On June 23, 2025, the "iFIND TBR Mycobacterium tuberculosis and Rifampicin Resistance Gene Detection Kit" independently developed by Rocgene was officially approved by the NMPA (National Medical Products Administration Registration No.: 20253401191). This product enables simultaneous identification of Mycobacterium tuberculosis and detection of rifampicin resistance. As a highly anticipated innovative product in the industry, it adopts China’s exclusive built-in ultrasonic technology combined with a nested amplification system. Ultrasonic lysis improves nucleic acid extraction efficiency, and dual amplification ensures detection of trace pathogens. As a major breakthrough in tuberculosis diagnosis, iFIND TBR, with its excellent detection performance, will provide clinicians with faster and more accurate diagnostic solutions, significantly enhance tuberculosis prevention and control capabilities, and offer strong technical support for the global End TB campaign.

iFIND TBR

Breaking Technical Barriers, Shining as a National Champion

01. Unique & Pioneering Technology

Built-in Ultrasonic Extraction System (Exclusive in China)

The iFIND built-in ultrasonic system is specially designed for difficult-to-extract strains such as Mycobacterium tuberculosis. It uses exclusive built-in ultrasonic technology to efficiently break through the tough cell walls of thick-walled bacteria. The built-in ultrasonic treatment effectively avoids aerosol contamination that may occur when opening lids for external ultrasound. The integrated design completes "wall breaking – extraction" synchronously without external equipment, greatly simplifying workflow and improving laboratory safety.

Nested Amplification Technology Platform (Exclusive in China)

iFIND uses an innovative nested amplification technology with two pairs of specific primers for stepwise amplification, effectively overcoming the plateau effect and achieving dual exponential high-efficiency amplification. Through two rounds of precise complementary pairing between specific primers and templates, the technology ensures ultra-high detection sensitivity while significantly improving specificity. This breakthrough design gives the system both outstanding performance and reliable accuracy.

Fully Enclosed Smart Cartridge Design (Simplest in China)

The iFIND fully automatic nucleic acid detection and analysis system, based on microfluidic technology, is equipped with an integrated closed cartridge preloaded with lyophilized detection reagents. It breaks many constraints of traditional molecular diagnostic laboratories regarding environmental conditions, supporting equipment, and operator skills, overturning the disadvantages of complex processes, cumbersome operation, time-consuming labor, and high environmental requirements. It truly realizes fully automatic nucleic acid detection: "Sample In, Result Out".

Modular Point-of-Care Testing Solution

iFIND features a fully modular design. Each detection unit is equipped with independent power, optical, and thermal modules, enabling on-demand testing and flexible combination of detection items. Modules operate completely independently without interference. A single module failure does not affect the whole instrument; new samples can be loaded at any time without impacting idle modules, greatly improving detection efficiency and equipment utilization.

02. Performance Comparable to International Brands

Evaluation results from the National Tuberculosis Reference Laboratory show that iFIND achieves excellent sensitivity (13.34 CFU/mL) for tuberculosis detection, nearly 10 times higher than the traditional Xpert method (131 CFU/mL), reaching the same level as Xpert Ultra (15.6 CFU/mL) (Source: Development and preliminary assessment of the iFIND TBR all-in-one molecular diagnostic assay for rapid detection of Mycobacterium tuberculosis and rifampicin resistance).

Multicenter clinical trial results among 1,117 enrolled samples show that iFIND and Xpert have 100% positive agreement and 95.97% negative agreement for TB identification, and 97.19% positive agreement and 99.57% negative agreement for rifampicin resistance. iFIND and Xpert demonstrate extremely high consistency.

03. Comprehensive Tuberculosis Detection Applications

As a professional tuberculosis diagnostic platform, iFIND provides a comprehensive testing menu from basic to extended panels. It currently covers Mycobacterium tuberculosis identification, rifampicin/isoniazid/fluoroquinolone resistance detection, and nontuberculous mycobacteria identification, and will continue to expand to new items such as Mycobacterium tuberculosis RNA detection. This stepped detection design meets the immediate needs of primary medical institutions while reserving cost-effective expansion space for future upgrading of their testing capabilities.

04. Verified & Recommended by Authoritative Institutions

The iFIND tuberculosis detection series has been validated by nearly 200 designated tuberculosis medical institutions, including provincial and municipal CDCs (such as the Chinese Center for Disease Control and Prevention), Beijing Chest Hospital, Wuhan Pulmonary Hospital, Hunan Chest Hospital, Shandong Public Health Clinical Center, Shenzhen Third People’s Hospital, and others. Meanwhile, due to its stable and excellent performance, simple and fast workflow, and high cost-effectiveness, iFIND is recommended by national tuberculosis professional associations as one of the preferred molecular POCT products for primary tuberculosis diagnosis and drug resistance detection.