Janssen Diagnostics has developed a molecular diagnostic test which will be used with the Biocartis’ Idylla™ platform, to determine Influenza and Respiratory Syncytial Virus (RSV) infections of the upper respiratory tract. The test was launched recently on November 30th.
Patient’s time is precious
Time plays a crucial role in determining if a patient is infected with influenza or Respiratory Syncytial Virus.
Respiratory viruses are one of the most important causes of morbidity and mortality globally and the influenza virus has killed at least 50 million to 100 million people in the last century alone. Children younger than 2 years and elderly people, are those with higher risks of complications. About 90% of influenza-associated deaths are related to people who are above 65 years. “In the population of the elderly and in the pediatric world, time plays a crucial role in determining if a patient is infected with influenza, Respiratory Syncytial Virus (RSV), or whether the symptoms are due to another cause,” says Daap Kooij, Global Business Leader at Janssen Diagnostics. "The Idylla™ Respiratory panel is able to generate reliable results in 50 minutes, and is compatible with the time that the patient spends in the ER after admission. Using Idylla™ close to the patient, preferably at the point-of-care, will support doctors with actionable information in the diagnosis and choice of the optimal treatment solution.”
Most diagnostic tests which are being used currently, are rapid immunoassays, which are typically chosen due to their low cost and convenience. However, one of the major disadvantages of these rapid tests, is their poor sensitivity and poor specificity. Negative samples are typically evaluated in a central lab with a more sensitive molecular test, delaying time-to-result by many hours. Positive samples are also retested in a central lab to rule-out false-positivity. “The new Idylla™ Respiratory IFV-RSV Panel, running on the Idylla™ platform, combines in one single product the speed of rapid tests, with the quality and sensitivity standards of central lab tests,” assures Kooij.
In just one Idylla™ cartridge, up to 30 different molecular targets can be tested. “Multiplexing, or the simultaneous detection of more than one biomarker from a single sample, is one of the most competitive features of Idylla™. One test or cartridge holds five reaction chambers, each capable of detecting six different targets.” The Idylla™ Respiratory IFV-RSV Panel is designed for the qualitative detection of the nucleic acids of Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, H275Y mutation of Influenza A subtype 2009 H1, Influenza B and RSV subtype A and RSV subtype B, from nasopharyngeal swabs of adult and pediatric patients. “Especially in the detection of the H275Y mutation especially, the indication of Tamiflu resistance, in the same test, is unique,” adds Kooij.
Diagnostics closer to the patient
The Idylla™ Respiratory IFV-RSV Panel received CE-IVD marking, on November 18, 2015. Janssen Diagnostics has appointed Biocartis as its worldwide co-exclusive distributor of the test. Today, it is being launched for commercial use in Europe, and other countries that recognize the CE-mark. The goal of Janssen Diagnostics and Biocartis, is to bring these tests as close as possible to the patients, and at the point-of-impact.
This will revolutionize the way we are practicing medicine.
“Initially, we targeted the clinical laboratories that had moderate complexity. However, flu-based tests such as our IdyllaTM IFV-RSV Panel, because of its easy-to-use IdyllaTM molecular diagnostics platform, are ideally suited for use outside the central laboratory setting. I am confident that this will succeed, as the IdyllaTM platform demonstrates that diagnostics can be conducted, in an easier, more accurate and faster manner. The Idylla™ Respiratory IFV-RSV Panel can be performed in as little as 50 minutes, and requires less than one minute of hands-on time,” claims Kooij.
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