COVID waived testing
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Does anyone have a COVID waived test that Neg result does not need a confirmation? If you do, can you please share your device's package insert? We have the Sofia 2 that we can use the covid test option however, the package insert states the following:
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID19.
Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID19.
Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing
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Have a look at Cepheid:
I am wondering if you perform the Antigen onsite and then send the PCR can you bill for both since they are 2 different platforms?
The Cepheid is great and molecular so you do not need confirmation but they are pricey.
COMBO TEST & SARS ONLY
SARS: Presumptive Negative - with this interpretive data: "Negative results, from patients with symptom onset beyond five days, should be treated as presumptive and, if inconsistent with clinical signs or necessary for patient management, should be re-tested with an alternative molecular assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative result should be considered in the contest of a patient's recent exposures, history, presence of clinical signs and symptoms consistent with COVID-19."
This information listed is directly from the package inserts.
We felt by stating the results where presumptive negative we left the onus on the provider to do additional testing if warranted. Our providers will order a respiratory panel if they are still suspicious.
It all goes back to who your accrediting agency is and what "should, may" really mean!