Comparative Testing of TVTs and Cyto-Chex BCTs

• Research type

  Research Study

• Full title

  Comparative Testing of Caltag Medsystems' TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) and Streck Cyto-Chex Blood Collection Tubes (BCTs)

• IRAS ID

  165328

• Contact name

  Rosalie Ward

• Contact email

  Rosalie.Ward@sth.nhs.uk

• Sponsor organisation

  Caltag Medsystems Ltd

• Clinicaltrials.gov Identifier

  STH18399, STH Project Number

• Duration of Study in the UK

  0 years, 4 months, 1 days

• Research summary

  To demonstrate that the lymphocyte profile of human blood collected in Caltag Medsystems’ TransFix/EDTA Vacuum Blood Collection Tubes® (TVTs) is stabilized for at least 14 days and to compare the performance of the product against Streck Cyto-Chex® Blood Collection Tubes (BCTs), a leading market competitor, over a 15 day stability period.

  To demonstrate the product performance for clearance by the US Food and Drug Administration (FDA), this study aims to verify the above statement via evaluation in a clinical setting at three independent external sites.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  14/NW/1531

• Date of REC Opinion

  22 Jan 2015

• REC opinion

  Further Information Favourable Opinion