Molecular Genetic and Serology Tests for Microorganisms in Human Hosts
OMB NO: 0925-0651
EXPIRATION DATE: 01/31/2025
Introduction
GTR is now accepting submission of clinical and research tests for microorganisms - bacteria, viruses, and parasites - that play a role in human health and infectious disease. You will now be able to register molecular genetic tests such as nucleic acid amplification tests for microorganisms, and serology tests to detect the presence of antibodies that indicate the host's exposure and response to the microorganism. Some examples of the types of tests which can be registered are nucleic acid amplification and serologic tests for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus which causes COVID-19, real-time multiplex RT-PCR tests for norovirus, a gastrointestinal pathogen, and tests for the human microbiome.
Before you can submit a test, your laboratory must be registered in GTR. You will need to log into the Submission Portal.
Manual Test Submission using the Submission Portal wizard user interface
Clinical and research microbe tests in GTR can be registered manually using the Submission Portal user interface. On the home page for your GTR submissions, under 'Tests in this lab', click on 'Submit tests'. On the submission page, go to the section 'Submit a single test'. The default selection is for a clinical genetic test. Change 'Genetic' to 'Microbe'. If you are adding a research test, change 'Clinical' to 'Research'. Click 'Add a new test'.
Clinical microbe test
Research microbe test
Bulk Submission using the Spreadsheet Template with All Clinical Test Fields
This mode of submission is for clinical tests only. See Detailed instructions.
API Submission
This mode of submission is for clinical tests only. See Detailed instructions.