COVID-19 RT-PCR Testing Options

SalivaDirect™ COVID-19 RT-PCR Test

SalivaDirect™ is a new and innovative RT-PCR testing method for SARS-CoV-2 detection that was developed by the Yale School of Public Health.

TaqPath™ COVID-19 RT-PCR Test

Endeavor DNA Laboratories provides RT-PCR testing for SARS-CoV-2 detection using the TaqPath™ COVID-19 Combo Kit manufactured by Thermo Fisher Scientific.

COMPARE THE TWO TESTS

SalivaDirect™

  • RT-PCR COVID-19 test and NOT an antigen or antibody test

  • FDA authorized for SARS-CoV-2 detection

  • Approved for International travel

  • Saliva sample collection

  • Same day results available*

TaqPath™

  • RT-PCR COVID-19 test and NOT an antigen or antibody test

  • FDA authorized for SARS-CoV-2 detection

  • Approved for International travel

  • Nasopharyngeal swab sample collection

  • Results in 24 to 48 hours

HOW SAMPLES ARE COLLECTED

What is SalivaDirect™

SalivaDirect™ is a new and innovative RT-PCR testing method for SARS-CoV-2 detection developed by the Yale School of Public Health and authorized for use by the FDA under Emergency Use Authorization (EUA) 202097.

While SalivaDirect™ still relies on similar molecular processes as other RT-PCR tests for SARS-CoV-2 detection, it involves a much simpler collection process that only requires saliva. Other testing often requires nasopharyngeal (NP) or nasal swabs, which can be uncomfortable and may discourage people from getting tested. With SalivaDirect™, we only require a small amount of saliva to perform accurate RT-PCR testing for SARS-CoV-2.

Approval to use the SalivaDirect™ testing protocol requires a high complexity CLIA certified laboratory such as Endeavor DNA Laboratories. The Yale School of Public Health has designated Endeavor DNA Laboratories as authorized to perform SalivaDirect™ testing. Find our Yale designation here.

*Rapid Turnaround

SalivaDirect™ COVID-19 RT-PCR results are provided within 12-24 hours from collection, Monday – Friday. Same day results are available if collection appointments are made prior to 11am. All testing is performed by Endeavor DNA Laboratories. We do not send your sample off for testing elsewhere.

Sensitivity

The SalivaDirect™ method reflects 100% clinical specificity and 94.6% clinical sensitivity. Endeavor DNA Laboratories has confirmed the Limit of Detection (LoD) to be 3 copies/µl in concordance with the SalivaDirect™ EUA. More information on SalivaDirect™ validation results can be found here.

Why is SalivaDirect™ Cheaper?

SalivaDirect™ is unique because researchers at Yale worked out how to make the sample collection process easier and the laboratory testing process more efficient. Worldwide shortages of testing supplies continue to be an issue and SalivaDirect™ provides an accurate and highly sensitive alternative that avoids expensive collection devices and time-consuming laboratory testing processes. Endeavor DNA Laboratories is able to pass on these efficiencies to our customers and patients making this test more affordable compared to other SARS-CoV-2 RT-PCR tests.

Important Information about SalivaDirect™

The assay is for in vitro diagnostic use under the FDA Emergency Use Authorization Only. 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. 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.”

SalivaDirect™ Patient Fact Sheet

SalivaDirect™ Healthcare Provider Fact Sheet

What is TaqPath™

Endeavor DNA Laboratories provides RT-PCR testing for SARS-CoV-2 detection using the TaqPath™ COVID-19 Combo Kit manufactured by Thermo Fisher Scientific. The TaqPath™ COVID-19 Combo Kit is authorized for use by the FDA under Emergency Use Authorization (EUA) 200010. Testing of SARS-CoV-2 using this kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

Swab Sample

The collection device for the TaqPath™ COVID-19 RT-PCR test is a Nasopharyngeal (NP) swab that also includes a transport tube containing a special preservative solution. When you arrive for your appointment, our highly trained staff will walk you through the entire swabbing process before collecting your sample. More information from Thermo Fisher Scientific regarding the TaqPath COVID-19 RT-PCR test can be found here and here.

Rapid Turnaround

TaqPath™ COVID-19 RT-PCR results are provided within 24-48 hours from collection, Monday – Friday. All testing is performed by Endeavor DNA Laboratories. We do not send your sample off for testing elsewhere.

Sensitivity

Analytical performance of the TaqPath™ COVID-19 Combo Kit was evaluated by determining the limit of detection (LoD). The LoD study establishes the lowest SARS-CoV-2 viral concentration (Genomic Copy Equivalents or GCE) that can be detected by the TaqPath™ COVID-19 Combo Kit. The LoD when using Nasopharyngeal (NP) swabs is 10 GCE/reaction (or 250 GCE/mL). The clinical specificity of the TaqPath™ COVID-19 Combo Kit is 100%

Important Information about the TaqPath™ COVID-19 Combo Kit

The assay is for in vitro diagnostic use under the FDA Emergency Use Authorization Only. This test has not been FDA cleared or approved. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

TaqPath™ Patient Fact Sheet

TaqPath™ Healthcare Provider Fact Sheet

NEED A COVID-19 RT-PCR TEST FOR INTERNATIONAL TRAVEL?

Most countries accept RT-PCR tests that use either saliva or nasopharyngeal swabs. A few countries may only accept nasopharyngeal swabs. Double check with your airline or travel destination before making your appointment with us.

Timing

Most countries with travel restrictions require RT-PCR tests be taken within 72 hours of your departure. Find out how they determine the timing before making your appointment with us. 

Important: Try to avoid traveling on Mondays. Endeavor DNA Laboratories is closed Saturday and Sunday, so it can be difficult to meet the 72 hour test window. 

BEWARE OF COMPANIES ADVERTISING ANTIGEN TESTS OR RAPID COVID-19 TESTS FOR INTERNATIONAL TRAVEL

 

BE SURE YOU ARE GETTING THE RIGHT TYPE OF TEST

 

MOST COUNTRIES WILL NOT ACCPECT ANTIGEN TESTS OR RAPID COVID-19 TESTS FOR ENTRY

Our COVID-19 RT-PCR results report will include:

  • Information about the type of test (COVID-19 RT-PCR)
  • Your name and birthdate
  • Specimen Type
  • The date of your specimen collection (your appointment date)
  • The date your results are issued.
  • Laboratory information: address, contact information, and CLIA ID number

If your destination country requires additional information on your COVID-19 RT-PCR report, please contact us at covid19@endeavordna.com before making your appointment.

FREQUENTLY ASKED QUESTIONS

Unlike rapid or antigen COVID-19 tests which are prone to accuracy issues, the COVID-19 RT-PCR test is considered the gold standard in detecting active coronavirus infection. A COVID-19 RT-PCR test detects genetic material called RNA from SARS-CoV-2, the virus that causes COVID-19. To learn more, visit the FDA’s website on Coronavirus Testing Basics.

RT-PCR stands for reverse transcription polymerase chain reaction. It is the most sensitive and accurate method available for detecting SARS-CoV-2, the virus that causes COVID-19. RT-PCR tests, also be referred to as molecular and/or nucleic acid amplification tests (NAAT), detect RNA of the coronavirus. Endeavor DNA Laboratories only offers RT-PCR testing for COVID-19 and does not offer antigen testing.

Antigen tests, also referred to as rapid tests, can produce results in 15 minutes. However, they are not very sensitive and can have a high false negative rate. Whereas RT-PCR testing is detecting genetic material from the coronavirus, antigen tests detect proteins produced by the coronavirus. The CDC and WHO do not recommend antigen testing for diagnosis. In fact, if you test negative for an antigen test, the medical recommendation is to confirm your negative result with an RT-PCR test!

After you have scheduled your appointment, you will be assigned an Appointment Number. When you arrive for your appointment, you will be asked to verify your Appointment Number, after which our trained sample collector will collect your specimen and take it directly to the lab for testing. For more details on the SalivaDirect™ sample collection process, please watch our video here. For more details on the TaqPath™ swab collection process, please watch our video here.

No. We are the accredited, CLIA registered laboratory that will perform your RT-PCR test. Because we do not ship your samples to another facility, we are able to provide results as quickly as the same day we receive your sample.

If you are exhibiting symptoms of COVID-19 or have been exposed to someone who has recently tested positive, you should get tested right away.

If you are traveling, most international destinations with travel restrictions require proof of a negative COVID-19 RT-PCR test.

Some countries require a nasopharyngeal (NP) swab and will not accept saliva specimens. Most countries do not care. Make sure to check with your airline, or check with the consulate, Embassy, or Ministry of Health in your destination country.

Testing is available for ages 3 and up.

No. We do not accept insurance for testing. Payment is due at the time of scheduling your appointment. We have specifically chosen this pay option to ensure you are not billed later by your insurance company. There are no additional or hidden fees.

Whether or not you will be reimbursed depends on your specific policy. We do not require a physician’s referral for testing, but some insurance providers may require this for reimbursement. Please contact your insurance provider for reimbursement options.

Absolutely! Even though our laboratory is located in El Paso, our testing is available to anyone willing to get their samples taken at our facility.

Absolutely! RT-PCR testing for COVID-19 is available to citizens of all countries.

Same day results are available for SalivaDirect™ testing Monday-Friday provided you schedule your appointment prior to 11am that day. For appointments made after 11am, results will be issued the next business day.

For nasopharyngeal swab tests, results are typically released 24 hours after your appointment, but may take as long as 48 hours.

Please note for all testing appointments scheduled on Friday after 11am, results will be issued the following Monday at the earliest. Endeavor DNA Laboratories is closed Saturday and Sunday.

If you tested positive, you should contact your primary healthcare physician or local hospital and follow the CDC guidelines for self-isolation.

Results are shared with public health authorities as required by law. See our Terms and Conditions.

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