The test

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

Indications

  • 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 only.
  • Blood collection and centrifugation must be done on the same day.
  • EDTA plasma samples can be stored at -20°C for up to one year.

Sample stability and shipment

  • Only EDTA plasma samples should be used.
  • 12 hours at room temperature (only suitable for dispatch within a hospital or diagnostic center or by courier).
  • Up to 3 days at 4° – 8°C.
  • Up to 1 year at -20°C.

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
  • Dilute EDTA-plasma samples 1:100 with sample-/washing buffer
  • Pipette 50 µl blank, standards (ready-to-use), control (ready-to-use) and samples in duplicate into the ELISA-strips
  • Incubate 60 minutes at room temperature
  • Wash
  • 50 µl anti M2-PK bio (1:100)
  • Incubate 30 minutes at room temperature
  • Wash
  • 50 µl POD-Streptavidin (ready-to-use)
  • Incubate 30 minutes at room temperature (in the dark)
  • Wash
  • 100 µl substrate solution (ready-to-use)
  • Incubate 15 minutes at room temperature (in the dark)
  • Add 100 µl stop solution (ready-to-use)
  • Read plate at OD 450 or OD 450 – OD 620
  • Evaluate with standard curve using a log-log scale