Pan-Plasmodium band sensitivity for Plasmodium falciparum detection in combination malaria rapid diagnostic tests and implications for clinical management

Malaria Journal

Research

Qin Cheng¹  Iveth J González²  Sandra Incardona²  Jane Cunningham³  John W Barnwell⁴  Jeffrey Glenn⁴  Roxanne R Rees-Channer⁵  Peter L Chiodini⁶  Michelle L Gatton⁷ 

[1] Drug Resistance and Diagnostics, Australian Army Malaria Institute, Brisbane, Australia;FIND (Foundation for Innovative New Diagnostics), Geneva, Switzerland;Global Malaria Programme, World Health Organization, Geneva, Switzerland;Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Center for Global Health, Atlanta, USA;National Institute for Health Research University College London Hospitals Biomedical Research Centre, Hospital for Tropical Diseases, London, UK;National Institute for Health Research University College London Hospitals Biomedical Research Centre, Hospital for Tropical Diseases, London, UK;London School of Hygiene and Tropical Medicine, London, UK;School of Public Health and Social Work, Queensland University of Technology, GPO Box 2434, Qld 4001, Brisbane, Australia;

关键词: Malaria;    Rapid diagnostic test;    HRP2;    pLDH;    Persistent antigenemia;   

DOI  :  10.1186/s12936-015-0629-z

 received in 2014-12-15, accepted in 2015-03-01,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundMalaria rapid diagnostic tests (RDTs) are appropriate for case management, but persistent antigenaemia is a concern for HRP2-detecting RDTs in endemic areas. It has been suggested that pan-pLDH test bands on combination RDTs could be used to distinguish persistent antigenaemia from active Plasmodium falciparum infection, however this assumes all active infections produce positive results on both bands of RDTs, an assertion that has not been demonstrated.MethodsIn this study, data generated during the WHO-FIND product testing programme for malaria RDTs was reviewed to investigate the reactivity of individual test bands against P. falciparum in 18 combination RDTs. Each product was tested against multiple wild-type P. falciparum only samples. Antigen levels were measured by quantitative ELISA for HRP2, pLDH and aldolase.ResultsWhen tested against P. falciparum samples at 200 parasites/μL, 92% of RDTs were positive; 57% of these on both the P. falciparum and pan bands, while 43% were positive on the P. falciparum band only. There was a relationship between antigen concentration and band positivity; ≥4 ng/mL of HRP2 produced positive results in more than 95% of P. falciparum bands, while ≥45 ng/mL of pLDH was required for at least 90% of pan bands to be positive.ConclusionsIn active P. falciparum infections it is common for combination RDTs to return a positive HRP2 band combined with a negative pan-pLDH band, and when both bands are positive, often the pan band is faint. Thus active infections could be missed if the presence of a HRP2 band in the absence of a pan band is interpreted as being caused solely by persistent antigenaemia.

【 授权许可】

CC BY   
© Gatton et al.; licensee BioMed Central. 2015