Low specificity of 2 tetanus rapid tests in Cambodia

Abstract

Objectives: Rapid testing for tetanus on serum or blood allows for an immediate evaluation of individual protection against tetanus in developed countries, using a "single step" immunochromatographic technique using tetanus toxoid. The specificity of these tests, compared to the reference method for tetanus, mouse serum neutralization testing, has however never been assessed in these countries, due to the difficulty to perform serum neutralization titration in mice, because of animal testing bioethical regulations.

Population and methods: A collection of sera from adult volunteers in Cambodia, living in rural environment, was tested for tetanus antibodies by ELISA in France, and by mouse serum neutralization in Vietnam. This allowed estimating the sensitivity and specificity of 2 rapid tetanus tests, available on the market: TQS™ and Tetanotop™.

Results: The sensitivity of these tests was adequate, compared to mice serum neutralization test, for a test threshold of 0.01 IU/mL, (100% for TQS™, 91% for Tetanotop™), but their specificity was very low (1% for TQS™ and 13% for Tetanotop™).

Conclusion: The results prove that these rapid tests for the assessment of individual protection against tetanus should not be used in the adult rural Cambodian population.

Keywords: Cambodge; Cambodia; ELISA; Elisa; Mouse serum neutralization test; Quick test; Test de séroneutralisation sur souris; Tests de diagnostic rapides; Tetanus; Tétanos.