Qualitative detection of Zika virus RNA in paired urine and serum from individuals meeting CDC Zika virus clinical or epidemiologic criteria
Provides qualitative detection of Zika virus RNA from urine 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.
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.
For the most up-to-date Zika epidemiology and testing recommendations, visit www.cdc.gov/zika/
The FDA requires that urine specimens be tested in conjunction with a paired serum specimen; order RZIKS / Zika Virus, PCR, Molecular Detection, Serum for the paired serum specimen.
The following algorithms are available in Special Instructions:
Real-Time Reverse Transcription Polymerase Chain Reaction (PCR)/DNA Probe Hybridization
Microencephaly
Vector-Borne Illness
The FDA requires that urine specimens be tested in conjunction with a paired serum specimen; order RZIKS / Zika Virus, PCR, Molecular Detection, Serum for the paired serum specimen.
The following algorithms are available in Special Instructions:
Urine
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.
The FDA requires that urine specimens be tested in conjunction with a paired serum specimen; order RZIKS / Zika Virus, PCR, Molecular Detection, Serum for the paired serum specimen.
Order questions and answers concerning pregnancy, exposure, and display of symptoms are required.
Question ID | Description | Answers |
---|---|---|
PREG1 | Is patient pregnant? |
Yes No |
EXPO1 | Has patient had Zika exposure? | |
SYMP1 | Has patient been symptomatic? |
Container/Tube: Sterile container
Specimen Volume: 1 mL
Collection Instructions:
1. Collect random urine in a sterile container.
2. Label specimen as urine.
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
0.3 mL
Other | Urine containing preservatives |
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Urine | Refrigerated (preferred) | 7 days | |
Frozen | 7 days |
Qualitative detection of Zika virus RNA in paired urine and serum from individuals meeting CDC Zika virus clinical or epidemiologic criteria
The FDA requires that urine specimens be tested in conjunction with a paired serum specimen; order RZIKS / Zika Virus, PCR, Molecular Detection, Serum for the paired serum specimen.
The following algorithms are available in Special Instructions:
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 South-East 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. Among symptomatic patients, fever, headache, retro-orbital pain, conjunctivitis, maculopapular rash, myalgias and arthralgias are commonly reported. 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 for 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 (NAAT) have received emergency use authorization (EUA) through the Food and Drug Administration (FDA). 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 CDC 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.
Negative
A positive test result indicates the presence of Zika virus RNA in the specimen. The FDA requires that urine specimens be tested in conjunction with a paired serum specimen. However, a positive result in either specimen is consistent with recent infection.
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 PCR inhibition or reagent failure. A new specimen should be collected for testing if clinically indicated.
This assay is for in vitro diagnostic use under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) only.
Negative Zika virus RT-PCR 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-sera or 14 days-urine after onset of symptoms.)
The RealStar Zika virus RT-PCR Kit US by Altona Diagnostics received Emergency Use Authorization from the FDA on May 13, 2016. The letter can be accessed at www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM501023.pdf
Details regarding the performance characteristics for the RealStar Zika virus RT-PCR kit, as established by the Altona Diagnostics, can be viewed at www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM501027.pdf
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. MMWR Morb Mortal Wkly Rep 2016 Jul 25;65:739-744
2. United States Food and Drug Administration. Emergency Use Authorizations (Medical Devices). 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
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 (cDNA), followed by PCR amplification of specific target sequences and detection by target specific probes. Probes specific for Zika RNA are labelled with the fluorophore FAM. The kit also contains an internal control that is labeled with the fluorophore JOE. The internal control is added to the nucleic acid extraction procedure and undergoes reverse transcription and amplification in parallel to Zika virus specific RNA that may be present in patient specimens. The different dye labeled probes allows 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 available at www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM501027.pdf)
Tuesday, Thursday
This test has been cleared, approved, or is exempt 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.
87662
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
RZIKU | Zika Virus, PCR, Urine | 85623-7 |
Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
---|---|---|
47916 | Zika Urine PCR Result | 85623-7 |
48058 | Zika Urine Interpretation | 69048-7 |
PREG1 | Is patient pregnant? | 11449-6 |
EXPO1 | Has patient had Zika exposure? | 88636-6 |
SYMP1 | Has patient been symptomatic? | 75325-1 |