. DATA COLLECTION AND ANALYSIS: For each study, two review authors independently extracted a standard set of data using a tailored data extraction form. We grouped comparisons by type of RDT (defined by the combinations of antibodies used), and combined in meta‐analysis where appropriate. Average sensitivities and specificities are presented alongside 95% confidence intervals (95% CI). MAIN RESULTS: We included 47 studies enrolling 22,862 participants. Patient characteristics, sampling methods and reference standard methods were poorly reported in most studies. RDTs detecting 'non‐falciparum' parasitaemia Eleven studies evaluated Type 2 tests compared with microscopy, 25 evaluated Type 3 tests, and 11 evaluated Type 4 tests. In meta‐analyses, average sensitivities and specificities were 78% (95% CI 73% to 82%) and 99% (95% CI 97% to 99%) for Type 2 tests, 78% (95% CI 69% to 84%) and 99% (95% CI 98% to 99%) for Type 3 tests, and 89% (95% CI 79% to 95%) and 98% (95% CI 97% to 99%) for Type 4 tests, respectively. Type 4 tests were more sensitive than both Type 2 (P = 0.01) and Type 3 tests (P = 0.03). Five studies compared Type 3 tests with PCR; in meta‐analysis, the average sensitivity and specificity were 81% (95% CI 72% to 88%) and 99% (95% CI 97% to 99%) respectively. RDTs detecting P.vivax parasitaemia Eight studies compared pLDH tests to microscopy; the average sensitivity and specificity were 95% (95% CI 86% to 99%) and 99% (95% CI 99% to 100%), respectively. AUTHORS' CONCLUSIONS: RDTs designed to detect P. vivax specifically, whether alone or as part of a mixed infection, appear to be more accurate than older tests designed to distinguish P. falciparum malaria from non‐falciparum malaria. Compared to microscopy, these tests fail to detect around 5% ofP. vivax cases. This Cochrane Review, in combination with other published information about in vitro test performance and stability in the field, can assist policy‐makers to choose between the available RDTs. 12 April 2019 No update planned Review superseded This Cochrane Review has been superseded by Choi 2019 https://doi.org/10.1002/14651858.CD013218 John Wiley & Sons, Ltd 2014-12-18 /pmc/articles/PMC4453861/ /pubmed/25519857 http://dx.doi.org/10.1002/14651858.CD011431 Text en Copyright © 2015 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration. This is an open access article under the terms of the Creative Commons Attribution‐Non‐Commercial Licence, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Abba, Katharine Kirkham, Amanda J Olliaro, Piero L Deeks, Jonathan J Donegan, Sarah Garner, Paul Takwoingi, Yemisi Rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or Plasmodium vivax malaria in endemic countries |
title | Rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or Plasmodium vivax malaria in endemic countries |
title_full | Rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or Plasmodium vivax malaria in endemic countries |
title_fullStr | Rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or Plasmodium vivax malaria in endemic countries |
title_full_unstemmed | Rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or Plasmodium vivax malaria in endemic countries |
title_short | Rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or Plasmodium vivax malaria in endemic countries |
title_sort | rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or plasmodium vivax malaria in endemic countries |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4453861/ https://www.ncbi.nlm.nih.gov/pubmed/25519857 http://dx.doi.org/10.1002/14651858.CD011431 |
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