Sekisui Diagnostics: Lateral flow testing

Q: What are the brand names of your lateral flow testing technologies for influenza?
• OSOM Ultra Flu A&B
• OSOM Influenza A&B

Q: How long have they been on the market?
• OSOM Ultra Flu A&B (2015)
• OSOM Influenza A&B (2006)

Q: CLIA certificates?
• The OSOM Ultra Flu A&B is CLIA-waived on Nasal and Nasopharyngeal Swabs. It also meets the “re-class” performance criteria as defined in FDA ruling 21CFR 8663328.

Q: Most logical call points?
Anyone performing flu testing, including:
• Family Practice
• OB/GYN
• Internal Medicine
• Retail/Pharmacy clinics
• Hospitals
• Health/Wellness Clinics

Q: Layperson’s description of how the technology works
OSOM Ultra Flu A & B utilizes the chemical extraction of viral antigens followed by solid-phase immunoassay technology for the detection of extracted antigen, influenza A and/or B. If influenza antigens are present in the specimen, they will react with anti-influenza antibody and bind to the immobilized anti-influenza antibody on the membrane, and generate a colored line at the Test line position (A and/or B). The rest of the sample and the unbound/bound dye complexes continue to migrate to the Control line position C.

Q: Often-heard objections?
Historically there have been some challenges with rapid lateral flow devices and their variability in performance. While they tend to show good specificity, they can deliver less-than-optimal sensitivity in respiratory specimens compared to RT-PCR or viral culture.

Q: Responses to objections.
Physicians and laboratorians can reduce this variability by taking the following steps:
• Obtain specimens for influenza testing as soon as possible after illness onset, ideally within four days.
• Know the prevalence of influenza in the area.
• Ensure proper collection and storage conditions of the specimen before testing.

Q: Other pertinent points for reps to be aware of?
Rapid lateral flow testing is still a viable option for testing and is frequently used in point-of-care settings due to its cost-effectiveness, ease-of-use, and rapid results (often available in 15 minutes or less). These tests give doctors the ability to begin antiviral therapy (while reducing antibiotic use) during a single patient visit, ultimately leading to a decrease in hospitalizations and fewer unnecessary tests.
(For more information, see Interim Guidance for Specimen Collection, Processing, and Testing for Patients with Suspected Infection with Novel Influenza A Viruses Associated with Severe Disease in Humans, Centers for Disease Control and Prevention, https://www.cdc.gov/flu/avianflu/h7n9/specimen-collection.htm)