Multi-laboratory comparison of three commercially available Zika IgM enzyme-linked immunosorbent assays

Basile, Alison Jane; Goodman, Christin H.; Horiuchi, Kalanthe; Sloan, Angela; Johnson, Barbara W.; Kosoy, Olga; Laven, Janeen; Panella, Amanda J.; Sheets, Isabel; Medina, Freddy A.; Mendoza, Emelissa J; Epperson, Monica; Maniatis, Panagiotis; Semenova, Vera; Steward‐Clark, Evelene; Wong, Emily Y.; Biggerstaff, Brad J.; Lanciotti, Robert S.; Drebot, Michael A.; Safronetz, David; Schiffer, Jarad

doi:10.1016/j.jviromet.2018.06.018

Cited by 22 publications

(22 citation statements)

References 29 publications

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“…For the NovaLisa ® ZIKV IgM ELISA, higher test specificities were reported by Basile et al . (98%, n = 155) [ 49 ] and for this study (100%, n = 120) as compared to results reported by Safronetz et al . [ 50 ].…”

Section: Discussionsupporting

confidence: 76%

Evaluation of eight commercial Zika virus IgM and IgG serology assays for diagnostics and research

et al. 2021

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Several commercial Zika virus (ZIKV) serology assays have been developed since the recognition of ZIKV outbreaks as a Public Health Emergency of International Concern in 2016. However, test interpretation for ZIKV serology can be challenging due to antibody cross-reactivity with other flaviviruses like dengue virus (DENV). Therefore, we sought to evaluate the performance of eight commercially available ZIKV IgM and IgG assays across three testing platforms, namely, immunochromatographic tests (ICT), ELISAs and immunofluorescence tests (IIFT). The test panel comprised of 278 samples, including acute and convalescent sera or plasma from ZIKV-confirmed, DENV-confirmed, non-ZIKV and non-DENV patients, and residual sera from healthy blood donors. The ZIKV IgM and IgG serology assays yielded higher test sensitivities of 23.5% - 97.1% among ZIKV convalescent samples as compared to 5.6% - 27.8% among ZIKV acute samples; the test specificities were 63.3% - 100% among acute and convalescent DENV, non-DENV samples. Among the ELISAs and IIFTs, the Diapro ZIKV IgM ELISA demonstrated high test sensitivity (96%) and specificity (80%) when tested on early convalescent samples, while the Euroimmun ZIKV IgG ELISA yielded the highest test specificity of 97% - 100% on samples from non-ZIKV patients and healthy blood donors. For rapid ICTs, the LumiQuick IgM rapid ICT yielded low test sensitivity, suggesting its limited utility. We showed that commercial ZIKV IgM and IgG serology assays have differing test performances, with some having moderate to high test sensitivities and specificities when used in a dengue endemic setting, although there were limitations in IgG serology.

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Section: Discussionsupporting

confidence: 76%

Evaluation of eight commercial Zika virus IgM and IgG serology assays for diagnostics and research

et al. 2021

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“…Fortunately, advances in flaviviral diagnostics have significantly improved accurate and timely diagnosis which can have a direct and positive effect on patient care. For instance, several ELISA and lateral flow assays are commercially available that can simultaneously detect DENV antigen, IgM and IgG antibodies (8)(9)(10)(11). This can help health care providers easily distinguish between early, primary, and secondary infections.…”

Section: Introductionmentioning

confidence: 99%

The Clinical Features of Co-circulating Dengue Viruses and the Absence of Dengue Hemorrhagic Fever in Pakistan

Khan

Prakoso

Imtiaz

et al. 2020

Front. Public Health

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Dengue virus (DENV) is the most common and widespread arboviral infection worldwide. Though all four DENV serotypes cocirculate in nature, the clinicopathological framework of these serotypes is undefined in Pakistan. A cross-sectional, observational study was performed to document the circulation of various arboviruses in the Sindh region of Pakistan. Here we describe a population of patients diagnosed with DENV spanning a 2-year period. This study used an orthogonal system of NS1 antigen ELISA followed by RT-PCR for DENV detection and subtyping. A total of 168 NS1 positive patients were evaluated of which 91 patients were serotyped via RT-PCR. There was no significant difference between sex or age for infection risk and peak transmission occurred during the Autumn months. DENV2 was the most common serotype followed by DENV1 then DENV3, then DENV4. The data show that DENV1 patients were more likely to have abnormal liver function tests; DENV2 infected patients were more likely to exhibit arthralgia and neurological symptoms; DENV3 patients were more likely to complain of burning micturition and have elevated lymphocyte counts and low hematocrit; and DENV4 patients were more likely to report headaches and rash. Notably, no dengue hemorrhagic fever or other manifestations of severe dengue fever were present in patients with primary or secondary infections. We were able to identify significantly more NS1 antigen positive patients than RT-PCR. This study demonstrates that all four DENV serotypes are co-circulating and co-infecting in Pakistan.

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“…Thus, when ELISA assays using the NS1 protein are compared with IIF-and other laboratory results are used for the final classification of cases, such as those from PCR or PRNT-the concordance, sensitivity and specificity values of the first assay are 81.1%, 65.9% and 100%, with IIF being 86.0%, 96.8% and 72.5%, respectively, which represents a substantial improvement in specificity [11]. Assays with the NS1 protein show greater specificity than those obtained using other virus proteins such as E/prM recombinant protein, although sensitivity may be affected [12].…”

Section: Discussionmentioning

confidence: 94%

Evaluation of the LIAISON XL Zika Capture IgM II for the Diagnosis of Zika Virus Infections

Pérez‐Olmeda

Sánchez-Seco

Vázquez

et al. 2020

Viruses

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The aim of this study is to evaluate the performance characteristics of the LIAISON XL Zika Capture IgM II. For this purpose we tested 128 samples obtained from recent infections caused by the Zika (ZIKV; 74 samples), dengue (DENV; 10 samples), chikungunya (CHIK V; 11 samples), rubella (RUBV; 10 samples) and measles (MeV; 10 samples) viruses, as well as human parvovirus B19 (HPVB19; 13 samples). The results of the assay under evaluation are compared with those obtained from an indirect immunofluorescence (IIF) assay, and the discrepancies are resolved by considering other laboratory results (PCR and a plaque-reduction neutralization test). The LIAISON showed excellent sensitivity (100%). The specificity (91.25%) was hampered by some false-positive results in recent dengue virus, chikungunya virus, measles virus and human parvovirus B19 infections. The method evaluated is adequate, but the low specificity makes it necessary to consider the clinical and epidemiological contexts of patients, as well as other laboratory results.

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Multi-laboratory comparison of three commercially available Zika IgM enzyme-linked immunosorbent assays

Cited by 22 publications

References 29 publications

Evaluation of eight commercial Zika virus IgM and IgG serology assays for diagnostics and research

Evaluation of eight commercial Zika virus IgM and IgG serology assays for diagnostics and research

The Clinical Features of Co-circulating Dengue Viruses and the Absence of Dengue Hemorrhagic Fever in Pakistan

Evaluation of the LIAISON XL Zika Capture IgM II for the Diagnosis of Zika Virus Infections

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