Multi-country evaluation of the sensitivity and specificity of two commercially-available NS1 ELISA assays for dengue diagnosis

Autor: Axel Kroeger, Didye Ruiz, Susana Vázquez, Roger Gaczkowski, Shamala Devi Sekaran, Eva Harris, Elci Villegas, Eric Martinez, María G. Guzmán, Iris Villalobos, Thomas Jaenisch, Juan Carlos Mercado, Prisca Susan A. Leano, Angel Balmaseda, Herminia Benduzu, Vo Thi Ty Hang, Sutee Yoksan, Efren Dimano, Jeremy Farrar, Cameron P. Simmons
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Dengue virus
Viral Nonstructural Proteins
medicine.disease_cause
Antibodies
Viral
Dengue fever
Dengue
Medicine
Medical diagnosis
Child
Antigens
Viral
biology
lcsh:Public aspects of medicine
Virology/Diagnosis
Middle Aged
Infectious Diseases
Child
Preschool
Geographic regions
Research Article
Infectious Diseases/Tropical and Travel-Associated Diseases
Adult
medicine.medical_specialty
lcsh:Arctic medicine. Tropical medicine
Adolescent
lcsh:RC955-962
Enzyme-Linked Immunosorbent Assay
Sensitivity and Specificity
Virology/Emerging Viral Diseases
Young Adult
Disease severity
Internal medicine
Virology
wc_528
Infectious Diseases/Viral Infections
Humans
In patient
Aged
qy_4
business.industry
Public Health
Environmental and Occupational Health
Infant
lcsh:RA1-1270
medicine.disease
Immunoglobulin M
Infectious Diseases/Neglected Tropical Diseases
Immunology
biology.protein
Reagent Kits
Diagnostic
business
Multi country
Zdroj: PLoS Neglected Tropical Diseases, Vol 4, Iss 8 (2010)
PLoS Neglected Tropical Diseases
ISSN: 1935-2735
Popis: 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. Methodology/Principal Findings 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/Significance 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.
Author Summary Dengue is the most important mosquito-borne viral disease of humans and an enormous public health burden in affected countries. Early, sensitive and specific diagnosis of dengue is needed for appropriate patient management as well as for early epidemic detection. Commercially available assays that detect the dengue virus protein NS1 in the plasma/serum of patients offer the possibility of early and rapid diagnosis. Here we evaluated two commercially available ELISA kits for NS1 detection (Pan-E Dengue Early ELISA and the Platelia™ Dengue NS1 Ag). Results were compared against a reference diagnosis in 1385 patients in 6 countries in Asia and the Americas. 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 combination of NS1 and IgM detection in samples collected in the first few days of fever increased the overall dengue diagnostic sensitivity.
Databáze: OpenAIRE
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