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Test Directory Zika Virus RNA, Qualitative TMA Panel, Serum/Urine

Zika Virus RNA, Qualitative TMA Panel, Serum/Urine

Test Summary

This test is intended for the qualitative detection of Zika virus in serum and urine from individuals who meet the Centers for Disease Control and Prevention (CDC) clinical and epidemiological criteria for Zika virus testing. Zika viruses are primarily transmitted by Aedes aegypti and Aedes albopictus mosquitos [1].

Most individuals with a Zika virus infection are asymptomatic. Individuals with symptomatic infections may experience fever, rash, and muscle/joint pain [2].

Per the 2019 CDC guidelines, testing is recommended only for symptomatic pregnant women with a history of living in or traveling to a geographic area at risk for Zika. For current testing guidelines, see https://www.cdc.gov/zika/hc-providers/testing-guidance.html

For individuals meeting the CDC criteria, concurrent testing of serum and urine is recommended as soon as possible after symptom onset. Zika infection shares clinical and epidemiological features with other arbovirus infections such as Dengue and Chikungunya. For CDC guidelines on testing concurrently for Zika and Dengue, see https://www.cdc.gov/dengue/healthcare-providers/testing/testing-guidance.html

1. Subcommittee on Laboratory Practices, ASM, and Public Relations Committee, Pan American Society for Clinical Virology (PASCV). Zika Virus: An Update on the Disease and Guidance for Laboratory Testing. September 2022. Accessed May 9, 2023. https://asm.org/Guideline/Zika-virus-An-update-on-the-disease-and-guidance-f
2. Sharp TM, et al. MMWR Recomm Rep. 2019 Jun 14;68(1):1-10.

Aliases

Specimen Collection

Special Instructions

N/A

Preferred Specimen

3 mL serum and 2 mL urine collected in an Aptima® urine collection kit

Minimum Volume

1.5 mL serum • 2 mL urine

Instructions

⁠⁠⁠⁠⁠⁠⁠Note: Both serum and urine, with the same collection date, are required for each patient.

Collect blood in a serum separator tube or a standard red-top, allow blood to clot at room temperature. The specimen should be centrifuged as soon as possible, and serum transferred to a new aliquot tube.

Urine should always be collected with a patient-matched serum specimen.

Urine: Direct patient to provide urine into a urine collection cup free of any preservatives. 2 mL of urine must be transferred into the Aptima specimen transport tube within 72 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.

Transport refrigerated (cold packs) to local quest accessioning laboratory.
Transport frozen (dry ice): If shipping directly to the performing laboratory by an overnight air courier. Specimens must not be left in lock bins.

Patient Preparation

N/A

Storage

⁠⁠⁠⁠⁠⁠⁠Serum: Transport tube
Urine: Aptima urine collection kit

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Serum
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 30 days
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Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 30 days

Limitations

N/A

Other Acceptable Specimens

N/A

Unacceptable Specimens

Samples received in original collection container

Order Code

ZKAPCR

EPIC (Premier) Code

LAB5851

Includes

N/A

CPT Code

87662 (x2)

Billing Code

700000

CPT Statement

Methodology

Transcription Mediated Amplification (TMA)

FDA Status

The test is only for use under the Food and Drug Administration's Emergency Use Authorization.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Reference Range

Zika RNA, Serum	Not detected
Zika RNA, Urine	Not detected

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 2 - 3 days