Prospective evaluation of nonstructural 1 enzyme-linked immunosorbent assay and rapid immunochromatographic tests to detect dengue virus in patients with acute febrile illness.
We prospectively evaluated the Bio-Rad nonstructural 1 (NS1) enzyme-linked immunosorbent assay (ELISA) and lateral flow immunochromatographic assay (LFIA) in comparison to an in-place reverse transcription-polymerase chain reaction for dengue diagnosis. Among 537 consecutive samples from patients with acute febrile disease, 264 (49.2%) tested positive in reverse transcription-polymerase chain reaction (RT-PCR), 156 (29.1%) in NS1-antigen (Ag) ELISA, and 125 (23.3%) in NS1-Ag LFIA. Compared to the RT-PCR status, the specificity was 100% for the NS1-Ag ELISA and LFIA, but their respective sensitivities were 61.2% [95% confidence interval (CI), 55.2-67.2] and 49.4% (95% CI, 43.2-55.6), with nadirs of 37.9% and 24.1% on day 6 of illness. The NS1-Ag ELISA and LFIA were positive, respectively, for 48.0% and 40.7% of the secondary infections versus 85.0% and 66.7% of the primary infections. For patients <5 years old, NS1-Ag ELISA and LFIA reached respective sensitivities of 100% and 90.5%. Reports of results of dengue NS1-Ag assays should specify that negativity does not preclude DENV infection, and require further investigations in the case of severe disease.
Laboratoire de Virologie-Immunologie, EA 4537, Centre Hospitalier Universitaire de Fort-de-France, Université des Antilles et de la Guyane, 97200 Fort-de-France, Martinique.
Fatiha
F
Najioullah
Emilie
E
Combet
Laure
L
Paturel
Jenny
J
Martial
Laurence
L
Koulmann
Laurent
L
Thomas
Yves
Y
Hatchuel
André
A
Cabié
Raymond
R
Cesaire
D000293:Adolescent; D000328:Adult; D000956:Antigens, Viral / Q000235:genetics / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D002845:Chromatography; D003715:Dengue / Q000175:diagnosis*; D003716:Dengue Virus / Q000502:physiology*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012367:RNA, Viral / Q000235:genetics; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017361:Viral Nonstructural Proteins / Q000235:genetics* / Q000276:immunology*; D055815:Young Adult
D000956:Antigens, Viral; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic; D017361:Viral Nonstructural Proteins