The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection.
BACKGROUND
The serological diagnosis of acute dengue virus infection relies on the detection of dengue-specific immunoglobulin M (IgM) antibodies. Immunochromatographic tests are rapid diagnostic tests (RDTs) that can be performed at the bedside, but they have not been fully validated for diagnosis of dengue infection.


METHODS
More than 20 RDTs for diagnosis of acute dengue infection are commercially available. Of these, 8 were selected for evaluation of performance by use of characterized dengue and nondengue serum specimens, and results were compared with those of a previously published dengue IgM/IgG enzyme-linked immunosorbent assay in conjunction with dengue virus serotyping by reverse-transcriptase polymerase chain reaction.


RESULTS
Assay sensitivities were low, ranging from 6.4% (95% confidence interval [CI], 4.0%-9.7%) to 65.3% (95% CI, 59.9%-70.5%), and specificities ranged from 69.1% (95% CI, 61.4%-76.0%) to 100% (95% CI, 97.8%-100%). Of the 8 tests, only 2 had sensitivities of >50%, the level considered to be clinically useful, and, of these, 1 had relatively low specificity (69.1%). Samples collected early in the infection were less likely to test positive than those collected later. A thermal stability study demonstrated a loss in performance of some RDTs when they were stored at a high ambient temperature for 3 months.


CONCLUSIONS
Users of RDTs for dengue should be aware that many of these tests have a diagnostic accuracy that falls well below the manufacturers' claims. If an acute specimen yields a negative result, a convalescent serum sample should be tested to confirm the result. No RDT adequately differentiated primary and secondary dengue infections, and the tests should not be used for this purpose.
Centre for Clinical Vaccinology and Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom. stuart@tropmedres.ac
Stuart D
SD
Blacksell
Paul N
PN
Newton
David
D
Bell
James
J
Kelley
Mammen P
MP
Mammen
David W
DW
Vaughn
Vanaporn
V
Wuthiekanun
Amornwadee
A
Sungkakum
Ananda
A
Nisalak
Nicholas P J
NP
Day
D000208:Acute Disease; D000914:Antibodies, Viral / Q000097:blood; D003715:Dengue / Q000097:blood / Q000175:diagnosis*; D003716:Dengue Virus / Q000235:genetics / Q000302:isolation & purification*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D012984:Software; D006113:United Kingdom
D000914:Antibodies, Viral