Parkview Health Laboratory: Test Directory

Medical Necessity Documentation:

Patient Preparation:

Specimen Requirements:

3.0 mL Serum from a Red Top Tube in a Plastic Vial
and
2.0 mL Urine in a Aptima Urine Collection Kit

Collection Instructions: Order Zika test separately from other tests - on a separate test requisition

Serum:

Allow blood to clot at room temperature.
Centrifuge and separate the serum into plastic vial within 4 hours of collection.
Mark as "Irreplaceable Specimen".
Avoid freeze-thaw cycles

Urine:

Direct patient to provide urine into a urine collection cup free of any preservatives.
2.0 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.
Mark as "Irreplaceable Specimen".

Transport & Storage: Temperature/Stability: Unacceptable Ambient
7 days Refrigerated (Transport)
30 days Frozen

Rejection Criteria: Heparinized specimens • leaking, uncapped or broken containers • exceeding 7 days old • Non-validated specimen types • Serum received in spun SST

Reference Range:

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

Critical Ranges:

Test Comments:

Methodology: Real-Time Reverse Transcriptase Polymerase Chain Reaction

Clinical Significance: Testing should only be performed on individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or 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 epidemiologic criteria for which Zika virus testing may be indicated, such as possible sexual transmission). 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 may be detected in serum for approximately 4-7 days following onset of symptoms; but may be detected longer in a pregnant woman, thus the optimum time to perform serum RNA testing is during the first week after the onset of clinical illness in non-pregnant patients. During pregnancy, the duration of viremia and/or viruria may be prolonged. Evidence suggests that pregnant women may have detectable virus in serum for up to 14 days or longer, therefore PCR testing is recommended at least up to 14 days or longer in a pregnant woman. Optimal time for testing urine is within 14 days of symptoms. For patients who are 2-12 weeks post-symptom onset, serologic testing should be considered. 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.

Documentation:

CD Suggests this testing when Symptomatic : <2 weeks after symptom or Asymptomatic and NOT living in an area with active Zika virus transmission: <2 weeks after possible exposure

Custom Panel: No

Turn Around Time: 3 to 4 days

Days Performed: Monday, Tuesday, Wednesday, Thursday, Friday, Saturday

Sites Performed: Quest - Chantilly to San Juan Capistrano

PHL Test Code: MSOT

EPIC Test Code:

Send Out Test Code: 94221

Alternate Test Names: Zika Virus RNA, Qualitative, Real-Time-PCR Panel; Zika Virus RNA, Qualitative, RT-PCR Panel

Included Tests:

CPT Coding: 87798 x 2

Parkview Laboratory: Test Directory

Zika Virus Qualitative, Panel

PRODUCTION SCHEDULE