Procalcitonin (PCT) Rapid Test (1 pc/box)

Procalcitonin (PCT) Rapid Test

The Procalcitonin (PCT) Rapid Test Kit is designed for the qualitative detection of procalcitonin in human whole blood, serum, or plasma samples. This kit aids in the diagnosis of inflammatory processes.

Procalcitonin is a precursor of calcitonin, typically produced by the C-cells of the thyroid gland. During severe infections, PCT is rapidly produced by other tissues as well, leading to elevated serum PCT concentrations. First described by Assicot et al. in 1993 as an inflammatory protein, numerous clinical studies have since confirmed the utility of PCT as a biomarker. PCT is more specific for bacterial infections compared to other inflammatory markers such as C-reactive protein (CRP) and white blood cell count (WBC), as viral infections, autoimmune diseases, and allergic disorders do not induce PCT production. This test kit is intended strictly for professional use.

Specifications

Product Name: Procalcitonin (PCT) Rapid Test Kit

Sample Types: Whole blood / Serum / Plasma

Packaging: 1 test/box

Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com

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

Expiration Date: 2026.05.

Kit Contents

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 lancet
• 1 alcohol swab
  
• 1 instruction manual in English

Instructions for Using the Lancet

1. Remove the yellow single-use lancet from its packaging.

2. Remove the transparent cap.

3. Press it firmly against the fingertip. The lancet will automatically release.

4. After use, dispose of the lancet in a sharps container or trash.

Performing the Test:

1. Allow the test kit, sample, and controls to reach room temperature (15-30°C) before testing.

2. Remove the test cassette from the sealed pouch and place it on a clean, flat surface. Label with patient or control ID. For best results, use within 1 hour after opening.

3. Using the pipette, add 2 drops (approx. 50 µL) of serum/plasma or 3 drops (approx. 75 µL) of whole blood into the sample well (S). Start the timer immediately. Avoid air bubbles and do not allow the sample to enter the result window.

4. If no flow occurs after 1 minute, add 1 drop of buffer into the sample well (S).

5. Wait for colored lines to appear. Read the result at 10 minutes. Do not interpret results after 20 minutes.

Performance

• Positive agreement with EIA: 98.9% (95% CI: 96.8% – 99.6%)

• Negative agreement with EIA: 100% (95% CI: 99.0% – 100%)

• Overall agreement with EIA: 99.5% (95% CI: 98.7% – 99.8%)

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