Recently, a number of provincial disease control agencies and tuberculosis prevention and control units in China have successively released performance verification and evaluation reports on the fully automatic nucleic acid testing system iFIND, comparing its performance with the global mainstream testing systems Xpert MTB/RIF and Xpert Ultra from multiple dimensions. The results showed that iFIND was highly consistent with the Xpert series in the identification of Mycobacterium tuberculosis and the detection of rifampicin resistance, especially Xpert Ultra.

Key Performance Data at a Glance

1. Shanghai Center for Disease Control and Prevention (Xpert MTB/RIF).

Identification of Mycobacterium tuberculosis: positive coincidence rate 100%, negative coincidence rate 93.33%, total coincidence rate 98.33%, Kappa value 0.9545

Rifampicin resistance detection: resistance coincidence rate 93.33%, sensitive coincidence rate 100%, total coincidence rate 97.78%, Kappa value 0.9492

Conclusion: iFIND and Xpert MTB/RIF results are highly consistent, more convenient to operate, and suitable for low-level laboratories.

Screenshot of the conclusion of the Shanghai Center for Disease Control and Prevention report

2. Report of the Jiangsu Provincial Center for Disease Control and Prevention (Xpert MTB/RIF).

Mycobacterium tuberculosis identification: positive coincidence rate 96.40%, negative coincidence rate 70.17%, overall agreement rate 84.29%, Kappa value 0.680

Rifampin resistance detection: resistance coincidence rate 90.91%, sensitive coincidence rate 97.78%, total coincidence rate 97.03%, Kappa value 0.853

Detection limit: iFIND detection limit is better than XpertMTB/RIF, especially more sensitive to low bacterial count samples.

Conclusion: iFIND and Xpert MTB/RIF have a high positive rate in the identification of Mycobacterium tuberculosis, and strong agreement in rifampicin resistance.

Screenshot of the conclusion of the report of the Jiangsu Provincial Center for Disease

3. Report of the Guangdong Provincial Tuberculosis Control Center (Xpert Ultra)

Mycobacterium tuberculosis identification: positive coincidence rate 97.73%, negative coincidence rate 100%, total coincidence rate 100%, Kappa value 0.9117

Rifampicin resistance test: resistance coincidence rate 100%, sensitive coincidence rate 100%, total coincidence rate 100%, Kappa value 1 (and concoincidence rate for culture method is also 100%)

Sensitivity: According to published study data, iFIND TBR systems exhibit excellent detection sensitivity.Its lower limit of detection (LoD) for the Mycobacterium tuberculosis complex ≤ 15 CFU/mL, while its lower limit of detection (LoD) for rifampicin resistance genes ≤ 111 CFU/mL. The measured data of the previous study (identification of 13.34 CFU/mL and drug resistance of 109.79 CFU/mL) are highly consistent with the above claimed indicators, which fully verifies the reliability and accuracy of its detection performance. Link: Here it comes! Here it comes! RocgeneiFIND published

for the first time to demonstrate its real-world performance

Screenshot of the conclusion of the report of the Guangdong Provincial Tuberculosis Control Center

ROCGENE

As the only product in China that truly benchmarks Xpert, iFIND TBR is highly consistent with Xpert in terms of methodology and operation process. Both adopt a fully automatic "sample in, result out" integrated platform, realizing true on-the-spot inspection. The research data further confirms that iFIND TBR is not only "similar" to Xpert in form, but also achieves "similarity" in detection performance. In particular, compared with Xpert Ultra, the consistency of the two test results is higher than 0.9, achieving a high degree of consistency.