CYFRA 21-1 POCT Kit

Intended use

This CYFRA 21-1 POCT Kit is based on the fluorescence immunoassay for the quantitative detection of CYFRA 21-1 in multiple samples like human serum and plasma sample by self-developed LYOFIA® system.

For in vitro diagnostic use only.

Summary

Cytokeratin 19 (CK19) is a soluble cytokeratin fragment 21-1. Cytokeratin is an intermediate filament component that constitutes the cytoskeleton, and is found throughout human epithelial cells. At present, 20 different cytokeratins have been found. With the help of two monoclonal antibodies KS19.1 and BM19.21, the cytokeratin A white 19 fragment, which is CYFRA21-1, can be detected.

Squamous cell carcinoma, also known as epidermal carcinoma, is a malignant tumor that occurs in the epidermis or adnexal cells, and the cancer cells have different degrees of keratinization. It is more common in areas covered by squamous epithelium, such as skin, mouth, lips, esophagus, cervix, vagina, etc. In addition, although some parts such as bronchi, bladder, renal pelvis, etc. are not covered by squamous epithelium, they can form squamous cell carcinoma through squamous metaplasia.

Why Test CYFRA21-1?

Clinically, 80-85% of lung cancer patients are non-small cell lung cancer, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma, etc., and lung squamous cell carcinoma is one of the common types of non-small cell lung cancer. Serum CYFRA21-1 is one of the preferred markers for non-small cell lung cancer, and it has a high auxiliary diagnostic value for squamous cell carcinoma. The positive rate of serum CYFRA21-1 in the diagnosis of lung cancer is 63%, and the positive rate for diagnosis of lung squamous cell carcinoma is the highest,up to 78%.

CYFRA21-1 as a biomarker for prognosis and recurrence. In the case of unclear ring-shaped shadows in the lungs and the serum CYFRA21-1 concentration>30ng/ml, the diagnosis of primary bronchial lung cancer is more likely. The serum concentration of CYFRA21-1 is positively correlated with the clinical stage of the tumor, and it can also be an effective indicator for tracking early recurrence of lung cancer after surgery, radiotherapy and chemotherapy. High serum concentration levels of CYFRA21-1 indicate advanced disease and poor prognosis. The sign of successful surgery is the rapid decline of serum CYFRA2-1 concentration, otherwise, it means that the lesion has not been completely cleared, and the serum level rises after a decrease, indicating recurrence of the disease. Cancer > large cell carcinoma > J cell carcinoma, so it is recommended to screen for lung cancer to detect CYFRA21-1,CEA,NSE and ProGRP.

Advantage

· Accurate

The CV. of Repeatability and within-laboratory imprecision is no more than 10%,the CV. of inter-lot imprecision is no more than 15%.

· Fast

The CYFRA 21-1 POCT Kit detects the levels of CYFRA21-1 in serum or plasma samples within just 10 minutes.

· Easy to use

Without the use of cumbersome laboratory equipment,but just requiring minimally trained laboratory personnel.

PRODUCT PARAMETER

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