Test Information
Test Name:
Cortisol
Manufacturer:
Roche
Instrument:
Roche Cobas Analyzer
Quality Standard
Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) establishes quality standards for laboratory testing and an accreditation program for clinical laboratories. Moderate or high complexity tests are subject to specific laboratory standards governing certification, personnel, proficiency testing, patient test management, quality assurance, quality control, and inspections.
FDA/LDT:
FDA Approved Test
Number:
K152227
Compliance Standard:
ISO 15223-1
Quality Control
Laboratory Quality Control (QC) is the procedure used to detect and correct potential errors in a labs analytical measurement process prior to the release of patient results. Internal QC, tested identically to patient samples, is performed on a regular basis at Vibrant America Clinical Laboratory to ensure the precision and accuracy of patient sample results.
QC Levels:
2
QC Frequency:
Daily
QC Material:
BioRad LiquichekTM Immunoassay Plus Control
Calibration
Calibration is the process to establish the relationship between a biomarkers analytical signal and corresponding concentration. The goal is to ensure the precision and accuracy of a testing system by standardizing it with a reference system established by manufacture.
Calibration Levels:
2
Calibration Frequency:
28 Days
Calibration Material:
Roche Cortisol II CalSet
External quality assessment / proficiency testing
As a clinical laboratory accredited by the College of American Pathologists (CAP), Vibrant America uses Proficiency Testing (PT) programs provided by CAP, an external CMS-approved agency, to constantly and objectively assess the performance of the lab. PT samples are analyzed in the same manner as patient samples, and results are compared to a peer group of laboratories. The purpose is to identify potential problems in laboratory practices, generate corresponding corrective action(s), and improve the overall performance of the lab. Vibrant America Clinical Laboratory performs PT on a regular basis to ensure the highest of standards, and has continuously achieved performance of high quality.
Quality Assurance Program:
College of American Pathologists
Evaluation Frequency:
Thrice per year
Last Performed On:
2023-03-20
Analyte Reference Range
Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) establishes quality standards for laboratory testing and an accreditation program for clinical laboratories. Moderate or high complexity tests are subject to specific laboratory standards governing certification, personnel, proficiency testing, patient test management, quality assurance, quality control, and inspections.
Analyte Reportable Range
The reportable range is defined as the range of test values over which the relationship between the instrument, kit, or systems measurement response is shown to be valid (US CFR 493 February 28, 1992).
Analyte reportable range:
0.400 – 630.0 ug/dL
Quality statement
Vibrant America Clinical Laboratory is committed to delivering services that consistently meet the requirements and expectations of our customers. The commitment to quality includes considerations involving the use of continually developing methods, good practices, our own desire to constantly improve, and operating under an effective Quality Management System that meets regulatory requirements.
