A non-invasive, recommended alternative for COVID-19 mass testing.

1CARE Diagnostics is one of the few laboratories across the US that has the approval to perform SalivaDirect COVID-19 testing.

In seeking COVID-19 testing, our partners  may choose SalivaDirect as a non-invasive and more affordable option. This test is developed with mass testing and observation in mind.

Interested submitting samples?

The science behind SalivaDirect

SalivaDirect™, a new non-invasive approach to testing possible COVID-19 cases, was developed at the Yale School of Public Health. This process is highly recommended for large-scale testing and offers several benefits, when compared to traditional testing processes.

The test relies on rt-PCR technology, like any other rt-PCR-based COVID test. The difference is that a saliva sample (spit) is collected, which is then extracted for the RNA component of the virus. The extracted sample is then put through the PCR process to obtain the final result of the samplepositive or negative for the SARS-Covid-19 virus. The sensitivity and efficiency of this test is similar to nasal sample-based methods.

The stability of the saliva sample is significantly better than the nasal sample, however, eliminating the need for expensive collection equipment.

SalivaDirect, a new approach at testing possible COVID-19 cases, was developed at the Yale School of Public Health. This process is highly recommended to be used for large-scale testing and offers several benefits compared to traditional testing processes.

The Yale School of Public Health has approved 1CARE Diagnostics as a testing laboratory to perform COVID-19 saliva testing.

Why choose SalivaDirect?

SalivaDirect™ is less invasive, less painful, and more affordable. Moreover, unlike a nasopharyngeal (NP) swab, it requires only a small saliva sample. With the supervision of a healthcare professional, it lets an individual collect his or her own saliva sample, completely without the need for swabs or other collection tools.

SalivaDirect™ takes less than a minute to conduct, a fast process for individuals and a safe one for the healthcare professionals, whose risks of being exposed to COVID-19 will be reduced. More importantly, SalivaDirect is highly accurateit produces a 94% success rate, compared to an NP test.

Regaining normalcy with SalivaDirect

A saliva-based approach at detecting COVID-19 is easier to facilitate and probe.

The FDA also granted SalivaDirect with an emergency use authorization (EUA).

What does it mean? Going back to our normal lives will happen sooner than we think.

This test has not been FDA cleared or -approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
The emergency use of this test 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.