How to submit information in the Basics section of the submission form for clinical microbe tests
This page is organized according to the sections you see on the Basics tab. You can click on the name of the section below to navigate to that section of this document.
Please note that most sections in the form provide tool tips, accessible by this icon (
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Test Information
This test is for: Clinical (minimal). Laboratories in the United States are required to have a current CLIA license in order to provide clinical tests.
If you mistakenly initiate a submission for a research test using the clinical test forms, please discontinue and return to the homepage by clicking the 'GTR Submission' link at the top left of your browser. To submit a research microbe test, see this documentation.
Laboratory test name (minimal). Enter the name of the test as you want it to be publicly displayed in the GTR. This name will be searchable by users.
Short test name (optional). The short test name is the shortened name or mneumonic used by the lab to identify the test. This may be a test name used in conjunction with a test order code for quick test menus, electronic medical records or HL7 systems and programs.
Manufacturer's test name, if any (optional). Enter the manufacturer's name of the commercial test or kit used in the submitted assay. If the test is an entirely laboratory developed test, there should not be a manufacturer's test name.
Search terms, if any (optional). Enter any search terms you wish to be associated with your submitted test. You do not need to enter keywords such as the disease/condition, gene, variant, or test name. These will all automatically be included in a search. Relevant terms may include keywords such as archived or previously used test names. Limit to one search term per entry box. Use the 'add another search term' button to add additional entries.
Purpose of the test (minimal). Select the appropriate test purpose(s) or indication(s) from the choices provided. Multiple selections are allowed.
Diagnosis - Identification or confirmation of disease
Drug response - Evaluation of sequence variation influencing an individual’s reaction to specific medications, as in a pharmacogenetic test. Includes assessment of risk for adverse drug reactions.
Microbe identification - Identification of the microorganism(s) involved
Monitoring - Periodic or continuous evaluation of a disease or condition over time, including a patient’s response to medical treatment.
Predictive - Information from the test can be used to determine or predict the potential risk of eventually developing a disease or a disorder.
Screening - Evaluation of a target population to identify the affected subgroup.
Therapeutic management - Information can be used to determine therapeutic decision making.
Viral load - Evaluates the viral load following infection.
Target population for this test (recommended). Describe which segment(s) of the population should be tested for the indication and why. Example: Hospitalized patients undergoing surgery should be screened for methicillin-resistant Staphylococcus aureus.
Citations for target population (recommended). Enter references supporting statements provided in 'Target population for this test'.
Test development (recommended). Select a single option for how the test was developed. Intended to help delineate the differences in certification requirements between the test types. Options include:
FDA-reviewed (has FDA test name) - The test, test kit or reagents either have FDA approval or are currently in FDA review.
Manufactured (research use only; not FDA-reviewed) - The test or primary parts of the test are purchased from a commercial entity and have not gone through FDA review.
Modified FDA (has FDA-reviewed entry, but with lab modifications/field changes) - The test, test kit or reagents used in the test have undergone FDA review and are approved, however the submitting laboratory has augmented some part of the test or testing protocol.
Test developed by laboratory (no manufacturer test name) - This test is developed, produced and performed by the submitting laboratory. Also known as LDT.
FDA Review Information
Has there been FDA review of the test? (optional). Select the option (Y/N) corresponding to if the test or any portion of the test including reagents has been reviewed or is pending review by the FDA.
FDA Category designation When 'No' is selected from 'Has there been FDA review of this test?', the options for FDA Category designation are:
EUA - Emergency Use Authorization
FDA exercises enforcement discretion
Not applicable
When 'Yes' is selected from 'Has there been FDA review of this test?', the FDA Review information section will appear.
Item reviewed (optional). From the options indicated, select the portion of the test that has been reviewed or is pending review by the FDA. Choices include:
ASR - Analyte-specific reagents
Assay(s)
IVDMIA - In Vitro Diagnostic Multivariate Assay(s)
Instrument(s)
Test kit(s)
Other - Please specify
FDA category designation (optional). When 'yes' is selected for the 'Has there been FDA review of this test?', the options include:
FDA exercises enforcement discretion
IUO - Investigational Use Only - The performance characteristics of this product have not been established.
IVD - In Vitro Device
RUO - Research Use Only - Not for use in diagnostic procedures.
Not applicable
FDA regulatory status (optional). This field is shown only when 'yes' is selected from the 'Has there been FDA review of this test?'. From the options provided, select the status of the item reviewed. Choices include:
FDA cleared/approved
FDA exempt
Pending
Not submitted
Other - Please specify.
FDA application # (optional). This field is shown only when 'yes' is selected from the 'Has there been FDA review of this test?'. Enter the FDA application number associated with the item reviewed. A link to the FDA website will be automatically provided to display documents for the application # provided in this section. Users of the GTR website will be allowed to access this link.
Upload FDA approval document (optional). This field is shown only when 'yes' is selected from the 'Has there been FDA review of this test?'. Upload the final FDA approval summary document. A link to the FDA website will be automatically provided to display documents for the application # provided in this section. Users of the GTR website will be allowed to access this link.
New York State CLEP (NYS CLEP) test approval #
Status (minimal if test holds NYS certification, otherwise optional). If the test has been reviewed by 'NYS CLEP', enter the status of the NYS CLEP approval for the test. Options include:
Approved
Pending
Grandfathered
Exempt
Test approval # (minimal if test holds NYS certification, otherwise optional). Enter the test approval number provided by NYS CLEP for the approved test.
Save your work
Don't forget to save your work by clicking the Save & Continue button at the bottom of the page! If you need to interrupt or delay data entry, you can return at a later time and you will be taken to the last tab you saved.
If any required fields or data inconsistencies are detected on this page, an error message will display after you click Save & Continue indicating what the issue is. The field(s) that need attention will be outlined in red. Please correct your data and click "Save & Continue" again.