Lomina CRP Protein test

You want to see if you have cutaneous inflammation? Use the LOMINA CRP test as the first general indicator, an elevated blood level of which indicates the presence of an acute infection, but also the risk of developing diseases later in life.

Intended Use:

LOMINA CRP Protein is an immunochromatographic test, based on two specific antibodies against human CRP. The concentration-dependent formation of test lines allows a rapid semi-quantitative determination of CRP in whole blood samples.  

C-reactive Protein Test (CRP)

C-reactive Protein (CRP) in patient’s sera has been found in association with acute infections, necrotic conditions and a variety of inflammatory disorders. There is a strong correlation between serum levels of CrP and the onset of the inflammatory process. Monitoring the levels of CrP in patient’s sera indicates the effectiveness of treatment and the assessment of patient recovery. It is used in particular to differentiate bacterial infections from virus infections.

Available Packaging Variants:

Usable Biological Material:

The test is developed and tested for the use of serum, plasma and whole blood samples.

Whole blood

Major Parameters, Characteristics & Limits

Test duration: 15 min

IVD category: IVD other

Disease category: Inflammation

Sensitivity: 98.8% (95% CI: 95.6%-100%)
Specificity: 98.7% (95% CI: 96.6%-99.6%)
Accuracy: 98.7% (95% CI: 97.0%-99.6%)

What level of CRP is considered normal, and when do we talk about an unnatural increase? A level of up to 5mg/l of blood is considered natural for a healthy person. Higher CRP values, which range from 5 to 40 mg/l, may indicate inflammation or viral infection, while in bacterial infections the values normally range from 40 to 200 mg/l and in severe infections (sepsis) or burns the values may even exceed 200 mg/l. Infections with Gram-negative bacteria can cause up to 500 mg/l. However, higher numbers do not automatically mean only illness or injury.

Principle:

The LOMINA CRP Protein Test Device is an immunochromatographic test, based on two specific antibodies against human CRP. The concentration-dependent formation of test lines allows a rapid semi-quantitative determination of CRP in whole blood samples.

The test device is applied with the test sample which is diluted with buffer solution. The sample now moves through the test strip. If the test sample contains CRP, it attaches to the first anti-CRP antibody which is conjugated with a red gold colloidal for color marking. The red CRP antibody-gold complex, together with the sample liquid, diffuses through the membrane that is pre dispensed with Test line of the second anti-CRP antibody. The CRP-antibody-gold complex is immobilized by the antibodies coated on the membrane leading to the formation of red lines.

The intensity of Test Line depends on the CRP concentration in the sample. A test band (T) signal weaker than the reference band (R) indicates that the CRP level in the specimen is between 10-30 mg/l. A test band (T) signal equal or close to the reference band (R) indicates that the CRP level in the specimen is approximately 30 mg/l. A test band (T) signal stronger than the reference band (R) indicates that the CRP level in the specimen is above 30 mg/l.

The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

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Instructions for use (IFU)

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CE Certificate

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High sensitivity and specificity of tests

Quick test
evaluation

Tested in accredited laboratories

Simple
application

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