EasyNat TB-CPA Diagnostic Kit

Target SDGs

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

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

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