Rapid antigen tests for dengue virus serotypes and Zika virus in patient serum

被引：161

作者：

Bosch, Irene ^{[1
,2
]}

de Puig, Helena ^{[1
,3
]}

Hiley, Megan ^{[1
]}

Carre-Camps, Marc ^{[1
,4
]}

Perdomo-Celis, Federico ^{[5
]}

Narvaez, Carlos F. ^{[5
]}

Salgado, Doris M. ^{[5
]}

Senthoor, Dewahar ^{[1
]}

O'Grady, Madeline ^{[1
]}

Phillips, Elizabeth ^{[1
]}

Durbin, Ann ^{[1
,6
]}

Fandos, Diana ^{[1
,4
]}

Miyazaki, Hikaru ^{[1
]}

Yen, Chun-Wan ^{[1
]}

Gelvez-Ramirez, Margarita ^{[7
,8
]}

Warke, Rajas V. ^{[9
]}

Ribeiro, Lucas S. ^{[10
]}

Teixeira, Mauro M. ^{[10
]}

Almeida, Roque P. ^{[11
]}

Munoz-Medina, Jose E. ^{[12
]}

Ludert, Juan E. ^{[13
]}

Nogueira, Mauricio L. ^{[14
]}

Colombo, Tatiana E. ^{[14
]}

Terzian, Ana C. B. ^{[14
]}

Bozza, Patricia T. ^{[15
]}

Calheiros, Andrea S. ^{[15
]}

Vieira, Yasmine R. ^{[16
]}

Barbosa-Lima, Giselle ^{[16
]}

Vizzoni, Alexandre ^{[16
]}

Cerbino-Neto, Jose ^{[16
]}

Bozza, Fernando A. ^{[16
,17
]}

Souza, Thiago M. L. ^{[15
,18
]}

Trugilho, Monique R. O. ^{[19
,20
]}

de Filippis, Ana M. B. ^{[21
]}

de Sequeira, Patricia C. ^{[21
]}

Marques, Ernesto T. A. ^{[22
,23
]}

Magalhaes, Tereza ^{[22
,24
]}

Diaz, Francisco J. ^{[25
]}

Restrepo, Berta N. ^{[26
]}

Marin, Katerine ^{[26
]}

Mattar, Salim ^{[27
]}

Olson, Daniel ^{[28
]}

Asturias, Edwin J. ^{[28
]}

Lucera, Mark ^{[29
]}

Singla, Mohit ^{[30
]}

Medigeshi, Guruprasad R. ^{[31
]}

de Bosch, Norma ^{[32
]}

Tam, Justina ^{[1
,33
]}

Gomez-Marquez, Jose ^{[1
]}

Clavet, Charles ^{[33
]}

机构：

[1] MIT, Inst Med Engn & Sci, Cambridge, MA 02139 USA

[2] Mt Sinai Sch Med, Dept Med, New York, NY 10029 USA

[3] MIT, Dept Mech Engn, Cambridge, MA 02139 USA

[4] Univ Ramon Llull, Inst Quim Sarria, Barcelona, Spain

[5] Univ Surcolombiana, Fac Salud, Programa Med, Neiva, Colombia

[6] Harvard Med Sch, Div Med Sci, Program Virol, Boston, MA 02115 USA

[7] Univ Ind Santander, Santander, Colombia

[8] AEDES Program, Santander, Colombia

[9] HiMedia Labs Pvt Ltd, Bombay, Maharashtra, India

[10] Univ Fed Minas Gerais, Inst Ciencias Biol, Immunopharmacol Grp, Ave Antonio Carlos 6627, Belo Horizonte, MG, Brazil

[11] Univ Fed Sergipe, Hosp Univ, Empresa Brasileira Serv Hosp EBSERH, Dept Med Interna & Patol, Aracaju, Brazil

[12] Inst Mexicano Seguro Social, Lab Cent Epidemiol, Ave Jacarandas S-N, Mexico City 02990, DF, Mexico

[13] Inst Politecn Nacl CINVESTAV IPN, Ctr Invest & Estudios Avanzados, Dept Infect & Patogenesis Mol, Mexico City, DF, Mexico

[14] Fac Med Sao Jose Rio Preto FAMERP, Sao Jose Do Rio Preto, Brazil

[15] Fiocruz MS, Oswaldo Cruz Fdn, Immunopharmacol Lab, Rio De Janeiro, Brazil

[16] Fiocruz MS, Natl Inst Infect Dis Evandro Chagas, Rio De Janeiro, Brazil

[17] DOr Inst Res & Educ IDOR, Rio De Janeiro, Brazil

[18] Fiocruz MS, Ctr Technol Dev Hlth CDTS, Natl Inst Sci & Technol Innovat Neglected Dis INC, Rio De Janeiro, Brazil

[19] Fiocruz MS, Toxinol Lab, Rio De Janeiro, Brazil

[20] Fiocruz MS, Ctr Technol Dev Hlth CDTS, Rio De Janeiro, Brazil

[21] Fiocruz MS, Flavivirus Lab, Rio De Janeiro, Brazil

[22] Fiocruz MS, Aggeu Magalhaes Res Ctr, Recife, PE, Brazil

[23] Univ Pittsburgh, Dept Infect Dis & Microbiol, Pittsburgh, PA 15213 USA

[24] Colorado State Univ, Dept Microbiol Immunol & Pathol, Ft Collins, CO 80523 USA

[25] Univ Antioquia, Sch Med, Immunovirol Grp, Medellin, Colombia

[26] Univ CES, ICMT, Sabaneta, Antioquia, Colombia

[27] Univ Cordoba, Monteria, Cordoba, Colombia

[28] Univ Colorado, Sch Med, Dept Pediat, Div Infect Dis, Aurora, CO 80045 USA

[29] Univ Colorado, Sch Med, Dept Med, Div Infect Dis, Aurora, CO 80045 USA

[30] All India Inst Med Sci, Dept Paediat, New Delhi, India

[31] Translat Hlth Sci & Technol Inst, Faridabad, India

[32] Univ Cent Venezuela, Caracas, Venezuela

[33] WEAC, Winchester, MA 01890 USA

[34] Univ Massachusetts, Dept Engn, Boston, MA 02125 USA

[35] Harvard Med Sch, Dept Microbiol & Immunobiol, Boston, MA 02115 USA

来源：

SCIENCE TRANSLATIONAL MEDICINE | 2017年 / 9卷 / 409期

基金：

巴西圣保罗研究基金会; 英国惠康基金;

关键词：

OF-CARE TESTS; NS1; ANTIGEN; DIAGNOSIS; URINE; INFECTIONS; SAMPLES; SALIVA; IGM;

D O I：

10.1126/scitranslmed.aan1589

中图分类号：

Q2 [细胞生物学];

学科分类号：

071013 [干细胞生物学];

摘要：

The recent Zika virus (ZIKV) outbreak demonstrates that cost-effective clinical diagnostics are urgently needed to detect and distinguish viral infections to improve patient care. Unlike dengue virus (DENV), ZIKV infections during pregnancy correlate with severe birth defects, including microcephaly and neurological disorders. Because ZIKV and DENV are related flaviviruses, their homologous proteins and nucleic acids can cause cross-reactions and false-positive results in molecular, antigenic, and serologic diagnostics. We report the characterization of monoclonal antibody pairs that have been translated into rapid immunochromatography tests to specifically detect the viral nonstructural 1 (NS1) protein antigen and distinguish the four DENV serotypes (DENV1-4) and ZIKV without cross-reaction. To complement visual test analysis and remove user subjectivity in reading test results, we used image processing and data analysis for data capture and test result quantification. Using a 30-ml serum sample, the sensitivity and specificity values of the DENV1-4 tests and the pan-DENV test, which detects all four dengue serotypes, ranged from 0.76 to 1.00. Sensitivity/specificity for the ZIKV rapid test was 0.81/0.86, respectively, using a 150-mu l serum input. Serum ZIKV NS1 protein concentrations were about 10-fold lower than corresponding DENV NS1 concentrations in infected patients; moreover, ZIKV NS1 protein was not detected in polymerase chain reactionpositive patient urine samples. Our rapid immunochromatography approach and reagents have immediate application in differential clinical diagnosis of acute ZIKV and DENV cases, and the platform can be applied toward developing rapid antigen diagnostics for emerging viruses.

引用

页数：13

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