Lab Regulatory Accreditation Tools & Performance Training
Our Service Department conducts IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) for each and every diagnostic instrument installation (3500 Dx, 7500 Dx, and ViiA™ 7 Dx). In addition, OQ/PQ is performed after each critical service intervention.
Use our panel of inhibitors to assist with assay evaluation. The AcroMetrix Inhibition Panel is a seven-member panel that provides defined quantities of commonly recognized and accepted assay inhibitors including heparin, lipids, bilirubin, and hemolyzed plasma. This panel can be used in a variety of ways, including assay validation, instrument evaluation, commercial and in-house assay characterization, and troubleshooting.**
Operator Training Panels
Training panels are designed to meet the need for operator qualification and for assessing the performance of nucleic acid test procedures for the detection of pathogens in human samples. The panels help ensure that nucleic acid testing procedures are properly validated and that test results are consistent across manufacturers, testing laboratories, operators, platforms, and assay formats. AcroMetrix reagents offer operator training panels for HIV, HBV, HCV, and WNV, which allow workers to compare results across platforms and between laboratories.**
For instruments and reagents used for clinical purposes, please make sure to comply with local regulatory requirements.
* EZQC™ Online is intended to assist laboratories in meeting their verification or validation requirements. Each laboratory is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and specific accreditation requirements.
** Unless otherwise noted, all products are for research use only, not for use in diagnostic procedures.