Updated on February 14, 2024

·

Created on August 27, 2015

EasyNat TB-CPA Diagnostic Kit

Upcoming Update

EasyNat TB-CPA Diagnostic Kit is an early screening tool for pulmonary tuberculosis (TB) for low resource countries.

Tested By
  • Chinese Center for Disease Control and Prevention (China CDC)
Content Partners
Unknown

Author

Product Description

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.

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$4.50

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies, NGOs

Distributors / Implementing Organizations

Ustar Biotechnologies (Hangzhou) Ltd.

Manufacturing/Building Method

The product is mass-produced by Ustar Biotechnologies (Hangzhou) Ltd. in China.

Intellectural Property Type

Patent

User Provision Model

Product can be purchased from distributors in their respective countries Interview with representative

Distributions to Date Status

15,000 test strips as of July 2015 Interview with representative

Consumables

Disposable micropipette tips, 6.5-10ml centrifuge tubes, 1.5ml centrifuge tubes, with safe-lock feature, saline

Detection sensitivity

87%

Indispensable equipment for function (Y/N)

Micropipette, centrifuge, vortex, heating block or water bath, timer

Maintenance or calibration required by user at time of use? (Y/N)

Unknown

Number of Tests Performed

20 per box

Time required for procedure (minutes)

120

Design Specifications

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

Product Schematics

Technical Support

Provided by the manufacturer

Replacement Components

Ustar Biotechnologies provides reagents in liquid form or glassified form on request.

Lifecycle

Single-use, disposable tests Interview with representative

Manufacturer Specified Performance Parameters

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

Vetted Performance Status

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.

Safety

No listed hazards but the kit uses frozen materials and temperature controlled transport is important for effective use.

Complementary Technical Systems

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).

Academic Research and References

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.

IF Design Award, “EasyNAT TB CPA Kit“, 2014

Quimin You, Hangzhou, “ENCLOSED UNIT FOR RAPID DETECTION OF A TARGET NUCLECACID AMPLIFICATION PRODUCT“, US 8,415,141 B2, United States Patent, 2013

Compliance with regulations

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.

Evaluation methods

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.

Other Information

None

Comments from the Community

2 Comments

  1. Emily says:

    Manufacturing/building method: According to photos on their Facebook page, the bio-bags are manufactured in Belgium (https://www.facebook.com/ba… ) and the frames are manufactured in Taiwan (https://www.facebook.com/ba… ).

  2. Jeremy Schonhorn says:

    An isothermal NAT to determine TB is a useful technology. The ability to monitor TB accurately and safely will help physicians and health care providers detect infection and manage therapy. The TB device as implemented by Ustar Biotechnologies is promising but with shortcomings.

    The requirement for the user to provide a heat source to heat water to process samples and for nucleic acid amplification limits portability to remote locations. The requirement for cold chain for critical enzymes is also a limitation to usage in remote locations.

    Additionally, since multiple steps need to be performed to run the kit, operators will need appropriate training. As the device will be tethered to a facility with the necessary systems to operate the test, this may be a moderate limitation to deployment.

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