Now Available – Corona Virus Testing
Coronavirus Disease 2019, or COVID-19, is a novel respiratory disease that has been characterized as a pandemic by the World Health Organization. Arctic has developed new diagnostic tests for the virus that causes COVID-19 (referred to as SARS-CoV-2). Rapid identification of individuals with this virus is important in addressing this escalating public health issue.
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.
Assay Workflow
The combined RT-PCR reaction together with the high-throughput processing on the MassARRAY system enables testing of up to hundreds or thousands of samples per day.
Results are typically available within 1-2 days of your sample being received by the lab.
Test Description
The Arctic 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.
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 five known distinct regions within the SARS-CoV-2 genome. Amplification of more than 1 target will signify a positive result; amplification of only one target will signify an indeterminate (inconclusive) result; and no amplification of any 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.
- Nasopharyngeal Swab
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.
The option to retest if indeterminate is available.
Note: The cash price for COVID-19 tests is $119