sharon sanders
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[h=1]Interim Guidance for Zika Virus Testing of Urine ? United States, 2016[/h] Early Release / May 10, 2016 / 65
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Diagnostic testing for Zika virus infection can be accomplished using molecular and serologic methods. Real-time reverse transcription?polymerase chain reaction (rRT-PCR) is the preferred test for Zika virus infection because it can be performed rapidly and is highly specific (1,2). However, in most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness (2,3). Recent reports using adaptations of previously published methods (2,4) suggest that Zika virus RNA can be detected in urine for at least 2 weeks after onset of symptoms (3,5?7). Currently, the CDC Trioplex rRT-PCR assay is the only diagnostic tool authorized by the Food and Drug Administration for Zika virus testing of urine (1). Other laboratory-developed tests will need in-house validations to adequately characterize the performance of the assay and meet Clinical Laboratory Improvement Amendments requirements. Further investigation is needed to determine the sensitivity and utility of Zika virus rRT-PCR on urine specimens collected ≥14 days after onset of symptoms.
On the basis of the newly available data, CDC recommends that Zika virus rRT-PCR be performed on urine collected <14 days after onset of symptoms in patients with suspected Zika virus disease. Zika virus rRT-PCR testing of urine should be performed in conjunction with serum testing if using specimens collected <7 days after symptom onset (8). A positive result in either specimen type provides evidence of Zika virus infection. Procedures for the collection and submission of body fluids, including urine specimens, have been described previously (9). CDC recommendations for Zika virus testing of serum and other clinical specimens remain unchanged at this time (8). CDC will continue to review and update guidance for Zika virus testing as new data become available.
[h=2]References[/h]
Suggested citation for this article: Interim Guidance for Zika Virus Testing of Urine ? United States, 2016. MMWR Morb Mortal Wkly Rep. ePub: 10 May 2016. DOI:http://dx.doi.org/10.15585/mmwr.mm6518e1.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.
References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.
All HTML versions of MMWR articles are generated from final proofs through an automated process. This conversion might result in character translation or format errors in the HTML version. Users are referred to the electronic PDF version (http://www.cdc.gov/mmwr) and/or the original MMWR paper copy for printable versions of official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.
Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.
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Diagnostic testing for Zika virus infection can be accomplished using molecular and serologic methods. Real-time reverse transcription?polymerase chain reaction (rRT-PCR) is the preferred test for Zika virus infection because it can be performed rapidly and is highly specific (1,2). However, in most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness (2,3). Recent reports using adaptations of previously published methods (2,4) suggest that Zika virus RNA can be detected in urine for at least 2 weeks after onset of symptoms (3,5?7). Currently, the CDC Trioplex rRT-PCR assay is the only diagnostic tool authorized by the Food and Drug Administration for Zika virus testing of urine (1). Other laboratory-developed tests will need in-house validations to adequately characterize the performance of the assay and meet Clinical Laboratory Improvement Amendments requirements. Further investigation is needed to determine the sensitivity and utility of Zika virus rRT-PCR on urine specimens collected ≥14 days after onset of symptoms.
On the basis of the newly available data, CDC recommends that Zika virus rRT-PCR be performed on urine collected <14 days after onset of symptoms in patients with suspected Zika virus disease. Zika virus rRT-PCR testing of urine should be performed in conjunction with serum testing if using specimens collected <7 days after symptom onset (8). A positive result in either specimen type provides evidence of Zika virus infection. Procedures for the collection and submission of body fluids, including urine specimens, have been described previously (9). CDC recommendations for Zika virus testing of serum and other clinical specimens remain unchanged at this time (8). CDC will continue to review and update guidance for Zika virus testing as new data become available.
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[h=2]References[/h]
- Food and Drug Administration. Zika virus emergency use authorization. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2016.http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm
- Lanciotti RS, Kosoy OL, Laven JJ, et al. Genetic and serologic properties of Zika virus associated with an epidemic, Yap State, Micronesia, 2007. Emerg Infect Dis 2008;14:1232?9. CrossRefPubMed
- Bingham AM, Cone M, Mock V, et al. Comparison of Zika virus testing in serum, urine and saliva specimens from travel-associated Zika virus disease cases?Florida, 2016. MMWR Morb Mortal Wkly Rep 2016;65. Epub May 10, 2016.
- W?hre T, Maagard A, Tappe D, Cadar D, Schmidt-Chanasit J. Zika virus infection after travel to Tahiti, December 2013. Emerg Infect Dis 2014;20:1412?4. CrossRef PubMed
- de M Campos R, Cirne-Santos C, Meira GL, et al. Prolonged detection of Zika virus RNA in urine samples during the ongoing Zika virus epidemic in Brazil. J Clin Virol 2016;77:69?70.CrossRef
- Roz? B, Najioullah F, Ferg? JL, et al. ; GBS Zika Working Group. Zika virus detection in urine from patients with Guillain-Barr? syndrome on Martinique, January 2016. Euro Surveill 2016;21:30154. CrossRef PubMed
- Gourinat AC, O?Connor O, Calvez E, Goarant C, Dupont-Rouzeyrol M. Detection of Zika virus in urine. Emerg Infect Dis 2015;21:84?6. CrossRef PubMed
- CDC. Memorandum: revised diagnostic testing for Zika, chikungunya, and dengue viruses in US public health laboratories. Atlanta, GA: US Department of Health and Human Services, CDC; 2016. http://www.cdc.gov/zika/pdfs/denvchikvzikv-testing-algorithm.pdf
- CDC. Collection and submission of body fluids for Zika virus testing. Atlanta, GA: US Department of Health and Human Services, CDC; 2016. http://www.cdc.gov/zika/hc-providers/body-fluids-collection-submission.html
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Suggested citation for this article: Interim Guidance for Zika Virus Testing of Urine ? United States, 2016. MMWR Morb Mortal Wkly Rep. ePub: 10 May 2016. DOI:http://dx.doi.org/10.15585/mmwr.mm6518e1.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.
References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.
All HTML versions of MMWR articles are generated from final proofs through an automated process. This conversion might result in character translation or format errors in the HTML version. Users are referred to the electronic PDF version (http://www.cdc.gov/mmwr) and/or the original MMWR paper copy for printable versions of official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.
Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.
[h=5]File Formats Help:[/h] How do I view different file formats (PDF, DOC, PPT, MPEG) on this site?
http://www.cdc.gov/mmwr/volumes/65/wr/mm6518e1.htm?s_cid=mm6518e1_e
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- Page last reviewed: May 10, 2016
- Page last updated: May 10, 2016