CellaVision DM96 leucocyte and flagging evaluation of Advia 2120i
Research type
Research Study
Full title
Evaluation of CellaVision DM9600 leucocyte classification to verify flagging performance of the Advia 2120i.
IRAS ID
236782
Contact name
William Thomas
Contact email
Sponsor organisation
Cambridge University Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
Hypothesis
The CellaVision DM9600 will provide an accurate and precise method for the enumeration of leucocytes comparable to that of the gold standard, manual microscopy. The suspect flags and large unstained cell parameter produced by the Advia 2120i will provide sensitive and specific evidence for the presence of atypical leucocytes associated with haematological malignancies.Summary
The processing of a full blood counts (FBC) in a Haematology laboratory is a core routine test that is used to screen for a multitude of haematological conditions. With regards to leukaemia, suspicious white cells are flagged by the analyser for manual blood film review by a Biomedical Scientist using light microscopy. There has been for some time disparity in the sensitivity and specificity of the flagging algorithms used to detect primitive white cells by haematology analysers. In addition, the processing of manual blood films using light microscopy is a labour intensive task and one in which is putting more pressure on NHS laboratories as workload increases.The study will involve the use of blood samples from two cohorts, healthy volunteers and those with Haematological malignancies. Both will be given a participant information sheet and if willing, can complete a consent form. This will involve a single blood sample being taken and anonymised for a full blood count and manual blood film. The blood film that is reviewed by manual microscopy will then undergo a digital blood film review. The leucocyte differential from both techniques and assessment of the analyser suspect flagging will then be performed.
The study will be conducted over an 6 month period and involve the comparison of blood film results produced manually compared to a digital technique, and the analysis of the specificity and sensitivity of the analyser flags to detect particular cells present in the patient/volunteer's blood.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0333
Date of REC Opinion
3 May 2018
REC opinion
Favourable Opinion