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Molecular Genetic and Serology Tests for Microorganisms in Human Hosts

OMB NO: 0925-0651

EXPIRATION DATE: 01/31/2025

Burden Statement

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.

In the GTR Submission Portal, on the home page for your lab, Under 'Submission of Tests', click to expand the section 'Microbe Tests'. Click 'Add a clinical test' or 'Add a research test'.

Add a new clinical microbe test

Clinical microbe test

See Detailed instructions.

Research microbe test

See Detailed instructions.

Bulk Submission using the Spreadsheet Template with All Clinical Test Fields

This mode of submission is for clinical tests only. See Detailed instructions.

Last updated: 2022-05-13T23:00:11Z