Test Order
Test Order
Rubella Serology CDC-10246
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
Serum separated from whole blood by centrifugation.
The following conditions may result in the specimen being rejected for testing:
• Specimen is hemolyzed, lipemic, or bacterially contaminated.
• Specimen is not frozen upon receipt at CDC.
The following conditions may result in the specimen being rejected for testing:
• Specimen is hemolyzed, lipemic, or bacterially contaminated.
• Specimen is not frozen upon receipt at CDC.
Minimum Volume Required
0.1 mL; 0.5-1 mL preferred
Collection, Storage, and Preservation of Specimen Prior to Shipping
Optimum time-point for collection is 5 days after onset of symptoms (fever and rash). For suspected congenital rubella syndrome (CRS), collect sample as soon after birth as possible. If paired sera are to be collected, the second sample should be collected 14 to 21 days after the acute specimen was collected.
Collect blood into a serum separation tube (serum-separation tube (STT), red-top, or tiger top. Do not add anticoagulants or preservatives. Do not freeze whole blood prior to separating serum. Aseptically transfer serum to a sterile tube after centrifugation and prior to shipping, preferably into a tube that has an externally threaded cap with an o–ring seal. Serum samples should not be stored at room temperature (15-25°C) for longer than 8 hours after collection. Refrigerate serum (2-8°C) within 8 hours of collection and store for up to 48 hours. If the samples will be stored for more than 48 hours, freeze specimens (-20°C or lower). Serum specimens can be stored frozen (-20°C or lower) prior to shipping for a maximum of two months. Avoid multiple freeze/thaw cycles which may cause loss of antibody activity and give erroneous results.
Collect blood into a serum separation tube (serum-separation tube (STT), red-top, or tiger top. Do not add anticoagulants or preservatives. Do not freeze whole blood prior to separating serum. Aseptically transfer serum to a sterile tube after centrifugation and prior to shipping, preferably into a tube that has an externally threaded cap with an o–ring seal. Serum samples should not be stored at room temperature (15-25°C) for longer than 8 hours after collection. Refrigerate serum (2-8°C) within 8 hours of collection and store for up to 48 hours. If the samples will be stored for more than 48 hours, freeze specimens (-20°C or lower). Serum specimens can be stored frozen (-20°C or lower) prior to shipping for a maximum of two months. Avoid multiple freeze/thaw cycles which may cause loss of antibody activity and give erroneous results.
Transport Medium
Not applicable
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. All serum specimens should be frozen prior to shipping to CDC and should be shipped frozen on dry ice 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
IgG antibody detected by Enzyme Immunoassay (EIA), IgM antibody detected by EIA
Turnaround Time
10 Days
Interferences & Limitations
If a serum collected less than 5 days after onset is negative, a second sample is necessary to confirm/rule out rubella.
Additional Information
For additional information on serology assays, see https://www.cdc.gov/rubella/lab/lab-testing-procedures.html and refer to the serology section.
For additional details on sample collection, storage, and transport, see https://www.cdc.gov/rubella/lab/specimen-collection-shipment.html
CDC Points of Contact
Version
2.3