Evaluation of the diagnostic value of a rapid diagnostic test kit for detection of rubella virus

Abstract

 Rubella is a respiratory infection caused by the Rubella virus. Although most cases of the disease are mild, when pregnant women contact with the virus, it can lead to severe birth defects in the fetus. Therefore, screening and early
diagnosis of rubella infection are necessary. In pursuit of this objective, we have conducted research and developed
a rapid test kit for the rubella virus antigen. The test kit is based on a lateral flow immunoassay that utilises gold nanoparticles. This study aimed to characterise the test kit by evaluating its detection threshold, cross-reactivity with
several pathogens, repeatability, sensitivity, and specificity. The results showed that the test kit is capable of detecting
samples containing 105 PFU of the rubella virus. The kit did not show any cross-reactivity with samples containing pathogens such as Staphylococcus aureus, Streptococcus pyogenes, Candida albicans, the measles virus, influenza
virus or Adenovirus. The test kit exhibited 100% reproducibility for both negative and positive samples. Its sensitivity and specificity were determined to be 98 and 99%, respectively.