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CLL - Residual Disease Update

on Friday, 11 January 2019. Posted in Homepage, Haematology

CLL - Residual Disease Update

Website update for CLL MRD

Minimal residual disease for CLL is performed by flow cytometry within the Cell Markers Lab in Haematology. The procedure for measurement has been reviewed and updated in line with current recommendations1. The new panel provides clearer delineation of CLL populations and is able to exclude other minor B cell populations such as haematogones and plasma cells.

Sample requirements remain the same: either 1-2mls of Bone marrow or 4-5 mls PB in EDTA (although additional sample may be advisable in patients who are leucopenic).

Samples should be received and tested within 48 hours to ensure meaningful results (note that the laboratory is not open at weekends).

Reporting of CLL MRD has also been updated to provide additional information and will include:

A summary statement

A quantitation (%)                       ONLY if the level is at or above the limit of quantitation

Limit of detection (LOD)         The percentage above which CLL cells can be recognised but there are                                                                        too few to be reliably quantified.

Limit of quantitation (LOQ)    The minimum percentage at which CLL cells may be quantified.

LOD and LOQ are calculated for each patient sample.

The procedure has been optimised to achieve an LOD of 0.004% and an LOQ of 0.01%, but this is dependent upon the cellularity of the sample and may therefore be higher (and thus less sensitive).

1A complementary role of multiparameter flow cytometry and high-throughput sequencing for minimal residual disease detection in chronic lymphocytic leukaemia: a European Research Initiative on CLL study.

Rawstron et al

Leukaemia2016 Apr;30(4):929-36. doi: 10.1038/leu.2015.313. Epub 2015 Dec 7

Notification of Change: upgrade of instrumentation For Virology Real-Time PCR testing

on Thursday, 24 May 2018. Posted in Homepage

In order to improve the service to our users we have upgraded the instrumentation used to perform the testing and detection of Viral and Bacterial nucleic acids by real time PCR. A full validation of the change has been performed and users will be informed of any change in performance characteristics.
However, these assays now lie outside our scope of accreditation as assessed by UKAS. UKAS have been informed and will assess the assays on the new instrumentation as an extension to scope of our accreditation at our next inspection. This is normal procedure when changing platforms.

Update on Blood Transfusion Service - HGS Pathology

Written by Craig Webster on Tuesday, 02 October 2018. Posted in Homepage, Haematology, General

Update on Blood Transfusion Service - HGS Pathology

On the 1st October 2018, the current UKAS accredited Blood Group and Antibody screen offered by HGS laboratories will no longer be performed on the Biorad blood grouping analysers. We are currently in the process of validating the replacement Grifols blood grouping analysers. An extension to scope has been submitted for this test to be accredited at our UKAS assessment in October 2018.

BD Vacutainer Tube Guide

on Tuesday, 18 September 2018. Posted in Homepage, Blood Sciences

BD Vacutainer Tube Guide

The BD Vacutainer tube guide detailing order of draw and special instruction can be downloaded from the Downloads tab or by clicking here

Changes to GAD (Glutamic Acid Decarboxylase) assay

on Tuesday, 02 October 2018. Posted in Homepage, General

Due to a change in Manufacturer the reference range and storage conditions for the GAD (Glutamic Acid Decarboxylase) antibody assay have changed. Reference range 0-5 IU/mL Samples storage within laboratory -20C

Notification of change: New enzymatic creatinine method

on Tuesday, 04 September 2018. Posted in Homepage, Biochemistry

Implemenatation date: Monday 10th September 2018

From the Monday 10th September 2018 laboratories across Heartlands, Good Hope and Solihull will be implementing a new and improved creatinine test.

Please see attached document for a summary of changes we expect to see with the new test.

Note: there is no change to specimen handling instructions. Serum separator tube (SST) is the recommended sample type. Further information will be available on the website (http://www.heftpathology.com/) in due course.

If you have queries relating to this notification please do not hesitate to contact us:

Dr Mark Thomas (Telephone: 0121 424 3156 or email: This email address is being protected from spambots. You need JavaScript enabled to view it.)

Duty Biochemist (Telephone: 0121 424 2198 or bleep 2506)

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HTA licence number is 12366

Protection of Personal Information – Laboratory Medicine comply with the Trust Data Protection Policy and have procedures in place to allow the Directorate and it’s employees to comply with the Data Protection Act 1998 and associated best practice and guidance.

The Trust Laboratories at Heartlands Hospital, Good Hope Hospital and Solihull Hospital were awarded UKAS (United Kingdom Accreditation Service) accreditation to the internationally recognised ISO 15189 standard in May 2015. For a list of accredited tests and other information please visit the test database http://www.heftpathology.com/frontpage/test-database.html.
Tests not appearing on this scope are either under consideration or in the process of accreditation and so currently remain outside of our scope of accreditation. However, these tests have been validated to the same high standard as accredited tests and are performed by the same trained and competent staff.

For further information contact Louise Fallon, Quality Manager, 0121 424 1235

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