Multi-country evaluation of the sensitivity and specificity of two commercially-available NS1 ELISA assays for dengue diagnosis.
BACKGROUND
Early diagnosis of dengue can assist patient triage and management and prevent unnecessary treatments and interventions. Commercially available assays that detect the dengue virus protein NS1 in the plasma/serum of patients offers the possibility of early and rapid diagnosis.


RESULTS
The sensitivity and specificity of the Pan-E Dengue Early ELISA and the Platelia Dengue NS1 Ag assays were compared against a reference diagnosis in 1385 patients in 6 countries in Asia and the Americas. Platelia was more sensitive (66%) than Pan-E (52%) in confirmed dengue cases. Sensitivity varied by geographic region, with both assays generally being more sensitive in patients from SE Asia than the Americas. Both kits were more sensitive for specimens collected within the first few days of illness onset relative to later time points. Pan-E and Platelia were both 100% specific in febrile patients without evidence of acute dengue. In patients with other confirmed diagnoses and healthy blood donors, Platelia was more specific (100%) than Pan-E (90%). For Platelia, when either the NS1 test or the IgM test on the acute sample was positive, the sensitivity versus the reference result was 82% in samples collected in the first four days of fever. NS1 sensitivity was not associated to disease severity (DF or DHF) in the Platelia test, whereas a trend for higher sensitivity in DHF cases was seen in the Pan-E test (however combined with lower overall sensitivity).


CONCLUSIONS
Collectively, this multi-country study suggests that the best performing NS1 assay (Platelia) had moderate sensitivity (median 64%, range 34-76%) and high specificity (100%) for the diagnosis of dengue. The poor sensitivity of the evaluated assays in some geographical regions suggests further assessments are needed. The combination of NS1 and IgM detection in samples collected in the first few days of fever increased the overall dengue diagnostic sensitivity.
Guzman
Maria G
MG
Virology Department, Pan American Health Organization/World Health Organization Collaborating Center, Instituto de Medicina Tropical Pedro Kouri, Habana, Cuba.
Jaenisch
Thomas
T
Gaczkowski
Roger
R
Ty Hang
Vo Thi
VT
Sekaran
Shamala Devi
SD
Kroeger
Axel
A
Vazquez
Susana
S
Ruiz
Didye
D
Martinez
Eric
E
Mercado
Juan C
JC
Balmaseda
Angel
A
Harris
Eva
E
Dimano
Efren
E
Leano
Prisca Susan A
PS
Yoksan
Sutee
S
Villegas
Elci
E
Benduzu
Herminia
H
Villalobos
Iris
I
Farrar
Jeremy
J
Simmons
Cameron P
CP
D000293:Adolescent; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D000956:Antigens, Viral / Q000097:blood*; D002648:Child; D002675:Child, Preschool; D003715:Dengue / Q000175:diagnosis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood; D007223:Infant; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D017361:Viral Nonstructural Proteins / Q000097:blood*; D014773:Virology / Q000379:methods*; D055815:Young Adult
D000914:Antibodies, Viral; D000956:Antigens, Viral; D007075:Immunoglobulin M; D011933:Reagent Kits, Diagnostic; D017361:Viral Nonstructural Proteins
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