Pre-analytical stability of haematinics, lactate dehydrogenase and phosphate in whole blood at room temperature up to 24 h, and refrigerated serum stability of lactate dehydrogenase, folate and vitamin B12 up to 72 h using the CRESS checklist.

Objectives: There is a lack of analyte stability data in whole blood (WB). The aim of this study was to determine the allowable delay in WB processing for lactate dehydrogenase (LDH), folate, vitamin B12, iron and phosphate measurement. The stability of LDH, folate and vitamin B12 was also assessed in stored serum at clinically relevant time points.

Current practice and recommendations for managing transgender patient data in clinical laboratories in the United Kingdom and Republic of Ireland.

Background: Transgender people may avoid seeking medical care due to previous negative experiences and fear of discrimination. Clinical laboratories can contribute to a poor patient experience and clinical outcome when the design and functionality of laboratory information management systems (LIMS) do not consider the needs of transgender patients. This survey aimed to capture current practices in United Kingdom and Republic of Ireland clinical laboratories concerning how transgender patient data and test requests are managed throughout the total testing process.

Stability of direct renin concentration and plasma renin activity in EDTA whole blood and plasma at ambient and refrigerated temperatures from 0 to 72 hours.

Objectives: The aim of this study was to determine the appropriate transport and storage conditions for blood taken for direct renin concentration and plasma renin activity measurement, and whether cryoactivation of prorenin is seen at time points relevant to clinical practice.

Methods: Blood was extracted from n=10 volunteers into K-EDTA tubes. Stability of renin was assessed in whole blood stored at room temperature (15-25 °C) and in the refrigerator (2-8 °C) at 0 h, 8 h, and 24 h.

Stability of Anti-thyroid Stimulating Hormone Receptor Antibody in Whole Blood and Serum: Caution Required for Reflective and Batch Testing.

Introduction: Anti-thyroid stimulating hormone receptor antibody (TRAb) stability is stated as 7h at 20-25°C in the Roche Elecsys assay kit insert. The purpose of this study was to determine TRAb stability in whole blood and serum to assess the suitability of samples for reflective and weekly batch testing (with a single freeze-thaw cycle).

Methods: In the first study, blood from = 5 volunteers was used to assess: (1) stability in whole blood at room temperature up to 24h, and (2) stability in serum at 4-8°C up to 72h.

A survey of practice in the management of haemolysis, icterus and lipaemia in blood specimens in the United Kingdom and Republic of Ireland.

Background: Haemolysis, icterus and lipaemia (HIL) are common interferants in laboratory medicine, potentially impacting patient care. This survey investigates HIL management in medical laboratories across the UK and Republic of Ireland (ROI).

Methods: A survey was sent to members of key professional organisations for laboratory medicine in the UK and ROI.

Glu-C, an alternative digestive enzyme for the quantitative LC-MS/MS analysis of an IgG-based antibody biotherapeutic.

Aim: LC-MS/MS bottom-up quantitation of proteins has become increasingly popular with trypsin as the most commonly used protease. However, trypsin does not always yield suitable surrogate peptides. An alternative enzyme, Glu-C, was used to generate surrogate peptides for quantifying a bispecific IgG1 biotherapeutic antibody in preclinical matrices.

Sex steroid hormone stability in serum tubes with and without separator gels.

Background: A pilot study showing a decrease in androstenedione concentration in serum collected into gel-containing serum tubes (STs) triggered an investigation of the effect of serum collection tube on steroid hormone stability.

Methods: In the main study, two tube types were examined: BD Vacutainer® SST™II Advance and BD Vacutainer® Serum Tube. Forty-seven serum samples from apparently healthy volunteers were collected and analysed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) for testosterone, androstenedione, 17-hydroxyprogesterone (17-OHP) (n=20); and oestradiol (n=27).

An analysis of the impact of pre-analytical factors on the urine proteome: Sample processing time, temperature, and proteolysis.

Purpose: We have examined the impact of sample processing time delay, temperature, and the addition of protease inhibitors (PIs) on the urinary proteome and peptidome, an important aspect of biomarker studies.

Experimental Design: Ten urine samples from patients with varying pathologies were each divided and PIs added to one-half, with aliquots of each then processed and frozen immediately, or after a delay of 6 h at 4°C or room temperature (20-22°C), effectively yielding 60 samples in total. Samples were then analyzed by 2D-PAGE, SELDI-TOF-MS, and immunoassay.

Protein Biomarker Research in UK Hospital Clinical Biochemistry Laboratories: A Survey of Current Practice and Views.

Background: With the increasing drive for more and better disease biomarkers to underpin the stratified or personalised medicine agenda, clinical biochemistry laboratories should be ideally placed to play a major role in their translation into clinical practice. However, little is known about the current extent of biomarker-related research activity in UK National Health Service clinical biochemistry departments.

Methods: In December 2010, an online questionnaire was sent to active UK members of the Association for Clinical Biochemistry (ACB) to determine the extent of their current research activity and involvement in protein biomarker discovery and translation, including an assessment of the awareness of proteomics.

A comparison of the analytical performance of five commercially available assays for neutrophil gelatinase-associated lipocalin using urine.

Background: Neutrophil gelatinase-associated lipocalin (NGAL) is a promising biomarker for acute kidney injury that is beginning to be used in clinical practice in addition to research studies. The current study describes an independent validation and comparison of five commercially available NGAL assays, focusing on urine samples. This is an essential step in the translation of this marker to clinical use in terms of allowing valid inter-study comparison and generation of robust results.