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  • Regulatory status:RUO
  • Type:Sandwich ELISA
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Cat. No. Size Price

RGD001R 96 wells (1 kit)
PubMed Product Details
Technical Data


Sandwich ELISA


Serum, Plasma


At ambient temperature. Upon receipt, store the product at the temperature recommended below.


Store the complete kit at 2–8°C. Under these conditions, the kit is stable until the expiration date (see label on the box).

Calibration Range

0.079 – 50 ng/mL

Limit of Detection

0.15 ng/mL

Intra-assay (Within-Run)

CV: 3,5%

Inter-assay (Run-to-Run)

CV: 7,1%

Spiking Recovery


Dilution Linearity



Research topic



Cytokeratins are epithelial markers whose expression is not lost during malignant transformation. CYFRA 21-1 is a cytokeratin-19 fragment that is soluble in serum and can be used as circulating tumor marker. Although expressed in all body tissues, its major occurrence is in the lung, particulary in lung cancer tissues. CYFRA 21-1 is a sensitive and specific tumor marker of non-small-cell lung cancer (NSCLC), especially of squamous cell subtype (1,2,3). It also reflects the extent of the disease and has an independent prognostic role along with performance status and disease stage in NSCLC (4,5,6). In addition, detection of serum CYFRA 21-1 allows for identification of high risk patients that may benefit from adjuvant chemotherapy (7), and enables the early detection of progressive disease in recurrent NSCLC (8). Additionally, CYFRA 21-1 has been described as a useful marker for esophageal squamous cell carcinoma (9) and for therapy monitoring of bladder cancer (10). The TM-CYFRA 21-1 ELISA uses the two mouse monoclonal antibodies KS19.1 and BM19.21 to determine cytokeratin-19 fragments.

Summary References (10)

References to CYFRA 21-1

  • Andreadis C. et al. Serum CYFRA 21-1 in patients with invasive bladder cancer and its relevance as a tumor marker during chemotherapy. J. Urol.; 2005; 174(5); 1771-5.
  • Farlow E.C. et al. A multi-analyte serum test for the detection of non-small cell lung cancer. Br. J. Cancer; 2010; 103(8); 1221-8.
  • Holdenrieder S., et al. Nucleosomes and CYFRA 21-1 indicate tumor response after one cycle of chemotherapy in recurrent non-small cell lung cancer. Lung Cancer; 2009; 63(1); 128-35.
  • Molina R. et al. Mucins CA 125, CA 19.9, CA 15.3 and TAG-72.3 as tumor markers in patients with lung cancer: comparison with CYFRA 21-1, CEA, SCC and NSE. Tumour Biol.; 2008; 29(6); 371-80.
  • Muley T., Dienemann H., Ebert W. Increased CYFRA 21-1 and CEA levels are negative predictors of outcome in p-stage I NSCLC. Anticancer Res. 2003; 23(5b); 4085-93.
  • Pujol J.L. et al. CYFRA 21-1 is a prognostic determinant in non-small-cell lung cancer: results of a meta-analysis in 2063 patients. Brit. J. Cancer; 2004; 90(11); 2097-2105.
  • Rastel D. et al. CYFRA 21-1, a sensitive and specific new tumour marker for squamous cell lung cancer. Report of the first European multicentre evaluation. CYFRA 21-1 Multicentre Study Group.
  • Tomita M. et al. Prognostic significance of tumour marker index based on preoperative CEA and CYFRA 21-1 in non-small cell lung cancer. Anticancer Res.; 2010; 30(7); 3099-102.
  • Wieskopf B., et al. Cyfra 21-1 as a biologic marker of non-small cell lung cancer. Evaluation of sensitivity, specificity, and prognostic role. Chest; 1995; 108(1); 163-9.
  • Yamamoto K. et al. CYFRA 21-1 is a useful marker for esophageal squamous cell carcinoma. Cancer; 1997; 1;79(9); 1647-55.
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