The study evaluated the Rapid Detection Flu Test for the direct detection of influenza A and B in clinical respiratory samples and compared the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the 3M test to the BinaxNOW test. Both rapid tests provide results in less than 20 minutes. In addition, the study also evaluated the performance of the test as compared to two conventional methods of diagnosing influenza A and B, direct fluorescent antibody staining (DFA) (1.5 to 3 hours for results) and rapid cell culture (R-Mix) (24 to 48 hours to results).
“Clinicians battling infection during the height of the flu season have two great needs: tests that work rapidly and tests that can accurately pinpoint patients both with and without influenza,” said Christine Ginocchio, PhD, lead author and director of microbiology, virology and molecular diagnostics from the Department of Laboratory Medicine at the North Shore–LIJ Health System Laboratories. “The results demonstrated that the 3M Rapid Detection Flu A+B Test is more reliable and much more sensitive than the BinaxNOW test. This is positive news for clinicians as they prepare for this year’s flu season.”
Study results found that:
— The 3M test demonstrated superior analytical sensitivity (>1 log) for the detection of both influenza A and B as compared to the BinaxNOW test.
— The 3M test demonstrated superior clinical sensitivity (P = 0.008) for the detection of influenza A as compared to the BinaxNOW test (70.79 percent versus 46.07 percent, respectively) and was less sensitive than DFA (approximately 70.79 percent versus 80.90 percent).
— The 3M test demonstrated superior clinical sensitivity for the detection of influenza B as compared to the BinaxNOW test (P = <0.0001) and DFA (86.79 percent versus 37.74 percent and 73.58 percent, respectively).
— The automated reading of test results eliminated the potential for user misreading or misinterpretation of test results.
— The easy to use reader and printer provided documentation of instrument quality control and test results.
The study included a total of 500 prospective respiratory specimens – from out-patients and in-patients ages two weeks to 99 years – submitted for routine viral culture and DFA. The evaluation was based on 464 samples with valid results for all four tests.
“As a highly contagious disease, quick and accurate diagnosis is essential to limit influenza spread, and potentially reduces costs and improves patient outcomes in the healthcare setting,” said Jeff Hillins, medical diagnostics global business manager for 3M Health Care. “This study showed the 3M Rapid Detection Flu A+B Test is able to quickly and reliably detect the influenza virus, which will help hospital laboratories.”
Source: 3M Health Care