Diagnosis of rubella infection in symptomatic individuals. 

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

See Rubella (German Measles), Acute/Suspected Active Disease, Serum IgM		ID: LAB10006

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

Detection is most successful when specimens are collected on the first day of rash through 4 days following rash onset. Detection may be successful as late as 7 days post rash onset. 

For suspected Congenital Rubella Syndrome, collect both serum and NP swab samples as soon as possible after birth.
For samples collected from suspected congenital rubella syndrome (CRS) cases, the collection window is from birth to 3 months of age. 

A negative test result does not rule out infection with rubella virus.

Detected, Not Detected, Equivocal, Indeterminate

Real-time RT-PCR

***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:  

Nasopharyngeal swab is preferred. 
Nasal or buccal swabs are not acceptable.
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.
All swab types should be placed in 2 mL of standard viral transport medium (VTM) or Universal Transport Medium (UTM) and should not be allowed to dry out. 
DO NOT USE cotton swabs or non-flocked synthetic swabs due to the presence of PCR inhibitors and poor absorbency, respectively.

•	Refrigerate (2-8°C) immediately following collection and store for up to 10 days. 
•	If samples are stored for more than 10 days, freeze specimens (-70°C or lower). 
•	All samples should be frozen (-70°C or lower) and shipped on dry ice.