Crp C reactive protein test (20 pieces)

Product description: Finecare CRP (C-reactive protein) quantitative rapid test

No prescription is required for this product.

Usage

The Finecare CRP quantitative rapid test is intended in combination with the Finecare(TM) FIA measuring device for the quantitative determination of C-reactive protein (CRP) in human whole blood or serum.The test uses fluorescence immunoassay technology and is used to detect a cardiovascular risk factor (hsCRP) and to diagnose infections and inflammation.

Summary

C-reactive protein (CRP) is produced in the liver in response to interleukin-6 and is a well-known marker of inflammation.Serum CRPlevels can increase from normal values below 5 mg/L to up to 500 mg/L, depending on the severity of the infection or inflammation.High-sensitivity CRP (hsCRP) is an important risk factor for atherosclerosis and cardiovascular disease (CVD).

The following values are recommended for diagnosing inflammatory diseases and assessing the risk of CVD:

An CRPvalue of less than 1.0 mg/L indicates a low CVDrisk in the absence of a general inflammatory situation.Values between 1.0 and 3.0 mg/L indicate a moderate CVDrisk, while values above 3.0 mg/L indicate a high CVDrisk.An CRPvalue above 10 mg/L may indicate infection, with values between 10 and 20 mg/L indicating a mild bacterial or viral infection.Values between 20 and 50 mg/L indicate a moderate bacterial infection, while values above 50 mg/L indicate a severe bacterial infection.

Test principle

The Finecare CRP quantitative rapid test is based on a sandwich immunodetection method.When used, the CRPantigen in the blood sample binds to fluorescent-coated CRPantibodies in the membrane.The sample liquid passes through the nitrocellulose matrix of the test strip by capillary action.The complexes of detection antibodies and CRP combine with immobilized CRPantibodies on the test strip.The signal intensity of the fluorescence corresponds to the amount of stored CRP and is displayed by the Finecare FIA meter as the CRPconcentration in the blood sample.The measurement range of the CRPtest system is between 0.5 and 200 mg/L, with a detection limit of 0.5 mg/L.

Precautions

This test kit is intended exclusively for in vitro diagnostic use.Do not mix the components of different test kits or use the tests after the expiration date.Only use test cards with the lot number indicated on the ID chip and do not use test cards that are damaged or not completely sealed.The Finecare CRP quantitative rapid test can only be used with the Finecare FIA measuring device.Protect the test cards and the measuring device from vibrations and magnetic fields.Use separate, clean pipette tips for each blood sample and detection buffer.Handle all blood samples, used test cards, pipette tips, and detection buffer tubes in accordance with regulations for handling potentially infectious material.The measurement results should always be interpreted in conjunction with clinical findings and other laboratory values.

Material

The kit includes 25 test cards, 1 ID chip, 25 detection buffer vessels, 25 whole blood collection capillaries with caps, pipette tips, test instructions and instructions for using the whole blood collection capillaries.Additionally, you will need a Finecare FIA meter, alcohol swabs, sterile lancets, a centrifuge (only when using serum) and a stopwatch (when using the rapid test mode).

Storage and stability

Store the detection buffer and the Finecare CRP quantitative rapid test cards at 4 to 30°C.The shelf life is 24 months from production.The test cards should be used no later than 1 hour after opening the foil packaging.

Sample collection and preparation

The test can be performed with serum or whole blood.When using fingertip whole blood samples, please refer to the enclosed instructions for using the whole blood collection capillaries.To obtain whole blood samples by venipuncture, perform venipuncture according to standard procedures.The test should be carried out as soon as possible after sample collection.When using serum or plasma, separate the serum/plasma from the cellular components as quickly as possible to avoid hemolysis.

Test execution

Please note the instructions for the Finecare FIA measuring device before you start carrying out the test.The test should be carried out at room temperature. Check the enclosed ID chip and insert it into the measuring device.Use the enclosed whole blood collection capillaries according to the instructions or pipette 8.5 µL whole blood or 5 µL serum/plasma into the detection buffer vessel.Mix sample material and buffer by swirling the detection buffer vessel back and forth for 1 minute.Apply either 75 µL of the sample mixture with the pipette or 3 drops of sample mixture using the enclosed capillaries into the sample application area of the test card.For the standard test, insert the test card into the test strip holder with the sample application field first and click on "Test" in the display.The countdown is started and after 3 minutes the measurement result is shown on the display.For the rapid test, store the test card on a smooth, even surface after sample application and time the reaction time with a stopwatch.After exactly 3 minutes, insert the test card into the test card holder and click on "Test" in the display.

Quality control

Each Finecare CRP quantitative rapid test card contains an internal control that meets the requirements of routine quality control.This internal control is carried out every time a patient sample is tested.An invalid result of this internal control causes an error message from the Finecare FIA measuring device.The test should then be repeated.For internal quality control with the Finecare CRP control material, please note the instructions included with the controls and the instructions for use of the Finecare FIA measuring device.

Limitations of the test

This test was developed for testing human serum or whole blood samples.The results of examinations with the Finecare CRP quantitative rapid test should always be interpreted in the context of all clinical and laboratory data.If the CRP or hsCRP test result does not agree with the clinical examinations, additional tests should be carried out.False-positive results can be caused by cross-reactions with some similar antibodies in the blood, as well as by similar epitopes of non-specific components in the blood that react with the fluorescent antibodies. EDTA or another anticoagulant (e.g. heparin or citrate) is recommended for obtaining plasma.Other factors may interfere with the Finecare CRP quantitative rapid test and produce erroneous results.These can be technical or handling errors, as well as additional substances in the blood samples.

This leaflet was last revised in October 2017.

Source: Information in the package insert

As of: 01/2019