Influenza Class II device
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Dear POCC,
January 2018 is the deadline for manufacturers to comply with the FDA's reclassification requirements for Influenza antigen kits from class I to class II.
We're in the process of meeting with different vendors. I would appreciate any feedback you're willing to share, i.e. pros and cons with your POC flu and Strep A analyzers (Alere i, Cobas Liat, Veritor & Sofia, etc.)
Is anyone upgrading from antigen FIA analyzer to a molecular system for their POC SA and Flu? If so, why.
Thank you in advance. Your feedback will very helpful to when choosing an instrument.
Ramona
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Currently using Vertior and like it. Easy to use for staff. Would love to move to molecular, it if wasn't so expensive.
We looked at the Liat and Alere I. Molecular would be great but the cost is a huge issue. Our billing department even said that some insurances weren't reimbursing to cover the cost.
We had BD for a few seasons. Last year we implemented the new strep on the Veritor system and then the company backordered the product that we never got to use it.
We are moving to Sophia 2 this season.
I've been doing research on molecular systems and yes, they're very expensive. Although they offer volume pricing it is still expensive when compared to rapid antigen tests. That being said, Sofia and Veritor are class II devices but they're essentially POC Influenza antigen test readers. I haven't verified this but I suspect that sensitivity and specificity are probably the same or not much higher than the visual antigen kits.
We were looking at molecular because they offer better sensitivity and results are definitive. No need to send out negatives. But pricing is a big issue and may be the deciding factor for many, including us.
Thank you for sharing your experience. I appreciate it.
We would like a system that does both strep A and influenza.
Lacey--thanks for your feedback.
We met with Roche. this week. We have scheduled demos with Sofia and Alerei in the next 2 weeks. I got a chance to see the Alere at the POCC conference at MSCK last week. Haven't scheduled a demo yet but I'm looking at Veritor also.
I knew going in that cost may be the deciding factor but I didn't expect molecular to be as expensive as it is.
We are a physician's group with multiple offices. We would have loved to have switched to molecular as we also think it's superior technology. Fortunately were forewarned by a vendor some major insurance payers aren't covering it in an outpatient setting. We were forced to stick with immunoassay technology until payers catch up with the technology.
That is the unfortunate truth.