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.
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
Challenge your Instrument Throughout the Reportable Range with Acusera Linearity Verifier Sets
Complimentary data reduction software is provided delivering an immediate indication of performance.
Samples are provided in a user-friendly format with both liquid and lyophilised options available.
An extended open vial stability keeps waste to a minimum and ensures availability of product for troubleshooting.
Supplied in a minimum of 5 levels to accurately challenge the AMR and remove the need for manual dilution.
Ensure specific instrument requirements are met with the availability of dedicated solution for both Roche Cobas and Beckman systems.
Multi-analyte calibration verifiers will reduce costs, storage space and the number of products required to cover your test menu.
Solutions for Roche Cobas Analysers
Solutions for Beckman Analysers
Calibration verification or linearity assessment is defined as the testing of materials of known concentration in the same manner as patient specimens to ensue the test system is accurately measuring samples throughout the reportable range.
CLIA recommend calibration verification once every six months and/or in the event of; a reagent lot change, major preventative maintenance, replacement of critical parts, when QC materials are outside acceptable limits or reflect an unusual trend and as part of new instrument validation.
