Evaluation of Aptima Zika Virus Assay

Autor(es)

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

• Tipo de documento: Artigo Científico
• Fonte: Journal of Clinical Microbiology; v. 55, n. 7, p. 2198-2203, JUL 2017.
• Citações Web of Science: 10

Resumo

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. (AU)

• Processo FAPESP: 16/15021-1 - Estudo clínico-epidemiológico em coorte prospectiva de gestantes infectadas pelo vírus Zika em São José do Rio Preto
• Beneficiário: Maurício Lacerda Nogueira
• Modalidade de apoio: Auxílio à Pesquisa - Pesquisa em Políticas Públicas para o SUS
• Processo FAPESP: 13/21719-3 - Estudo epidemiológico da dengue (sorotipos 1 a 4) em coorte prospectiva de São José do Rio Preto, São Paulo, Brasil, durante 2014 a 2018
• Beneficiário: Maurício Lacerda Nogueira
• Modalidade de apoio: Auxílio à Pesquisa - Temático
• Processo FAPESP: 15/12295-0 - Diagnóstico de arboviroses brasileiras e emergentes em pacientes e mosquitos em duas regiões distintas do Brasil
• Beneficiário: Ana Carolina Bernardes Terzian
• Modalidade de apoio: Bolsas no Brasil - Pós-Doutorado