National Vaccine Information Center

Laboratory requirements prior to vaccination with DENGVAXIA

Published: May 25, 2024

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 Dengue Lab Test

The CDC reviewed all available dengue IgG tests available in the U.S. and found that two tests were satisfactory for sensitivity, but no single test met the specificity requirement of 98 percent.  Sensitivity in testing is the ability of a test to accurately confirm the presence of the disease, while specificity is the ability of a test to accurately determine that a disease is not present. 

As a result, the CDC states that a two-test algorithm using both the EUROIMMUN Anti-Dengue Virus NS1 Type 1-4 ELISA (IgG) and the CTK BIOTECH On Site Dengue IgG Rapid Test must be used prior to DENGVAXIA vaccination. The use of this two-test algorithm reportedly met the requirement for both sensitivity (greater than or equal to 75 percent) and specificity (greater than or equal to 98 percent). As of May 2024, neither test recommended for use by the CDC has been cleared by the FDA. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Dengue and the Dengue vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

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