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ScheBo® · Biotech AG
Netanyastrasse 3
35394 Giessen
Germany

Phone +49 (0)641 / 4996-0
Fax +49 (0)641 / 4996-77
Email-contact

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 Tumor 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 Tumor 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 Tumor 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



AEO-Certificate
The Main Customs Office of Giessen, Germany issued an AEO-F Certificate (Authorized Economic Operator – Customs Simplifications plus Security and Safety) to ScheBo Biotech AG on September 30, 2011.
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Lecture DDW 2011: New molecular markers: M2-PK
Lecture of Prof. Dr. Sybille Mazurek on WEO/OMED Colorectal Cancer Screening Committee Meeting DDW 2011.
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Biomarker ′M2-PK′ Identified as Key Enzyme in Cancer Diagnosis and Therapy
Ground Breaking Findings on Understanding Cancer Published in ′Science′
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Video: Focus 2010 lecture on M2-PK
The high sensitivity (c.80%) and high specificity (>90%) of the M2-PK stool test for colorectal cancer screening and detection, plus benefits for patients, laboratories and doctors, was presented at Focus 2010
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Tumour M2-PK as a stool marker for colorectal cancer
Comparative analysis in a large sample of unselected older adults vs colorectal cancer patients.
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Coeliac disease and pancreatic exocrine insufficiency
The data have shown that pancreatic insufficiency, demonstrated by low faecal pancreatic elastase-1 levels, is common in adult coeliac disease patients.
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ISO-Certificate
Our ISO-Cerficate as pdf-download.
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