CDC has established strict accuracy criteria for the laboratory tests considered acceptable proof of past DENV infection before vaccination of a child.
No test is perfectly accurate: wrong results lead to different types of risk. A false negative test result means a child who is at increased risk of severe dengue would not be protected by vaccination. A false positive test means a child who was not at high risk of severe dengue would be vaccinated, potentially increasing the child’s risk of severe dengue if the child experiences a subsequent DENV infection.
All dengue IgG tests for pre-vaccination screening must have a minimum specificity of at least 98% to minimize the chance of misclassifying a person who should have a true negative test result as positive. This high specificity minimizes the risk of vaccinating a person who should not be vaccinated.
Pre-vaccination screening tests must also have a sensitivity of at least 75% to accurately identify a high proportion of children and adolescents with past dengue virus infections who can benefit from vaccination.
Acceptable laboratory confirmation of previous dengue virus infection can be obtained by:
- Evidence of prior acute dengue virus infection with
- Positive dengue RT-PCR test result, or
- Positive dengue NS1 antigen test result
- OR, positive results on BOTH of the following anti-dengue virus IgG antibody tests in a two-step testing algorithm:
- EUROIMMUN Anti-Dengue Virus NS1 Type 1-4 ELISA (IgG) and
- CTK BIOTECH OnSite Dengue IgG Rapid Test
Visit www.cdc.gov/dengue/vaccine/hcp/testing.html. for additional information about laboratory testing requirements for vaccination with Dengvaxia. As additional tests are evaluated and approved as acceptable, information will be updated by CDC.
Vaccinators are encouraged to use the CDC prevaccination checklist to evaluate patient eligibility: www.cdc.gov/dengue/resources/DVBD_FS_Vaccination_Checklist-508.pdf.