Format

Send to

Choose Destination
PLoS One. 2018 May 14;13(5):e0197395. doi: 10.1371/journal.pone.0197395. eCollection 2018.

An assessment of false positive rates for malaria rapid diagnostic tests caused by non-Plasmodium infectious agents and immunological factors.

Author information

1
School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.
2
Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Center for Global Health, Atlanta, Georgia, United States of America.
3
Drug Resistance and Diagnostics, Australian Defence Force Malaria and Infectious Diseases Institute, Brisbane, Australia.
4
Hospital for Tropical Diseases and London School of Hygiene and Tropical Medicine, London, United Kingdom.
5
FIND (Foundation for Innovative New Diagnostics), Geneva, Switzerland.
6
Global Malaria Programme, World Health Organization, Geneva, Switzerland.

Abstract

BACKGROUND:

Malaria rapid diagnostic tests (RDTs) can produce false positive (FP) results in patients with human African trypanosomiasis and rheumatoid factor (RF), but specificity against other infectious agents and immunological factors is largely unknown. Low diagnostic specificity caused by cross-reactivity may lead to over-estimates of the number of malaria cases and over-use of antimalarial drugs, at the cost of not diagnosing and treating the true underlying condition.

METHODS:

Data from the WHO Malaria RDT Product Testing Programme was analysed to assess FP rates of 221 RDTs against four infectious agents (Chagas, dengue, Leishmaniasis and Schistosomiasis) and four immunological factors (anti-nuclear antibody, human anti-mouse antibody (HAMA), RF and rapid plasma regain). Only RDTs with a FP rate against clean negative samples less than 10% were included. Paired t-tests were used to compare product-specific FP rates on clean negative samples and samples containing non-Plasmodium infectious agents and immunological factors.

RESULTS:

Forty (18%) RDTs showed no FP results against any tested infectious agent or immunological factor. In the remaining RDTs significant and clinically relevant increases in FP rates were observed for samples containing HAMA and RF (P<0.001). There were significant correlations between product-matched FP rates for RF and HAMA on all RDT test bands (P<0.001), and FP rates for each infectious agent and immunological factor were also correlated between test bands of combination RDTs (P≤0.002).

CONCLUSIONS:

False positive results against non-Plasmodium infectious agents and immunological factors does not appear to be a universal property of malaria RDTs. However, since many malaria RDTs have elevated FP rates against HAMA and RF positive samples practitioners may need to consider the possibility of false positive results for malaria in patients with conditions that stimulate HAMA or RF.

PMID:
29758050
PMCID:
PMC5951549
DOI:
10.1371/journal.pone.0197395
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Public Library of Science Icon for PubMed Central
Loading ...
Support Center