We will periodically provide an update from various sources around COVID-19 testing and reporting
April 14, 2020 Reporting Update
April 8, 2020 4 part update:
Reporting of SARS-COV2 Results
CMS Guidance for Laboratory Developed Tests for Nucleic Acid Detection
EUA Status for SARS-COV-2 LDT’s
Serology testing for IgM and IgG specific to SARS-COV-2
The Ovation LIMS has out-of-the box support for COVID-19 testing and reporting. With the goal of unleashing the testing capacity of labs, ready to use capabilities include online order entry, standardized infectious disease workflow, automated interpretation following FDA and CDC guidelines, branded report template, and multimodal report delivery.
As the COVID-19 pandemic rages globally, access to testing has become incredibly important, not only for a patient’s own health and safety, but also for the health and safety of the community. Since we are all being affected by this, Ovation wants to enable labs to rapidly do something that makes a difference.
Ovation’s Head of Clinical Affairs, Dr. Pauline Gee, has consolidated information that we think might be helpful to labs seeking to bring up this testing. Please see our COVID-19 Validation Guide which lays out the exact steps a lab needs to take in order to develop a COVID-19 test and begin accepting patient samples.
Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency | Read More
FDA FAQs on Diagnostic Testing for SARS-CoV-2 | Read More
What If I Do Not Have…? | Read More
Virtual Town Halls, weekly on Wednesday afternoons from 3-4p EST, from March 25th through April 29th | Read More
Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19) | Read More
Medicare Administrative Contractor (MAC) COVID-19 Test Pricing Fact Sheet | Read More
Testing Resources for COVID-19 | Read More
