Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG
| Autor: | Anne-Claire Andries, Philippe Buchy, Vantha Te, Veasna Duong, Rekol Huy, Chantha Ngan, Sivuth Ong, Patrich Lorn Try, Bunthin Y, Kim Kim Sroin |
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| Přispěvatelé: | Institut Pasteur du Cambodge, Réseau International des Instituts Pasteur (RIIP), Ministry of Health [Phnom Penh], Pediatric Department, Kampong Cham Provincial hospital [Cambodia], Takeo Provincial Hospital, The study was supported by the French ministry of Research, Andries AC, Duong V, Ngan C, Ong S, Huy R, Sroin KK, Te V, Y B, Try PL, Buchy P |
| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Male
Viral Diseases MESH: Reagent Kits Diagnostic NS1 serology MESH: Dengue Viral Nonstructural Proteins Dengue virus Antibodies Viral medicine.disease_cause Dengue fever 0302 clinical medicine MESH: Pregnancy Pregnancy Emerging Viral Diseases MESH: Child clinical management Medicine Prospective Studies 030212 general & internal medicine Child Prospective cohort study Antigens Viral Immunoassay MESH: Immunoglobulin G evaluation biology lcsh:Public aspects of medicine Medical record MESH: Immunoglobulin M 3. Good health MESH: Point-of-Care Systems Infectious Diseases Child Preschool [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology Female Sample collection Cambodia MESH: Antigens Viral MESH: Immunoassay Research Article Neglected Tropical Diseases medicine.medical_specialty lcsh:Arctic medicine. Tropical medicine lcsh:RC955-962 Point-of-Care Systems 030231 tropical medicine Context (language use) Microbiology Sensitivity and Specificity 03 medical and health sciences Virology Internal medicine Humans Biology MESH: Diagnostic Tests Routine Retrospective Studies MESH: Clinical Laboratory Techniques MESH: Humans Clinical Laboratory Techniques Diagnostic Tests Routine business.industry MESH: Cambodia MESH: Child Preschool Public Health Environmental and Occupational Health lcsh:RA1-1270 Retrospective cohort study MESH: Retrospective Studies medicine.disease dengue MESH: Male MESH: Prospective Studies MESH: Sensitivity and Specificity Viral Disease Diagnosis Immunoglobulin M Immunoglobulin G Immunology biology.protein MESH: Viral Nonstructural Proteins Reagent Kits Diagnostic business MESH: Female MESH: Antibodies Viral |
| Zdroj: | PLoS Neglected Tropical Diseases PLoS Neglected Tropical Diseases, Public Library of Science, 2012, 6 (12), pp.e1993. ⟨10.1371/journal.pntd.0001993⟩ PLoS Neglected Tropical Diseases, Vol 6, Iss 12, p e1993 (2012) |
| ISSN: | 1935-2727 1935-2735 |
| DOI: | 10.1371/journal.pntd.0001993⟩ |
| Popis: | Background Dengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the detection of NS1 and IgM/IgG antibodies. The evaluation was made prospectively in the field conditions and included the study of the impact of its use as a point-of-care test for case management as well as retrospectively against a panel of well-characterized samples in a reference laboratory. Methodology/Principal Findings During the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy. Conclusions In the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management. Author Summary Dengue is a potentially life-threatening viral disease. Symptoms are often not specific hence the importance to confirm the diagnosis during the early stage of the disease. Nevertheless, until recently only specialized laboratories were able to confirm dengue diagnosis. The discovery of the NS1 protein as a marker of infection has allowed the development of point-of-care tests for a rapid diagnosis confirmation. These tests have previously been evaluated by laboratories, but their performances have never been assessed in field conditions. In this study we evaluated the performance of SD Bioline Dengue Duo kit when tests were performed by hospital laboratories staff in a dengue hyper-endemic country. We also assessed the impact of the test results on the clinical management decision. The combination of NS1 test with antibodies detection improved the performance, though discordances on IgM and IgG results were observed between the hospitals and the national reference laboratories. Physicians treated patients according to their clinical diagnosis and did not take negative results into consideration. |
| Databáze: | OpenAIRE |
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