Medical Device Ck-MB: CRP Semi-Quantitative Rapid Test Strip
PRECAUTIONS
The CrP Test Strip is an immunochromatographic test, based on two specific antibodies against human CrP. The concentration-dependent formation of test lines allows a rapid semiquantitative determination of CrP in whole blood samples.
The tip of the test strip is dipped into the test sample which is diluted with buffer solution. The sample now moves through the test strip from bottom to top. 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 lines of different amounts 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 number of lines depends on the CrP concentration in the sample. The more CrP is contained in the sample, the more red lines become
visible.
The control line serves as a procedural control and indicates that sufficient volume of specimen has been added and membrane wicking has occurred.
INTERPRETATION OF RESULTS
QUALITY CONTROL
- ● Internal procedural controls are included in the test. Control band appearing in the control regions is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
- ● External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
The CRP test strip is very user-friendly and requires only a minute amount of serum, plasma, or whole blood sample for a successful test. It delivers results quickly and accurately, making it an excellent choice for diagnostic centers, hospitals, and laboratories looking for a reliable tool in determining inflammation status or cardiovascular risk of their subjects. Utilizing this medical device Ck-MB, healthcare professionals can expedite their processes and make timely decisions, enhancing the quality of care provided to patients. The CRP Semi-Quantitative Rapid Test Strip from QL Biotech is a significant addition to any medical toolset that seeks to adopt advanced technology for improved patient outcomes. At QL Biotech, we are devoted to contributing positively towards the world of medical diagnostics, providing unmatched solutions that truly make a difference.