COVID-19 Diagnostic Testing: Now Available
Please note that IMD Path is not a Collection Center.
We perform the SARS-CoV-2 (COVID-19) RT-PCR Assay and are available to work with corporate clients and other high volume collection opportunities.
We do not test on an individual patient basis.
In a recent announcement the U.S. Food and Drug Administration (FDA) has warned of potentially false-negative results, associated with qPCR testing protocols. IMD Path wants to assure clients and patients we validated and follow CDC testing protocol for Sars-CoV-2 RT-PCR testing. This protocol targets zones to identify the presence of SARS CoV-2 virus. Our viral load measurements have stringent guidelines and have the EUA FDA approval as designated by CDC protocol.
Utilization of the IMD Path-SARS-CoV-2 (Covid-19) RT-PCR Assay
Among the main features of this testing IMD:
Strives to meet it’s goal of a 1-2 Business Day Turnaround Time for all patient and client specimens upon receiving
Provide Physician Guided Support through each testing checkpoint
Provide all clients and offices with test logistics, collection kits, and oversee Health Department Certified Notification of Results
Testing Media Options
Statement of Compliance
This test is a modification of the FDA EUA-authorized assay, CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. The modification is validated using a bridging study and is permitted under the FDA modifications policy in the Policy for Coronavirus Disease-2019 Tests. The bridging study was performed by lntegrated Molecular Diagnostics Pathology, Inc. (IMD Path), 12635 E. Montview Blvd., Suite 360, Aurora, CO 80045. This test has not been cleared or approved by the FDA, however, such clearance/approval is not required, as the laboratory is regulated and qualified under the Clinical laboratory Improvements Amendments (CLIA) to perform high-complexity clinical laboratory testing. This test is used for clinical purposes and should not be regarded as investigational or for research use.