EasyNat TB-CPA Diagnostic Kit

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}

Provided by the manufacturer

Single-use, disposable tests ^{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.

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