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Cytomark

Welcome to Cytomark - A division of Caltag Medsystems

Cytomark are dedicated to the development of cell stabilisation reagents for use in flow cytometry. Based in Buckingham, Cytomark specialise in the development of two key product areas: TransFix® and Blood Controls.

TransFix® is a CE marked solution for IVD use that prevents cellular degradation in human peripheral blood for analytical testing purposes. Leucocytes and leucocytic antigens are stabilised for up to 14 days at sample storage temperatures between 2-8°C, and for 4 days at temperatures between 25-37°C . TransFix® is also used to stabilise CSF, bone marrow, and other samples prior to flow cytometric analysis. As a result, samples treated with TransFix® can be analysed at a more convenient time for the operator.. Our products are widely used for immunophenotyping purposes in hospitals and reference laboratories, as well as academic research institutions, pharmaceutical & biotechnology companies.

The ISO standard entitled 'ISO 15189: Medical laboratories - Particular requirements for quality and competence', refers to the requirement for reference samples during flow cytometer set up and running. Our Stabilised Human Whole Blood and CD4 Low and Normal Controls provide suitable reference samples for this purpose. The stabilisation process is robust, resulting in controls that are stable for up to 90 days from the date of manufacture when stored at 2 - 8°C, and have an open vial stability of 1 month.

Applications of TransFix: Human Blood Stablilisation

Without stabilisation, flow cytometric analysis of blood samples must be performed within 48 hours of venepuncture, as apoptosis and proteolytic degradation of cellular markers will detrimentally affect the immunophenotypic profile. Blood samples older than 48 hours are often no longer suitable for flow cytometric examination, exhibiting indistinguishable cell subsets and inaccurate absolute cell counts leading to erroneous clinical results. This may require a fresh sample to be taken, incurring extra costs and delayed analysis.

TransFix is a solution that stabilises leucocytes and leucocytic antigens for up to 14 days, preserving the absolute cell counts found in fresh blood and allowing differentiation of leucocyte sub-populations. This allows for an extended time frame for analytical testing.

Features and Benefits of TransFix

Features

  • Prevents leucocytes and leucocytic marker degradation for up to 14 days
  • Absolute cell counts of stabilised samples equivalent to fresh blood
  • Equivalent immunophenotypic profile to fresh blood with easily defined leucocyte sub-population (minimal adjustment of automatic gating strategies required)
  • Prevents cellular degradation: Low levels of debris
  • Apoptotic pathways blocked preserving cellular morphology
  • Easy to use, just add TransFix and mix by inversion
  • Multiple product formats available

Benefits

Stabilisation of whole blood allows for the following benefits:

  • Ability to batch samples prior to analysis for greater efficiency, reduced labour time, and reduced daily flow cytometer start-up costs
  • Time for samples to be transported to/from remote sites, such as reference labs, during clinical trials, or in resource poor countries
  • Reduction in the need to redraw blood due to degraded samples, for example for further testing after initial analysis
  • Accommodates for staff shortages or machine breakdown

For more information on the applications of blood stabilisation, TransFix performance data, case studies, protocols and references, please visit:

https://www.cytomark.co.uk/transfix_human_blood_stabilisation.php

Or contact us at:

Tel: 01280 827460
Email: cytomark@caltagmedsystems.co.uk

Applications of TransFix: Stabilisation of Cerebrospinal Fluid

Analysis of white blood cells in CSF is critical in the diagnosis of many infectious and inflammatory neurological disorders. As well as central nervous system involvement with lymphoproliferative disorders. Flow cytometric analysis can provide absolute cell counts and detect rare events with high sensitivity and specificity, however cells within CSF samples are typically low in number, sparse in concentration and degrade rapidly ex vivo. This results in the necessity to promptly test CSF specimens to prevent false negative results.

TransFix has been shown to stabilise malignant haematological cells in cerebrospinal fluid, making it possible to determine leucocyte subsets in CSF via flow cytometric analysis 72 hours after lumbar puncture. TransFix has therefore been has been recommended in guidelines published in the British Journal of Haematology

  • TransFix/EDTA CSF Sample Storage Tubesare specifically designed for the stabilisation of cells within CSF specimens.
  • Quality controlled against CSF substitute, including the markers CD14, CD4, CD8, CD19, CD20, Igκ, Igλ, CD56. (see CoAs for full details).
  • Specific protocol for CSF sample preparation with TransFix (see IFU).
  • Higher lymphocyte yield after 30 minutes compared to untreated samples (see case study 2).
  • The cellular component of CSF is stabilised for at least 72 hours allowing for determination of cell sub-populations and follow up analysis (see case study 3).
  • Light scatter and key antigen expression patterns are comparable to fresh samples (see case study 3and case study 4).
  • Markers stabilised include Markers stabilised include CD10, CD19, CD34 (see case study 3and case study 4), CD45, HLA-DR, and CD117 (see case study 3).

Benefits of Cerebrospinal Fluid Stabilisation

  • More time in which to conduct testing
  • Allows for further investigation after initial cytomorphological analysis has identified malignant cells, using an aliquot of the same sample.
  • Allows determination of leucocytic cell populations via flow cytometric analysis, up to 3 days after collection.
  • Reduced cell lysis during transportation of samples from the collection site to the laboratory.
  • Reduced need for repeat lumbar puncture
    • Reduced costs
    • Reduced trauma for child patients and parents
    • Reduced time spent re-sampling
  • Standardise Results:

For more information on the applications of CSF stabilisation, TransFix performance data, case studies, protocols and references, please visit:

https://www.cytomark.co.uk/transfix_CSF_stabilisation.php

Or contact us at:

T: +44 (0) 1280 827460
E: office@caltagmedsystems.co.uk

Application of TransFix: Circulating Tumour Cell Stabilisation

Tissue biopsies are invasive, cannot be used repeatedly, and only provide a representation of the organ of interest. Circulating tumour cell analysis provides a liquid “surrogate tumour biopsy”, providing an overall state of metastatic disease, in real time, without invasive procedures. CTC characterisation at the molecular level also has the potential to provide pharmacodynamic and predictive biomarkers and potentially provide use in revealing drug resistance in real time (3).

The use of Circulating Tumour Cell TransFix/EDTA Vacuum Blood Collection Tubes (CTC-TVTs) has facilitated the development of multiple CTC isolation and analysis methods, due to improved cell stability and recovery of these rare cells.

Benefits of CTC Stabilisation

The use of Circulating Tumour Cell TransFix/EDTA Vacuum Blood Collection Tubes has facilitated the development of multiple CTC isolation and analysis methods, due to improved cell stability and recovery of these rare cells.

This demonstrates that CTC-TVTs:

  • Stabilise samples in such a way that allow for isolation of CTC using size exclusion filtration. For example by using a Hamilton STARlet™ robot (see case study 1and case study 2), or ScreenCell Cyto Kits (see case study 3).
  • Stabilise samples in such a way that allow for isolation of CTCs using cellular surface markers, for example, by the EasySep human CD45 depletion kit (see case study 4) from whole blood.
  • Enables the microscopic analysis and enumeration of CTCs in metastatic breast and lung cancer patients at mean levels as low 0.41 CTC/mL and 0.04 CTC/mL respectively (see case study 2).
  • Enables the analysis of CTCs through high-resolution image flow cytometry (see case study 4)
  • Compatible with cell sorting, for example by the DEPArray™system, and mutation analysis via Sanger sequencing (see case study 3)

For more information on the applications of CTC stabilisation, case studies, protocols and references, please visit:

https://www.cytomark.co.uk/circulating_tumour_cell_stabilisation.php

Or contact us at:

Tel: 01280 827460
Email: cytomark@caltagmedsystems.co.uk

Applications of TransFix: Bone Marrow, Lymph Nodes, Exosomes and Animal Blood

TransFix can also be used for a number of applications. Find out more about these applications on the Cytomark website by clicking on the links below:

TransFix: Available Formats

TransFix/EDTA Vacuum Blood Collection Tubes (CE)
Plastic, direct draw collection tubes used to stabilise venous blood at the point of collection and preserve whole blood specimens for immunophenotyping by flow cytometry.

TVTs are available in 3ml or 9ml sizes. Each tube is prefilled with sufficient TransFix containing K3EDTA for the immediate anticoagulation and stabilisation of 3ml or 9ml of blood, respectively. TVTs are available in pack sizes of 1, 2 or 50 tubes.

Circulating Tumour Cell TransFix/EDTA Vacuum Blood Collection Tubes (RUO)
9ml blood collection tubes prefilled with sufficient TransFix for the collection and stabilisation of circulating tumour cells in whole human blood. These tubes are available in packs of 2 or 50.

TransFix/EDTA CSF Sample Storage Tubes (RUO)
TransFix/EDTA CSF Sample Storage Tubes consist of 5ml screw cap tubes containing 0.2ml of TransFix/EDTA, which can be used to stabilise up to 5ml of CSF. These tubes are available in packs of 2, 10, 25 and 50.

TransFix (CE)
TransFix is provided in 1 and 20ml aliquot sizes and in pack sizes of 10 and 50 1ml tubes. This gives the end user most flexibility with regard to application of TransFix to research samples.

TransFix Sample Storage Tubes (CE)
TransFix Sample Storage Tubes consist of 1.2ml tubes containing 0.2ml of TransFix. These tubes do not contain an anti-coagulant.

Custom Sizes
Cytomark are able to provide TransFix in alternative volumes and quantities. Please contact us with your requirements for further information.

Blood Controls

Routine haematological testing requires the use of reference material during machine set up such that validation prior to analysis of patient samples can be performed. Many also require repeat use of reference controls throughout the running period of the machine, ensuring sample processing, equipment and operators are all performing optimally, thereby providing quality assurance.

In Flow Cytometry however, it has not been the norm to use reference material since it has not previously been possible to stabilise samples for use as a reference. Using proprietary blood stabilisation technology, Cytomark can now produce stabilised human whole blood with both normal and low CD4 counts for use as blood controls. The stabilisation process is robust resulting in controls that are stable for up to 90 days from the date of manufacture when stored at 2 - 8°C, and an open vial stability of 1 month.

The stabilised controls allow gating, and forward and side scatter flow cytometric effects to be determined during machine set up and before and during analysis of patient samples.

The ISO standard entitled 'ISO 15189: Medical laboratories - Particular requirements for quality and competence', refers to the requirement for reference samples during flow cytometer set up and running. Cytomark's Stabilised Human Whole Blood and CD4 Low and Normal Controls provide suitable reference samples for this purpose.

Key Benefits of Cytomark's Blood Controls:

  • Verification of monoclonal antibodies and flow cytometry reagents
  • Validation of flow cytometer performance
  • Validation of operator technique
  • Verification of red blood cell lysis

Blood Controls Available:

Stabilised Human Whole Blood

The Stabilised Human Whole Blood control is supplied with a QC certificate detailing the expected count and range for T cells (CD3+), T helper cells (CD3+CD4+), T suppressor cells (CD3+CD8+), NK cells (CD56+)and B cells (CD19+).

CD4 Low and Normal Blood Controls

The CD4 Normal Blood Control contains CD4+ T cells in the normal range (410-1590 cells/µl) and the CD4 Low Blood Control contains CD4+ T cells in a low range (200-300 cells/µl). These controls can be purchased separately or as a pair.

If you would like to be alerted when a new batch of Blood Controls are released, please contact us.

If you are having difficulty downloading product data or require further information, please contact us.