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last updated: 2026-03-04 by BA
file_name: 2021-11-15_FDA Fact Sheet - Fact Sheet for Healthcare Providers.md
file_date: 2021-11-15
title: FDA Fact Sheet - Fact Sheet for Healthcare Providers
category: regulatory
subcategory: fda-policy
tags: 
source_file_type: pdf
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pdf_gdrive_url: https://drive.google.com/file/d/1XVkWqGSIzELmcylCR4lSIPlc8NVI62Cv
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/fda-policy/2021-11-15_FDA%20Fact%20Sheet%20-%20Fact%20Sheet%20for%20Healthcare%20Providers.pdf
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notes: 
summary_short: The FDA “Fact Sheet for Healthcare Providers – Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests” (updated Nov 15, 2021) provides standardized provider-facing risk/benefit, intended-use, and result-interpretation language for EUA-authorized molecular LDTs used on respiratory specimens from individuals suspected of COVID-19. It explains what positive and negative results mean, highlights false positive/false negative risks and variant-related performance limitations, and reiterates CLIA high-complexity and public health reporting expectations. It supports consistent communication to clinicians across laboratories operating under the molecular LDT umbrella EUA.


CONTENT

***INTERNAL TITLE:*** FACT SHEET FOR HEALTHCARE PROVIDERS  
Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests  
Updated: November 15, 2021  
Coronavirus Disease 2019 (COVID-19)

This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of a Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Test (Molecular LDT COVID-19 Authorized Test) that has been issued an Emergency Use Authorization (EUA) by FDA.

The Molecular LDT COVID-19 Authorized Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

**All patients whose specimens are tested with an authorized test will receive the Fact Sheet for Patients: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests.**

**This test is to be performed only using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.**

### What are the symptoms of COVID-19? 
Many patients with COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that, when present, symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat, new loss of taste or smell, nausea or vomiting or diarrhea. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus, and the median time to symptom onset is approximately 5 days. For further information on the symptoms of COVID-19 please see the link provided in "Where can I go for updates and more information?" section.

Public health officials have identified cases of COVID-19 throughout the world, including the United States. Please check the CDC COVID-19 webpage (see link provided in "Where can I go for updates and more information?" section at the end of this document) or your local jurisdictions website for the most up to date information.

### What do I need to know about COVID-19 testing? 
Current information on COVID-19 for healthcare providers is available at CDC’s webpage, *Information for Healthcare Professionals* (see links provided in "Where can I go for updates and more information?" section).

- The Molecular LDT COVID-19 Authorized Test can be used to test respiratory specimens validated in the laboratory that developed the test for COVID-19.
- The Molecular LDT COVID-19 Authorized Test should be ordered for the detection of nucleic acid from SARS-CoV-2 in individuals suspected of COVID-19 by their healthcare provider.
- The Molecular LDT COVID-19 Authorized Test is only authorized for use at the laboratory that developed the test for COVID-19 that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests.

Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available at the CDC’s website (see links provided in "Where can I go for updates and more information?" section).

When collecting and handling specimens from individuals suspected of being infected with the virus that causes COVID-19, appropriate personal protective equipment should be used as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in "Where can I go for updates and more information?" section).

### What does it mean if the specimen tests positive for the virus that causes COVID-19? 
A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and therefore the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Patient management should be made by a healthcare provider and follow current CDC guidelines.

The Molecular LDT COVID-19 Authorized Test has been designed to minimize the likelihood of false positive test results. However, it is still possible that this test can give a false positive result, even when used in locations where the prevalence is below 5%. In the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.

All laboratories using this test must follow the standard testing and reporting guidelines according to their appropriate public health authorities.

### What does it mean if the specimen tests negative for the virus that causes COVID-19?
A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. It is possible to test a person too early or too late during infection to make an accurate diagnosis via the Molecular LDT COVID-19 Authorized Test.

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing with an alternative method should be considered by healthcare providers in consultation with public health authorities. Additional testing may be helpful to ensure testing was not conducted too early.

Risks to a patient of a false negative test result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.

The performance of this test was established based on the evaluation of a limited number of clinical specimens. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARSCoV-2 and their prevalence, which change over time.

### What is an EUA?
The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.

An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19.

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).

### What are the approved available alternatives?
Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA, by FDA can be found by searching the medical device databases here: [https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases). A cleared or approved test should be used instead of a test made available under an EUA, when appropriate and available. FDA has issued EUAs for other tests that can be found at: [https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization).

### Where can I go for updates and more information?
#### CDC webpages:
**General:** [https://www.cdc.gov/coronavirus/2019-ncov/index.html](https://www.cdc.gov/coronavirus/2019-ncov/index.html)
**Symptoms:**
[https://www.cdc.gov/coronavirus/2019-ncov/symptoms-](https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html)
[testing/symptoms.html](https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html)
**Healthcare Professionals:** [https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html](https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html)
**Information for Laboratories:** [https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html](https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html)
**Laboratory Biosafety:** [https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html](https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html)
**Isolation Precautions in Healthcare Settings:** [https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html](https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html)
**Specimen Collection:** [https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html](https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html)
**Infection Control:** [https://www.cdc.gov/coronavirus/2019-ncov/php/infection-control.html](https://www.cdc.gov/coronavirus/2019-ncov/php/infection-control.html)

#### FDA webpages:
**General:** [www.fda.gov/novelcoronavirus](http://www.fda.gov/novelcoronavirus)
**EUAs:**(includes links to fact sheet for individuals and manufacturer’s instructions) [https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas](https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas)

#### LABORATORY CONTACT:
Contact information for the laboratory that developed the Molecular LDT COVID-19 Authorized Test must be provided to the Healthcare Provider in the test report or material/mechanism (e.g., email) that accompanies this Fact Sheet and the test results.