Frequently Asked Questions
What is the Detect Covid-19 Test™?
The Detect Covid-19 Test™ is a molecular in vitro diagnostic test using isothermal amplification and lateral flow technologies for the qualitative detection of RNA from SARS-CoV-2 ‒ the virus that causes Covid-19 ‒ in self-collected anterior nares (nasal) swab specimens. The test detects if you have an active infection with SARS-CoV-2, the virus that causes Covid-19, and can detect an infection at lower viral loads than antigen tests, allowing for earlier detection, whether or not you have symptoms.
Yes. The Detect test has been authorized by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for over-the-counter home use. It has not been FDA cleared or approved.
The test 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.
What technology does the Detect test use?
The Detect test uses RT-LAMP (Reverse Transcription Loop-mediated Isothermal Amplification) and lateral flow strip technologies to identify nucleic acids from a specific part of the SARS-CoV-2 genome called the Open Reading Frame 1ab (ORF1ab). SARS-CoV-2 is the virus that causes Covid-19. The Detect test also identifies nucleic acids from a human gene that serves as a control for sample collection, test reagents, and test execution.
How does the Detect Covid-19 Test compare with other at-home tests?
Diagnostic tests for Covid-19 include molecular and antigen tests. Most currently available at-home rapid tests are antigen tests.
Antigen tests look for protein markers on the outside of the virus that causes Covid-19 while molecular tests look for viral genomic material specific to the virus.
The Detect Covid-19 Test™ is a PCR-like molecular test - PCR tests are conducted by clinical laboratories and are considered the gold standard for diagnostic tests. Molecular tests amplify bits of viral RNA millions of times so that an active infection can be detected even when only small amounts of virus are present. Detect is a LAMP (loop-mediated isothermal amplification) test and therefore provides faster results than traditional PCR (Polymerase Chain Reaction) tests without sophisticated laboratory equipment but with similar accuracy and quality.
Antigen tests work best to see if a person is infectious by determining if they are at or near the peak of an infection. They can produce false negative results as there is some lag time between when someone gets infected and when the amounts of antigen in their samples are high enough for detection with an antigen test. The coronavirus replicates itself by putting its genetic material inside our cells. If you are testing a person at the stage when the virus is still replicating inside the cells, it may not have produced sufficient protein or shed the protein in large enough amounts to be detected yet by antigen testing.
Molecular tests such as the Detect Covid-19 Test are able to pick up very small amounts of viral RNA very early in an infection, so there is a low chance for false negative results, including among pre-symptomatic Covid-19 cases.
In a clinical study, no false positive results were observed with the Detect Covid-19 Test when interpreted correctly.
What is the accuracy of the Detect Covid-19 Test?
The following performance characteristics were established for the Detect test based on our clinical studies.
Accuracy is defined as the percent of samples that gave the expected result with the Detect Covid-19 Test™ in comparison with the reference PCR test, including all results, both positive and negative.
Sensitivity is defined as the percent of samples that gave the expected positive result with the Detect Covid-19 Test in comparison with the reference PCR test.
The Limit of Detection is defined as the lowest concentration of the viral genomic material that the test can consistently detect.
How does the Detect Covid-19 Test work?
The Detect test has been designed to be simple and easy to be used by anyone without any special training. To perform the test, you will need the following - a single-use Detect Covid-19 Test™, a reusable Detect Hub™ sold separately, and the Detect App™ available in app stores. The app is required to run the test, provides step-by-step video instructions, and helps with results interpretation.
The testing process involves a few minutes of hands-on work and ~55 minutes of sample processing in the Hub. The steps involve swabbing the nostrils using a soft-tip Swab, stirring the swab in a Test Tube that contains liquid, then mixing the sample with our proprietary reagent enclosed inside the Detect Cap, processing the sample in the Hub, and then inserting the tube into a Reader along with liquid provided in a Dropper. Reading the results is as simple as checking if there are one or two lines on the Reader strip.
In addition to the Detect App, detailed test instructions are also available here.
What is Detect’s policy about returns, cancellations, and refunds?
All sales made via our website are final. Except in the limited circumstances described below, we do not accept physical return of our products - used or unused - and we do not issue refunds. Make sure that you carefully review your purchase details and information related to our products before submitting your order.
We do not issue refunds or replacements for tests that are beyond their Use By date under any circumstances.
Replacements products will be provided at no additional charge if the following situations occur as confirmed by Detect:
Orders may be cancelled for a full refund prior to shipment from Detect.
Detect Verified™ purchases may be refunded in full within 30 days of purchase if the vouchers are unused. Any associated test kit and/or hub purchases are subject to the return/refund limitations described above.
Can I use my Detect test results to meet travel or venue requirements?
What do I need for the Detect Covid-19 Test?
You need a single-use Detect Covid-19 Test™, a reusable Detect Hub™, and the Detect App™ to perform the Detect test:
Each single-use test box includes the following and all components are to be disposed of after use:
The Detect Hub is sold separately and can be reused with any Detect Covid-19 Test and shared among multiple individuals. The Hub processes one sample at a time and the processing step takes ~ 55 minutes.
The Detect App is available to download for free in app stores for both iOS and Android smartphones.
What is the Detect Hub™?
The Detect Hub™ is needed for testing samples with the Detect Covid-19 Test testing samples with the Detect Covid-19 Test. It works similarly to a PCR machine used in laboratories to copy and amplify small segments of the viral genome from nasal swab samples. The processing step in the Hub takes about 55 minutes. Please ensure that the Hub is not unplugged during that step.
The Hub is reusable and can be used with multiple Detect Covid-19 Tests - as many as 2000+ tests based on our internal testing. The Hub processes one sample at a time. Multiple individuals may share a single Hub.
The Detect Hub comes with a USB cable and a power adapter and should be plugged into a wall outlet (100-240V AC).
The Detect Hub should be operated on a level surface, at room temperature only (59 ºF - 86 ºF) and not where the temperatures are too hot or too cold.
How do I get the Detect App? What type of phone do I need?
The Detect App™ is available to download for free to your smartphone in US versions of both Apple and Google app stores. The app provides step-by-step video instructions for the testing process and helps with result interpretation. The app also stores your test results history for easy reference when needed.
The Detect App is compatible with iPhone models released after 2013 and using the operating system IOS 13 or higher as well as Android models released after 2013 and the Android API level 26 (Android 8 or higher).
Do I need a doctor’s order or prescription to order the test?
No. The Detect test is available for use without a prescription or a doctor’s order.
Does the Detect test identify all variants of the Covid-19 virus?
Detect conducts routine surveillance of emerging SARS-CoV-2 variant strains and will continue to monitor effectiveness of our test for such variants. Based on bioinformatic analysis conducted as of March 19th, 2022, the Detect test is expected to recognize all currently known Variants of Concern. The mutations that characterize the Delta and Omicron variants (including the BA.2 Omicron subvariant) do not occur in the part of the viral genome targeted by the Detect test and are therefore not expected to affect the test's performance. Clinical validation with patient samples has not been done with the Detect test for these variants.
I am vaccinated against Covid-19, will that affect my test results?
No. None of the vaccines currently approved for use in the United States are expected to affect the Detect test results.
Who should take the Detect test?
The Detect Covid-19 Test™ is intended for non-prescription home use for individuals 2 years of age or older. The test can be self-administered by individuals aged 14 years or older, while adults can administer the test for children aged 2 to 13 years old. The test may be used whether you are or are not exhibiting symptoms of a Covid-19 infection as well as if you have been exposed to individuals who are confirmed to have an active infection with SARS-CoV-2, the virus that causes Covid-19.
Do I need to swab from deep inside the nose?
No. The Detect Covid-19 Test is designed to be easy-to-use and comes with a soft-tip swab that is comfortable to use. To collect a sample for the test, you need to insert the swab until only its tip is inside the nostril. There is no need to insert the swab deeper inside the nose.
Do you ship outside the United States?
No. At this time, the Detect test is only available within the United States. The Detect App can be downloaded from US versions of the app stores.
Is the test covered by insurance? Do you accept FSA/HSA?
You may pay for your Detect test and Detect Hub™ using a valid FSA/HSA payment card.
Additionally, as per the new federal administration guidelines, your purchase of the Detect tests made on or after January 15, 2022 may be eligible for reimbursement by your insurer. We recommend reaching out to your insurance carrier directly to discuss reimbursement including what is required to file a claim and their specific policies. Your order confirmation email is your purchase receipt. Detect™ is not currently part of any online network set up by insurers.
What is the shelf life of the test? How should I store it?
Each Detect test is labeled with a “Use By” date. Please ensure you check the date before using the test and only use the test if it has not expired. Typically, the test has a 3-month expiration from the date of manufacturing. This is determined by expiration dates of various components included in the test box. The tests you receive may have a shorter shelf life (1-2 months) depending on the order date. Our website provides up-to-date Use By date information for tests that are available at that time — please review carefully before you purchase. We will have tests with longer shelf life in the coming weeks.
The Detect test and the Detect Hub should be stored and used at room temperature (59 °F to 86 °F) away from direct sunlight. Do not store them in a refrigerator or hot location.
What is serial testing?
Serial testing involves testing the same person multiple times within a few days in order to increase the chances of identifying an infection early before the person is exhibiting any symptoms.
The Detect test should always be used for serial testing if your first test is negative and you don’t have symptoms or recent exposure to SARS-CoV-2, the virus that causes Covid-19. You should use a second test after at least 24 hours but within 48 hours. If the first or second test result is positive, then you are likely to be currently infected with the virus that causes Covid-19 and should consult with a healthcare provider.
What is an activation code?
Each Detect Covid-19 Test comes with a unique one-time use activation code printed inside of the test box. The code needs to be scanned or entered into the Detect App to start each test and access the video instructions.
What precautions are necessary to ensure a valid test result?
Please follow carefully the detailed instructions provided via the Detect App™ in order to ensure a valid result with your Detect test.
Why did I get an invalid result?
An invalid test result means there may have been an error in using the test. If you retest, please ensure you follow all instructions carefully.
Some of the reasons for an invalid test result include:
What can cause a false negative result?
A false negative result may occur if the sample was not collected properly due to incorrect swabbing of the nose or if the amount of the SARS-CoV-2 virus present on the swab is below the levels that can be detected by the test.
False negative results may also occur if the person is taking high dose biotin (Vitamin B7) supplements
Is it possible to get a false positive result?
Based on the clinical studies performed by Detect to validate the test, the test specificity is 100%, meaning the test correctly identified negative samples 100% of the time when results were interpreted correctly. This means the chances of a false positive result with the Detect test are extremely low.