A New Device to Aid in the Rapid Detection of Influenza A and Influenza B

3M™ Rapid Detection Flu A+B Test now gives health care providers a reliable and rapid new device to aid in the detection of patients potentially infected with the influenza virus.

By James Ingebrand, Global Business Director, 3M Infection Prevention

Influenza (“flu”) is a contagious respiratory illness. Each year, 5-20% of the U.S. population gets the flu. But some people, including older adults, young children and those with chronic medical conditions, are at increased risk for serious complications. According to the U.S. Centers for Disease Control, every year in the U.S., on average, more than 200,000 people are hospitalized from flu complications with approximately 36,000 people dying from the virus or its complications.

Hospitalizations and treatments associated with flu complications can have a significant impact on the healthcare system. The CDC estimates the cost of a severe flu epidemic to be $12 billion. Rapid and reliable detection, like that provided by the 3M Rapid Detection Flu A+B Test, combined with effective treatment decisions and infection control measures may help hospitals improve outcomes for patients, help protect at-risk populations and decrease the financial impact.

The 3M Rapid Detection Flu A+B Test utilizes an easy-to-use, automated 3M™ Rapid Detection Reader to deliver an objective identification of patients from nasopharyngeal swab, nasal wash or nasopharyngeal aspirate samples infected with either influenza A or influenza B virus in 15 minutes.

While other rapid tests for influenza A and influenza B can provide clinicians with quick results, the tests often lack sufficient sensitivity. The 3M Rapid Detection Flu A+B Test delivers both speed and clinical performance, giving health care providers reliable diagnostic information.

In a recent study at the North Shore University Hospital 1 , the sensitivities and specificities of BinaxNOW ® Influenza A&B Test and the 3M Rapid Detection Flu A+B Test for the detection of influenza A and influenza B were measured. The 3M Rapid Detection Flu A+B Test provided superior detection of both influenza A and influenza B in comparison to the BinaxNOW Influenza A&B Test. 1

In addition to superior detection, the 3M Rapid Detection Reader helps take the guesswork out of the lab. The automated 3M Rapid Detection Reader rapidly delivers a qualitative positive or negative result and differentiates influenza A and influenza B direct from the nasal specimen. By removing the subjective nature of visually reading the test results, which may lead to false negatives or false positives, lab managers can have more confidence in their test results and clinicians can have more confidence in their diagnoses.

Designed to provide health care staff with rapid, reliable diagnostic information, the 3M Rapid Detection Reader utilizes highly sensitive RAMP® technology. RAMP is a lateral flow immunoassay platform that delivers a reliable, qualitative positive or negative result and differentiates influenza A and influenza B direct from specimen in 15 minutes.

In this immunochromatographic-based test, a nasopharyngeal swab, nasal wash or nasopharyngeal aspirate sample is mixed with sample buffer and fluorescent-dyed particles, coated with anti-influenza A or influenza B antibodies. An aliquot is applied to the sample well of the single-use test cartridge. As the sample migrates along the strip, influenza-bound particles are captured by either anti-influenza A or anti-influenza B nucleoprotein monoclonal antibodies at the respective detection zone. Excess fluorescent particles are captured at the internal standard zone.

The 3M Rapid Detection Reader then measures the amount of fluorescence emitted by the complexes bound at the two detection zones and at the internal standard zone. The 3M Rapid Detection Reader calculates a ratio (RAMP Ratio) of each detection zone’s fluorescence reading to the internal standard zone fluorescence reading. The 3M Rapid Detection Reader compares these ratios to pre-defined threshold limits to determine a positive or negative result for influenza A and influenza B in the tested sample. This unique RAMP technology enables the 3M Rapid Detection Flu A+B Test to provide reliable results.

Additionally, the 3M Rapid Detection Reader incorporates built-in error checking and self-diagnostic functions that assure procedural control and the integrity of the results while automatically correcting for environmental and user variability. These include algorithms and measurements used to confirm acceptable operator technique, sample handling and assay performance. Insertion of the lot card into the 3M Rapid Detection Reader is the only calibration required.

Automatic recording and storage of test data in the 3M Rapid Detection Reader and/or on a USB drive, use of bar code scanner for sample identification and operator identification, automatic print function and Laboratory Information Systems (LIS) connectivity capability helps to further reduce the potential for reporting error by eliminating the need for manual recording and transferring of patient results.

A busy lab can’t always spare the manpower required to stop and read a test with a short result window. The 3M Rapid Detection Reader gives the lab personnel more flexibility in time and test management. The simple test procedure requires 3 minutes or less total hands-on time and is self-timed leaving the lab personnel free to attend other duties as the test runs. Combined with the automatic calibration and automatic recording and storage of test results, this is easily one of the most lab-friendly devices available.

For a rapid, reliable diagnosis of patients presenting with flu-like symptoms, the 3M Rapid Detection Flu A+B Test combines trusted science with innovative technology to deliver fast, objective results at an acceptable patient cost while helping labs manage workflow.

The 3M Rapid Detection Flu A+B Test System consists of the 3M TM Rapid Detection Control Module, 3M TM Rapid Detection Test Module and a 3M Rapid Detection Flu A+B Test kit. A printer and bar code scanner are also available as accessories.

The 3M Rapid Detection Flu A+B Test is FDA 510(k) cleared and currently available in the U.S. For further information or to sign up for a free evaluation, please visit www.howtocatchtheflu.com.

REFERENCES:

1 Clinical Evaluation of the 3M Rapid Detection Flu A+B Test, C. C. Ginocchio, M. Lotlikar, L. Falk, M. Kowerska, S. Aurora and M. Bornfreund. North Shore University Hospital, Manhasset, NY