Serodiagnosis of active rubella infection. 

Rubella IgM testing should be limited to suspected rubella cases. Routine IgM screening of pregnant women or fetus is not recommended. For suspected Congenital Rubella Syndrome, collect both serum and NP swab samples as soon as possible after birth. The Rubella serology IgM test should NOT be ordered alone.

For rubella immune status, IgG test, refer to Immune Status Profile, MMRV: LAB6586

All suspect or probable cases of Rubella must be reported to Infection Prevention and the Communicable Disease Branch of NC Public Health at (919) 733-3419 for PRIOR APPROVAL for laboratory testing.

See also Rubella (German Measles), Acute/Suspected Active Disease, Nasopharyngeal RT-PCR:  LAB10005

Rubella virus is an enveloped, positive-stranded RNA virus classified as a Rubivirus in the Matonaviridae family. Rubella is characterized by a mild, maculopapular rash along with lymphadenopathy, and a slight fever. About 25% to 50% of infections are asymptomatic. However, congenital rubella syndrome (CRS), a severe condition occurring when the virus crosses the placenta during early pregnancy, leads to devastating fetal defects such as deafness, heart abnormalities, cataracts, and intellectual disability. 
The average period of the incubation of rubella virus is 17 days, with a range of 12 to 23 days. People infected with rubella are most contagious when the rash erupts. But they can be contagious from 7 days before to 7 days after the rash appears. Rubella is transmitted primarily through direct or droplet contact from nasopharyngeal secretions. Humans are the only natural hosts. In temperate climates, infections usually occur during late winter and early spring.. 
Clinical Overview of Rubella | Rubella | CDC:  https://www.cdc.gov/rubella/hcp/clinical-overview/index.html

If a serum collected less than 5 days after onset is negative, a second sample is necessary to confirm/rule out rubella. The presence of Rubella IgM is indicative of a recent exposure but cannot differentiate between primary infection and vaccination. False-positive IgM serum may occur in persons with parvovirus infection, infectious mononucleosis, or rheumatoid factor.

Negative, Positive, or Equivocal/Borderline

Enzyme Immunoassay

***NOTE:  This order can be found by searching “Rubella” on the Epic Beaker Facility List***

○	Providers must call the Communicable Disease Branch of NC Public Health at (919) 733-3419 to acquire PRIOR APPROVAL for laboratory testing for all cases of suspected or probable Rubella (German Measles).
○	If testing is approved by Communicable Disease Branch of NC Public Health, provider must also contact Duke Microbiology at 684-2089 BEFORE collection to coordinate specimen and collection requirements. 

If onset of symptoms is less than 3 days, order Rubella (German Measles), Acute/Suspected Active Disease, Nasopharyngeal PCR [LAB10005] only.  
○	Submission requires DHHS form #3431:  https://slph.dph.ncdhhs.gov/Forms/3431-Virology.pdf
○	This form must be printed, completed and included in the bag along with the specimen(s).  Testing will not proceed without a completed document. 

If onset of symptoms is 3 days or greater (or if suspecting Congenital Rubella Syndrome), order BOTH Rubella (German Measles), Acute/Suspected Active Disease, Nasopharyngeal PCR [LAB10005] AND Rubella (German Measles), Acute/Suspected Active Disease, Serum IgM [LAB10006]
○	Submission requires THREE forms: All forms must be printed, completed and included in the bag along with the specimen(s).  Testing will not proceed without completed documents.
1.	DHHS form #3431 https://slph.dph.ncdhhs.gov/Forms/3431-Virology.pdf
2.	DHHS form #3445 https://slph.dph.ncdhhs.gov/Forms/SpecialSerologyForm-3445.pdf?ver=1.1
3.	CDC form #50.34 https://centersfordiseasecontrol.sharefile.com/share/view/sed42e98472b646ad87bf7f30a1df5085 For download and installation assistance call Duke IT Service Desk (919-684-2243)

If patient is being assessed for immunity status and not for acute/suspected active disease, order instead RUBELLA ANTIBODY, IGG [LAB496] [LAB496] 

Collection Requirements:

A minimum of 0.5 mL serum (1.0 mL preferred) should be collected and refrigerated promptly after collection. Temporary storage and transport temperature should be 2-8 ⁰C. If sera will be stored for >48 hours after collection, freeze specimens at -20°C or lower.

Hemolyzed, lipemic, or bacterially contaminated specimens are rejected.

•	Refrigerate serum (2-8°C) within 8 hours of collection and store for up to 48 hours. 
•	If samples are 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