Test Catalog

Test Id : RZIKU

Zika Virus, PCR, Molecular Detection, Random, Urine

Useful For
Suggests clinical disorders or settings where the test may be helpful

Qualitative detection of Zika virus RNA in paired urine and serum from individuals meeting CDC Zika virus clinical or epidemiologic criteria

Highlights

Provides qualitative detection of Zika virus RNA from urine collected during the acute phase of infection.

 

This test is intended for the evaluation of pregnant women and symptomatic nonpregnant individuals with potential exposure to Zika virus.

 

Due to similar clinical presentations, testing for RNA or IgM-class antibodies to dengue and chikungunya viruses, concurrently with Zika virus testing, is strongly recommended.

 

For the most up-to-date Zika epidemiology and testing recommendations, visit www.cdc.gov/zika/

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

The FDA requires that urine specimens be tested in conjunction with a paired serum specimen; order RZIKS / Zika Virus, PCR, Molecular Detection, Serum for the paired serum specimen.

 

The following algorithms are available in Special Instructions:

-Assessment for Zika Virus Infection

-Mosquito-borne Disease Laboratory Testing

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Real-Time Reverse Transcription Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Zika Virus, PCR, Urine

Aliases
Lists additional common names for a test, as an aid in searching

Microencephaly

Vector-Borne Illness

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

The FDA requires that urine specimens be tested in conjunction with a paired serum specimen; order RZIKS / Zika Virus, PCR, Molecular Detection, Serum for the paired serum specimen.

 

The following algorithms are available in Special Instructions:

-Assessment for Zika Virus Infection

-Mosquito-borne Disease Laboratory Testing

Specimen Type
Describes the specimen type validated for testing

Urine

Ordering Guidance

Due to similar clinical presentations, testing for RNA or IgM-class antibodies to dengue and chikungunya viruses, concurrently with Zika virus testing, is strongly recommended.

Additional Testing Requirements

The FDA requires that urine specimens be tested in conjunction with a paired serum specimen; order RZIKS / Zika Virus, PCR, Molecular Detection, Serum for the paired serum specimen.

Necessary Information

Order questions and answers concerning pregnancy, exposure, and display of symptoms are required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: Sterile container

Specimen Volume: 1 mL

Collection Instructions:

1. Collect random urine in a sterile container.

2. Label specimen as urine.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Other Urine containing preservatives

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 7 days
Frozen 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Qualitative detection of Zika virus RNA in paired urine and serum from individuals meeting CDC Zika virus clinical or epidemiologic criteria

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

The FDA requires that urine specimens be tested in conjunction with a paired serum specimen; order RZIKS / Zika Virus, PCR, Molecular Detection, Serum for the paired serum specimen.

 

The following algorithms are available in Special Instructions:

-Assessment for Zika Virus Infection

-Mosquito-borne Disease Laboratory Testing

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Zika virus is an RNA virus in the genus Flavivirus and is primarily transmitted through the bite of an infected Aedes species mosquito. Other means of transmission include through transfusion of blood and blood products, sexually through genital secretions, perinatally, vertically from mother to fetus, and potentially through contact with other body secretions such as tears and sweat.

 

Historically, most cases of Zika virus infection have occurred in parts of Africa and South-East Asia. However, Zika virus emerged in South America in early 2015 and is now endemic in over 50 countries in South, Central, and North America, including in several US territories and focal regions of the southern United States.

 

The majority (approximately 80%) of individuals infected with Zika virus are asymptomatic. Among symptomatic patients, fever, headache, retro-orbital pain, conjunctivitis, maculopapular rash, myalgias and arthralgias are commonly reported. Notably, these symptoms are not distinct and can be seen with other emerging arboviruses, including dengue and chikungunya. Therefore, diagnostic testing for each of these viruses is recommended in patients returning for areas where these viruses cocirculate. Intrauterine or prenatal infection with Zika virus has been causally linked to development of microcephaly, with the greatest risk for fetal abnormality occurring if the infection is acquired during the first trimester. Finally, Zika virus has also been associated with development of Guillain-Barre syndrome.

 

A number of Zika virus serologic and nucleic acid amplification tests (NAAT) have received emergency use authorization (EUA) through the Food and Drug Administration (FDA). The recommended tests vary by the patient's symptoms, course of illness, and whether or not the patient is pregnant.

 

For the most up-to-date information regarding CDC testing guidelines visit www.cdc.gov/zika/.

 

These guidelines are reflected in Assessment for Zika Virus Infection in Special Instructions.

 

Zika virus testing is not recommended for asymptomatic couples attempting conception, given the potential for false-positive and false-negative results. Additionally, it is well established the Zika virus may remain in reproductive fluids, despite negative serologic and molecular test results in blood and urine.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

A positive test result indicates the presence of Zika virus RNA in the specimen. The FDA requires that urine specimens be tested in conjunction with a paired serum specimen. However, a positive result in either specimen is consistent with recent infection.

 

A negative test result with a positive internal control indicates that Zika virus RNA is not detectable in the specimen.

 

A negative test result with a negative internal control is considered evidence of PCR inhibition or reagent failure. A new specimen should be collected for testing if clinically indicated.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This assay is for in vitro diagnostic use under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) only.

 

Negative Zika virus RT-PCR results do not preclude infection with Zika virus and should not be used as the sole basis for patient treatment or management decisions. All results should be interpreted by a trained professional in conjunction with review of the patient's exposure history and clinical signs and symptoms.

 

False-negative results may arise from degradation of Zika virus RNA during incorrect shipping or storage, and specimen collection after the period that Zika virus RNA is typically found in the patient (7 days-sera or 14 days-urine after onset of symptoms.)

Supportive Data

The RealStar Zika virus RT-PCR Kit US by Altona Diagnostics received Emergency Use Authorization from the FDA on May 13, 2016. The letter can be accessed at www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM501023.pdf

 

Details regarding the performance characteristics for the RealStar Zika virus RT-PCR kit, as established by the Altona Diagnostics, can be viewed at www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM501027.pdf

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Oduyebo T, Igbinosa I, Petersen EE, et al: Update: Interim Guidance for Health Care Providers Caring for Women of Reproductive Age with Possible Zika Virus Exposure-United States. MMWR Morb Mortal Wkly Rep 2016 Jul 25;65:739-744

2. United States Food and Drug Administration. Emergency Use Authorizations (Medical Devices). Available at www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm

3. Waggoner JJ, Pinsky BA: Zika Virus: Diagnostics for an Emerging Pandemic Threat. J Clin Microbiol 2016;54(4):860-867

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

The RealStar Zika Virus RT-PCR Kit by Altona Diagnostics is a TaqMan assay employing a reverse transcriptase (RT) reaction to convert RNA to complementary DNA (cDNA), followed by PCR amplification of specific target sequences and detection by target specific probes. Probes specific for Zika RNA are labelled with the fluorophore FAM. The kit also contains an internal control that is labeled with the fluorophore JOE. The internal control is added to the nucleic acid extraction procedure and undergoes reverse transcription and amplification in parallel to Zika virus specific RNA that may be present in patient specimens. The different dye labeled probes allows detection of Zika virus and the internal control simultaneously in corresponding detector channels of the LC 480 instrument. The test can be completed within 120 minutes following RNA extraction and is completed in a closed system.(Package insert: RealStar Zika Virus RT-PCR Kit US available at www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM501027.pdf)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Tuesday, Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

5 to 8 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87662

LOINC® Information

Test Id Test Order Name Order LOINC Value
RZIKU Zika Virus, PCR, Urine 85623-7
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
47916 Zika Urine PCR Result 85623-7
PREG1 Is patient pregnant? 11449-6
EXPO1 Has patient had Zika exposure? 88636-6
SYMP1 Has patient been symptomatic? 75325-1
48058 Zika Urine Interpretation 69048-7

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports