Enzyme Linked Immunosorbant Assay (ELISA) - IgM

Detection of IgM antibodies to the rubella virus by enzyme linked immunosorbant assay (ELISA).

• Rubella (German measles)
• Congenital rubella syndrome
• Congenital rubella infection

Serum or plasma (100 µL minimum) collected as soon as possible after rash onset, ideally within 7 days, and within 28 days of rash onset.

Collect blood in serum separator tubes (SST) or EDTA tubes.

Follow standard laboratory techniques to prepare serum or plasma. Store at 4°C and ship at room temperature or on wet ice for arrival at the NML within 3 days of collection. Otherwise, freeze (-20°C or below) and ship frozen on dry ice.

Shipping of specimens shall be done by a TDG certified individual in accordance with TDG regulations. For additional information regarding classification of specimens for the purposes of shipping, consult either Part 2 Appendix 3 of the TDG Regulations or section 3.6.2 of the IATA Dangerous Goods Regulations as applicable.

1. Suspected cases of rubella (typically with fever, rash and at least one of the following: arthralgia/ arthritis or lymphadenopathy or conjunctivitis) or history of rubella exposure.

2. 2. Suspected congenital rubella infection (CRI) / congenital rubella syndrome (CRS).

   This test should not be requested for screening of pregnant women without a history of probable exposure to rubella.

Completed Measles, Mumps, and Rubella requisition form. Include date of rash onset, date of fever onset, date of last rubella vaccination (if recent), travel history, date of possible rubella exposure and/or MARS identifier (from the Measles and Rubella Surveillance application on CNPHI) or case number, as applicable.

Please contact the lab in advance of sending samples. TThe NML is a WHO/PAHO accredited Measles and Rubella Regional Reference Laboratory. In order to assist in case classification, the NML might also perform rubella IgG and IgG avidity ELISAs.

Testing is done using a commercial ELISA assay: either the Euroimmun Anti-rubella Virus Glycoprotein ELISA (IgM) or Microimmune rubella IgM capture EIA (1). A positive IgM result is indicative of an acute rubella infection however false positives are possible. Results need to considered carefully within the context of the clinical and epidemiological information. A positive IgM result on its own is not sufficient to confirm a rubella case. Refer to reference 2 for the rubella case definition.

21 calendar days. Turnaround time can be as short as 3 calendar days, with proper notification.

1. Hiebert J, Zubach V, Charlton CL, Fenton J, Tipples GA, Fonseca K, Severini A. Evaluation of Diagnostic Accuracy of Eight Commercial Assays for the Detection of Rubella Virus-Specific IgM Antibodies. J Clin Microbiol. 2022 Jan 19;60(1):e0159721. doi: 10.1128/JCM.01597-21. Epub 2021 Oct 27. PMID: 34705533; PMCID: PMC8769748.
2. Public Health Agency of Canada (PHAC). Case definitions for diseases under national surveillance.CCDR. 2009;35(S2):June 16, 2011. Available at https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2009-35/definitions-communicable-diseases-national-surveillance/rubella.html  Accessed 2018-05-30
3. Best JM, S O’Shea, G. Tipples, N Davies, SM Al-Khusaiby, A Krause, LM Hesketh, L Jin, G Enders. Interpretation of rubella serology in pregnancy - pitfalls and problems. BMJ. 2002 Jul 20;325(7356) 147-8. Review.
4. Robinson JL, BE Lee, JK Preiksaitis, S Plitt, GA Tipples. Prevention of congenital rubella syndrome - What makes sense in 2006? Epidemiologic Reviews. 2006;28:81-87.
5. Tipples GA. Rubella diagnostic issues in Canada. J Infect Dis. 2011; Suppl 2: S659-S663.
6. World Health Organization. Manual for the laboratory diagnosis of measles and rubella virus infection. Third edition. 2018. Available at  https://www.technet-21.org/en/topics/laboratory-measles-rubella-manual
7. Bolotin S, Lim G, Dang V, Crowcroft N, Gubbay J, Mazzulli T and Schabas R. The utility of measles and rubella IgM serology in an elimination setting, Ontario, Canada, 2009-2014. PLoS One. 2017;12(8):e0181172. Published 2017 Aug 29. Available at https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0181172

Pathogen Safety Data Sheets: Infectious Substances – Rubella virus

For health professionals: Rubella

National case definition: Rubella

National case definition: Congenital rubella syndrome/infection

Rubella

Measles and Rubella Weekly Monitoring Reports

Interpretation of rubella serology in pregnancy (English only)
Interpretation of rubella serology in pregnancy (English only).pdf