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

• The price includes 5% VAT.

• The product can be ordered for professional use.

Procalcitonin (PCT) rapid test for the diagnosis of inflammatory processes

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

Procalcitonin (PCT) is a precursor of calcitonin and is normally produced in the C-cells of the thyroid gland. In severe infections, PCT is also rapidly produced in other tissues, and the serum PCT concentration rises to very high levels. Assicot et al. first described PCT as an inflammation-induced protein in 1993. Since then, numerous clinical studies have confirmed the usefulness of this marker. PCT is more specific for the detection of bacterial infection than other inflammatory markers such as C-reactive protein (CRP) and white blood cell count (WBC), because viral infections, autoimmune and allergic disorders do not induce PCT. The test kit can be ordered for professional use.

PCT rapid test specification

Product name: Procalcitonin (PCT) Rapid Test Kit
Sample: whole blood/serum/plasma
Packaging: 1 pc/box
Format: Cassette test
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
Expiry date: 31/03/2028

PCT rapid test kit contents

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 fingertip lancet
• 1 alcohol wipe
• 1 instructions for use in Hungarian

How to use the fingertip lancet

1. Take the yellow single-use lancet out of the packaging. Remove the transparent cap.
2. Press it against your fingertip. The needle will be released automatically.
3. After use, dispose of the lancet in the waste bin.

The visual aid is intended for healthcare professionals only. The product is not intended for self-testing.

Test procedure

Read the Instructions for Use carefully before performing the test! Before testing, allow the test, the sample and/or the controls to reach room temperature (15-30°C).

1. Remove the test from the sealed pouch and place it on a clean, level surface! Label the test with the patient or control identification! For best results, the assay should be performed within one hour of opening the pouch!

2. Dispense 2 drops of serum/plasma (approximately 50 μL) or 3 drops of whole blood (approximately 75 μL) into the sample well (S) of the device using the supplied disposable pipette, then start the timer.

Avoid trapping air bubbles in the sample well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

3. If migration has not started on the test after 1 minute, add 1 drop of buffer to the sample well (S).

4. Wait for the colored band(s) to appear. The result must be read at 10 minutes. Do not interpret the result after 20 minutes!

PCT rapid test performance

• Positive agreement with EIA: 272/(272+3) = 98.9% (96.8% - 99.6%)*
• Negative agreement with EIA: 380/(380+0) = 100% (99.0% - 100%)*
• Overall agreement with EIA: (272+380)/(272+3+380+0) = 99.5% (98.7% - 99.8%)*
  * 95% confidence interval

The test may only be used by competent professionals and healthcare workers! Carbon Web Kft. accepts no liability for use for self-testing purposes.

ATTENTION!
Under Government Decree No. 45/2014 (II. 26.), for health protection or hygiene reasons the product cannot be returned after delivery; therefore the 14-day right of return does not apply to this product. Section 29 (1) The consumer may not exercise the right under Section 20 (the consumer's right of withdrawal) in respect of (e) a product in sealed packaging which, for health protection or hygiene reasons, cannot be returned once opened after delivery.

Carbon Web Kft. is not responsible for fulfilling the legal obligations related to the Buyer's procurement procedure, as this falls within the Buyer's remit; its liability is limited solely to information on the intended use and to the goods delivered.