Detect™ Covid-19 Starter Kit
Everything you need to run your first Detect™ test. Includes the Detect™ Covid-19 Test and a reusable Detect™ Hub.
Suitable for ages 2+ years
Results in 1 hour
- 24/7 support
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Ordering tests for your business, school, or other organization? Talk to us.
This Detect Covid-19 Starter Kit includes one single-use Detect Test and a reusable Detect Hub. This product has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens. Download the Detect App to follow the step-by-step video tutorial and get your results.
- Suitable for ages 2+ years
- Test is single-use
- Hub is compatible with the Detect Covid-19 Test
- Requires the free Detect App (Android and iOS).
- Note: This test does not detect antibodies or immunity.
- High doses of biotin (Vitamin B7) supplements may lead to a false negative result.
For use under FDA Emergency Authorization only.
- This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA).
- For in vitro diagnostic use.
- 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 IVDs 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.
Detect™ Covid-19 Test
Already have a Detect™ Hub? Order a new Detect™ Covid-19 Test. For those who already have a Detect™ Hub.
Additional or replacement Detect™ Hub for your Detect™ Covid-19 Tests. The Detect™ Hub is reusable and required to complete the processing step for any Detect™ test.
For your organization
Clinically studied and validated
Shown to be on par with expensive PCR lab tests in FDA-reviewed clinical studies.
Across our clinical studies, our test is comparable to PCR tests.
We correctly identified positive samples 90.9% of the time in clinical studies.
We correctly identified negative samples 100% of the time in clinical studies.
Limit of Detection
Our Limit of Detection is 313 copies/swab (<1 copy/µL) in analytical studies, which is on par with widely used PCR lab tests.
A clinical study was conducted across two sites, with testing performed by untrained operators. The study enrolled symptomatic subjects and subjects with recent Covid-19 exposure, each of whom self-collected two nasal swab samples (adults) or had two nasal swab samples collected by an adult caregiver (children under 14). For each subject, one swab was collected and sent to a reference laboratory and tested using a high sensitivity FDA-authorized SARS-CoV-2 RT-PCR test by trained laboratory personnel as a comparator, while the other swab was tested using the Detect Covid-19 Test by the untrained subject or caregiver at the clinical site. Comparing the Detect Covid-19 Test’s results to those produced by the high sensitivity FDA-authorized SARS-CoV-2 RT-PCR test, the Positive Percent Agreement (PPA) was 90.9% (30/33) and the Negative Percent Agreement (NPA) was 100% (79/79) with expert interpretation.