Recent studies raise hope for all-virus protection
“Vaccination and antiviral therapy with adamantanes and neuraminidase (NA) inhibitors (e.g., oseltamivir) are used to prevent and treat influenza virus infections. Since its appearance in 2009, pandemic influenza A(H1N1)2009 virus has mostly had a predictable antiviral susceptibility pattern (i.e., amantadine resistant, oseltamivir susceptible). Resistant strains, with a histidine to tyrosine substitution (H275Y) in NA, have represented less than 1% of tested strains and were found mostly in patients with oseltamivir exposure. Recent surveillance studies suggest transmission of resistant virus to treatment-na”ive individuals in Europe and identified a different mutation (S247N) in up to 30% of isolates in Australia and Singapore. The latter strains had only mildly reduced sensitivity to oseltamivir. In one patient, however, both mutations were found (H275Y and S247N), resulting in highly resistant virus. These findings highlight the need for continuous surveillance, especially in high-risk patients, and indicate that resistance testing of influenza A(H1N1)2009 virus might become more important in the future. Currently, influenza vaccines are designed each year to provide protection against the subtypes that are most likely to dominate the following influenza season. Two recent studies identified broadly neutralizing antibodies that were effective against multiple or all subtypes of influenza A viruses. These findings raise the hope for new therapies and vaccines that, one day, might protect against all virus subtypes.”
—Robert Schlaberg, MD, MPH
Medical Director, Microbial Amplified Detection Laboratory,
and Assistant Medical Director,
Virology and Molecular Infectious Disease Laboratories
ARUP Laboratories, Salt Lake City, UT
Offers extensive test menu of highly complex and unique medical tests as national clinical and anatomic pathology reference laboratory as well as an innovative R&D laboratory
Same-day results aids clinically useful time frame
“Molecular diagnostics testing continues to see increased popularity with laboratories and has become an important component of respiratory-virus surveillance and patient management. Multiplex panels with a high number of viral targets allow physicians to differentiate between common colds and more serious respiratory infections, such as H1N1. The availability of respiratory panels allows physicians to triage difficult cases and provide targeted treatment for patients when appropriate. The newest generation of molecular respiratory panels can provide same-day results, providing physicians with the relevant information they need in a clinically useful time frame.”
—Jon Faiz Kayyem, PhD
Chief Scientific Officer
GenMark Diagnostics
Carlsbad, CA
Maker of eSensor XT-8 system and cartridge,
and reagents for cystic fibrosis, thrombophilia, and warfarin
Flexibility that labs demand
“We have had molecular diagnostic products for respiratory infections in the market for several years, and now laboratories have more options than ever that offer same day results. Today's molecular tests provide increased sensitivities over the incumbent testing methods, such as rapid influenza diagnostics tests (RIDTs) and culture-based methods. Along with improved performance, molecular methods for the detection of a range of respiratory pathogens can offer scalability and flexibility to meet a wide range of laboratory needs. A large menu of assays available today allows more personalized patient testing and the ability to quickly offer results for just what the clinician orders, be it influenza, respiratory syncytial virus, or less common causes.”
—Steven Visuri, PhD, Senior Director, R&D, Prodesse Products
Gen-Probe, Waukesha, WI
Maker of respiratory infectious disease tests Prodesse ProFlu+, ProFAST+, ProParaflu+, Pro hMPV+, ProAdeno+, and ProPneumo-1
Test several respiratory-trace pathogens simultaneously
“The recent emergence of influenza A H1N1-2009 emphasizes the need for rapid and comprehensive testing for respiratory infections. A respiratory-tract infection can be the result of one or more of dozens of viral or bacterial pathogens. The symptoms caused by these different pathogens are nearly indistinguishable — but how a healthcare provider chooses to treat a respiratory infection may depend greatly on a rapid and accurate diagnosis of the responsible pathogen. Consequently, the recent trend among manufacturers has been to develop multiplex assays that simultaneously test for several respiratory-tract pathogens. Equally important to testing for many of these pathogens, however, is the ability to generate and report the results to the healthcare provider in a clinically relevant time frame.”
—Wade Stevenson, FilmArray Product Manager
Idaho Technology, Salt Lake City, UT
Maker of R.A.P.I.D., R.A.P.I.D. LT and RAZOR EX instruments, and the LightScanner, LightScanner 32, and FilmArray instruments, and an expanding line of freeze-dried reagents and DNA/RNA purification kits
Evaluate diagnostic flu tests for ability to detect H1N1
“The need for a highly accurate rapid Flu A and B test has significantly increased in recent years; particularly the need for a rapid flu test that will accurately identify the H1N1 strain, which became a major global concern in 2009. The 2009 H1N1 virus that emerged caused the first global pandemic in more than 40 years and resulted in substantial illness, hospitalizations and deaths. In 2009, the CDC estimated that at least 1 million cases of 2009 H1N1 influenza had occurred in the United States, and the strain is predicted to linger on for several years. Of the CDC subtyped Flu A cases in the 2010-2011 Flu season, 38% were classified as H1N1. It is, therefore, important that you as a healthcare provider be sure to evaluate commercially available rapid influenza diagnostic tests for their ability to detect the H1N1 viral antigen in respiratory clinical specimens. This allows you to rapidly identify respiratory conditions and provide prompt and accurate medical assistance.”
—Larry Porter, President
LifeSign, Somerset, NJ
Maker of the Status Flu A&B test kit
Molecular move closer to the patient
“The 2009 H1N1 pandemic influenza outbreak was a seminal event for influenza testing. It showed, sometimes with tragic results for patients, that common flu testing methods were unsatisfactory. Rapid immunoassay-based tests provided results quickly but at 30% to 70% sensitive, many infected patients were not identified. Based on negative rapid test results, some clinicians falsely concluded their patients were not infected and, thus, did not start specific anti-viral therapy. Studies showed that anti-viral therapy delays in high-risk individuals (e.g., pregnant women) was associated with increased likelihood of the need for critical care and of death. Molecular testing (e.g., real-time PCR) proved to be more sensitive; the American Society for Microbiology indicated viral cell culture and PCR-based methods were preferred methods of testing. Molecular testing was generally available only through commercial reference labs, and the time required to send out specimens limited its clinical utility. Molecular testing had to move closer to the patient. Today, molecular platforms allow hospital labs to perform the same highly sensitive molecular tests once limited to reference labs. Large hospital labs are replacing traditional DFA and viral culture with molecular testing. The future of testing for all respiratory viruses, not just influenza, will be molecular. Bringing molecular testing nearer patients will continue, as innovations will soon allow testing to be done in emergency and urgent care center settings, and, perhaps some day, in physician offices. The H1N1 crisis illuminated gaps in our testing for influenza and accelerated the movement towards molecular diagnostics.”
—Jay M. Lieberman, MD
Medical Director, Infectious Diseases
Quest Diagnostics and its infectious-disease diagnostics business,
Focus Diagnostics, Cypress, CA
Developer of the Simplexa(3M) molecular test product line on the 3M Integrated Cycler
Assays, one day, will differentiate infectious agenst
“The 2009 H1N1 influenza pandemic acted as a catalyst for the medical community to expand its knowledge about respiratory diseases. This heightened interest has led to the investigation of respiratory disease co-infections, secondary infections associated with primary viral infections, and sub-clinical infections underlying chronic inflammatory diseases such as asthma and bronchopulmonary dysplasia. We will see more studies that not only identify new pathological agents but will also uncover the underlying roles of infectious agents in the etiology of chronic respiratory disease. Armed with this deeper understanding of the disease, the IVD industry will be able to improve the quality of patient care and the overall cost of treatment through the development of early detection and assays that effectively differentiate infectious agents. Because molecular diagnostics are today able to identify even the most 'minor' infectious agents, they are very well suited for this purpose. Moreover, these tests can be bundled according to the symptom being displayed by a patient or the type of pathogen families a clinician wants to focus on. This approach will improve considerably the ability to rapidly identify and differentiate pathogenic agents. Also, early detection of a pathogenic infection, and the ability to determine its resistance profile will become a major focus within the clinical lab. Taking these steps will enable healthcare providers to deliver rapid, tailored patient care, as well as increase patient responsiveness to current therapeutic regiments.”
—David L. Dolinger, PhD, Vice President, Business Development
Seegene, Gaithersburg, MD
Maker of Anyplex multiplex real-time PCR
What establishes gold standard for respiratory viral tests
“Labs and healthcare providers look for ways to improve efficiency while managing increasingly complex testing requirements. Viruses change from one flu season to the next, even within the course of a flu season. To address these issues, clinical labs, researchers in teaching hospitals, and epidemiologists in public health labs are increasingly choosing multiplexed molecular diagnostic assays for detection of respiratory viral illness. These assays provide the ability to simultaneously detect multiple viral pathogens, including identification of novel strains, with a faster turnaround time and greater sensitivity than traditional culture methods. Cost efficiencies and improved productivity in the lab, along with patient and public-health benefits associated with more rapid treatment and potentially improved patient outcomes, are establishing molecular diagnostic assays as the gold standard in respiratory viral testing.”
—Jeremy Bridge-Cook, PhD
Senior Vice President, Assay Group
Luminex Corp. , Austin, TX
Maker of xTAG Respiratory Viral Panel (RVP) Products
Optimizes lab operation and speeds results for clinicians
“A recent addition to the lab scene is a state-of-the-art open molecular-diagnostic testing system that automates cell lysis, nucleic-acid extraction, PCR set-up, amplification, and detection on a single platform. Its architecture allows clinical labs to run IVD tests (FDA-cleared or CE-marked). With walk-away automation and standardization of user-defined protocols — from sample processing through result detection — there is no longer a need for multiple platforms that require individual service and training. The system accommodates varying workloads and gives labs the ability to perform testing 24/7, processing from one to 24 samples per run and up to 96 samples per eight-hour shift. Similar to the development of smart-phone apps, the system's open architecture provides a vehicle to extend development of assays for emerging pathogens through partnerships with best-in-class IVD developers from diagnostics companies around the world. Multiple assays across three different disease categories — respiratory, diarrheal, and central nervous system — are being developed. With the flexibility of the open platform allows a hospital lab to quickly adapt to the challenges of emerging pathogens.”
—Stephen Clark, MS, Director of Marketing
BD Diagnostics – Diagnostic Systems, Franklin Lakes, NJ
Manufacturer of the BD MAX system
