Comparison of two dengue NS1 rapid tests for sensitivity, specificity and relationship to viraemia and antibody responses
Tóm tắt
Dengue is a major public health problem in tropical and subtropical countries. Rapid and easy diagnosis of dengue can assist patient triage and care-management. The detection of DENV NS1 on rapid lateral flow tests offers a fast route to a presumptive dengue diagnosis but careful evaluations are urgently needed as more and more people use them. The sensitivity and specificity of the Bio-Rad NS1 Ag Strip and SD Dengue Duo (NS1/IgM/IgG) lateral flow rapid tests were evaluated in a panel of plasma samples from 245 Vietnamese patients with RT-PCR confirmed dengue and 47 with other febrile illnesses. The NS1 rapid tests had similar diagnostic sensitivities (respectively 61.6% and 62.4%) in confirmed dengue cases but were 100% specific. When IgM/IgG results from the SD Dengue Duo were included in the test interpretation, the sensitivity improved significantly from 62.4% with NS1 alone to 75.5% when NS1 and/or IgM was positive and 83.7% when NS1 and/or IgM and/or IgG was positive. Both NS1 assays were significantly more sensitive for primary than secondary dengue. NS1 positivity was associated with the underlying viraemia as NS1-positive samples had a significantly higher viraemia than NS1-negative samples. These data suggest that the NS1 test component of these assays are highly specific and have similar levels of sensitivity. The IgM parameter in the SD Duo test improved overall test sensitivity without compromising specificity. The SD Dengue Duo lateral flow rapid test deserves further prospective evaluation in dengue endemic settings.
Tài liệu tham khảo
Guzman MG, Kouri G: Dengue: an update. Lancet Infect Dis. 2002, 2: 33-42. 10.1016/S1473-3099(01)00171-2.
Monath TP: Dengue: the risk to developed and developing countries. Proc Natl Acad Sci USA. 1994, 91: 2395-2400. 10.1073/pnas.91.7.2395.
Dussart P, Petit L, Labeau B, Bremand L, Leduc A, et al: Evaluation of Two New Commercial Tests for the Diagnosis of Acute Dengue Virus Infection Using NS1 Antigen Detection in Human Serum. PLoS Negl Trop Dis. 2008, 2: e280-10.1371/journal.pntd.0000280.
Bessoff K, Delorey M, Sun W, Hunsperger E: Comparison of 2 Commercially Available Dengue NS1 Capture Enzyme-Linked Immunosorbant Assays for Diagnosis of Acute DENV Infection with a Single Clinical Sample. Clin Vaccine Immunol. 2008
Kumarasamy V, Chua SK, Hassan Z, Wahab AH, Chem YK, et al: Evaluating the sensitivity of a commercial dengue NS1 antigen-capture ELISA for early diagnosis of acute dengue virus infection. Singapore Med J. 2007, 48: 669-673.
Kumarasamy V, Wahab AH, Chua SK, Hassan Z, Chem YK, et al: Evaluation of a commercial dengue NS1 antigen-capture ELISA for laboratory diagnosis of acute dengue virus infection. J Virol Methods. 2007, 140: 75-79. 10.1016/j.jviromet.2006.11.001.
Dussart P, Labeau B, Lagathu G, Louis P, Nunes MR, et al: Evaluation of an enzyme immunoassay for detection of dengue virus NS1 antigen in human serum. Clin Vaccine Immunol. 2006, 13: 1185-1189. 10.1128/CVI.00229-06.
Blacksell SD, Mammen MP, Thongpaseuth S, Gibbons RV, Jarman RG, et al: Evaluation of the Panbio dengue virus nonstructural 1 antigen detection and immunoglobulin M antibody enzyme-linked immunosorbent assays for the diagnosis of acute dengue infections in Laos. Diagn Microbiol Infect Dis. 2008, 60: 43-49.
Chuansumrit A, Chaiyaratana W, Pongthanapisith V, Tangnararatchakit K, Lertwongrath S, et al: The use of dengue nonstructural protein 1 antigen for the early diagnosis during the febrile stage in patients with dengue infection. Pediatr Infect Dis J. 2008, 27: 43-48. 10.1097/INF.0b013e318150666d.
Lapphra K, Sangcharaswichai A, Chokephaibulkit K, Tiengrim S, Piriyakarnsakul W, et al: Evaluation of an NS1 antigen detection for diagnosis of acute dengue infection in patients with acute febrile illness. Diagn Microbiol Infect Dis. 2008, 60: 387-391. 10.1016/j.diagmicrobio.2007.11.010.
Hang VT, Nguyet NM, Trung DT, Tricou V, Yoksan S, et al: Diagnostic Accuracy of NS1 ELISA and Lateral Flow Rapid Tests for Dengue Sensitivity, Specificity and Relationship to Viraemia and Antibody Responses. PLoS Negl Trop Dis. 2009, 3: e360-10.1371/journal.pntd.0000360.
Murray CK, Gasser RA, Magill AJ, Miller RS: Update on rapid diagnostic testing for malaria. Clin Microbiol Rev. 2008, 21: 97-110. 10.1128/CMR.00035-07.
Cardosa MJ, Wang SM, Sum MS, Tio PH: Antibodies against prM protein distinguish between previous infection with dengue and Japanese encephalitis viruses. BMC Microbiol. 2002, 2: 9-10.1186/1471-2180-2-9.
Innis BL, Nisalak A, Nimmannitya S, Kusalerdchariya S, Chongswasdi V, et al: An enzyme-linked immunosorbent assay to characterize dengue infections where dengue and Japanese encephalitis co-circulate. Am J Trop Med Hyg. 1989, 40: 418-427.
Simmons CP, Popper S, Dolocek C, Chau TN, Griffiths M, et al: Patterns of host genome-wide gene transcript abundance in the peripheral blood of patients with acute dengue hemorrhagic fever. J Infect Dis. 2007, 195: 1097-1107. 10.1086/512162.
Hunsperger EA, Yoksan S, Buchy P, Nguyen VC, Sekaran SD, et al: Evaluation of commercially available anti-dengue virus immunoglobulin M tests. Emerg Infect Dis. 2009, 15: 436-440. 10.3201/eid1503.080923.
Lubell Y, Hopkins H, Whitty CJ, Staedke SG, Mills A: An interactive model for the assessment of the economic costs and benefits of different rapid diagnostic tests for malaria. Malar J. 2008, 7: 21-10.1186/1475-2875-7-21.
Libraty DH, Young PR, Pickering D, Endy TP, Kalayanarooj S, et al: High circulating levels of the dengue virus nonstructural protein NS1 early in dengue illness correlate with the development of dengue hemorrhagic fever. J Infect Dis. 2002, 186: 1165-1168. 10.1086/343813.
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