According to the US Centers for Disease Control and Prevention, “molecular diagnostic testing combines laboratory testing with the precision of molecular biology and has revolutionized the way clinical and public health laboratories investigate the human, viral, and microbial genomes, their genes, and the products they encode. Molecular diagnostic tests are increasingly being used, and have supplanted numerous conventional tests, in many areas of laboratory medicine including oncology, infectious diseases, clinical chemistry, and clinical genetics. Advancements in molecular diagnostic testing will continue to improve the accuracy and speed by which we can detect microbial pathogens or analyze a patient’s genes, and is becoming an essential aspect of patient-tailored interventions and therapeutics.” The CDC further offers resources on next generation sequencing (NGS) and genetic testing reference materials.1
While these resources can provide excellent information, some facilities are still facing challenges in finding the right combination of cost (both initial and ongoing), clinical utility, and technology/automation that fits their clinical operations. However, new and exciting breakthroughs are taking place rapidly in this area of practice, and with improvements to sample preparation, image analysis, sequencing, and other vital areas, molecular diagnostics are becoming more widespread.
The following are just a couple examples of new technologies working in this area. As advanced systems continue to study microbiome disruptions, genomic instability, concentration and degradation of analytes, advanced PCR assays, and other approaches,2 hospital laboratories will continue to take advantage of these exciting developments in the treatment of disease.
VIROTROL and VIROCLEAR SARS-CoV-2 from Bio-Rad Laboratories
The VIROTROL SARS-CoV-2 and VIROCLEAR SARS-CoV-2 quality controls from Bio-Rad Laboratories are designed to be used in antibody testing of SARS-CoV-2. These serological controls are available for IVD use in the US. As independent, reactive, and non-reactive controls designed to monitor the precision of SARS-CoV-2 total IgG/IgM and IgG antibody testing procedures, VIROTROL and VIROCLEAR SARS-CoV-2 can provide laboratories with an independent assessment of their test systems for greater confidence in patient test results.
They are available in 3 separate classes to challenge the assay cutoff of a broad range of methodologies.
Precision Medicine from NovoPath
NovoPath’s Precision Medicine offers a cytogenetics reporting solution for anatomic pathology laboratories. With this system, labs can benefit from a multi-modality reporting solution that incorporates advanced genetics and biopsy tests into one report. This module can meet the unique and specialized requirements of the cytogenetics department with unlimited setup options for karyotype and FISH analysis and cell cultures recording. It allows users to predefine all test and culture defaults for fast accessioning and ease of use, assist diagnosticians by having appropriate resulting fields enabled or disabled automatically, and set cell culture defaults in order to cut down on data entry time. In addition, the system allows users to filter diagnoses and result interpretations as they apply to specific tests to speed result entry time and import FISH and karyotype images directly into NovoPath, eliminating the need for hard copies. Custom design results and images on patient reports are also available.
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