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Test Code VZIKU Zika Virus, PCR, Molecular Detection, Random, 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 US Food and Drug Administration requires that urine specimens be tested in conjunction with a paired serum specimen; order VZIKS / Zika Virus, PCR, Molecular Detection, Serum for the paired serum specimen.



Specimen Required


Container/Tube: Sterile container

Specimen Volume: 1 mL

Collection Instructions:

1. Collect random urine in a sterile container.

2. Label specimen as urine.


Secondary ID

619431

Useful For

Qualitative detection of Zika virus RNA in paired urine and serum from individuals meeting the Centers of Disease Control and Prevention Zika virus clinical or epidemiologic criteria

Testing Algorithm

Due to US Food and Drug Administration requirements, urine specimens must be tested in conjunction with a paired serum specimen. See Additional Testing Requirements

 

The following algorithms are available:

-Assessment for Zika Virus Infection

-Mosquito-borne Disease Laboratory Testing

Method Name

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

Specimen Type

Urine

Specimen Minimum Volume

0.3 mL

Specimen Stability Information

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

Reject Due To

Other Urine containing preservatives

Reference Values

Negative

Reference values apply to all ages.

Interpretation

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 polymerase chain reaction inhibition or reagent failure. A new specimen should be collected for testing if clinically indicated.

Method Description

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, followed by polymerase chain reaction (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 labeled with the fluorophore JOE. The internal control is added to the nucleic acid extraction procedure and undergoes RT and amplification in parallel to Zika virus-specific RNA that may be present in patient specimens. The different dye-labeled probes allow 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. Altona Diagnostics; Version 1.1, 03/2017)

Day(s) Performed

Tuesday, Thursday

Report Available

Same day/1 to 5 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87662

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VZIKU Zika Virus PCR, Urine 85623-7

 

Result ID Test Result Name Result LOINC Value
619458 Zika Urine PCR Result 85623-7
619459 Zika Urine PCR Interpretation 69048-7

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.