Firstly we would like to apologise for any delay in results you have recently experienced for NT-Pro-BNP. We have had ongoing issues with your current assay.

Abbott Laboratories, who supply our major laboratory biochemistry analysers and reagents, have released their new Alere NT-ProBNP assay. After careful evaluation, we have confirmed that the Alere NT-ProBNP assay is fit for purpose and we will move to measure NT-ProBNP on Wednesday 18th April 2018 .

Due to the assay being continuously available on the routine platform, there should be a dramatic increase in the turnaround times for these results.

There will be no change to reference ranges, with Chronic Heart Failure: National Clinical Guideline for Diagnosis and Management in Primary and Secondary Care: Partial Update (2010) still being used (see below).

>400 but <2000 ng/L: Refer for heart failure specialist assessment and echo (within 6 weeks)

>2000 ng/L: Refer urgently for heart failure specialist assessment and echo (within 2 weeks)

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 test database

There has been an unexpected delay in the analysis of routine urine samples. This has led to us having to reject a number of samples for analysis. 

We have been working to determine exact stability of each analyte and have found urine albumin to be less than had previously been established which has contributed to the  increased the number of samples we have had to reject. We would like to apologise for this delay and any inconvenience it may cause for you and your patients.

Please be assured that this incident has been fully investigated and processes have been put in place to stop such an incident occurring in the future.

Due to difficulties in obtaining sufficient kit supplies for our Renin workload, it is with regret that we will no longer be able to offer the measurement of Renin, and subsequently Aldosterone , from this laboratory.

We have been working closely with our colleagues at University Hospital Birmingham (UHB) and will be sending work there from the 28/2/2018. The Renin assay provided by UHB is an Immunoassay method (IDS iSYS) for renin mass with reference ranges comparable to the ones used at Heartlands.  See attached information.  The aldosterone method is a comparable assay by LC/MSMS.

The UHB laboratory is a UKAS accredited laboratory.  The aldosterone assay is already UKAS accredited and the Renin immunoassay will be assessed by UKAS as part of their next extension to scope application.

The aldosterone assay is in essence identical to the one used at Heartlands. It is a mass spec method and should have the same characteristics. The http://www.heftpathology.com/item/aldosterone.html information should be applicable.

There will be a slight change in the ratio cut offs used to take into account the renin method. We will be using the Endocrine guidelines ranges and use the 91 cut off with and Aldosterone greater than 750 as a “screen” positive interpretation. This is taken from the Endocrine guidelines on the investigation of Conns. https://academic.oup.com/jcem/article/93/9/3266/2596343

From a sample processing point of view continue to send the samples to Heartlands and we will  transport the samples to UHB.

Please contact the lab or duty biochemist if you have any queries

Revision to PNH screen by flow cytometry

From the 26^th February the current PNH screen will be updated.

The revised protocol will include analysis of monocytes in addition to neutrophils and red cells. Monocyte analysis provides additional evidence for PNH, and in some cases gives a truer reflection of PNH clone size.

The sensitivity of the assay has been determined and the lower limit of quantitation is 0.01% for both red cell and neutrophil analysis. To achieve this level of sensitivity we need to count a large number of cells.

In cases of neutropenia it can be difficult to acquire sufficient cells for the desired sensitivity. We therefore recommend that freshly taken, full EDTA tubes are sent. It may still not be possible to provide a result in severely neutropenic cases.

Monocyte analysis is less sensitive to small populations due to the lower number of monocytes available in samples.

Red cell analysis is performed to allow recognition of PNH type II and PNH type III clones and should not be used as a definitive measure of clone size. Please supply details of transfusion history.

It is possible to recognise tiny rbc and neutrophil clones at <0.01%, but these are not quantifiable.

The format of reports will be updated to reflect the changes and provide greater clarity of the results.

This will be reviewed during our October UKAS inspection.

Please contact the Haematology Cell Markers laboratory on 0121 424 0704 if you require further information.

The current UKAS accredited Glandular Fever screen offered by HEFT laboratories has been discontinued by Alpha Laboratories (the supplier). We are currently in the process of validating a replacement Glandular Fever screening kit (also supplied by Alpha Laboratories). An extension to scope will be submitted for this assay to be accredited at our next UKAS assessment in October 2018.