Dengue-4 false negative results by Panbio® Dengue Early ELISA assay in Brazil.
BACKGROUND
Dengue is a serious public health problem in numerous countries. The ability to rapidly diagnosis dengue is important for patient triage and management. Detection of dengue viral protein, NS1, represents a new approach to dengue diagnosis.


OBJECTIVE
The present study aims to evaluate if there are false negative results using the NS1 Ag rapid assay (Panbio(®) Dengue Early ELISA) in two different epidemiological situations (epidemic and non-epidemic).


METHODS
220 serum samples from patients with clinical symptoms of classical dengue fever were tested by NS1 antigen capture ELISA and Multiplex-Nested-PCR.


RESULTS
In samples collected in a non-epidemic period we found a 100% agreement of ELISA and RT-PCR in dengue negative samples and 85% agreement of ELISA and RT-PCR in dengue positive samples. But when we tested samples during an epidemic period (large DENV-4 outbreak) we found 15% false negative results (p<0.05) in dengue negative samples.


CONCLUSIONS
Due to false negative results for DENV-4, the sole use of the Panbio(®) Dengue Early ELISA assay as a screening method for monitoring circulating dengue serotypes must be reevaluated.
Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto, SP, Brazil; Universidade Estadual Paulista "Júlio de Mesquitta e Filho" (IBILCE/UNESP), São José do Rio Preto, SP, Brazil.
Tatiana Elias
TE
Colombo
Danila
D
Vedovello
Carlos Shigueru
CS
Araki
Hugo
H
Cogo-Moreira
Izalco Nuremberg Penha
IN
dos Santos
Andréia Francesli Negri
AF
Reis
Fabiana Rodrigues
FR
Costa
Lilian Elisa Arão Antônio
LE
Cruz
Liane
L
Casagrande
Livia José
LJ
Regatieri
Jurandir Ferreira
JF
Junior
Roberta Vieira de Morais
RV
Bronzoni
Diane J
DJ
Schmidt
Maurício Lacerda
ML
Nogueira
D001938:Brazil; D003715:Dengue / Q000175:diagnosis* / Q000821:virology*; D003716:Dengue Virus / Q000235:genetics / Q000302:isolation & purification; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards; D005188:False Negative Reactions; D006801:Humans; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic / Q000592:standards; D017361:Viral Nonstructural Proteins / Q000097:blood
D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic; D017361:Viral Nonstructural Proteins
Dengue; False negative results; NS1 Ag rapid assay