CEO SUMMARY: One of the hottest market segments in in vitro diagnostics (IVD) is rapid testing. However, because labs now often have multiple choices when selecting a rapid test, IVD manufacturers recognize the need to differentiate their products by adding additional features and benefits. In the case of 3M’s new rapid test for influenza, the ability of the system to deliver results directly into the laboratory information system is one such product differentiator.
ONE SIGN THAT THE MARKET for rapid testing is maturing is when in vitro diagnostics (IVD) manufacturers position their test kits with multiple features that promise to add value to laboratory customers.
That seems to be happening in the market segment of rapid testing for influenza. This is a sizeable market, since up to 20% of the U.S. population will suffer a case of influenza during the course of a year. Influenza is the cause of more than 200,000 hospitalizations and approximately 36,000 deaths annually.
Influenza Test Kits
Currently several manufacturers offer test kits for influenza, expanding the choices available to laboratories. 3M Company of St. Paul, Minnesota recognized this competition as it developed its own rapid test for influenza.
After an evaluation in one of the busiest virology labs in the country, 3M’s new rapid detection flu test performed with sensitivity and specificity comparable or better than other FDA approved immunoassays, and produced results in 15 minutes. However, recognizing the need to differentiate its rapid flu test from competing products, 3M designed its analyzer and rapid flu test system to send results directly to a laboratory information system (LIS). The new test is the 3M Rapid Detection Flu A+B Test.
One of the laboratories which participated in the evaluation of 3M’s rapid flu test was the University of Rochester Medical Center in Rochester, New York. Last year, the lab did 5,500 flu tests, about 10% of the total of 55,000 tests conducted in its virology lab, and just under 1% of the total 600,000 tests the medical center’s microbiology lab did last year.
Given the volume of tests the lab does every year, Marilyn Menegus, Ph.D., Director of Rochester Medical Center’s virus lab, was skeptical that this new rapid flue test would outperform the assays already in use at her lab, which included PCR testing. “Our lab evaluated it against two rapid tests and the direct fluorescent antibody (DFA) test,” noted Menegus, “Our initial evaluation showed that the 3M Rapid Detection Flu A+B Test was as good or better than our other tests in terms of specificity and sensitivity. Then over time, I saw that this rapid flu test had another advantage.”
Utility for Remote Labs
“The test system can report results directly to the LIS,” explained Menegus. “In settings like ours, where several remote laboratories may be performing rapid testing, a system like this eliminates all the subjectivity involved in interpreting the results.
“Once the test system is set up, it connects to the central computer and collects all the data from sites where it’s running,” she said. “Gathering data from remote sites is often problematic for lab directors. That’s because remote labs often have many different individuals running the test and multitasking on a number of different applications. This test minimizes the chances for error because it reports the results directly to the LIS.
“We recognize that this assay suffers the same disadvantage as all immunoassays do in terms of detecting flu in that it is not as sensitive as cell culture,” Menegus observed. “However, cell culture takes three days, and you can’t do too much with a patient who has the flu if you have to wait for three days. When triaging patients or considering antibiotics, a 15-minute result is needed and I can’t do that by any method other than the rapid assays.
“A number of studies were done with other rapid flu tests and demonstrated that, if an answer is produced quickly, prescribing habits and other disease management decisions can be significantly influenced” she stated. “The big benefit with this new assay is that it determines whether it is flu A or B. Thus, it can help in determining which medication to prescribe.”
The assay also was tested at the North Shore Long Island Jewish Health System, in Manhasset, New York. Christine Ginocchio, Ph.D., Director of Microbiology, Virology and Molecular Diagnostics at the health system, said, “Properly interpreting test results is critical, especially considering that most flu antiviral medications have a 48-hour recommended therapeutic window for prescribing. Thus false-positives or even delayed test results may result in misapplication of therapy or may reduce its effectiveness. Having an automated reader almost eliminates the potential for misinterpreting results, leading to a faster and more informed treatment decision, which results in better patient outcomes.”
THE DARK REPORT observes that 3M’s Rapid Detection Flu A+B Test System represents an example of how IVD manufacturers are working to pack more value into their test kits and testing systems. In particular, the ability of the system to feed results directly into the laboratory information system shows that IVD firms recognize the need of laboratories to reduce or eliminate any source of a potential error that could affect patient care.
Rapid Influenza Test Exports Data to LIS
ONE OF THE ADVANTAGES of the 3M Rapid Detection Flu A+B Test is that it can deliver results electronically within 15 minutes. 3M says the test represents the next generation of assays for the flu.
Requiring three minutes or less of prep time, the test can detect positive or negative results, differentiate influenza A from influenza B, and display the results on the 3M Rapid Detection Reader. In addition, the system allows labs to export the resulting data to a laboratory information system (LIS), reducing the potential for reporting error by eliminating the need for manual recording and transferring of results.