Swab collection is administered by a healthcare worker using a COVID-19 Collection kit, your sample is sent directly to a State of The Art Laboratory that is CLIA Certified and CAP Accredited where samples are processed and tested that day. The Real Time RT-PCR, DNA instrumentation that they use is cleared by the FDA’s Emergency Use Authorization (EUA).
Yes. The COVID-19 Nucleic Acid Amplification Testing detects the presence of the underlying virus SARS CoV-2 that causes COVID-19 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.
Nucleic Acid Amplification test that is run on Real Time-PCR Instrumentation.
THIS TEST IS FOR INDIVIDUALS WITH ACTIVE SYMPTOMS OR HEALTHCARE PROFESSIONALS or essential workers WITH KNOWN RECENT EXPOSURE TO AN INDIVIDUAL WHO HAS TESTED POSITIVE.
Nasal Swab: Nasopharyngeal swab submitted in viral transport media, which is a preferred sample type;
Mouth Swab: Oropharyngeal swab submitted in viral transport media, which is a preferred sample type;
Saliva: Oropharyngeal aspirate or washing submitted in a sterile, leak-proof, screw cap sputum collection cup or sterile dry container;
We expect results 24-72 hours after the laboratory receives the specimen.
Positive results will be treated as a critical result and will be called to the ordering physician or health care provider.
Yes.
Yes.
Not necessarily. COVID-19 assay detects the virus directly, within the established limits of detection for which it was validated. A positive result is considered definitive evidence of infection. However, a negative result does not definitively rule out infection. As with any test, the accuracy relies on many factors:
The test might not detect virus in an infected patient if the virus is not being actively shed at the time or site of sample collection.
The amount of time that a n individual was exposed prior to the collection of the specimen can also influence whether the test will detect the virus.
Individual responses to the virus can differ.
Whether the specimen we receive was collected properly, sent promptly, and packaged correctly.
Test results are a critical part of any diagnosis, but must be used by the clinician along with other information to form a diagnosis.
This test has not been reviewed by the FDA. For use in clinical laboratories by health care professionals following FDA guidance “Policy for Diagnostic Tests for Coronavirus Disease-2019 (COVID-19) during the Public Health Emergency”.