Zika Virus RNA, Qualitative Real-Time RT-PCR, Serum/Urine and IgM Panel

Test Code
36758

CPT Codes
87662 (x2), 86794

Preferred Specimen
6 mL serum and 3 mL urine collected in a sterile container without additives

Minimum Volume
2 mL serum • 1 mL urine

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

Collect blood in a serum separator Vacutainer® tube (preferred) or a standard red-top. Allow blood to clot at room temperature. Blood collection tube should be centrifuged as soon as possible and serum transferred into two plastic tubes (each containing 1 mL minimum) in order to avoid hemolysis.

Urine should be collected in a sterile container without additives. Urine should always be collected with a patient-matched serum specimen. Immediately refrigerate.

Transport refrigerated (cold packs) to local Quest Diagnostics accessioning laboratory.
IMPORTANT: If sample is being shipped directly to the performing laboratory facility by an overnight air courier, then transport it frozen on dry ice. Specimens must not be left in lock boxes.


Transport Temperature
Refrigerated (cold packs)

Specimen Stability
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 30 day

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Plasma • Serum received in a frozen Serum Separator Tube (SST®) • Serum received in an unspun Serum Separator Tube (SST®) • Serum received in a standard red-top tube (not transferred to plastic transfer tube)

Methodology
Immunoassay (IA) • Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

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

Setup Schedule
Sets up 6 days a week.

Report Available
Reports in 4 to 5 days.

Clinical Significance
Testing should only be performed on individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection); CDC Zika virus epidemiological criteria (e.g. history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated); and/or the CDC guidelines. Most people with Zika virus infection are asymptomatic. Symptomatic individuals typically experience a mild illness characterized by fever, joint pain, rash, or conjunctivitis. Clinical illness is usually self-limited and lasts a week or less. Not all symptomatic patients report all of these clinical findings, and Zika virus manifestations overlap significantly with those seen in other viral infections. The incubation period is unclear, but likely to be several days. Symptoms generally resolve on their own within a week.

Zika virus RNA is generally detectable in serum and/or urine during the acute phase of infection and up to 14 days following onset of symptoms, if present. Zika virus RNA may be detected longer in a pregnant woman. Thus, the optimum time to perform serum and urine RNA testing is during the first two weeks (<14 days) after the onset of clinical illness in non-pregnant symptomatic patients. During pregnancy, the duration of viremia and/or viruria may be prolonged. Evidence suggests that pregnant women may have detectable virus in serum and urine for up to 14 days or longer.

Zika virus IgM levels over the course of illness are not well characterized. IgM levels are variable, but can usually be detected within the first 2 weeks of symptoms and continuing in some patients for 12 or more weeks. Zika Virus Antibody (IgM) should be tested as a part of a multi-test algorithm recommended by the CDC. https://www.cdc.gov/zika/hc-providers/index.html.
Assay results are for the presumptive identification of IgM antibodies to Zika virus.

Pregnant women at risk for Zika virus in the U.S. and in endemic areas are of special concern due to the increased incidence of babies with microcephaly or other congenital defects if mothers are infected during pregnancy. Please refer to the CDC guidelines for the appropriate testing in pregnant women http://www.cdc.gov/zika/hc-providers/pregnant-woman.html

Testing recommendations for pregnant women are as follows:
• Symptomatic pregnant women with possible Zika virus exposure: Concurrent Zika virus PCR (Serum/Urine) and IgM testing are recommended as soon as possible, up to 12 weeks after symptom onset.
• Asymptomatic pregnant women, ongoing Zika virus exposure: Zika virus PCR (Serum/Urine) testing is recommended three times during pregnancy if Zika virus exposure is ongoing.
• Asymptomatic pregnant women, recent possible Zika virus exposure, but not ongoing: Testing is not routinely recommended, but should be considered on a case by case basis. If testing is performed, CDC recommends Zika virus PCR (serum/urine) and IgM testing.
• Pregnant women with possible exposure to Zika virus and who have a fetus with prenatal ultrasound findings consistent with congenital Zika virus infection: Zika virus PCR (Serum/Urine) and IgM testing is recommended.
Test results should be used in conjunction with clinical signs and symptoms, epidemiological information and relevant travel history to diagnose Zika virus infection.
Zika virus infection shares epidemiologic and clinical features with chikungunya, dengue, and other infections. Molecular and/or serologic testing for Zika virus infection may be useful to diagnose the etiology of a given (usually travel-related) illness and guide further testing and management as needed.

About the Test
The Zika Virus RNA, Qualitative, Real-Time RT-PCR, Serum/Urine and IgM Panel includes a real-time RT-PCR test intended for the qualitative detection of RNA from Zika virus in human serum and paired urine specimens and an IgM assay intended for the qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria: https://www.cdc.gov/zika/hc-providers/index.html

Test results are for the identification of Zika viral RNA and for the presumptive detection of IgM antibodies to Zika virus (ZIKV). Zika viral RNA is generally detectable in serum and urine during the acute phase of infection and up to 14 days following onset of symptoms, if present. A positive result for the PCR test in either specimen type provides evidence of Zika virus infection. Negative PCR test results do not rule out Zika virus infection and should not be used as the sole basis for patient management decisions. For urine, it is especially important to note that this is not the primary diagnostic specimen type. Negative results in urine do not necessarily mean that an individual is not infected. When negative results are obtained for this specimen type, attention should be directed to the result for the patient-matched serum specimen.

For the Zika Virus Antibody (IgM) test, reactive results are not definitive for diagnosis of Zika virus infection. False positive results are possible in patients with a history of infection with other Flaviviruses. Confirmation of the presence of anti-Zika virus IgM antibodies requires additional testing according to the latest CDC testing algorithms for the diagnosis of Zika virus infection. Results of the Zika Virus Antibody (IgM) test cannot be used as the sole basis of patient management decisions and must be combined with clinical observations, patient history, epidemiological information, and other laboratory evidences. Zika virus IgM levels over the course of illness are not well characterized. Negative IgM results do not preclude the possibility of Zika virus infection, past or present. Negative results may be seen in specimens collected before detectable levels of IgM antibody develop or after the window of detectable IgM is present.

Within the United States and its territories, positive Zika virus test results are reported, as required, to the appropriate public health authorities.

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, Serum/Urine and IgM Panel is only for use under the Food and Drug Administration’s Emergency Use Authorization.
• The tests included in this panel have not been FDA cleared or approved;
• The tests included in this panel have been authorized by FDA under an EUA for use by authorized laboratories;
• The tests included in this panel have been authorized only for the detection of RNA from Zika virus or for the diagnosis of Zika virus infection and not for any other viruses or pathogens; and
• The tests included in this panel are 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.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.