Zika Virus RNA, Qualitative, Real-Time RT-PCR Blood Test

Use:
This test is used to diagnose a Zika virus infection.

Test results are for the identification of Zika viral RNA. Zika viral RNA is generally detectable in blood during the acute phase of the infection. Following the onset of symptoms RNA may be detected in serum for approximately 7 days, or longer in a pregnant patient. A positive result provides evidence of Zika virus infection. Laboratories are required to report all positive results to the appropriate public health authorities.

Negative results do not rule out Zika virus infection and should not be used as the sole basis for patient management decisions. Serological testing should also be considered. Laboratory test results should always be considered in the context of clinical observations, patient history, and epidemiological information in making a final diagnosis and patient management decisions.

The Zika Virus RNA Qualitative Real-Time RT-PCR test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of RNA from Zika virus and not for any other viruses or pathogens; and
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(l) of the Act, 21 U.S.C. 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.

Recommended For:
Those experiencing symptoms such as a fever, rash, joint pain and pinkeye, all of which are associated with the Zika virus; Those who had sexual contact with someone who recently traveled from an area where Zika is present; Those who recently traveled to countries and territories with active Zika Virus Transmission as listed below; Women who are pregnant and have traveled to any of the countries and territories listed below.

Special Notes:
No special preparation is necessary prior to blood sample collection.

NOT AVAILABLE FOR CALIFORNIA OR NEVADA RESIDENTS. NO TESTING WILL BE PERFORMED IN OUR WEST HILLS, CA FACILITY.

Tests Included:
Zika Virus RNA Qualitative Real-Time RT-PCR – TC – 93870

Estimated Turn Around For Results:
2-10 Business Days
For an exact turnaround time for results, please contact us at Personalabs and we will contact the lab on your behalf as turnaround times vary depending on testing location or lab testing provider.

Countries and Territories with Active Zika Virus Transmission:

Americas:

• Anguilla
• Antigua and Barbuda
• Argentina
• Aruba
• The Bahamas
• Barbados
• Belize
• Bolivia
• Bonaire
• Brazil
• British Virgin Islands
• Cayman Islands
• Colombia
• Commonwealth of Puerto Rico, US territory
• Costa Rica
• Cuba
• Curacao
• Dominica
• Dominican Republic
• Ecuador
• El Salvador
• French Guiana
• Grenada
• Guadeloupe
• Guatemala
• Guyana
• Haiti
• Honduras
• Jamaica
• Martinique
• Mexico
• Nicaragua
• Palau
• Panama
• Paraguay
• Peru
• Saba
• Saint Lucia
• Saint Barthelemy
• Saint Martin
• Saint Vincent and the Grenadines
• Sint Eustatius
• Sint Maarten
• St. Kitts and Nevis
• Suriname
• Trinidad and Tobago
• Turks and Caicos
• United States – South Florida
• U.S. Virgin Islands
• Venezuela

Asia, Oceania and Pacific Islands:

• American Samoa
• Fiji
• Kosrae, Federated States of Micronesia
• Marshall islands
• New Caledonia
• Palau
• Papua New Guinea
• Samoa
• Singapore
• Tonga

Africa:

• Cape Verde