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Large-scale Clinical Evaluation Result on Ustar’s EasyNAT TB Diagnostic Published
Date : 2014-06-12

On 2 June 2014,an article entitled “A Multicenter Study of Cross-Priming Amplification for Tuberculosis Diagnosis at Peripheral Level in China” was published in the Journal of “Tuberculosis”, Elsevier Group. The article reports the results from a large-scale, multicenter clinical trial and implementation study using Ustar’s CPA and Lateral Flow Strip technology for the diagnosis of active pulmonary TB in peripheral labs at county-level hospitals in China.

The clinical trial, conducted at the county-level hospitals of four Provinces across central and northern China, focused on evaluating the practicability of the EasyNAT TB screening kit (Ustar Biotechnologies, Hangzhou, China) in low-resources settings.  It was carried out under the supervision of the Chinese Association for Tuberculosis Prevention and the National Tuberculosis Reference Laboratory, China National CDC and was completed in December 2012. 

EasyNAT™ is a CPA (Cross Priming Amplification) isothermal amplification based TB nucleic acid detection kit intended for use for rapid TB screening among patients suspected of pulmonary TB infection. In the trial a total of 2,200 patents presenting with 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 utilized for results analysis. Using L-J culture as the “gold standard”, EasyNAT demonstrated good sensitivity and specificity of 84.1% and 97.8%. The PPV and NPV were 83.4% and 97.9% respectively.  In smear negative specimens EasyNAT™ had a sensitivity of 59.8% and specificity of 98.0% with good prediction values. The testing significantly reduced the reporting time of 52.5 days for L-J culture to only 5 hours.  Furthermore, the laboratory technicians involved in the study reported that the EasyNAT testing procedures were highly acceptable and presented a lower bio-safety risk compared to culture. The experts involved in the evaluation recommended EasyNAT as a practical, rapid, easy-to-use screening tool in clinics, especially in low-resources settings.