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HelpTest ID VZIKS Zika Virus, PCR, Molecular Detection, Serum
Ordering Guidance
Due to similar clinical presentations, testing for RNA or IgM-class antibodies to dengue and chikungunya viruses, concurrently with Zika virus testing, is strongly recommended.
Specimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container: Sterile container
Specimen Volume: 0.5 mL
Collection Instructions:
1. Within 2 hours of collection, centrifuge and aliquot the serum into a sterile container.
2. Serum specimens not aliquoted from the serum gel collection tube into a sterile container will be rejected.
Useful For
Qualitative detection of Zika virus RNA in serum from individuals meeting the Centers of Disease Control and Prevention Zika virus clinical or epidemiologic criteria
Highlights
Provides qualitative detection of Zika virus RNA from serum collected during the acute phase of infection.
This test is intended for the evaluation of pregnant women and symptomatic nonpregnant individuals with potential exposure to Zika virus.
For the most up to date Zika epidemiology and testing recommendations, visit www.cdc.gov/zika/
Method Name
Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)/DNA Probe Hybridization
Reporting Name
Zika Virus PCR, SerumSpecimen Type
SerumSpecimen Minimum Volume
0.25 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 7 days | |
| Frozen | 7 days |
Reject Due To
| Gross hemolysis | Reject |
| Heat-inactivated specimen | Reject |
Clinical Information
Zika virus is an RNA virus in the genus Flavivirus and is primarily transmitted through the bite of an infected Aedes species mosquito. Other means of transmission include through transfusion of blood and blood products, sexually through genital secretions, perinatally, vertically from mother to fetus, and, potentially, through contact with other body secretions, such as tears and sweat.
Historically, most cases of Zika virus infection have occurred in parts of Africa and Southeast Asia. However, Zika virus emerged in South America in early 2015 and is now endemic in over 50 countries in South, Central, and North America, including in several US territories and focal regions of the southern United States.
The majority (approximately 80%) of individuals infected with Zika virus are asymptomatic. Fever, headache, retro-orbital pain, conjunctivitis, maculopapular rash, myalgias, and arthralgias are commonly reported among symptomatic patients. Notably, these symptoms are not distinct and can be seen with other emerging arboviruses, including dengue and chikungunya. Therefore, diagnostic testing for each of these viruses is recommended in patients returning form areas where these viruses cocirculate. Intrauterine or prenatal infection with Zika virus has been causally linked to development of microcephaly, with the greatest risk for fetal abnormality occurring if the infection is acquired during the first trimester. Finally, Zika virus has also been associated with development of Guillain-Barre syndrome.
A number of Zika virus serologic and nucleic acid amplification tests have received emergency use authorization through the US Food and Drug Administration. The recommended tests vary by the patient's symptoms, course of illness, and whether or not the patient is pregnant.
For the most up-to-date information regarding the Centers of Disease Control and Prevention testing guidelines, visit www.cdc.gov/zika/.
These guidelines are reflected in Assessment for Zika Virus Infection.
Zika virus testing is not recommended for asymptomatic couples attempting conception, given the potential for false-positive and false-negative results. Additionally, it is well established the Zika virus may remain in reproductive fluids despite negative serologic and molecular test results in blood and urine.
Reference Values
Negative
Reference values apply to all ages.
Interpretation
A positive test result indicates the presence of Zika virus RNA in the specimen.
A negative test result with a positive internal control indicates that Zika virus RNA is not detectable in the specimen.
A negative test result with a negative internal control is considered evidence of polymerase chain reaction inhibition or reagent failure. A new specimen should be collected for testing if clinically indicated.
Cautions
This assay is for in vitro diagnostic use under the US Food and Drug Administration emergency use authorization only.
Negative Zika virus reverse transcription polymerase chain reaction results do not preclude infection with Zika virus and should not be used as the sole basis for patient treatment or management decisions. All results should be interpreted by a trained professional in conjunction with review of the patient's exposure history and clinical signs and symptoms.
False-negative results may arise from degradation of Zika virus RNA during incorrect shipping or storage and specimen collection after the period that Zika virus RNA is typically found in the patient (7 days after onset of symptoms).
Clinical Reference
1. Oduyebo T, Igbinosa I, Petersen EE, et al. Update: Interim guidance for health care providers caring for women of reproductive age with possible Zika virus exposure-United States, July 2016. MMWR Morb Mortal Wkly Rep. 2016;65(29):739-744
2. United States Food and Drug Administration. Emergency Use Authorizations (Medical Devices). Updated September 7, 2022. Accessed October 1, 2024. Available at www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm
3. Waggoner JJ, Pinsky BA. Zika Virus: Diagnostics for an emerging pandemic threat. J Clin Microbiol. 2016;54(4):860-867
Method Description
The RealStar Zika Virus RT-PCR Kit by Altona Diagnostics is a TaqMan assay employing a reverse transcriptase (RT) reaction to convert RNA to complementary DNA, followed by polymerase chain reaction (PCR) amplification of specific target sequences and detection by target specific probes. Probes specific for Zika RNA are labeled with the fluorophore FAM. The kit also contains an internal control labeled with the fluorophore JOE. The internal control is added to the nucleic acid extraction procedure and undergoes RT and amplification in parallel to Zika virus-specific RNA that may be present in patient specimens. The different dye-labeled probes allow detection of Zika virus and the internal control simultaneously in corresponding detector channels of the LC 480 instrument. The test can be completed within 120 minutes following RNA extraction and is completed in a closed system.(Package insert: RealStar Zika Virus RT-PCR Kit US. Altona Diagnostics; Version 1.1, 03/2017)
Day(s) Performed
Tuesday, Thursday
Report Available
Same day/1 to 5 daysTest Classification
This test has received Emergency Use Authorization (EUA) by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
87662
NY State Approved
YesForms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.