Comparison of Four Serological Methods and Two Reverse Transcription-PCR Assays for Diagnosis and Surveillance of Zika Virus Infection

Balmaseda, Ángel; Zambrana, José Victor; Collado, Damaris; García, Nadezna; Saborío, Saira; Elizondo, Douglas; Mercado, Juan Carlos; González, Karla; Cerpas, Cristhiam; Nunez, Andrea C.; Corti, Davide; Waggoner, Jesse J.; Kuan, Guillermina; Burger-Calderon, Raquel; Harris, Eva

doi:10.1128/jcm.01785-17

Cited by 67 publications

(75 citation statements)

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“…2B and 3B). This was in agreement with a recent study of a blockade-of-binding ZIKV NS1 ELISA (25), in which the detection rate increased (77.4% to 98.3%) from early convalescent to late convalescent phases for the pZIKV panel and remained high (92.3% to 94.4%) for the ZIKVwprDENV panel. Our ZIKV NS1 IgG ELISA had an overall sensitivity of 100%, which is higher or compatible with those reported recently (79% to 100%) using the Euroimmun ZIKV NS1 IgG ELISA kit (41)(42)(43)(44).…”

Section: Discussionsupporting

confidence: 93%

“…A study of human MAbs against nonstructural protein 1 (NS1) revealed that most anti-NS1 MAbs derived from patients with pZIKV infection were specific to ZIKV, and Ͼ50% of those from patients with ZIKVwprDENV infection reacted to DENV (21); other studies using ZIKV-specific NS1 MAbs in blockade-of-binding enzyme-linked immunosorbent assays (ELISAs) showed that ZIKV NS1 protein in serodiagnosis can distinguish ZIKV and DENV (24,25). We reported previously that the combination of ZIKV and DENV1 NS1 ELISAs distinguishes pZIKV, primary DENV1 (pDENV1), secondary DENV (sDENV,) and ZIKVwprDENV infections (26).…”

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confidence: 99%

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Combination of Nonstructural Protein 1-Based Enzyme-Linked Immunosorbent Assays Can Detect and Distinguish Various Dengue Virus and Zika Virus Infections

Tyson

Tsai

et al. 2019

J Clin Microbiol

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The recent outbreaks of Zika virus (ZIKV) and associated birth defects in regions of dengue virus (DENV) endemicity emphasize the need for sensitive and specific serodiagnostic tests. We reported previously that enzyme-linked immunosorbent assays (ELISAs) based on the nonstructural protein 1 (NS1) of DENV serotype 1 (DENV1) and ZIKV can distinguish primary DENV1, secondary DENV, and ZIKV infections. Whether ELISAs based on NS1 proteins of other DENV serotypes can discriminate various DENV and ZIKV infections remains unknown. We herein developed DENV2, DENV3, and DENV4 NS1 IgG ELISAs to test convalescent- and postconvalescent-phase samples from reverse transcription-PCR-confirmed cases, including 25 primary DENV1, 24 primary DENV2, 10 primary DENV3, 67 secondary DENV, 36 primary West Nile virus, 38 primary ZIKV, and 35 ZIKV with previous DENV infections as well as 55 flavivirus-naive samples. Each ELISA detected primary DENV infection with a sensitivity of 100% for the same serotype and 23.8% to 100% for different serotypes. IgG ELISA using a mixture of DENV1-4 NS1 proteins detected different primary and secondary DENV infections with a sensitivity of 95.6% and specificity of 89.5%. The ZIKV NS1 IgG ELISA detected ZIKV infection with a sensitivity of 100% and specificity of 82.9%. On the basis of the relative optical density ratio, the combination of DENV1-4 and ZIKV NS1 IgG ELISAs distinguished ZIKV with previous DENV and secondary DENV infections with a sensitivity of 91.7% to 94.1% and specificity of 87.0% to 95.0%. These findings have important applications to serodiagnosis, serosurveillance, and monitoring of both DENV and ZIKV infections in regions of endemicity.

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Section: Discussionsupporting

confidence: 93%

mentioning

confidence: 99%

Combination of Nonstructural Protein 1-Based Enzyme-Linked Immunosorbent Assays Can Detect and Distinguish Various Dengue Virus and Zika Virus Infections

Tyson

Tsai

et al. 2019

J Clin Microbiol

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“…In particular, the assay has a 95% sensitivity and a specificity against DENV of 89% in patient samples >20 d after the onset of symptoms compared with RT-PCR results. In late convalescent samples (e.g., >7 mo postillness as in the samples used in the present study), the assay's sensitivity and specificity rose to 96 and 92%, respectively, in a validation study performed in Nicaragua (24,25). This study aimed to (i) determine the seroprevalence of anti-ZIKV antibodies after the first Zika epidemic in Managua, (ii) describe the age patterns of ZIKV infection, (iii) identify potential risk factors that correlate with ZIKV infection, and (iv) characterize the neighborhood-specific spatial distribution of ZIKV seroprevalence within our study populations.…”

mentioning

confidence: 57%

“…Our study used a new competition ELISA to detect total anti-ZIKV NS1 antibodies. The assay distinguishes between ZIKV and DENV infections with high sensitivity and specificity for up to several years postinfection and has been validated in six countries (including Nicaragua) (24,25). In particular, the assay has a 95% sensitivity and a specificity against DENV of 89% in patient samples >20 d after the onset of symptoms compared with RT-PCR results.…”

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confidence: 99%

Seroprevalence, risk factor, and spatial analyses of Zika virus infection after the 2016 epidemic in Managua, Nicaragua

Zambrana

Carrillo

Burger-Calderon

et al. 2018

Proc. Natl. Acad. Sci. U.S.A.

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In 2015, a Zika epidemic in Brazil began spreading throughout the Americas. Zika virus (ZIKV) entered Managua, Nicaragua, in January 2016 and caused an epidemic that peaked in July-September 2016. ZIKV seropositivity was estimated among participants of pediatric ( = 3,740) and household ( = 2,147) cohort studies, including an adult-only subset from the household cohort ( = 1,074), in Managua. Seropositivity was based on a highly sensitive and specific assay, the Zika NS1 blockade-of-binding ELISA, which can be used in dengue-endemic populations. Overall seropositivity for the pediatric (ages 2-14), household (ages 2-80), and adult (ages 15-80) cohorts was 36, 46, and 56%, respectively. Trend, risk factor, and contour mapping analyses demonstrated that ZIKV seroprevalence increased nonlinearly with age and that body surface area was statistically associated with increasing seroprevalence in children. ZIKV seropositivity was higher in females than in males across almost all ages, with adjusted prevalence ratios in children and adults of 1.11 (95% CI: 1.02-1.21) and 1.14 (95% CI: 1.01-1.28), respectively. No household-level risk factors were statistically significant in multivariate analyses. A spatial analysis revealed a 10-15% difference in the risk of ZIKV infections across our 3-km-wide study site, suggesting that ZIKV infection risk varies at small spatial scales. To our knowledge, this is the largest ZIKV seroprevalence study reported in the Americas, and the only one in Central America and in children to date. It reveals a high level of immunity against ZIKV in Managua as a result of the 2016 epidemic, making a second large Zika epidemic unlikely in the near future.

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“…Laboratory confirmation of a diagnosis for patient treatment must have sufficient clinical sensitivity and specificity to be useful, the criteria for which may be different than analytical sensitivity and specificity criteria specified by assays for use in vaccine trials. [38][39][40][41][42][43][44][45] Very few tests have gained Emergency Use Authorization (EUA) from the FDA. There are 2 MERS-CoV diagnostic tests, both molecular-based viral RNA detection, which received EUA in 2013 in response to the recognition of the significant potential for a future public health emergency.…”

Section: Diagnostics For Emerging Infectious Diseasesmentioning

confidence: 99%

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

Roberts¹

2019

Human Vaccines & Immunotherapeutics

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Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.

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Comparison of Four Serological Methods and Two Reverse Transcription-PCR Assays for Diagnosis and Surveillance of Zika Virus Infection

Abstract: 24Zika virus (ZIKV) is a mosquito-borne flavivirus that is responsible for recent explosive 25 epidemics in the Americas. Notably, ZIKV infection during pregnancy has been found to cause 26 congenital birth defects, including microcephaly, and ZIKV has been associated with Guillain

Cited by 67 publications

References 34 publications

Combination of Nonstructural Protein 1-Based Enzyme-Linked Immunosorbent Assays Can Detect and Distinguish Various Dengue Virus and Zika Virus Infections

Combination of Nonstructural Protein 1-Based Enzyme-Linked Immunosorbent Assays Can Detect and Distinguish Various Dengue Virus and Zika Virus Infections

Seroprevalence, risk factor, and spatial analyses of Zika virus infection after the 2016 epidemic in Managua, Nicaragua

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

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