Zika Virus RNA, Qualitative, Real-Time RT-PCR

Message
This test should be drawn at CompuNet’s Patient Service Centers due to specimen integrity issues. Keep refrigerated at all times until received at the lab and placed in -70◦ freezer. Note: Call Transportation (937-297-8262 option 1)for Integrity STAT pick-up ONLY IF SPECIMEN WOULD HAVE TO BE PLACED IN THE LOCKBOX.

Test Code
93870

CPT Codes
87662

Preferred Specimen
3 mL serum

Minimum Volume
1 mL

Other Acceptable Specimens
Serum separator tube (SST), received spun

Instructions
Collect blood in a standard red-top or serum separator vacutainer tube. Allow blood to clot at room temperature. Centrifuge and separate the serum from the cells or gel within 2 hours and transfer to plastic tube. Immediately refrigerate and keep refrigerated for up to 72 hours before shipping on dry ice. Avoid freeze-thaw cycles. Patient Service Centers (PSCs) and Hospital Clients are preferred collection sites since they are best equipped to maintain specimen stability and integrity. Specimens must not be left in lock boxes. Note: Transport refrigerated (cold packs) to your local Quest Diagnostics accessioning laboratory. Transport frozen (dry ice) to performing laboratory (Focus Diagnostics, Inc.).

Transport Temperature
Refrigerated (cold packs)

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

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Heparinized specimens • 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
Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

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

Setup Schedule
Set up: Mon-Sat a.m.; Report available: 2 days

Reference Range
Not detected

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 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 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.

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

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. Testing recommendations for pregnant women are as follows:
• Symptomatic pregnant women with possible Zika virus exposure: Concurrent Zika 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 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 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 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 infection shares epidemiologic and clinical features with chikungunya, dengue, and other infections. Molecular and/or serologic testing for Zika 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 is a real-time RT-PCR test intended for the qualitative detection of RNA from Zika virus in human serum 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. Zika viral RNA is generally detectable in serum during the acute phase of infection and up to 7 days following onset of symptoms, if present, or longer in a pregnant woman. A positive result provides evidence of Zika virus infection. Within the United States and its territories, positive Zika test results are reported, as required, to the appropriate public health authorities.

Negative results do not rule out Zika virus infection and should not be used as the sole basis for patient management decisions.

Co-collection of serum and urine for Zika Virus RNA, Qualitative, Real-Time RT-PCR and serological testing should also be considered for certain patients, based on the CDC guidelines https://www.cdc.gov/zika/hc-providers/testing-guidance.html. 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 test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of RNA from Zika virus and not for any other viruses or pathogens; and
• This test is 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.


Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153



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.