Recently, the newly released *Global Tuberculosis Report 2024* by the World Health Organization (WHO) showed that the estimated number of new tuberculosis (TB) cases in China in 2023 was 741,000 (748,000 in 2022), with an estimated TB incidence rate of 52 per 100,000 population, slightly lower than that in 2022 (53 per 100,000). Among the 30 high TB burden countries, China ranked the 3rd in the estimated number of TB cases, accounting for 6.8% of the global total (India 26%, Indonesia 10%). The estimated number of patients with multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) was 29,000 (7.3% of the global total), ranking the 4th worldwide. Globally, the TB incidence rate has only dropped by 8.3% in the past decade, far below the expected target. The main reason for the unsatisfactory effect is the lack of diagnostic technologies with high sensitivity, simple operation and more advantageous comprehensive use costs at the grassroots level.

Rocgene's meticulously crafted fully automated nucleic acid testing platform — iFIND, adopts a classic modular design combined with a fully enclosed cartridge. After one-step sample addition, test reports are generated automatically throughout the entire process without manual on-duty operation. It is currently the most suitable POCT product that conforms to the usage habits of medical institutions at all levels. Since its certification and launch in December 2023, it has attracted much attention from all walks of life.

The first systematic evaluation report on the "Mycobacterium Tuberculosis and Rifampicin Resistance Gene Detection Kit (TBR)" developed based on the iFIND platform was also released globally on the same day as the *Global Tuberculosis Report 2024*. The article was published in the journal *Frontiers in Cellular and Infection Microbiology* by the National Tuberculosis Reference Laboratory of the Chinese Center for Disease Control and Prevention, leading multiple domestic and foreign institutions. In the paper *Development and preliminary assessment of the iFIND TBR: all-in-one molecular diagnostic assay for rapid detection of Mycobacterium tuberculosis and rifampicin resistance*, researchers evaluated the performance of the iFIND system by testing standard strains and sputum samples from 173 suspected pulmonary tuberculosis patients.

According to the results of the article

01. The limit of detection (LOD) of iFIND TBR for TB identification is 13.34 CFU/ml (95% CI, 11.71–16.47 CFU/ml), which is superior to Xpert (131 CFU/ml) and on par with Xpert Ultra (15.6 CFU/ml).

02. The LOD of iFIND TBR for rifampicin resistance gene detection (100% mutation rate) is 109.79 CFU/ml (95% CI, 95–138.19 CFU/ml), and the detection sensitivity for heteroresistance can reach a 30% mutation ratio.

03. With the traditional culture method as the reference standard, test results of sputum samples from 173 suspected pulmonary tuberculosis patients showed that the sensitivity of iFIND TBR for the identification of Mycobacterium tuberculosis complex was 100% (95.94%-100%) and the specificity was 85.29% (74.61%-92.72%). The sensitivity and specificity of Xpert were 98.88% (93.90%-99.97%) and 89.71% (79.93%-95.76%), respectively, indicating a high consistency between the results of iFIND TBR and Xpert.

04. With phenotypic drug susceptibility testing as the reference standard, test results of sputum samples from 82 suspected pulmonary tuberculosis patients showed that the sensitivity of iFIND TBR for rifampicin resistance gene identification was 98.15% (95% CI, 90.11, 99.95) and the specificity was 85.71% (95% CI, 67.33, 95.97%). The sensitivity and specificity of Xpert were 94.44% (95% CI, 84.61, 98.84) and 92.86% (95% CI, 76.50, 99.12%), respectively, also indicating a high consistency between the results of iFIND TBR and Xpert.

Finally, the conclusion of the article stated: "As a novel molecular diagnostic method, iFIND TBR shows promising potential in accurately detecting tuberculosis and determining rifampicin susceptibility. The whole test procedure for iFIND TBR is simple to perform, can be completed within 90 minutes, and provides the advantages of high specificity, high sensitivity and rapid result reporting. This all-in-one approach has the potential as a simple, scalable, and time-saving alternative for tuberculosis and rifampicin resistance detection."

ROCGENE

As an optimal solution for TB detection, the iFIND system will present more comprehensive data to everyone with the further advancement of relevant research. Stay tuned for the "iFIND Magic"!

For more details, please refer to the full text at:

https://www.frontiersin.org/journals/cellular-and-infection-microbiology/articles/10.3389/fcimb.2024.1439099/full