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ANTIGEN TEST REGISTRATION

LabStat, LLC Concierge Services

YOUR ANTIGEN TEST REGISTRATION BEGINS HERE

Complete the following form carefully and completely, with accurate and current information to ensure your test is not delayed.

Be sure to read both the waiver and authorization in their entirety.

What Exactly is an Antigen Test?

The High-Level:

Antigen tests work by detecting bits of proteins known to exist on the surface of the SARS-CoV-2 virus – these are what are called Antigens. However, an Antigen test does not directly detect the virus itself.  Because of this, they’re also less accurate than a PCR Test, and cannot be used for making a clinical diagnosis.

Antigen tests still have practical value though – in particular because they take as little as 15 to 30 minutes to get results.  This is the reason they’re commonly referred to as the “rapid test.” 

The tradeoff for the speedy results – as you might have guessed by now – is that Antigen testing is significantly less accurate than a PCR Test.  A rapid Antigen test will be most accurate when used within a few days of the onset of symptoms, because that is when the highest concentration of viral material is present in the body. Still – because this test does not provide the same accuracy as a PCR Test, your healthcare provider will likely order a PCR Test to confirm a negative Antigen result if you were exposed to the virus, or if you’re showing potential symptoms.

 

The Technical Explainer:

The CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.