Sonora Quest is performing a test kit manufactured by EUROIMMUN, a PerkinElmer company. The assay kit package insert6 states that in the validation of the ELISAs, no cross-reactions to antibodies against worldwide-distributed coronaviruses were detected. Cross-reactions with antibodies against the closely related SARS-CoV(-1) and other known human coronaviruses (HKU1, NL63, OC43, or 229E) cannot be [...]

As stated in literature provided by EUROIMMUN, analytical specificity of the EUROIMMUN Anti-SARS-CoV-2 ELISA IgG antibody test is 98.5-99%. Due to the low homology of the SARS-CoV-2 S1 protein to the human coronavirus family (HCoV-229E, HCoV-NL63, HCoV-HKU1 or HCoV-OC43), cross-reactions to most of the human pathogenic representatives of this virus family are virtually excluded.

Sensitivity is normally used in the context of measuring sensitivity to detect the disease, however, in the context of serology, you are only measuring sensitivity to antibodies, not SARS-CoV-2. Because antibody testing is not used for diagnosis, sensitivity is less important than specificity. The focus is on maximizing specificity for IgG so that we have [...]

In medical diagnosis, test sensitivity is the ability of a test to correctly identify those with the disease (true positive rate), whereas test specificity is the ability of the test to correctly identify those without the disease (true negative rate).

The antibody testing does not need to be on its own requisition. However, if you’re submitting both a molecular test and an antibody test, the molecular test must be submitted on its own requisition in its own specimen bag.

To apply for AHCCCS or to obtain additional information, patients can visit https://azahcccs.gov/Members/GetCovered/apply.html or call the Applicant & Member Services 1(855)HEA-PLUS (1-855-432-7587). Calls are answered Monday through Friday 8 a.m. – 5 p.m.

Based on the regulations and expected coverage for testing, for our insured patients, Sonora Quest will bill the patient’s insurance directly.  For uninsured patients, Sonora Quest will pursue reimbursement from the Arizona Health Care Cost Containment System (AHCCCS) or the Department of Health and Human Services (HHS).  Sonora Quest is not billing patients for this [...]

Based on the regulations and expected coverage for testing, Sonora Quest is not billing patients for this testing when ordered by a physician. It is recommended that patients consult with a physician to determine the medical necessity of obtaining COVID-19 testing. A physician ordered test would likely be covered if the order meets coverage guidelines, [...]

The price of the test is $65 if billed directly to a healthcare provider’s office, and $99 if billed to insurance or if a patient decides to purchase the test themselves without a doctor’s order or insurance through our My Lab ReQuest™ solution. Based on the regulations and expected coverage for testing, for our insured patients, Sonora [...]

There are many point of care (POC) tests out in the market that have not been validated and/or have no EUA from the FDA. Many of these fingerstick tests show false positives or false negatives. This has resulted in the FDA being more restrictive with those testing options. Any test that Sonora Quest offers will [...]