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Zika Virus RNA, Qualitative TMA, Serum/Urine and IgM Panel
Test Code36758
CPT Codes
87662 (x2), 86794
Includes
Zika Virus RNA, Qualitative TMA Panel, Serum/Urine
Zika Virus Antibody (IgM)
Zika Virus Antibody (IgM)
Preferred Specimen
2 mL serum collected in each of two serum separator tubes or red-top tubes (no gel) and
2 mL urine collected in an Aptima® urine collection kit
2 mL urine collected in an Aptima® urine collection kit
Minimum Volume
1.5 mL serum (x2) • 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 2 aliquot tubes (each containing 1.5 mL minimum) to prevent hemolysis.
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.
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 2 aliquot tubes (each containing 1.5 mL minimum) to prevent hemolysis.
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.
Transport Container
Serum: Transport tube(s)
Urine: Aptima urine collection kit
Urine: Aptima urine collection kit
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Serum
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 30 days
Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 30 days
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 30 days
Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Samples received in original collection container • Grossly icteric
Methodology
Immunoassay (IA) • Transcription Mediated Amplification (TMA)
FDA Status
This test is only for use under the Food and Drug Administration's Emergency Use Authorization.
Setup Schedule
Set up: Mon-Sat; Report available: 4-5 days
Clinical Significance
This panel is intended for the qualitative detection of Zika virus in serum and urine and the presumptive qualitative detection of Zika virus IgM antibodies in serum 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 Zika infections are asymptomatic. Individuals with symptomatic infections may experience fever, rash, and muscle/joint pain [2].
Per the 2019 CDC guidelines, a nucleic acid amplification test (NAAT) and an IgM antibody test should be performed on maternal serum and a NAAT on maternal urine for pregnant women who live in or have traveled (during the pregnancy) to geographic areas at risk for Zika and who have a fetus with prenatal ultrasound findings consistent with congenital Zika virus infection. For current testing guidelines, see https://www.cdc.gov/zika/hc-providers/testing-guidance.html
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. Serologic results may be difficult to interpret due to cross-reactivity between Zika IgM and Dengue IgM antibodies. If Zika virus NAAT results are negative, a presumptive positive Zika IgM result requires additional confirmatory testing. Zika IgM antibodies can persist for months or years following infection. Therefore, the presence of Zika IgM antibodies may not indicate a recent infection.
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.
Most individuals with Zika infections are asymptomatic. Individuals with symptomatic infections may experience fever, rash, and muscle/joint pain [2].
Per the 2019 CDC guidelines, a nucleic acid amplification test (NAAT) and an IgM antibody test should be performed on maternal serum and a NAAT on maternal urine for pregnant women who live in or have traveled (during the pregnancy) to geographic areas at risk for Zika and who have a fetus with prenatal ultrasound findings consistent with congenital Zika virus infection. For current testing guidelines, see https://www.cdc.gov/zika/hc-providers/testing-guidance.html
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. Serologic results may be difficult to interpret due to cross-reactivity between Zika IgM and Dengue IgM antibodies. If Zika virus NAAT results are negative, a presumptive positive Zika IgM result requires additional confirmatory testing. Zika IgM antibodies can persist for months or years following infection. Therefore, the presence of Zika IgM antibodies may not indicate a recent infection.
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.
