E.Coli Antigen Rapid Test Kit (1 pc/box)

E.Coli Antigen Rapid Test Kit

The Escherichia coli (E.Coli) antigen rapid test is a qualitative immunochromatographic assay for the detection of E. coli antigen in human stool samples. E. coli is a Gram-negative, facultative anaerobic bacterium commonly found as part of the normal intestinal flora in the lower gastrointestinal tract.

Certain E. coli strains, especially Shiga-toxin producing E. coli (STEC), are pathogenic and can cause foodborne illnesses such as hemorrhagic colitis and hemolytic uremic syndrome (HUS). These infections are particularly prevalent and severe in children, infants, and the elderly. This test kit is intended for professional use in clinical and laboratory settings to aid in rapid diagnosis and effective infection management. For professional use.

E.Coli Antigen Rapid Test Specifications

Product Name: E.Coli Antigen Rapid Test Kit

Sample Type: Human stool specimen

Packaging: 1 test/box

Test Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3rd Floor, Building 4, No. 1418, Moganshan Road, Hangzhou, Zhejiang, China, Email: imd.assuretech@diareagent.com

EC REP: Lotus NL B.V., Koningin Julianaplein 10, Le Verd, 2595AA, The Hague, Netherlands, Email: peter@lotusnl.com

Expiration Date: 2026.11.

E.Coli Antigen Rapid Test Kit Contents

• 1 test cassette

• 1 sample dilution tube with buffer solution

• 1 instruction manual in English

Testing Procedure

Read the instruction manual carefully before performing the test. Ensure the test device, sample, and controls are at room temperature (15-30°C).

Collect stool sample as per the instructions.

After sample collection:

1. Remove the test cassette from its sealed pouch and place it on a clean, flat surface. Mark the cassette with patient or control ID. For best results, perform the test within 1 hour of opening.

2. Using the dilution tube, add 2 drops of the sample solution to the sample well (S) on the cassette. Avoid bubbles and do not let the liquid touch the result window.

3. Wait for the colored bands to appear. Results can be read within 10 minutes; after 20 minutes, the result is invalid.

Performance

• Relative Sensitivity: >99.9% (97.5%–100%)*

• Relative Specificity: 99.6% (97.9%–99.9%)*

• Overall Agreement: 99.8% (98.6%–100%)*

*95% confidence intervals

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.

Instructions