EasyNat TB-CPA Diagnostic Kit
Ustar Biotechnologies (Hangzhou) Ltd
EasyNat TB-CPA Diagnostic Kit is an early screening tool for pulmonary tuberculosis (TB) for low resource countries.
The EasyNat TB-CPA Diagnostic Kit is designed as a screening tool for active pulmonary tuberculosis (TB) to improve the detection rate in people with suspected TB infection. The kit allows for rapid diagnostics that can be conducted without highly specific and expensive equipment as well as highly skilled staff. It is useful in many low-income settings where tuberculosis control is lacking.
Currently sold in China, Singapore, Philippines, Indonesia, India, South Africa, Canada and USA. Interview with representative
However, there are 22 countries in which Ustar Biotechnologies identifies as “high TB burden” including Afghanistan, Bangladesh, Brazil, Cambodia, China, Democratic Republic of Congo, Ethiopia, India, Indonesia, Kenya, Mozambique, Myanmar, Nigeria, Pakistan, Philippines, Russian Federation, South Africa, United Republic of Tanzania, Thailand, Uganda, Viet Nam, Zimbabwe.
Ustar Biotechnologies (Hangzhou) Ltd.
4-5 USD (price includes sample preparation, amplification and detection)
There are many methods of detecting pulmonary TB. Five competitors are Xpert MTB/RIF, LPA, LAMP, SAT-TB. RT-PCR and FQ-PCR can also be used for detection of TB but require the use of expensive laboratory equipment and so they are less ideal for low-resource countries.
Goal 3: Good health and well-being
The product is mass-produced by Ustar Biotechnologies (Hangzhou) Ltd. in China.
Product can be purchased from distributors in their respective countries Interview with representative
15,000 test strips as of July 2015 Interview with representative
The EasyNAT TB kit relies on Ustar’s microbe detection platform which integrates CPA amplification technology and a disposable, contamination-proof DNA detection device. The testing involves three steps: 1. Liquifiy sputum and extract DNA to produce an amplification template and add it into in a 0.2 ml Eppendorff tube containing the CPA reagents; 2. Put the tube into a heat block maintaining 63℃ for one-hour for isothermal amplification 3. Insert the amplified tube into the Ustar disposable DNA detection device for qualitative read-out in 15 minutes. The turn-around time is about 3 hours from sample retrieval to results and provides a clear, ‘positive/negative’ read-out on the paper test strips.
Kit components include: 1. Disposable Nucleic Acid Extraction Device (with 3ml Syringe) x 20 pieces 2. 1ml Syringe x 20 pieces 3. Lysis Buffer – 15ml x 1 bottle 4. Wash Buffer 50ml x 1 bottle 5. Elution Buffer 3ml x 1 bottlle 6. 5ml Vial x 20 vials 7. 2ml Tube x 20 tubes 8. 0.6ml Tube x 20 tubes
Kit Weight: 500g/20 tests. There are two boxes for one TB kit, Kit A: 9.5cm x 6.5cm x 5.5cm, 53g; and Kit B:25cm x 19cm x 15cm, 1.2kg. Interview with representative
More information can be found in the patent.
Provided by the manufacturer
Ustar Biotechnologies provides reagents in liquid form or glassified form on request.
Single-use, disposable tests Interview with representative
Testing turn-around time is about 3 hours. The amplification and DNA detection process takes place in a sealed-off condition thus preventing cross-contamination. EasyNAT TB detects as low level as 10 pathogens per 1 ml. It is fast, easy-to-use, and requires no costly qPCR machine and PCR infrastructure, no cold-chain required. Interview with representative
In a large clinical trial ran by the Chinese Anti-tuberculosis Association at 4 county-level TB hospitals in China (n=2,200), EasyNAT TB proved: 1) high sensitivity 84.1% & Specificity 97.8%, using L-J solid media and 16S rRNA sequencing results as the gold standard; 2) Sensitivity 59.8% in smear negative samples; 3) recommended as a rapid screening test for active TB as it reduced turn-around time from 54 days to 4-5 hours. Interview with representative
The Ifakara Health Institute conducted a 147-participant study in Tanzania and concluded that the EasyNAT assay has a 66.7% sensitivity.
Testing organizations include: the Chinese Anti-tuberculosis Association, the Chinese Center for Disease Control and Prevention, with the Chinese PLA General Hospital, Beijing, China, and the Ifakara Health Institute.
No listed hazards but the kit uses frozen materials and temperature controlled transport is important for effective use.
Additional equipment is required in protocol and not provided with product. This includes: isothermal metal heater or water bath, vortex mixer, micropipette and disposable tips, timer, and a centrifuge (optional).
Fang R, et al., Cross- priming amplification for rapid detection of Mycobacterium tuberculosis in sputum specimens. J Clin Microbiol 2009;47:845-847.
Michael S. Cordray and Rebecca R. Richards-Kortum. Review: Emerging Nucleic Acid–Based Tests for Point-of-Care Detection of Malaria. The American Society of Tropical Medicine and Hygiene; 87(2): 223-230. doi:10.4269/ajtmh.2012.11-0685
Xichao Ou et al., A multicenter study of Cross-Priming Amplification for tuberculosis diagnosis at peripheral level in China. Elsevier: Tuberculosis. 2014
Mhimbira FA, Detection of Mycobacterium tuberculosis by EasyNAT diagnostic kit in sputum samples from Tanzania. J Clin Microbiol. 2015 Apr;53(4):1342-4. doi: 10.1128/JCM.03037-14. Epub 2015 Jan 21.
McNerneya Ruth, New tuberculosis diagnostics and rollout International Journal of Infectious Diseases, Volume 32, March 2015, Pages 81–86
S. Deng et al., Accuracy of Commercial Molecular Diagnostics for the Detection of Pulmonary Tuberculosis in China: A Systematic Review., Sci. Rep., vol. 9, no. 1, pp. 1–11, Dec. 2019, doi: 10.1038/s41598-019-41074-8.
EasyNAT TB had also undergone verification testing at China National Institute for Controls of Pharmaceutical and Biological Products (NICPBP) in Beijing in 2008. Regulatory approval details unknown.
Clinical evaluation conducted at Shanghai Centers for Disease Control from March to June of 2008. EasyNAT TB had also undergone verification testing at China National Institute for Controls of Pharmaceutical and Biological Products (NICPBP) in Beijing in 2008. EasyNAT TB passed national reference panel with lowest detection level of 10 bac. copy/ml.
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