Analytical sensitivity of current best-in-class malaria rapid diagnostic tests

Malaria Journal

Research Article

Dionicia Gamboa¹  Iveth J. González²  Xavier C. Ding²  Peter L. Chiodini³  Roxanne R. Rees-Channer³  Rushini Perera³  Alfredo Mayor⁴  Alfons Jimenez⁵ 

[1] Departamento de Ciencias Celulares y Moleculares, Facultad de Ciencias y Filosofía & Instituto de Medicina Tropical Alexander Von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru;FIND, Geneva, Switzerland;Hospital for Tropical Diseases, University College London Hospitals NHS Foundation Trust, London, UK;ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic-Universitat de Barcelona, Barcelona, Spain;Centro de Investigação em Saúde da Manhiça (CISM), Maputo, Mozambique;ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic-Universitat de Barcelona, Barcelona, Spain;Spanish Consortium for Research in Epidemiology and Public Health (CIBERESP), Madrid, Spain;

关键词: Malaria rapid diagnostic test;    HRP2;    pLDH;    Analytical sensitivity;   

DOI  :  10.1186/s12936-017-1780-5

 received in 2016-10-07, accepted in 2017-03-17,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundRapid 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.MethodsThirteen 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.ResultsThe 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.ConclusionThe 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.

【 授权许可】

CC BY   
© The Author(s) 2017