Intended use statement
The QCI Secondary Analysis Connector software is intended to aid in the selection of potential disease-causing variants observed in genomic next-generation sequencing data. The software also provides quality metrics to help laboratories assess the quality of the sequencing data and analysis results. This software does not replace - and should be used within - the framework of professional association guidelines and a laboratory's defined SOP which was reviewed as part of an accreditation agency such as the Clinical Association for Pathology (CAP) or CAP like accreditation. Results must be reviewed by qualified laboratory personnel. QIAGEN SOFTWARE PRODUCTS ARE NOT INTENDED AS A PRIMARY DIAGNOSTIC TOOL BY PHYSICIANS OR TO BE USED AS A SUBSTITUTE FOR PROFESSIONAL HEALTHCARE ADVICE. EACH LABORATORY IS RESPONSIBLE FOR ENSURING COMPLIANCE WITH APPLICABLE INTERNATIONAL, NATIONAL, AND LOCAL CLINICAL LABORATORY REGULATIONS AND OTHER SPECIFIC ACCREDITATION REQUIREMENTS.