Evaluation of aptima zika virus assay

Ping Ren, Daniel A. Ortiz, Ana C.B. Terzian, Tatiana E. Colombo, Mauricio L. Nogueira, Nikos Vasilakis, Michael J. Loeffelholz

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

The Zika virus (ZIKV) epidemic in the Americas poses a public health emergency that requires a swift response. Accurate and reliable ZIKV diagnostic tests serve as an important tool for limiting the spread of ZIKV infections. The Aptima Zika virus assay (Hologic, Marlborough, MA) performed on the automated Panther system is a rapid and high-throughput method for detecting ZIKV RNA using transcriptionmediated amplification (TMA) technology. We evaluated the performance characteristics of the Aptima Zika virus assay on clinical serum and urine specimens (n=124) from two different patient populations and samples spiked with ZIKV from three different lineages (n=10). Compared to the real-time reverse transcription-PCR (rRTPCR) reference method, the Aptima ZIKV assay detected ZIKV RNA with a diagnostic accuracy of 94.8% (95% confidence interval [CI], 89.4 to 97.6), a sensitivity of 94.7% (95% CI, 73.5 to 99.9), and a specificity of 94.8% (95% CI, 88.9 to 97.8). Similar results were obtained regardless of whether a serum or urine source was used. The limits of detection of the assay at a 95% detection probability were 11.5 genome copy equivalents (GCE)/ml (95% fiducial limits, 7.9 to 20.2) in serum and 17.9 GCE/ml (95% fiducial limits, 13.1 to 27.5) in urine. The Aptima Zika virus assay results were highly reproducible (99%), and no cross-reactivity was seen during the testing of a panel of 95 specimens with potentially interfering substances, such as clinically relevant bacteria, fungi, and viruses, including other flaviviruses. The excellent performance characteristics and the convenience of a fully automated testing system make the Aptima ZIKV assay an attractive choice for clinical laboratories detecting ZIKV RNA from serum and urine.

Original languageEnglish (US)
Pages (from-to)2198-2203
Number of pages6
JournalJournal of Clinical Microbiology
Volume55
Issue number7
DOIs
StatePublished - Jul 1 2017

Fingerprint

Urine
RNA
Confidence Intervals
Serum
Zika Virus
Genome
Flavivirus
Routine Diagnostic Tests
Reverse Transcription
Limit of Detection
Emergencies
Fungi
Public Health
Viruses
Technology
Bacteria
Polymerase Chain Reaction
Population
Zika Virus Infection

Keywords

  • Aptima Zika virus assay
  • Sensitivity
  • Specificity

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Ren, P., Ortiz, D. A., Terzian, A. C. B., Colombo, T. E., Nogueira, M. L., Vasilakis, N., & Loeffelholz, M. J. (2017). Evaluation of aptima zika virus assay. Journal of Clinical Microbiology, 55(7), 2198-2203. https://doi.org/10.1128/JCM.00603-17

Evaluation of aptima zika virus assay. / Ren, Ping; Ortiz, Daniel A.; Terzian, Ana C.B.; Colombo, Tatiana E.; Nogueira, Mauricio L.; Vasilakis, Nikos; Loeffelholz, Michael J.

In: Journal of Clinical Microbiology, Vol. 55, No. 7, 01.07.2017, p. 2198-2203.

Research output: Contribution to journalArticle

Ren, P, Ortiz, DA, Terzian, ACB, Colombo, TE, Nogueira, ML, Vasilakis, N & Loeffelholz, MJ 2017, 'Evaluation of aptima zika virus assay', Journal of Clinical Microbiology, vol. 55, no. 7, pp. 2198-2203. https://doi.org/10.1128/JCM.00603-17
Ren P, Ortiz DA, Terzian ACB, Colombo TE, Nogueira ML, Vasilakis N et al. Evaluation of aptima zika virus assay. Journal of Clinical Microbiology. 2017 Jul 1;55(7):2198-2203. https://doi.org/10.1128/JCM.00603-17
Ren, Ping ; Ortiz, Daniel A. ; Terzian, Ana C.B. ; Colombo, Tatiana E. ; Nogueira, Mauricio L. ; Vasilakis, Nikos ; Loeffelholz, Michael J. / Evaluation of aptima zika virus assay. In: Journal of Clinical Microbiology. 2017 ; Vol. 55, No. 7. pp. 2198-2203.
@article{89bc119b2dd3495fb8b553354483a64e,
title = "Evaluation of aptima zika virus assay",
abstract = "The Zika virus (ZIKV) epidemic in the Americas poses a public health emergency that requires a swift response. Accurate and reliable ZIKV diagnostic tests serve as an important tool for limiting the spread of ZIKV infections. The Aptima Zika virus assay (Hologic, Marlborough, MA) performed on the automated Panther system is a rapid and high-throughput method for detecting ZIKV RNA using transcriptionmediated amplification (TMA) technology. We evaluated the performance characteristics of the Aptima Zika virus assay on clinical serum and urine specimens (n=124) from two different patient populations and samples spiked with ZIKV from three different lineages (n=10). Compared to the real-time reverse transcription-PCR (rRTPCR) reference method, the Aptima ZIKV assay detected ZIKV RNA with a diagnostic accuracy of 94.8{\%} (95{\%} confidence interval [CI], 89.4 to 97.6), a sensitivity of 94.7{\%} (95{\%} CI, 73.5 to 99.9), and a specificity of 94.8{\%} (95{\%} CI, 88.9 to 97.8). Similar results were obtained regardless of whether a serum or urine source was used. The limits of detection of the assay at a 95{\%} detection probability were 11.5 genome copy equivalents (GCE)/ml (95{\%} fiducial limits, 7.9 to 20.2) in serum and 17.9 GCE/ml (95{\%} fiducial limits, 13.1 to 27.5) in urine. The Aptima Zika virus assay results were highly reproducible (99{\%}), and no cross-reactivity was seen during the testing of a panel of 95 specimens with potentially interfering substances, such as clinically relevant bacteria, fungi, and viruses, including other flaviviruses. The excellent performance characteristics and the convenience of a fully automated testing system make the Aptima ZIKV assay an attractive choice for clinical laboratories detecting ZIKV RNA from serum and urine.",
keywords = "Aptima Zika virus assay, Sensitivity, Specificity",
author = "Ping Ren and Ortiz, {Daniel A.} and Terzian, {Ana C.B.} and Colombo, {Tatiana E.} and Nogueira, {Mauricio L.} and Nikos Vasilakis and Loeffelholz, {Michael J.}",
year = "2017",
month = "7",
day = "1",
doi = "10.1128/JCM.00603-17",
language = "English (US)",
volume = "55",
pages = "2198--2203",
journal = "Journal of Clinical Microbiology",
issn = "0095-1137",
publisher = "American Society for Microbiology",
number = "7",

}

TY - JOUR

T1 - Evaluation of aptima zika virus assay

AU - Ren, Ping

AU - Ortiz, Daniel A.

AU - Terzian, Ana C.B.

AU - Colombo, Tatiana E.

AU - Nogueira, Mauricio L.

AU - Vasilakis, Nikos

AU - Loeffelholz, Michael J.

PY - 2017/7/1

Y1 - 2017/7/1

N2 - The Zika virus (ZIKV) epidemic in the Americas poses a public health emergency that requires a swift response. Accurate and reliable ZIKV diagnostic tests serve as an important tool for limiting the spread of ZIKV infections. The Aptima Zika virus assay (Hologic, Marlborough, MA) performed on the automated Panther system is a rapid and high-throughput method for detecting ZIKV RNA using transcriptionmediated amplification (TMA) technology. We evaluated the performance characteristics of the Aptima Zika virus assay on clinical serum and urine specimens (n=124) from two different patient populations and samples spiked with ZIKV from three different lineages (n=10). Compared to the real-time reverse transcription-PCR (rRTPCR) reference method, the Aptima ZIKV assay detected ZIKV RNA with a diagnostic accuracy of 94.8% (95% confidence interval [CI], 89.4 to 97.6), a sensitivity of 94.7% (95% CI, 73.5 to 99.9), and a specificity of 94.8% (95% CI, 88.9 to 97.8). Similar results were obtained regardless of whether a serum or urine source was used. The limits of detection of the assay at a 95% detection probability were 11.5 genome copy equivalents (GCE)/ml (95% fiducial limits, 7.9 to 20.2) in serum and 17.9 GCE/ml (95% fiducial limits, 13.1 to 27.5) in urine. The Aptima Zika virus assay results were highly reproducible (99%), and no cross-reactivity was seen during the testing of a panel of 95 specimens with potentially interfering substances, such as clinically relevant bacteria, fungi, and viruses, including other flaviviruses. The excellent performance characteristics and the convenience of a fully automated testing system make the Aptima ZIKV assay an attractive choice for clinical laboratories detecting ZIKV RNA from serum and urine.

AB - The Zika virus (ZIKV) epidemic in the Americas poses a public health emergency that requires a swift response. Accurate and reliable ZIKV diagnostic tests serve as an important tool for limiting the spread of ZIKV infections. The Aptima Zika virus assay (Hologic, Marlborough, MA) performed on the automated Panther system is a rapid and high-throughput method for detecting ZIKV RNA using transcriptionmediated amplification (TMA) technology. We evaluated the performance characteristics of the Aptima Zika virus assay on clinical serum and urine specimens (n=124) from two different patient populations and samples spiked with ZIKV from three different lineages (n=10). Compared to the real-time reverse transcription-PCR (rRTPCR) reference method, the Aptima ZIKV assay detected ZIKV RNA with a diagnostic accuracy of 94.8% (95% confidence interval [CI], 89.4 to 97.6), a sensitivity of 94.7% (95% CI, 73.5 to 99.9), and a specificity of 94.8% (95% CI, 88.9 to 97.8). Similar results were obtained regardless of whether a serum or urine source was used. The limits of detection of the assay at a 95% detection probability were 11.5 genome copy equivalents (GCE)/ml (95% fiducial limits, 7.9 to 20.2) in serum and 17.9 GCE/ml (95% fiducial limits, 13.1 to 27.5) in urine. The Aptima Zika virus assay results were highly reproducible (99%), and no cross-reactivity was seen during the testing of a panel of 95 specimens with potentially interfering substances, such as clinically relevant bacteria, fungi, and viruses, including other flaviviruses. The excellent performance characteristics and the convenience of a fully automated testing system make the Aptima ZIKV assay an attractive choice for clinical laboratories detecting ZIKV RNA from serum and urine.

KW - Aptima Zika virus assay

KW - Sensitivity

KW - Specificity

UR - http://www.scopus.com/inward/record.url?scp=85021303877&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85021303877&partnerID=8YFLogxK

U2 - 10.1128/JCM.00603-17

DO - 10.1128/JCM.00603-17

M3 - Article

VL - 55

SP - 2198

EP - 2203

JO - Journal of Clinical Microbiology

JF - Journal of Clinical Microbiology

SN - 0095-1137

IS - 7

ER -