Details:

Alternative Title:
PLoS One
Publisher's site:
http://dx.doi.org/10.1371/journal.pone.0197395
Personal Author:
Gatton, Michelle L. ; Ciketic, Sadmir ; Barnwell, John W. ; Cheng, Qin ; Chiodini, Peter L. ; ... More +
Gatton, Michelle L. ; Ciketic, Sadmir ; Barnwell, John W. ; Cheng, Qin ; Chiodini, Peter L. ; Incardona, Sandra ; Bell, David ; Cunningham, Jane ; González, Iveth J. Less -
Description:
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.


Subject:
[+]
Antigens, Protozoan
Chagas Disease
Dengue
Diagnostic Tests, Routine
False Positive Reactions
Humans
Immune System
Leishmaniasis
Malaria
Plasmodium Vivax
Reproducibility Of Results
Schistosomiasis
Sensitivity And Specificity

Source:
PLoS One. 13(5).
Pubmed ID:
29758050
Pubmed Central ID:
PMC5951549
Document Type:
Journal Article
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:55a69b2c529b432d086735d5065a371096bcc53f6843500d12ce0f84a5cfa319
File Type:

Supporting Files

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