Development of the Abbott RealTime ZIKA assay for the qualitative detection of Zika virus RNA from serum, plasma, urine, and whole blood specimens using the m2000 system

Frankel, Matthew; Pandya, Kinnari; Gersch, Jeffrey; Siddiqui, Sarah; Schneider, George J.

doi:10.1016/j.jviromet.2017.05.002

Cited by 13 publications

(9 citation statements)

References 34 publications

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“…The final ZIKV rRT-PCR assay with current peer-reviewed literature is the Abbott RealTime ZIKV RT-PCR, which targets the prM and NS3 genes and can be performed with WB, plasma, serum, and urine samples, using the mSample RNA preparation system kit and automated m2000sp and m2000rt instruments (Abbott Molecular Inc., Des Planes IL). Compared to the Altona RealStar ZIKV rRT-PCR, the Abbott ZIKV rRT-PCR demonstrated positive and negative agreement rates of 96.5% and 71.4% in serum samples and 72.4% and 71.4% in urine samples, respectively, with LLoD values of 30 copies/ml for serum samples and 40 copies/ml for urine and plasma samples, as reflected in the assay IFU (58).…”

Section: Performance Of Molecular Assays With Fda Eua For Detection Omentioning

confidence: 93%

Diagnostic Testing for Zika Virus: a Postoutbreak Update

Theel

Hata

2018

J Clin Microbiol

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Section: Performance Of Molecular Assays With Fda Eua For Detection Omentioning

confidence: 93%

Diagnostic Testing for Zika Virus: a Postoutbreak Update

Theel

Hata

2018

J Clin Microbiol

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“…However, as this method allows the simultaneous detection of both specific and nonspecific PCR products, it produces false positives. Frankel et al (2017) developed the Abbott Real-Time ZIKA assay, and the detection limit of this assay was shown to be 120 copy/lL in whole blood. Moreover, Balm et al (2012) developed a sensitive and specific one-step RT-qPCR assay, and the lower limit of detection of this assay was 140 RNA copy/PCR.…”

Section: Discussionmentioning

confidence: 99%

Micro-droplet Digital Polymerase Chain Reaction and Real-Time Quantitative Polymerase Chain Reaction Technologies Provide Highly Sensitive and Accurate Detection of Zika Virus

Hui

Qin

et al. 2018

Virol. Sin.

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The establishment of highly sensitive diagnostic methods is critical in the early diagnosis and control of Zika virus (ZIKV) and in preventing serious neurological complications of ZIKV infection. In this study, we established micro-droplet digital polymerase chain reaction (ddPCR) and real-time quantitative PCR (RT-qPCR) protocols for the detection of ZIKV based on the amplification of the NS5 gene. For the ZIKV standard plasmid, the RT-qPCR results showed that the cycle threshold (Ct) value was linear from 10 to 10 copy/μL, with a standard curve R of 0.999 and amplification efficiency of 92.203%; however, a concentration as low as 1 copy/μL could not be detected. In comparison with RT-qPCR, the ddPCR method resulted in a linear range of 10-10 copy/μL and was able to detect concentrations as low as 1 copy/μL. Thus, for detecting ZIKV from clinical samples, RT-qPCR is a better choice for high-concentration samples (above 10 copy/μL), while ddPCR has excellent accuracy and sensitivity for low-concentration samples. These results indicate that the ddPCR method should be of considerable use in the early diagnosis, laboratory study, and monitoring of ZIKV.

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“…The assay was highly specific and sensitive with a limit of detection (LOD) of 120 copies/ml in whole blood, 40 copies/ml in urine and plasma, and 30 copies/ml in serum 399 . While, Hancock et al 400 used electronic health records (RT‐PCR) in a syndromic surveillance program to monitor asymptomatic pregnant women from American Samoa in order to establish a timeline to cease routine testing.…”

Section: Molecular Assaysmentioning

confidence: 99%

Recent progresses and remaining challenges for the detection of Zika virus

Zhang

Chen

et al. 2021

Medicinal Research Reviews

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Zika virus (ZIKV) has emerged as a particularly notorious mosquito‐borne flavivirus, which can lead to a devastating congenital syndrome in the fetuses of pregnant mothers (e.g., microcephaly, spasticity, craniofacial disproportion, miscarriage, and ocular abnormalities) and cause the autoimmune disorder Guillain‐Barre' syndrome of adults. Due to its severity and rapid dispersal over several continents, ZIKV has been acknowledged to be a global health concern by the World Health Organization. Unfortunately, the ZIKV has recently resurged in India with the potential for devastating effects. Researchers from all around the world have worked tirelessly to develop effective detection strategies and vaccines for the prevention and control of ZIKV infection. In this review, we comprehensively summarize the most recent research into ZIKV, including the structural biology and evolution, historical overview, pathogenesis, symptoms, and transmission. We then focus on the detection strategies for ZIKV, including viral isolation, serological assays, molecular assays, sensing methods, reverse transcription loop mediated isothermal amplification, transcription‐mediated amplification technology, reverse transcription strand invasion based amplification, bioplasmonic paper‐based device, and reverse transcription isothermal recombinase polymerase amplification. To conclude, we examine the limitations of currently available strategies for the detection of ZIKV, and outline future opportunities and research challenges.

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Development of the Abbott RealTime ZIKA assay for the qualitative detection of Zika virus RNA from serum, plasma, urine, and whole blood specimens using the m2000 system

Cited by 13 publications

References 34 publications

Diagnostic Testing for Zika Virus: a Postoutbreak Update

Diagnostic Testing for Zika Virus: a Postoutbreak Update

Micro-droplet Digital Polymerase Chain Reaction and Real-Time Quantitative Polymerase Chain Reaction Technologies Provide Highly Sensitive and Accurate Detection of Zika Virus

Recent progresses and remaining challenges for the detection of Zika virus

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