EasyNAT™ TB Screening kit large-scale clinical evaluation completed in China
A clinical trial focused on evaluating practicability of EasyNAT™ TB screening kit (Ustar Biotechnologies, Hangzhou, China) in low-resources clinical settings has been successfully completed in China in December 2012. The clinical trial, organized by Chinese Association for Tuberculosis Prevention entrusted by Ustar Biotechnologies, was conducted in four county-level hospitals of four Provinces across central and northern China, with technical support from both TB referential laboratory China National CDC and the Provincial CDCs
EasyNAT™ is a CPA(Cross Priming Amplification) isothermal amplification based TB nucleic acid detection kit intended for use in fast TB screening among patients suspected of pulmonary TB infection. In the trial a total of 2,200 patents presenting suspicious PTB symptoms were included. Sputum specimens were taken for testing with AFB smear, L-J solid culture, CPA and DNA sequencing for strain identification. Clinical diagnosis was also taken into the results analysis. Using L-J culture as “gold standard”, EasyNAT™ shows sound sensitivity of 84.1% and specificity of 97.8%. The PPV and NPV are 83.4% and 97.9% respectively. In smear negative specimens EasyNAT™ shows a sensitivity of 59.8% and specificity of 98.0% with good prediction values. The testing significantly reduces reporting time of 52.5 days of L-J culture to only 5 hours. Besides，the laboratory technicians report easy acceptance in testing operations and less bio-safety risks. The experts involved in the evaluation are highly agreed with its practicability for being used as a fast, easy-to-use screening tool in clinics, especially in low-resources settings.