CDC Advisory On Zika Testing Urine

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This is an official CDC HEALTH ADVISORY Distributed via the CDC Health Alert Network  May 25, 2016, 14:15 EST (2:15 PM EST)  CDCHAN-00389 Diagnostic Testing of Urine Specimens for  Suspected Zika Virus Infection

[niman]

This is an official CDC HEALTH ADVISORY Distributed via the CDC Health Alert Network  May 25, 2016, 14:15 EST (2:15 PM EST)  CDCHAN-00389 Diagnostic Testing of Urine Specimens for  Suspected Zika Virus Infection Summary  On May 13, 2016, the Centers for Disease Control and Prevention (CDC) issued interim guidance(http://www.cdc.gov/mmwr/volumes/65/wr/mm6518e1.htm) that recommends Zika virus rRT-PCR testing of urine collected less than 14 days after symptom onset, along with testing of patient-matched serum samples, for the diagnosis of suspected Zika virus infection (1). The purpose of this Health Alert Network (HAN) health update is to further disseminate information about the interim guidance to clinical and public health professionals. Background  Zika virus is a mosquito-borne flavivirus. Zika virus infection during pregnancy can cause microcephaly and other severe fetal brain defects. Zika virus infection is also associated with Guillain-Barré syndrome. Transmission of Zika can occur through mosquito bite, from a pregnant woman to her fetus, through sexual contact with an infected male, and possibly through blood transfusion. The most common symptoms of Zika virus disease are fever, rash, joint pain, or conjunctivitis. Other common symptoms include muscle pain and headache. Evidence from case reports and experience from related flavivirus infections indicate that the incubation period for Zika is likely a few to 14 days. Diagnostic testing for Zika virus infection can be accomplished using molecular and serologic methods. The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) (http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm) for several diagnostic assays to detect Zika virus infection (2). The EUAs authorize real-time reverse transcription-polymerase chain reaction (rRT-PCR) assays to detect Zika virus RNA in specified clinical sample types, and an immunoglobulin M (IgM) antibody capture enzyme-linked immunosorbent assay (ELISA) to detect anti-Zika virus IgM antibodies in serum and cerebrospinal fluid. The CDC Trioplex rRT-PCR assay is authorized by FDA for Zika virus testing of urine and serum. Anti-Zika IgM antibodies develop during the first week of illness and persist for approximately 12 weeks following infection. However, extensive cross-reactivity can occur in flavivirus serological assays, and therefore additional tests, such as the plaque reduction neutralization test (PRNT), are necessary to distinguish Zika virus infection from other flavivirus infections. CDC recommendations for Zika virus testing of serum and other clinical specimens remain unchanged at this time. Please contact your state or local health department to facilitate testing. Recommendations for Health Care Providers and Public Health Practitioners Collect urine samples within 14 days post symptom onset along with patient-matched serum samples for those who match CDC Zika virus clinical and/or epidemiological testing criteria for Zika virus infection. Perform Zika virus rRT-PCR testing on urine, in conjunction with testing of serum using the appropriate molecular or serologic assay, based on days post symptom onset. Additional Considerations 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: limited data in pregnant women suggest that viremia in serum might be prolonged in pregnancy (4, 5). References CDC. Interim guidance for Zika virus testing of Urine – United States, 2016.MMWR Morb Mortal Wkly Rep 2016; 65. DOI: http://dx.doi.org/10.15585/mmwr.mm6518e1. Food and Drug Administration. Emergency Use Authorizations.http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm Comparison of Test Results for Zika Virus RNA in Urine, Serum, and Saliva Specimens from Persons with Travel-Associated Zika Virus Disease — Florida, 2016http://www.cdc.gov/mmwr/volumes/65/wr/mm6518e2.htm Driggers RW, Ho CY, Korhonen EM, et al. Zika virus infection with prolonged maternal viremia and fetal brain abnormalities. N Engl J Med. March 30, 2016. DOI: 10.1056/NEJMoa1601824 Bocanegra C. Zika virus infection in pregnant women in Barcelona, Spain. Clin Microbiol Infect. April 3, 2016. DOI: 10.1016/j.cmi.2016.03.025.  For More Information General information about Zika virus and disease: http://www.cdc.gov/zika/ Zika virus information for clinicians: http://www.cdc.gov/zika/hc-providers/index.html Memorandum – Revised diagnostic testing for Zika, chikungunya, and dengue viruses in US Public Health Laboratories (not updated with urine guidance): http://www.cdc.gov/zika/state-labs/index.html Diagnostic testing: http://www.cdc.gov/zika/hc-providers/diagnostic.html Collection and submission of body fluids for Zika virus testing:  http://www.cdc.gov/zika/hc-providers/body-fluids-collection-submission.html DEPARTMENT OF HEALTH AND HUMAN SERVICES The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations. Categories of Health Alert Network messages: Health Alert         Requires immediate action or attention; highest level of importance Health Advisory   May not require immediate action; provides important information for a specific incident or situation Health Update     Unlikely to require immediate action; provides updated information regarding an incident or situation HAN Info Service Does not require immediate action; provides general public health information

[niman]

This is an official CDC HEALTH ADVISORY Distributed via the CDC Health Alert Network  May 25, 2016, 14:15 EST (2:15 PM EST)  CDCHAN-00389 Diagnostic Testing of Urine Specimens for  Suspected Zika Virus Infection

Please note: HAN category has been corrected to Health Update. This is an official CDC HEALTH UPDATE Distributed via the CDC Health Alert Network  May 25, 2016, 14:15 EST (2:15 PM EST)  CDCHAN-00389 Diagnostic Testing of Urine Specimens for  Suspected Zika Virus Infection Summary  On May 13, 2016, the Centers for Disease Control and Prevention (CDC) issued interim guidance(http://www.cdc.gov/mmwr/volumes/65/wr/mm6518e1.htm) that recommends Zika virus rRT-PCR testing of urine collected less than 14 days after symptom onset, along with testing of patient-matched serum samples, for the diagnosis of suspected Zika virus infection (1). The purpose of this Health Alert Network (HAN) health update is to further disseminate information about the interim guidance to clinical and public health professionals. Background  Zika virus is a mosquito-borne flavivirus. Zika virus infection during pregnancy can cause microcephaly and other severe fetal brain defects. Zika virus infection is also associated with Guillain-Barré syndrome. Transmission of Zika can occur through mosquito bite, from a pregnant woman to her fetus, through sexual contact with an infected male, and possibly through blood transfusion. The most common symptoms of Zika virus disease are fever, rash, joint pain, or conjunctivitis. Other common symptoms include muscle pain and headache. Evidence from case reports and experience from related flavivirus infections indicate that the incubation period for Zika is likely a few to 14 days. Diagnostic testing for Zika virus infection can be accomplished using molecular and serologic methods. The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) (http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm) for several diagnostic assays to detect Zika virus infection (2). The EUAs authorize real-time reverse transcription-polymerase chain reaction (rRT-PCR) assays to detect Zika virus RNA in specified clinical sample types, and an immunoglobulin M (IgM) antibody capture enzyme-linked immunosorbent assay (ELISA) to detect anti-Zika virus IgM antibodies in serum and cerebrospinal fluid. The CDC Trioplex rRT-PCR assay is authorized by FDA for Zika virus testing of urine and serum. Anti-Zika IgM antibodies develop during the first week of illness and persist for approximately 12 weeks following infection. However, extensive cross-reactivity can occur in flavivirus serological assays, and therefore additional tests, such as the plaque reduction neutralization test (PRNT), are necessary to distinguish Zika virus infection from other flavivirus infections. CDC recommendations for Zika virus testing of serum and other clinical specimens remain unchanged at this time. Please contact your state or local health department to facilitate testing. Recommendations for Health Care Providers and Public Health Practitioners Collect urine samples within 14 days post symptom onset along with patient-matched serum samples for those who match CDC Zika virus clinical and/or epidemiological testing criteria for Zika virus infection. Perform Zika virus rRT-PCR testing on urine, in conjunction with testing of serum using the appropriate molecular or serologic assay, based on days post symptom onset. Additional Considerations 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: limited data in pregnant women suggest that viremia in serum might be prolonged in pregnancy (4, 5). References CDC. Interim guidance for Zika virus testing of Urine – United States, 2016.MMWR Morb Mortal Wkly Rep 2016; 65. DOI: http://dx.doi.org/10.15585/mmwr.mm6518e1. Food and Drug Administration. Emergency Use Authorizations.http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm Comparison of Test Results for Zika Virus RNA in Urine, Serum, and Saliva Specimens from Persons with Travel-Associated Zika Virus Disease — Florida, 2016http://www.cdc.gov/mmwr/volumes/65/wr/mm6518e2.htm Driggers RW, Ho CY, Korhonen EM, et al. Zika virus infection with prolonged maternal viremia and fetal brain abnormalities. N Engl J Med. March 30, 2016. DOI: 10.1056/NEJMoa1601824 Bocanegra C. Zika virus infection in pregnant women in Barcelona, Spain. Clin Microbiol Infect. April 3, 2016. DOI: 10.1016/j.cmi.2016.03.025.  For More Information General information about Zika virus and disease: http://www.cdc.gov/zika/ Zika virus information for clinicians: http://www.cdc.gov/zika/hc-providers/index.html Memorandum – Revised diagnostic testing for Zika, chikungunya, and dengue viruses in US Public Health Laboratories (not updated with urine guidance): http://www.cdc.gov/zika/state-labs/index.html Diagnostic testing: http://www.cdc.gov/zika/hc-providers/diagnostic.html Collection and submission of body fluids for Zika virus testing:  http://www.cdc.gov/zika/hc-providers/body-fluids-collection-submission.html DEPARTMENT OF HEALTH AND HUMAN SERVICES The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations. Categories of Health Alert Network messages: Health Alert         Requires immediate action or attention; highest level of importance Health Advisory   May not require immediate action; provides important information for a specific incident or situation Health Update     Unlikely to require immediate action; provides updated information regarding an incident or situation HAN Info Service Does not require immediate action; provides general public health information