Performance and technical specifications

Intended use

AroCell TK 210 ELISA is intended for the measurement of Thymidine Kinase 1 (TK1) in human serum.

Regulatory approvals

AroCell TK 210 ELISA is CE-marked and compliant with the European Union IVD directive. The product is registered by the Swedish Medical Product Agency.

AroCell TK 210 ELISA is labeled For Research Use Only in the USA, China, S. Korea, Tunisia, Algeria, and Morocco.

Technical specifications

Assay format: Microplate sandwich ELISA
Size: 1 × 96 wells
Dynamic Range: 0–17 µg/L
Precision: 1.85 µg/L (5.1%)
11.53 µg/L (3%)
Incubation Time: 4.75 h
Sample Type: Serum
Sample Size: 180 µL
Species: Human
Controls are Included

Performance characteristics

Reference range 0-0.35 µg/L.
AroCell recommends that users determine their own reference range.
Limited of detection 0.19 µg/L
Measuring range 0.19 – 17 µg/L
The range may be extended by increasing sample dilution.
Dilution recovery <5% deviation from linearity.
Precision within assay At TK1 conc. 1.85 µg/L: CV% = 4.9%
At TK1 conc. 11.53 µg/L: CV% = 1.9%
Precision between assay At TK1 conc. 1.85 µg/L: CV% = 0.9%
At TK1 conc. 11.53 µg/L: CV% = 2.2%
Precision total At TK1 conc. 1.85 µg/L: CV% = 5.1%
At TK1 conc. 11.53 µg/L: CV% = 3.0%

 

Typical calibration curve obtained using AroCell TK 210 ELISA. Plot of A450nm versus [TK1] μg/L. This is for illustration only. Do not use for the calculation of samples (ref. 31-11TF710B1-05).

References

  1. Zhou, J. et al. The Proliferation Marker Thymidine Kinase 1 in Clinical Use. Molecular and Clinical Oncology 1 (2013), 18-28.
  2. Alegre, M.M. et al. Thymidine Kinase 1 Upregulation is an Early Event in Breast Tumor Formation. Journal of Oncology. Volume 2012, (2012). Article ID 575647, 5 pages.
  3. Guan, H. et al. Thymidine Kinase 1 Expression in Atypical Ductal Hyperplasia Significantly Differs from Usual Ductal Hyperplasia and Ductal Carcinoma In-Situ: A Useful Tool in Tumor Therapy Management. Mol Med Rep. 2(6): (2009), 923-9.
  4. Alegre, M.M. et al. Thymidine Kinase 1: A Universal Marker for Cancer. Cancer and Clinical Oncology. 2(1) 2013.
  5. Wu, C. et al. Production and Characterization of a Novel Chicken IgY Antibody Raised Against C-Terminal Peptide from Human Thymidine Kinase 1. Immunol Methods 277 (2003), 157-169.
  6. Bjöhle, J. et al. Serum Thymidine Kinase Activity Compared With Ca 15-3 in Locally Advanced and Metastatic Breast Cancer Within a Randomized Trial. Breast Cancer Res Treat. 139(3) (2013), 751-8.
  7. Chen, F. et al. Serum Thymidine Kinase 1 Levels Predict Cancer-Free Survival Following Neoadjuvant, Surgical and Adjuvant Treatment of Patients with Locally Advanced Breast Cancer. Molecular and Clinical Oncology. 1 (2013), 894-902.
  8. He, Q. et al. Thymidine Kinase 1 in Serum Predicts Increased Risk of Distant or Loco-regional Recurrence Following Surgery in Patients with Early Breast Cancer. Anticancer Research 26 (2006), 4753-4760.
  9. Jagarlamudi, K.K. et al. Breast and Prostate Cancer Patients Differ Significantly in Their Serum Thymidine Kinase 1 (TK1) Specific Activities Compared with Those Found in Hematological Malignancies and Blood Donors: Implications of Using Serum TK1 as a Biomarker. BMC Cancer 15 (2015), 66.
  10. Kumar, J.K. et al. A Clinical Evaluation of the TK 210 ELISA in Sera from Breast Cancer Patients Demonstrates High Sensitivity and Specificity at All Stages of the Disease. Tumor Biology 37(9) (2016), 11937-11945.