The test

Further indications, specificity and sensitivity, method of detection, sample material, sample stability and shipment, short protocol


  • Complementary investigation in the diagnosis of renal cell carcinoma
  • Monitoring response to therapy
  • Early detection of relapse or of metastasis
  • Monitoring of tumor agressiveness
  • Diagnostic support and patient follow-up:
    – Colorectal Cancer
    – Gastric Cancer
    – Oesophageal Carcinoma
    – Lung Cancer
    – Breast Cancer
    – Pancreatic Cancer

High specificity and sensitivity

Highly specific correlation between M2-PK concentration and tumor malignancy.

Renal Cell Carcinoma:
Specificity: >90% Sensitivity: 70-100% (depends on Robson stage)

Methode of detection

Sandwich ELISA with two monoclonal antibodies highly specific for human M2-PK. The ELISA kit is based on a microtiter plate (96 well format) with 12 single strips x 8 wells sutiable for up to 42 samples in duplicate.

Sample material

  • Human EDTA-plasma. Other sample material such as serum, heparin plasma or citrate plasma must not be used.
  • Haemolytic, icteric or lipaemic samples are not suitable for Tumor M2-PK measurement.

Sample stability and shipment

  • Blood samples must be collected into EDTA tubes. Samples must be centrifuged and the supernatant EDTA-plasma must be carefully removed into storage tubes within 24 hours of blood collection.
  • EDTA-plasma samples are stable for 3 days at 4-8 °C or for up to 1 year at -20 °C.
  • EDTA-plasma samples diluted with sample/washing buffer 1x may be stored for up to 1 day at 4-8 °C and for 10 days at -20 °C. Avoid repeated freeze-thaw cycles.

Short protocol for the experienced user

Important: The short protocol is not a substitute for the detailed protocol given in the instruction manual!

  • Prepare the sample/washing buffer 1x
  • Dilute EDTA-plasma samples (10 µl EDTA-Plasma + 1000 µl sample/washing buffer 1x)
  • Reconstitute lyophilized standards and control with sample/washing buffer 1x
  • Pipette 50 µl blank, standards, control and samples in duplicate into the ELISA-strips – Incubate 60 minutes at room temperature – Wash
  • Add 50 µl Tumor M2-PK EDTA-Plasma Test Complex (ready-to-use)
    – Incubate 30 minutes at room temperature in the dark – wash
  • Add 100 µl TMB-Substrate solution (ready-to-use)
    – Incubate 15 minutes at room temperature in the dark
  • Add 100 µl TMB-Stop solution (ready-to-use)
  • Read plate at OD 450 or OD 450-OD 620 between 5 and 30 minutes after addition of the TMB-Stop solution
  • Evaluate with standard curve using a log-log scale