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Test Order
Test Order
Rubella Detection
CDC-10242
Synonym(s)
German measles, three day measles
CDC Pre-Approval Needed
None
Supplemental Information Required
Provide the following information on the CDC 50.34 Specimen Submission Form: date of onset, date of specimen collection, date(s) of MMR vaccination, and any recent travel history. Provide information on pregnancy status if applicable. Provide any preliminary results available.
Supplemental Form
None
Performed on Specimens from
Human
Acceptable Sample/ Specimen Type for Testing
Nasopharyngeal swabs are preferred specimen types. Other acceptable specimen types include: throat swabs and urine.
Minimum Volume Required
Urine: 1 mL, not to exceed 50 mL.
Throat and nasopharyngeal swabs: 1-3 mL of viral transport medium.
Throat and nasopharyngeal swabs: 1-3 mL of viral transport medium.
Collection, Storage, and Preservation of Specimen Prior to Shipping
Throat and nasopharyngeal swabs: detection is most successful when samples are collected the first day of rash through 3 days following rash onset. Detection may be successful as late as 7 days post rash onset. Samples collected from suspected congenital rubella syndrome (CRS) cases, the collection window is from birth to 3 months of age for nasopharyngeal swab, throat swab, and urine specimens.
Nasopharyngeal swabs and throat swabs should be collected with commercial swab products designed for the collection of throat/nasopharyngeal specimens or flocked polyester fiber swabs. Cotton swabs are not acceptable. Swabs should be placed in 2 mL of standard viral transport medium (VTM) and should not be allowed to dry out. Ream the swab around the rim of the tube to retain cells and fluid in the tube. The swab should be broken off and left in the tube. Immediately after collection, throat and nasopharyngeal swab specimens can be refrigerated at 2-8°C for up to 72 hours. After 72 hours, these specimens should be frozen at -20°C or lower. Prior to being shipped to CDC, throat and nasopharyngeal swab specimens should be frozen at -20°C or lower and shipped overnight to CDC on dry ice. Throat and nasopharyngeal swab specimens should arrive at CDC within 30 days of being frozen -20°C or lower.
Urine: Up to 50 ml of urine should be collected in a sterile, leakproof container. Urine specimens should be stored refrigerated (2-8°C) immediately after collection and shipped to CDC overnight on cold packs. Urine specimens must arrive at CDC within 7 days after specimen collection. Urine cannot be frozen.
Nasopharyngeal swabs and throat swabs should be collected with commercial swab products designed for the collection of throat/nasopharyngeal specimens or flocked polyester fiber swabs. Cotton swabs are not acceptable. Swabs should be placed in 2 mL of standard viral transport medium (VTM) and should not be allowed to dry out. Ream the swab around the rim of the tube to retain cells and fluid in the tube. The swab should be broken off and left in the tube. Immediately after collection, throat and nasopharyngeal swab specimens can be refrigerated at 2-8°C for up to 72 hours. After 72 hours, these specimens should be frozen at -20°C or lower. Prior to being shipped to CDC, throat and nasopharyngeal swab specimens should be frozen at -20°C or lower and shipped overnight to CDC on dry ice. Throat and nasopharyngeal swab specimens should arrive at CDC within 30 days of being frozen -20°C or lower.
Urine: Up to 50 ml of urine should be collected in a sterile, leakproof container. Urine specimens should be stored refrigerated (2-8°C) immediately after collection and shipped to CDC overnight on cold packs. Urine specimens must arrive at CDC within 7 days after specimen collection. Urine cannot be frozen.
Transport Medium
Viral transport medium (VTM) for nasopharyngeal or throat swabs. Swabs should be immersed in 1-3 mL of viral transport medium. Transport medium is not required for urine.
Specimen Labeling
Test is subject to CLIA regulations and requires two patient identifiers (e.g., patient first and last name, date of birth, unique patient identifier from time of collection, such as a medical record number) on the specimen container and on the test requisition.
Shipping Instructions which Include Specimen Handling Requirements
CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday – Friday. Frozen throat and nasopharyngeal swabs specimens should be shipped on dry ice overnight. Refrigerated urine specimens should be shipped with refrigerated or frozen cold packs overnight.
Ship To:
[Insert CDC Point of Contact]
Centers for Disease Control and Prevention
RDSB/STATT Unit 81
1600 Clifton Road, NE
Atlanta, GA 30329
[Insert CDC Point of Contact’s Telephone Number]
All samples must be shipped in accordance with all applicable local, state and federal regulations.
Ship To:
[Insert CDC Point of Contact]
Centers for Disease Control and Prevention
RDSB/STATT Unit 81
1600 Clifton Road, NE
Atlanta, GA 30329
[Insert CDC Point of Contact’s Telephone Number]
All samples must be shipped in accordance with all applicable local, state and federal regulations.
Methodology
Laboratory developed real-time reverse-transcription polymerase chain reaction (RT-PCR) assay
Turnaround Time
10 Days
Interferences & Limitations
A negative result should not be used to rule out rubella infection as many variables can affect specimen quality. The real-time assay has not been cleared or approved by the FDA. The performance characteristics have been established by Viral Vaccine Preventable Diseases Branch (VVPDB)
Additional Information
For additional information on rubella RNA detection, see https://www.cdc.gov/rubella/lab/lab-testing-procedures.html and refer to the RNA Detection section.
CDC Points of Contact
Version
3.4
Content Credential