We are thrilled to present two educational guides that delve into the newly updated minimum performance specifications for Proficiency Testing by CLIA (Clinical Laboratory Improvement Amendments). These regulations, set to be implemented by 2024, aim to enhance the accuracy and reliability of test results in clinical laboratories. Here, we introduce these invaluable resources designed to assist laboratories in navigating the evolving landscape of proficiency testing.
1. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Microbiology):
Our first guide focuses on the specific regulations and requirements pertaining to microbiology proficiency testing. With a comprehensive exploration of these guidelines, this guide is a useful resource for microbiology labs striving to ensure precision and integrity in their testing procedures. From the required categories of testing to maintaining optimal testing conditions, the guide details the updates that promote adherence to the highest standards of quality and safety.
2. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Non-Microbiology):
For non-microbiology laboratories, our second guide delves into the updated proficiency testing regulations concerning various analytes. From chemistry to haematology, molecular diagnostics to immunology, this guide offers a comprehensive overview of the new requirements and minimum performance specifications. By embracing these regulations, medical laboratories can uphold the utmost accuracy and reliability in their test results, ensuring optimal patient care and clinical decision-making.
Elevating Laboratory Practices:
These educational guides are indispensable tools that empower laboratories to navigate the changing landscape of proficiency testing regulations. By staying informed and adopting the updated minimum performance specifications, laboratories can maintain compliance, demonstrate excellence, and ultimately deliver the highest quality of care to their patients.
Accessing the Guides:
We invite you to access these comprehensive educational guides by following the link provided below. They offer a wealth of knowledge and practical insights, serving as essential references for laboratory professionals, quality managers, and anyone involved in clinical diagnostics.
With the implementation of updated CLIA proficiency testing regulations on the horizon, these educational guides come at a crucial time. By embracing the knowledge and guidance they provide, laboratories can navigate the changing landscape with confidence and ensure their adherence to the highest standards of proficiency testing. Together, let’s strive for excellence, precision, and patient-centric care in clinical laboratory practices.
Stratifying risk of acute kidney injury in pre and post cardiac surgery patients using a novel biomarker-based algorithm and clinical risk score - 2019
Blood and urinary cytokine balance and renal outcomes at cardiac surgery - 2021
Acute kidney injury risk in orthopaedic trauma patients pre- and post-surgery using a biomarker algorithm and clinical risk score - 2020
Stratifying Risk of Acute Kidney Injury in Pre- and Post-Cardiac Surgery Patients Using a Novel Biomarker Based Algorithm and Clinical Risk Score - 2020
ARID
Plasma Soluble Tumor Necrosis Factor Receptor Concentrations and Clinical Events After Hospitalization- Findings From the ASSESS-AKI and ARID Studies - 2022
Diabetic Nephropathy
On tissue chemical derivatization in mass spectrometry imaging - 2021
Biomarkers for Detecting Kidney Dysfunction in Type-2 Diabetics and Diabetic Nephropathy Subjects A Case-Control Study to Identify Potential Biomarkers - 2022
Analysis of reactive aldehydes in urine and plasma of type-2 diabetes mellitus patients through liquid chromatography-mass spectrometry: Reactive aldehydes as potential markers of diabetic nephropathy - 2023
HABIO
op68 value engineered translation an example for bladder cancer diagnosis - 2019
Thrombomodulin Expression in Bladder Cancer Tissue and Its Association with Prognosis and Patient Survival - 2020
Biomarkers to assess the risk of bladder cancer in patients presenting with haematuria are gender-specific - 2022
Stratifying risk of disease in haematuria patients using machine learning techniques to improve diagnostics - 2024
HABIO Diabetes
Clinical features and predictive biomarkers for bladder cancer in patients with type 2 diabetes presenting with haematuria - 2022
MACE
A novel algorithm for cardiovascular screening using conjunctival microcirculatory parameters and blood biomarkers - 2022
MAST4Health
The 9th Santorini Conference: Systems Medicine, Personalised Health and Therapy. “The Odyssey from Hope to Practice”, Santorini, Greece, 30 September – 3 October 2018
The polymorphism rs6918289 located in the downstream region of the TREM2 gene is associated with TNF-α levels and IMT-F - 2018
Peripheral blood mononuclear cells extracts VEGF protein levels and VEGF mRNA: Associations with inflammatory molecules in a healthy population - 2019
Epigenome-wide association study in healthy individuals identifies significant associations with DNA methylation and PBMC extract VEGF-A concentration - 2020
A genetic determinant of VEGF-A levels is associated with telomere attrition - 2021
Epigenome‑wide association study detects a novel loci associated with central obesity in healthy subjects - 2021
Nutrigenetic Interactions Might Modulate the Antioxidant and Anti-inflammatory Status in Mastiha-Supplemented Patients With NAFLD - 2021
Association of Dietary Patterns with MRI Markers of Hepatic Inflammation and Fibrosis in the MAST4HEALTH Study - 2022
Epigenome-Wide Association Study (EWAS) of Blood Lipids in Healthy Population from STANISLAS Family Study (SFS) - 2022
Myocardial Infarction
Diagnostic Performance of a Combination Biomarker Algorithm for Rule- Out of Acute Myocardial Infarction at Time of Presentation to the Emergency Department, Using Heart-Type Fatty Acid-Binding Protein and High-Sensitivity Troponin T tests - 2018
An Algorithm Based on Combining hs-cTnT and H-FABP for Ruling Out Acute Myocardial Infarction - 2019
NASH / NAFLD
Non-alcoholic fatty liver disease—A pilot study investigating early inflammatory and fibrotic biomarkers of NAFLD with alcoholic liver disease - 2022
Polypharmacy
A review of the prescribing culture of anti-depressants across government districts in Northern Ireland - 2023
Post-Traumatic Stress Disorder
The Intensity and Impact of Chronic Pain, a Story of Difficulty Sleeping and Post-Traumatic Stress Disorder - 2019
Sleep, a Governor of Morbidity in PTSD: A Systematic Review of Biological Markers in PTSD-Related Sleep Disturbances - 2020
Post-traumatic stress disorder: A biopsychosocial case-control study investigating peripheral blood protein biomarkers - 2021
Improving sleep in a population at high risk of trauma: A pilot study examining self-reported sleep, psychological symptomology and actigraphy measured night-time sleep - 2022
Post-Traumatic Stress Disorder: Identifying Potential Differences in Participant Response to CAPS-5 Life Events Checklist Questionnaire Based on Gender - 2022
Sleep Disturbances and Chronic Pain as Potential Indicators for Therapeutic Intervention in Subjects with Post-Traumatic Stress Disorder - 2023
Feto-maternal indicators of cardiac dysfunction as a justification for the cardiac origins for pre-eclampsia - 2024
Prostate Cancer
Diagnostic classifiers for stratifying patients at risk of prostate cancer - 2019
Biomarkers That Differentiate Benign Prostatic Hyperplasia from Prostate Cancer: A Literature Review - 2020
A Novel Combination of Serum Markers in a Multivariate Model to Help Triage Patients Into “Low-” and “High-Risk” Categories for Prostate Cancer - 2022
Oncology
Design and selection of anti-PD-L1 single-domain antibody and tumor necrosis factor superfamily ligands for an optimal vectorization in an oncolytic virus- 2023
DEVELOPMENT OF A BIOCHIP ARRAY FOR THE SIMULTANEOUS DETECTION OF CANCER BIOMARKERS ON THE RANDOM ACCESS, FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER
DEVELOPMENT OF A DUPLEX BIOCHIP ASSAY FOR THE SIMULTANEOUS DETECTION OF ANTI-THYROGLOBULIN AND ANTI-THYROID PEROXIDASE ANTIBODIES ON THE FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER
DEVELOPMENT OF NEW BIOCHIP ARRAYS FOR THE DETERMINATION OF BIOMARKERS RELATED TO ACUTE KIDNEY INJURY APPLIED TO THE EVIDENCE INVESTIGATOR ANALYSER
DEVELOPMENT OF A NEW BIOCHIP BASED IMMUNOASSAY FOR THE DETECTION OF PARATHYROID HORMONE APPLIED TO THE EVIDENCE EVOLUTION ANALYSER
DEVELOPMENT OF A HIGHLY MULTIPLEXED MOLECULAR ASSAY FOR DETECTION OF INFECTION IN CF AIRWAYS
Repeatability and within-laboratory precision were assessed (n=80): Assay Repeatability Within-laboratory precision CV (%) CV (%) VCAM-1 4.5 6.8 ICAM-1 5.6 8.8 ESEL 12.8 16.6 PSEL 3.5 4.7 LSEL 5.7 8.2 17.096, 097.105RDRT DEVELOPMENT OF A BIOCHIP ARRAY FOR THE DETECTION OF ADHESION MOLECULES ON THE NEW RANDOM ACCESS FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER
DEVELOPMENT OF A NEW BIOCHIP BASED IMMUNOASSAY UNAFFECTED BY DHEA-S INTERFERENCE FOR THE ACCURATE MEASUREMENT OF SERUM PROGESTERONE
DEVELOPMENT OF A BIOCHIP ARRAY FOR THE RAPID, SIMULTANEOUS DETECTION OF PEPSINOGEN I, PEPSINOGEN II AND GASTRIN 17, ON THE NEW RANDOM ACCESS, FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER
CLINICAL EVALUATION OF A RAPID FULLY-AUTOMATED MULTIPLEX BIOCHIP ARRAY FOR STROKE DIAGNOSIS
DEVELOPMENT OF A NEW BIOCHIP ARRAY APPLIED TO THE NEW RANDOM ACCESS FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER FOR THE SIMULTANEOUS MEASUREMENT OF TSH, FREE T4 AND FREE T3
DEVELOPMENT OF A NEW BIOCHIP BASED IMMUNOASSAY FOR THE MEASUREMENT OF TOTAL 25-HYDROXYVITAMIN D IN SERUM AND THE ACCURATE CLASSIFICATION OF VITAMIN D STATUS
DEVELOPMENT OF A BIOCHIP ASSAY FOR THE DETECTION OF THYROXINE-BINDING GLOBULIN (TBG) ON THE NEW RANDOM ACCESS FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER
GENETIC DIAGNOSIS OF MONOGENIC OR POLYGENIC FAMILIAL HYPERCHOLESTEROLEMIA IN NORTHERN IRELAND: EVALUATION OF THE RANDOX FH ARRAYS IN COMBINATION WITH THE RANDOX 6SNP POLYGENIC HYPERCHOLESTEROLEMIA ARRAY
DEVELOPMENT OF A BIOCHIP ARRAY FOR THE SIMULTANEOUS MEASUREMENT OF DISTINCT FATTY ACID-BINDING PROTEINS (FABPs)
DEVELOPMENT OF A NEW ENZYME-LINKED IMMUNOSORBENT ASSAY KIT TO DETECT NGAL IN HUMAN SERUM AND ITS APPLICATION TO CHRONIC KIDNEY DISEASE
SCREENING AND SELECTION OF ANTIBODIES FOR THE DETECTION OF MIP-1 ALPHA AND ITS APPLICATION TO THE STUDY OF CHRONIC KIDNEY DISEASE
DEVELOPMENT OF A 4-PLEX BIOCHIP ARRAY FOR THE EARLY DETECTION OF CHRONIC KIDNEY DISEASE
DEVELOPMENT OF A THIRD GENERATION TSH ASSAY ON THE NEW RANDOM ACCESS EVIDENCE EVOLUTION FULLY AUTOMATED BIOCHIP ANALYSER
APPLICATION OF THE NEW RANDOM ACCESS, FULLY AUTOMATED BIOCHIP ANALYSER EVIDENCE EVOLUTION TO SIMULTANEOUSLY MEASURE ANALYTES RELATED TO ENDOCRINE FUNCTION
STRATIFYING RISK OF ACUTE KIDNEY INJURY IN PRE AND POST CARDIAC SURGERY PATIENTS USING A NOVEL BIOMARKER-BASED ALGORITHM AND CLINICAL RISK SCORE
