FIND and Cepheid recently requested trial applications to evaluate the effect and performance of diagnosing rifampicin resistance and tuberculosis (TB) using the GeneXpert Omni system from Cepheid when it is used along with the Xpert MTB/RIF Ultra assay.
The new Xpert MTSB/RIF Assay, part of the company’s GeneXpert platform, has demonstrated notable promise in offering rapid, sensitive diagnosis using molecular tests. The goal is to quickly detect TB, and the new tools have been launched in more than 100 countries.
After launching GeneXpert in South Africa three years ago, the nation has shown a decline in the incidence of TB. In India, where the new tool was studied in 18 different locations, it has been credited with an increase in diagnosing resistant TB by five times.
Still, the new tool has not been confirmed as adequate to a smear replacement test when used in other nations. This is because GeneXpert cannot be used in many microscopy center settings.
In addition, the new tools do not have a strong sensitivity like the cultures, specifically concerning people who have paucibacillary and sputum-scarce TB. This will affect the performance and usefulness of the assay in the long term.
