Transfix

Intermedico ApS

 

 

Viadukt allé 16 - 2900 Hellerup

T: 4814 1939

F: 4814 1959

info@intermedico.dk

Cvr: 26172578

Transfix - A Cellular Antigen Stabilisation Reagent

TransFix is a patented, CE marked stabilisation solution that prevents cellular degradation in human and animal blood for analytical testing purposes.

 

TransFix is validated for the stabilisation of whole blood for flow cytometric analysis. The active components of TransFix stabilise leukocytes and leukocytic antigens for up to 10 days at sample storage temperatures of between 2-25°C (1) and for 4 days at temperatures between 25-37°C (2).

 

TransFix is added to whole blood samples at the time of venepuncture, immediately stabilising the cells for up to 10 days. This provides flexibility with testing and reduces the impact of unexpected staff shortages or machine breakdown in laboratory settings. The extended storage time also allows samples to be transportated to/from remote sites, reduction in repeat testing and the ability to batch samples for testing. These benefits all have the potential to reduce costs for the laboratory.

 

TransFix is available in several formats (CE unless stated), including: TransFix/EDTA Vacuum Blood Collection Tubes, TransFix Sample Storage Tubes, TransFix/EDTA CSF Sample Storage Tubes (RUO) and TransFix in bulk format.

 

TransFix is CE marked but can also be used for research purposes.

 

 

Benefits of TransFix®

•Stabilises cell surface antigens for a minimum of 10 days at 2-25°C (1) and for 4 days at 37°C (2)

•Easy to use, just add TransFix and mix by inversion

•Ensures sample integrity during transportation between clinical sites

•Eliminates the need for weekend and evening work

•Reduces the impact of unexpected machine breakdown or staff shortages

•Allows for repeat testing of samples without the need for patient recall and repeat phlebotomy

•Greater efficiency in testing – allows for batching of samples prior to testing

•Reduction in costs associated with the above advantages

 

Sample Stability

 

Whole blood degrades over time and blood samples older than 48 hours are no longer suitable for flow cytometric examination. Addition of TransFix to blood samples at the time of collection has been shown to significantly extend the integrity of the samples. We have demonstrated that the immunophenotypic profile is maintained for up to 10 days, including markers: CD3, CD4, CD8, CD10, CD16, CD19, CD34, CD45, CD56, and MPO.

 

Sample Transport & Batching

 

The use of TransFix is beneficial in situations where sample storage, batching or transportation is required prior to analysis. This may be particularly relevant in resource poor or remote areas of the world where there may be extended transit times between the phlebotomy site and laboratory. TransFix treated samples may also be batched together before transportation, thereby reducing the number of shipments to the laboratory and thus reducing costs. In addition, the batching of samples for testing may result in reduced laboratory staffing costs.

 

TransFix also reduces the need to recall patients for additional phlebotomy by extending the window of opportunity for sample testing, resulting in significant cost savings. This may be useful in circumstances where unexpected delays in testing have occurred, e.g. machine break down or transportation delay. TransFix may also reduce the need for out of hours testing as treated samples can be stored until normal working hours. The use of TransFix may therefore reduce the costs associated with out-of-hours testing.

 

Easy To Use

 

Samples should be treated with TransFix as soon as possible after phlebotomy. Samples are added to TransFix, inverted and then stored at 2-8°C. The sample can then be treated as a “routine” preparation for subsequent analysis. The dilution factor must be taken into account when calculating cell absolute counts.

NameArt noSize

 

TransFix® Vacuum Blood Collection Tubes - CE

 

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

 

TransFix/EDTA Vacuum Blood Collection Tubes are designed, manufactured and CE marked by Vacutest KIMA s.r.l, Italy and contain Cytomark CE marked TransFix.

 

 

Product Code Description

 

TVT-03-2 TransFix/EDTA Vacuum Blood Collection Tubes (2 x 3ml tubes)

TVT-03-50 TransFix/EDTA Vacuum Blood Collection Tubes (50 x 3ml tubes)

TVT-09-2 TransFix/EDTA Vacuum Blood Collection Tubes (2x 9ml tubes)

TVT-09-50 TransFix/EDTA Vacuum Blood Collection Tubes (50 x 9ml tubes)

 

 

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.

 

 

Product Code Description

 

TF-01-2 TransFix Sample Storage Tubes (2 x 1.2ml tubes)

TF-01-10 TransFix Sample Storage Tubes (10 x 1.2ml tubes)

TF-01-25 TransFix Sample Storage Tubes (25 x 1.2ml tubes)

TF-01-50 TransFix Sample Storage Tubes (50 x 1.2ml tubes)

 

TransFix® - CE

 

TransFix is provided in the following aliquot sizes. This gives the end user most flexibility with regard to application of TransFix to research samples.

 

 

Product Code Description

 

TFB-01-1 1ml vial TransFix – sample

TFB-20-1 20ml vial TransFix Bulk

 

Cerebrospinal Fluid Stabilisation with TransFix® EDTA

 

Leukocytes in cerebrospinal fluid (CSF) provide a marker for suspected central nervous system (CNS) localised leukemia or lymphoma. Since CSF cells are often low in numbers and degrade quickly, it has been recognised that stabilisation of CSF is important. TransFix® can be used to stabilise patient CSF samples for research use, providing accurate and reliable flow cytometric data.

 

The active components of TransFix stabilise leukocytes and leukocytic antigens. By using TransFix/EDTA CSF Sample Storage Tubes to stabilise CSF leukocytes it is possible to determine leukocytic sub-populations via flow cytometric analysis up to 10 days after collection (1-5).

 

Evaluation Study: CSF Screening for Suspected CNS localised leukemia or lymphoma

 

Evaluation studies into the use of TransFix/EDTA for stabilising CSF samples from patients with suspected CNS localised leukemia or lymphoma are being conducted*. Results to date indicate the following:

•Lymphocyte cell recovery of most subsets observed in TransFix/EDTA treated CSF samples matched or exceeded that of the fresh samples

•Antigen expression profiles in TransFix/EDTA treated CSF are maintained for 3-7 days and are comparable to equivalent fresh, untreated CSF samples

•The diagnostic conclusion would have remained the same for all patients using TransFix/EDTA treated samples compared to fresh

•Results suggested that TransFix/EDTA can be used successfully to stabilise CSF samples for screening purposes.

 

 

N.B. Currently TransFix EDTA Sample Storage Tubes are validated for research use only. They are not validated for immunophenotyping and leukaemia screening.

 

*In collaboration with Haematology Oncology Diagnostics at the Bristol Royal Infirmary.

 

Sample Preparation for Flow Cytometry

 

Sample preparation is detailed in the 'Information for Use' documents associated with each product (see below).

 

TransFix/EDTA CSF Sample Storage Tubes - RUO

 

TransFix/EDTA CSF Sample Storage Tubes can be used to stabilise from 1-5ml of CSF. These tubes are available in packs of 10, 25 and 50. 2 pack sample sizes for evaluation are also available.

 

 

Product Code Description

 

TF-CSF-5-2 2 x 5ml CSF Sample Storage tubes containing 0.2ml TransFix/EDTA - sample

TF-CSF-5-10 10 x 5ml CSF Sample Storage tubes containing 0.2ml TransFix/EDTA

TF-CSF-5-25 25 x 5ml CSF Sample Storage tubes containing 0.2ml TransFix/EDTA

TF-CSF-5-50 50 x 5ml CSF Sample Storage tubes containing 0.2ml TransFix/EDTA

 

 

 

 

Instructions to use