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    • Training
    • Online Store
    • Book Appointment
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  • COVID-19 TESTING
  • Testing
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  • CRLCLEAR LOGIN
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  • Online Store
  • Book Appointment

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COVID-19 Self-Collection Kits

Authorized dealer for: 


CRL Rapid Response™ Saliva Test.


Easily self-collected and shipped to Clinical Reference Laboratories for quick results. 


Results are typically provided in 48 hours!

Curbside Pick Up Available

Securely purchase online and select the curbside pickup option. Then drive to our collection facility and we will bring your order out to you. 

CRL Rapid Response™ Saliva Test

contents of a saliva based test kit

CRL RAPID RESPONSE™ SALIVA TEST

NEWS!

FDA EUA Authorized to ship directly to donor and does not need to be overseen by a healthcare professional.


CRL RAPID RESPONSE™ is an FDA EUA Authorized saliva-based molecular test that is easily self-collected and shipped to Clinical Reference Laboratory (CRL) for lab testing. As of July 30, 2020, the FDA has authorized this test to be self-collected without being overseen by a healthcare professional!


Results are generally available within 48 hours and will confirm if the COVID-19 virus is detected in the saliva of the individual.


No nasal swab is required, collection is minimally invasive and can be reliably self-administered without the assistance of a healthcare worker.


Developer: Roche Molecular Systems, Inc.

Distributor: Clinical Reference Laboratory, Inc.

Dealer: Staff-Worthy

Test: Elecsys IL-6

Laboratory: Clinical Reference Laboratory, Inc.


This test has been authorized by FDA under an EUA for use by authorized laboratories; Emergency Use Authorization (EUA) request for distribution and/or use of the DNA Genotek OMNIgene® ORAL OM-505 saliva collection device for the collection and stabilization of saliva in buffer to transport viral SARS-CoV-2 RNA from patients suspected of COVID-19 by a healthcare provider. The specimen collection device is for use in conjunction with molecular diagnostic testing performed at a clinical laboratory using an in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 that is authorized for use with the home collected kit. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.  

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CRL RAPID RESPONSE™ Additional Information

EUA CRL Letter of Authorization 07-30-2020 OCC2 (pdf)

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CRL Rapid Response Press Release_7.31.20 (pdf)

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Saliva Is More Sensitive For COVID Detection (pdf)

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EMERGENCY USE AUTHORIZATION (EUA) SUMMARY (pdf)

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Questions?

What Tests Are Used To Diagnose COVID-19?

The FDA EUA Authorized two types of tests for diagnosing COVID-19 — molecular and antigen.


  • Molecular test. This test detects genetic material of the virus using a lab technique called polymerase chain reaction (PCR). Also called a PCR test, a health care worker collects fluid from a nasal or throat swab or from saliva. Results may be available in minutes if analyzed onsite or several days if sent to an outside lab. Molecular tests are considered very accurate when properly performed by a health care professional, but the rapid test appears to miss some cases. The FDA EUA authorized certain COVID-19 at-home test kits, when determined to be appropriate by a healthcare provider: A nasal swab kit and a saliva kit. The sample is mailed to a lab for testing. The FDA warns consumers against buying unauthorized home tests, because they may be inaccurate and unsafe.


  • Antigen test. This newer COVID-19 test detects certain proteins that are part of the virus. Using a nasal or throat swab to get a fluid sample, antigen tests can produce results in minutes. Because these tests are faster and less expensive than molecular tests are, some experts consider antigen tests more practical to use for large numbers of people. A positive antigen test result is considered very accurate, but there's an increased chance of false negative results — meaning it's possible to be infected with the virus but have negative antigen test results. So antigen tests aren't as sensitive as molecular tests are. Depending on the situation, the doctor may recommend a molecular test to confirm a negative antigen test result.

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