Influenza testing
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For those of you not using a molecular based test for flu testing, are you confirming all of your negatives with culture?
Thanks!
Cindy
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Cindy,
we do not perform any reflex testing for negative influenza rapid POC testing. We use the Sofia flu kit. Patients will have fully recovered from most typical respiratory infections before the results of a viral culture come back. Reflexing to a molecular based test would be too cost prohibitive for every negative rapid screen. Unlike group A pharyngitis, needing to be reflexed due to the potential adverse outcome of an undetected Group A infection, except in rare cases, patients will fully recover from an influenza infection.
Reflex testing of a negative influenza screen should only be performed on a case by case basis, only when a patient's overall health is taken into account. In these cases, a rapid turn around time by a PCR method would be the test of choice and in many cases a multiplexed test that detects multiple viral or bacterial components may be the best alternative. PCR should now be considered the gold standard over culture.
We use the Quidel Influenza A+B kit for Sofia as well . The package insert states “A Negative test is presumptive and it is recommended these results be confirmed by viral culture or an FDA –cleared Influenza A+B molecular assay. We are Joint Commission inspected and they interpret a recommendation as a requirement. We do confirm all patient tests that are both Negative for A+B and also any that are Positive for both A+B as indicated in the package insert.
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Elizabeth,
What method are you using for the confirmation? We are also Joint Commission accredited and have concerns over the package insert.
We have to send our confirmations to Quest (they use PCR) because they will accept a nasal swab in VCM. Our main lab has Cepheid which requires a nasopharyngeal specimen. We do not want our Medical Assistants collecting Nasopharyngeal swabs.
CONFIDENTIALITY NOTICE: This e-mail and any accompanying
attachments may be privileged, confidential and may contain protected health
information about an identified patient or is otherwise protected from
disclosure. State and federal law protect the confidentiality of this
information. If the reader of this message is not the intended recipient; you
are prohibited by law from using, disclosing, reproducing or distributing this
information; please immediately notify the sender and delete or otherwise
destroy the original message and any attachments(s) and copies.
Disclaimer
The information contained in this communication from the sender is confidential. It is intended solely for use by the recipient and others authorized to receive it. If you are not the recipient, you are hereby notified that any disclosure, copying, distribution or taking action in relation of the contents of this information is strictly prohibited and may be unlawful.
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Thank you Gregory. If you are not doing the confirmations whether it be culture or PCR, how are you getting around the package insert recommending it? We are in the process of switching to Sofia 2, and this issue was brought to my director's attention from another vendor.
Elizabeth said <We do not want our Medical Assistants collecting Nasopharyngeal swabs.>
I hear that, Elizabeth! Our RNs do not collect them either. Gotta be an MD or provider. And no washes!
Cindy, from what I understand (and possibly this depends on state regs as well? not sure) some lab directors will take the responsibility to conduct a study then sign off on 'not' having to send in confirms. "The data shows..."
We are CAP certified, for waived testing a recommendation is just that, a recommendation. It is left up to Provider discretion to use back up PCR testing on POC Influenzas. Moving to molecular in POC would be too cost prohibitive.