Coronavirus
Testing

Why Molecular Testing?

Molecular testing is capable of detecting active COVID-19 infections in the human body. Unique genetic markers of the virus can be found in RNA that only remains in the body while the virus invades and replicates itself. One of the benefits of molecular testing is its sensitivity in detecting active infection, allowing patients to receive appropriate treatment and take measures to prevent spreading the disease.

Test Options

Coronavirus Disease (COVID-19) Virus Testing

by RT-PCR (FDA-authorized test*)

Overview
  • Uses reverse transcription polymerase chain reaction (RT-PCR) test to detect viral presence.
  • Test results will be labeled positive, negative, or indeterminate.
  • The option to retest if indeterminate is available.
TAT
Results are typically available within 24-48 hours of your sample being received by the lab.
Cost
$100 (self-pay). Email covid19@fulgentgenetics.com for more information.
Sensitivity
99.9% at >3 copies/uL
Specificity
99.9% at >3 copies/uL
Test Description

The Fulgent Coronavirus Disease (COVID-19) RT-PCR test is a reverse transcription polymerase chain reaction test to detect SARS-CoV-2, the virus that causes COVID-19. This method is also called a nucleic acid amplification test (NAAT).

The SARS-CoV-2 primer and probe sets are designed to detect RNA from 2019-nCoV in specimens from patients who meet CDC 2019-nCoV clinical criteria. Primer and probe set sequences are based on CDC recommended guidelines that identify two known distinct regions within the SARS-CoV-2 genome. Amplification of both targets will signify a positive result; amplification of one of two targets will signify an indeterminate (inconclusive) result; and no amplification of either target, but amplification of internal control, will signify a negative result. Inconclusive results will require a new sample for testing.

* This test has been authorized by the FDA under an Emergency Use Authorization (EUA). This means that while the laboratory performing this test has validation data to support offering this test, it has not been approved or cleared by the FDA. This test has only been authorized by the FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen. It is only authorized during the duration of the COVID-19 emergency declaration by federal regulators under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Please see the Patient Fact Sheet and the Healthcare Provider Fact Sheet for additional information. Additional information can be found on the FDA's website.

To view our COVID-19 Privacy FAQs, click here.

Sample Types & Limitations

Sample Type
Click to see collection instructions. Please see “how to order” for instructions on sample preparation and ordering processes.
Limitations

No laboratory test is 100% accurate. A positive test is a strong indication that the sample we received is from someone who is infected, but there is some possibility of a false negative result due to test performance or sample contamination issues. A negative test does not completely rule out an infection. If you have symptoms (fever, cough, fatigue, etc.), you should take precautionary measures regardless of the result of this test. Consult a physician or the CDC website for more information.

How long a person needs to be infected before testing positive, and whether an infected person can be identified by the test before displaying symptoms, are currently unknown.


How to Order

If you require a sample collection kit, please contact us at clientservices@fulgentgenetics.com.

PLEASE NOTE: Orders may only be placed by physicians and medical institutions

To learn about our at-home testing option, visit www.PictureGenetics.com/covid19.

Instructions for Submitting

Swab and Saliva Samples

FOR SINGLE ORDERS
Download and complete the appropriate Test Requisition Form (TRF)
Or contact covid19@fulgentgenetics.com to request testing
Sample Requirements:
  1. Collect using standard procedure for selected sample type/kit.
  2. Label each specimen with at least two unique identifiers that match the order paperwork (e.g. - patient first and last name; DOB; MRN).
  3. Store specimens at 2-8°C and ship overnight at ambient temperature or on ice pack (preferred).
Send Completed TRF and Collected Sample to:

Fulgent Genetics
4373 Santa Anita Ave
El Monte, CA 91731


More about the Coronavirus

For more information on COVID-19, visit the CDC’s website and/or WHO’s website.
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