The way that H.pylori testing is performed has changed within the Microbiology department. A H.pylori stool antigen test is now in place, and is awaiting UKAS accreditation which will be assessed in January. Therefore users must be aware that this test is currently unaccredited. Tests are accredited to internationally recognised standards for medical laboratories ISO 15189. The previous H.pylori Ab test which utilised patient serum is no longer available.

Additionally, the methods for Cryptococcal antigen detection have changed. Previously, an antigen agglutination test was performed which is now no longer utilised within the department. The department now utilises a lateral flow test which is currently unaccredited: UKAS are assessing the extension to scope in January.

The department has also applied for an extension to scope for CPE testing, to include the chromogenic agar which we utilise and a PCR platform. This means that currently the CPE testing is unaccredited. The extension to scope is being assessed by UKAS in January.

From the 1st September 2020 onwards, the FISH service previously provided by the ROH Pathology Department will be transferred to the Molecular Pathology Diagnostic Service (MPDS) based at the QEHB.

All FISH tests previously performed in the ROH Pathology Laboratory have been validated again at the QEHB site following UKAS standards; these tests are awaiting submission for consideration within an extension to scope (ETS) application for accreditation. In the mean time, those tests will not fall under our scope of accredited tests but will be performed within our ISO accredited Laboratory.

Any external requests should be made to MPDS directly, as below. If you have any query, please feel free calling or/and emailing us.

Molecular Pathology

The Haematology Laboratory have moved to using a new Sickle Screening test kit in order to harmonise our testing method across all sites. 

The Specialist Coagulation Laboratory have started using a new Chromogenic FVIII assay, in addition to the one-stage FVIII assay. This is useful at diagnosis as some genetic variants for FVIII deficiency give discrepant results between one-stage and Chromogenic assays. It is also a useful assay if an inhibitor to FVIII is suspected.

Routine coagulation have started using a new back up semi-automated analyser so we can reliably check samples that fail on our fully automated system.  These failures are usually due to lipaemia or low fibrinogen. This will help us provide a more robust service to critically ill patients.

These tests are not currently accredited to ISO 15189 but will be added as part of our extension to scope in March 2021.

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