Case definition and classification criteria for congenital rubella syndrome

Category	Definition
Suspected	An infant who does not meet the criteria for a probable or confirmed case (as defined below) but who has ≥1 of the following clinical findings of CRS: Cataracts Congenital glaucoma Congenital heart disease (most commonly PDA or PPS) Hearing loss Pigmentary retinopathy Purpura Hepatosplenomegaly Jaundice Microcephaly Developmental delay Meningoencephalitis Radiolucent bone disease
Probable	Either
	An infant who does not have laboratory evidence of CRI (as defined below) but has ≥2 of the following clinical findings, without a more plausible etiology: Cataracts or congenital glaucoma* Congenital heart disease (most commonly PDA or PPS) Hearing loss Pigmentary retinopathy
	OR
	An infant who does not have laboratory evidence of CRI (as defined below) but has ≥1 of the following clinical findings, without a more plausible etiology: Cataracts or congenital glaucoma* Congenital heart disease (most commonly PDA or PPS) Hearing loss Pigmentary retinopathy Plus ≥1 of the following clinical findings: Purpura Hepatosplenomegaly Microcephaly Developmental delay Meningoencephalitis Radiolucent bone disease
Confirmed	An infant with both: Clinical findings of CRS (≥1 of the findings listed above) Plus Laboratory evidence of CRI, as demonstrated by any of the following: Isolation of rubella virus Detection of rubella-specific IgM in the infant Rubella IgG titer in the infant that persist at a higher level and for a longer time than expected from transfer of maternal antibody (ie, rubella IgG titer that does not drop at the expected rate of a 2-fold decline per month)^¶ Positive PCR for rubella virus
Infection only	An infant without any clinical findings of CRS (listed above) but with laboratory evidence of CRI (as defined above)^Δ

This table summarizes the criteria used to define and classify CRS and CRI based upon clinical and laboratory findings. These definitions were approved by the Council of State and Territorial Epidemiologists (CSTE) in 2009 and were adopted by the CDC in 2010. They continue to be the definitions used in the United States and many other regions.

CRS: congenital rubella syndrome; PDA: patent ductus arteriosus; PPS: peripheral pulmonary artery stenosis; CRI: congenital rubella infection; IgM: immunoglobulin M; IgG: immunoglobulin G; PCR: polymerase chain reaction; CDC: Centers for Disease Control and Prevention.

* In probable cases, if the infant has both eye-related findings (cataracts and congenital glaucoma), they should be considered as a single finding.

¶ Infants with clinical findings of CRS who test negative soon after birth should be retested later in infancy. Approximately 20% of infected infants tested for rubella IgM may not have detectable titers before age one month.

Δ In cases classified as infection only, if any compatible clinical finding (eg, hearing loss) is identified later, the case is reclassified as confirmed.

Adapted from: Lanzieri T, Redd S, Abernathy E, Icenogle J. Congenital rubella syndrome. In: Manual for the Surveillance of Vaccine-Preventable Diseases, Roush SW, Baldy LM, Hall MAK (Eds), National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention 2020. https://www.cdc.gov/vaccines/pubs/surv-manual/chpt15-crs.html (Accessed on May 10, 2023).

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Case definition and classification criteria for congenital rubella syndrome