I further acknowledge that this consent does not establish a patient provider relationship between delware diagnostic labs or any of its partners and that services are being provided fo the limited purpose of COVID-19 RT-PCR testing. Should follow-up medical care be required, it is my responsibility to seek it through a primary care physician or health clinic.I also understand that per state regulations my result will be reported to the appropriate state departments.

THE RESPIRATORY PATHOGEN PANEL ASSAYS ARE NOT 510K CLEARED, BUT MANAGED BY CMS AND FDA UNDER THE CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) AS A LABORATORY DEVELOPED TEST (LDT). THE ANALYTICAL PERFORMANCE CHARACTERISTICS OF THESE ASSAYS HAVE BEEN DETERMINED BY DELAWARE DIAGNOSTIC LABS (DDL). THE ASSAYS HAVE BEEN VALIDATED PURSUANT TO THE CLIA REGULATIONS AND ARE USED FOR CLINICAL PURPOSES. THE TESTING IS PERFORMED USING A DNA PROBE-BASED REAL TIME RT-PCR METHODOLOGY.(NUCLEIC ACID AMPLIFICATION TEST (NAAT))

PAYMENTS EXPECTED AT THE TIME OF THE TEST (IF SELF-PAY) COVID-19 TESTING IS COVERED BY MOST INSURANCE POLICIES. COMPLETE AND ACCURATE INSURANCE INFORMATION IS REQUIRED FOR PROCESSING.

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