Quidel: Analyzer reader(s)
Q: What are the brand names of your reader-based technologies for influenza?
Sofia® 2
Sofia®
Q: How long have they been on the market?
Sofia® 2: New
Sofia®: 2012
CLIA certificates?
CLIA-waived
Q: Most logical call points
Hospital and Physician Office Labs, Urgent Care
Q: Layperson’s description of how the technology works
Sofia 2 and Sofia use fluorescence technology combined with proven lateral flow cassettes to produce highly accurate results that are quick, automated and objective.
Q: Often-heard objections
• “Lateral flow tests are unreliable.”
• “Your test is too slow compared to my current test.”
• “My staff is not used to using instruments for flu testing…it seems too complicated.”
• “I am looking to go with molecular testing.”
Q: Responses to objections:
• Sofia Influenza A+B performance has been well established compared to both viral culture and molecular methods, with results that compare very favorable to many molecular platforms.
• Sofia 2 offers Advance Result Technology, delivering highly accurate, objective and automated results in as few as 3 minutes.
• Sofia 2 and Sofia are designed to meet the needs of all lab environments. If you’re a small physician office, they both can be as simple as you need; if you’re a large health system, they both can be as comprehensive as you need them to be.
• Sofia Influenza A+B FIA has been studied compared to multiple molecular platforms and shown very good correlation to those platforms, particularly in the first 48 hours after symptom onset. This period is the most valuable, given the ability to use antiviral therapy with the most success in shortening duration of symptoms.
Other pertinent points for reps to be aware of
Sofia 2 and Sofia benefit from the power of Virena®. Our remote access feature allows users across multiple instruments and multiple facilities, highly secure desktop access to all user activity across their system. It also provides the Virena map, which allows near real-time data around emerging infectious disease trending…all at no cost to the user. It does not require costly interfaces either; the hardware and service are included for all Sofia 2 and Sofia users.
Quidel: Molecular diagnostics
Q: What is/are the brand name of your molecular diagnostic technology for influenza?
Solana® Influenza A+B
Q: How long has it been on the market?
Ten months
Q: CLIA certificate?
Moderately complex
Q: Most logical call points?
• Hospital lab
• Physician’s office lab (moderately complex)
• Urgent care lab
• Moderately complex Student Clinics/University Clinics
• Reference lab
Q: Layperson’s description of how the technology works
Helicase Dependent Amplification (HDA) works similar to traditional PCR, where targeted genetic material is amplified and measured to show the presence or absence of the target. The differences include:
• Doesn’t utilize thermocycling. Uses the same temperature throughout the reaction, which dramatically reduces the assay time to under an hour and simplifies the instrument.
• A helicase (enzyme) is used to unwind the DNA instead of a really high temperature.
Q: Often-heard objections?
• “Solana Influenza A+B Assay is not CLIA-waived.”
• “TAT of ~45 minutes is too long.”
Q: Responses to objections
• Per the Centers for Disease Control and Prevention, molecular testing is not needed on all patients with suspected influenza, but is most appropriate for hospitalized patients if a positive test would result in a change in clinical management.
• Because molecular costs more than lateral flow, it is not cost-effective or necessary to run molecular on every single patient suspected of having the flu, in accordance with the above guidelines.
• Therefore, in the majority of cases, lateral flow should be run first. If the result is a negative, and the physician suspects the patient has the flu or if the patient is very sick/elderly/immunocompromised (i.e., someone for whom the flu could create serious complications), a sample should then be reflexed to molecular.
Q: Other pertinent points for reps to be aware of
• Can batch up to 12 samples at a time.
• Lowest in class invalid rate.
• Compatible with both nasal and nasopharyngeal swabs and with many medias (Remel M4/M4-RT/M5/M6, BD UTM, Copan eSwab).
• Additional novel content such as HSV 1+2/VZV and Step A+C/G available alongside flu on the Solana platform.
• Solana has Virena capability, which allows customers to see influenza A+B prevalence rates at sites in their institution and institutions in their area.