C-Reactive Protein (CRP) Rapid Test (1 pc/box)

C-Reactive Protein (CRP) Rapid Test Kit

The high-sensitivity C-Reactive Protein (CRP) semi-quantitative rapid test (whole blood/serum/plasma) is designed for the detection of CRP levels in human blood samples. This test aids in assessing active inflammatory conditions and evaluating cardiovascular disease risk.

CRP is a well-established acute-phase marker of inflammation, commonly used in clinical settings for bacterial infections, ischemic tissue necrosis, and other active inflammatory states. Recent studies highlight CRP's predictive value for future coronary artery disease in apparently healthy individuals and its prognostic significance in acute coronary syndrome patients.

According to guidelines from the American Heart Association (AHA) and Centers for Disease Control and Prevention (CDC), CRP levels between 1-3 mg/L indicate moderate risk, while levels above 3 mg/L signify high risk for cardiovascular diseases. Levels below 1 mg/L correspond to low risk. This test has a minimum detection level (MDL) of 1 mg/L (T line), with reference lines representing 3 mg/L (R line). For professional use.

Specifications

Product Name: C-Reactive Protein (CRP) Rapid Test Kit

Sample Types: Whole blood, serum, plasma

Packaging: 1 pc/box

Test 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: November 2026

C-Reactive Protein (CRP) Rapid Test Kit Contents

• 1 x Test cassette

• 1 x Disposable pipette

• 1 x Plastic vial with buffer solution

• 1 x Lancet for fingertip blood collection

• 1 x Capillary tube

• 1 x Alcohol swab

• 1 x User 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.

Test Procedure

Please read the user manual carefully before performing the test. Collect the sample according to the instructions. Before use, ensure that all devices, reagents, samples, and/or controls have reached room temperature (15°C-30°C).

After sample collection:

1. Open the sealed pouch and use the test immediately for best results.

2. Add 3 drops of diluted sample to the sample well (S) of the cassette using the pipette.

3. Start timing and read results within 5 minutes; do not interpret after 7 minutes.

Performance

• Intra-Assay Precision: Over 98% accuracy for repeated tests at CRP concentrations of 1, 3, and 10 mg/L.

• Inter-Assay Precision: Over 98% accuracy across 10 independent tests on different batches with CRP concentrations of 1, 3, and 10 mg/L.

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