Coronavirus Test (COVID‑19)

The LetsGetChecked Coronavirus (COVID-19) Test was recently put to the test by the Food and Drug Administration (FDA) in their SARS-CoV-2 (the virus that causes COVID-19) reference panel comparison. The goal of this FDA comparison was to help healthcare providers and consumers compare the performance of various coronavirus tests on the market.

Our home collection test was found to have a high level of analytic sensitivity. This means that you can have confidence in the result you receive from our easy and gentle test. From our state-of-the-art laboratories to our teams of clinical scientists, the LetsGetChecked COVID-19 test is a trusted option for those looking to test from the safety and convenience of home.

Find out more about the panel on the FDA website

If you receive a positive result you should remain in self-isolation, and inform your healthcare provider of your result. You should follow the guidance provided by the Centers for Disease Control and Prevention (CDC).

If you develop emergency warning signs for COVID-19 get medical attention immediately. Emergency warning signs include*:

• Difficulty breathing or shortness of breath
• Persistent pain or pressure in the chest
• New confusion or inability to arouse
• Bluish lips or face

*This list is not all inclusive. Please consult your medical provider for any other symptoms that are severe or concerning.

The length of time between a person becoming infected with the type of coronavirus that causes COVID-19 disease and developing symptoms can vary. Symptoms usually develop between 2-14 days after being exposed to the virus, with the average length of time being about 5 days.

You can find information about COVID-19 on the Centers for Disease Control (CDC) website. This website provides information about how to protect yourself and others from the coronavirus, and what to do if you become unwell.

When there are no FDA-approved or cleared tests available, and other criteria are met, the FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization(EUA).

The LetsGetChecked's At-Home Coronavirus Test (COVID-19) has not been FDA cleared or approved, but has been authorized for emergency use by FDA under EUA for use by authorized laboratories. The EUA for this test 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 for the detection and/or diagnosis of the virus that causes COVID-19. LetsGetChecked’s Sure-track Test is the only FDA EUA-authorized at-home Coronavirus (COVID-19) test that owns all aspects of the testing service.

This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in Vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal, Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

For everyone’s safety LetsGetChecked uses a sample transport media which inactivates the virus (meaning it is no longer infectious), but preserves it for analysis. This means that the virus is deactivated or killed in the transport tube and so will protect anyone should it spill or get opened before arriving in the lab.

Following the release of your results, an official lab report will become available on your patient dashboard within your LetsGetChecked account.

This report will contain the details of the test performed, including:

• Infectious disease tested
• Testing date
• Results Summary
• Test provider

These include reverse-transcription polymerase chain reaction (RT-PCR) or transcription-mediated amplification (TMA) tests, gold-standard diagnostic tests for COVID-19.

These tests work by amplifying the amount of genetic material of the SARS-CoV-2 virus so that it can be detected and analyzed by our team of clinical scientists within our CLIA-certified labs.

For every order of our at-home coronavirus test (COVID-19), we will provide you with an automatic itemized receipt via email which you can use for reimbursement purposes from your health insurance provider or health coverage plan. Reimbursement for this test is at the discretion of your provider.

Your itemized receipt will include:

• Date of service
• Customer name
• Name of the service provider
• Contact information of service provider
• Type of product or service
• Description of expenses

If you have queries about whether this at-home coronavirus test (COVID-19) is eligible for reimbursement, please get in touch with the provider directly.

We are also accepting FSA or HSA payments for our at-home coronavirus test (COVID-19), simply use your account card at checkout to spend your FSA or HSA dollars on this test

Activating the test connects you to the unique alphanumeric barcode within your LetsGetChecked sample collection kit. The laboratory cannot process your sample if the test is not activated and linked to you. You should only activate your test when you are ready to take your sample.

Yes. LetsGetChecked has a team of board-certified physicians who will review your order and results and have created detailed result breakdowns for your testing journey.

Our nursing team is on standby throughout the testing process and, if your test results are abnormal, you will receive a call to discuss your results and next steps.

Keeping your personal data secure is important to us. We use appropriate technical and organizational measures to ensure security and confidentiality of your information, and only share your information where required to deliver our products and services or where we have a legal basis to do so. All samples are disposed of following analysis.

Your samples are processed in the same labs used by primary care providers, hospitals and government programs.

LetsGetChecked laboratories are CLIA approved and CAP-accredited, which are the highest levels of accreditation.

Sample collection kits are manufactured within our ISO 13485 accredited facility, the highest level of accreditation for medical devices.

We don't accept insurance at this time. We work to keep our tests as affordable as possible and our test costs are generally lower than the costs incurred from a trip to a healthcare provider.

We accept many Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA) cards. They can be used in the same way that a debit or credit card would be used at checkout.