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Implementing a new laboratory IT system and how to avoid the pitfalls

Interpretation of ISAC

Coagulopathy has been shown to play an important role in COVID 19 infection. Reported abnormal coagulation laboratory values in severe COVID-19 are most notably a 3-to-4-fold increase in D-Dimer (Yao et al., 2020).

Several studies showed that elevated D-dimer in COVID-19 patients is associated with higher mortality. A retrospective cohort study carried out by Zhou, et al. (2020) also associated D-Dimer > 1000ng/ml with higher odds of in-patient death.

At the onset of the COVID 19 pandemic, there was no consensus as to how D-Dimer levels should be used for the management of COVID-19 patients. In April 2020, PAHT decided to use a D-Dimer cut-off of 1000 ng/ml to determine anticoagulation dosage. The source of reference used by PAHT in their decision making employed a D-Dimer assay with a cut off value of 500 ng/ml for the exclusion of venous thromboembolism (VTE). This raised an issue as the source of reference used by PAHT at the time employed a D Dimer assay with a cut-off value of 230 ng/ml for the exclusion of VTE. This meant the trust was unable to implement the new COVID 19 care bundle at the time. The haematology laboratory wanting to do whatever possible to assist patient care agreed to change the current D-Dimer methodology immediately to support the trust COVID 19 care bundle.

The verification and implementation of the new D-Dimer assay with cut of 500 ng/ml for the exclusion of VTE was completed within four weeks. A risk assessment and a change control were put in place to ensure users were made aware of the change in cut-off limit.

This verification and implementation of the new assay was possible through the hard and collaborative work of the haematology technical team with shared vision, motivation coupled with team engagement and strong leadership.

A case study into iron deficiency polycythaemia diagnosis, looking at the pathology and how this relates to the results we see and investigations to confirm diagnosis.

Global travel and migration trends have meant a huge increase in the numbers of people exposed to tropical parasitic diseases. Thus, there is an increasing need for robust, reproducible and reliable screening as well as diagnostic techniques. These existing and emerging technologies all currently co-exist; each with their own specific and general pitfalls and limitations.

Thus, the need for fit-for-purpose qualitative EQAs or Proficiency Testing schemes for these parasite diagnostics remains pivotal and very timely. My talk at this congress will present findings and recommendations from Parasitology EQA schemes offered by UK NEQAS and will highlight the importance of quality management in the field.

Meet your Haematology Portfolio examiners

Myeloma screening is a high volume investigation pathway, performed by both Biochemsitry and Immunology laboratories. National audit data has shown there to be high variation between laboratories on the implementation of this workflow, leading to potentially inconsistent patient care geographically.

This talk will aim to cover the following areas:

Give brief foundation knowledge on serum electrophoresis/immunodisplacement/immunofixation
Introduce the Myeloma UK Best practice guidelines for Myeloma screening
Discuss Mass spec methods for analysing monoclonal protein
Discuss monitoring of myeloma patients and monitoring of Monoclonal gammopathy of undetermined significance (MGUS) patients.

A myositis-related autoantibody can now be identified in the majority of patients with myositis. They identify homogeneous patient subgroups and are key tools in developing a personalised approach to disease management. There is substantial clinical interest in exploiting myositis autoantibodies as biomarkers, and consequently, a large number of commercial assays have been developed for their detection. Several different commercial assays have now been developed to detect myositis relevant autoantibodies. Many have been developed with the practicalities of clinical practice in mind, offering rapid, affordable, and often multiplex testing. Despite this progress, the perfect system has yet to be realised.

Commercial testing systems do not detect all known myositis relevant autoantibodies and concerns have been raised about the sensitivity and specificity of some assays, including to their ability detect some autoantibodies strongly associated with malignancy and ILD; important causes of mortality and morbidity.

The advantages and disadvantages of different myositis autoantibody testing systems will be discussed. Evidence for the reliability of different types of assays in comparison to immunoprecipitation, as the reference standard, will be reviewed along with testing strategies that make the most of existing technology.

This presentation will introduce basic sleep physiology related to the pathophysiological mechanisms Narcolepsy is a rare but debilitating neurological sleep disorder, with a worldwide prevalence of 25-50 per 100,000 people. Onset is most common during the adolescent years, though a diagnostic delay of around 10 years is common. There is currently no cure, though symptoms can be managed using pharmacotherapy. Biochemistry services provide an important role in confirming a diagnosis of narcolepsy in line with current international guidelines such as the International Classification of Sleep Disorders 3rd edition (ICSD-3).

The aims of this talk are to:

1. Introduce basic sleep physiology related to the pathophysiological mechanisms underpinning narcolepsy.

2. To describe the signs and symptoms of narcolepsy and their impact on patients.

3. To review the diagnosis of narcolepsy including the role of biomarkers such as HLA type and CSF hypocretin.

4. To summarise treatment options for narcolepsy.

Networks – how Greater Manchester is making it work for them