You see, the burden of H1N1 is felt far beyond those stricken with the disease -- every day, hundreds if not thousands of patients with infections (that may or may not be swine flu) wait in US emergency departments while their inpatient bed assignments are determined by the results of a slow, unreliable swab test. Do they need an isolation bed? They'll wait hours to find out, and the results may not even be that accurate.

But the FDA is helping the situation along, with this recent announcement:

DxNA announced today that the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its 2009 H1N1 influenza virus diagnostic test for use in DxNA's GeneSTAT(TM) detection platform. The new platform enables fast detection of the 2009 H1N1 influenza virus with a portable device weighing less than 10 pounds. In the United States, an Emergency Use Authorization (EUA) is a legal means for the FDA to authorize new medical devices or drugs during a declared public health emergency.

"This new diagnostic test has the potential to significantly reduce the impact of 2009 H1N1 influenza by allowing for testing under appropriate laboratory conditions achievable even in a local hospital setting," says Phillip H. Grimm, President and Chief Executive Officer of DxNA LLC.

The small and lightweight kit works as a module in the GeneSTAT system, a portable tabletop instrument about the size of a coffee machine.

More from DxNA (which is a terrific name for a company that makes DNA diagnosis equipment)...

Demo video of the DxNA's GeneSTAT system:

Using technology known as nuclear magnetic resonance spectroscopy, the researchers were able to identify a chemical "fingerprint" for the type of pneumonia caused by the bacterium Streptococcus pneumoniae, and compare this to the chemical fingerprints for other types of pneumonia and noninfectious lung diseases.

Findings from the study, conducted by Slupsky and colleagues in Canada and Australia, are discussed in a research profile in the December issue of the Journal of Proteome Research. A patent is pending on the diagnostic procedure.

"This is the first study to demonstrate that NMR-based analysis of metabolites in urine has the potential to provide rapid diagnosis of the cause of pneumonia," said Slupsky, an assistant professor in UC Davis' departments of Nutrition, and Food Science and Technology. She is also a faculty member in UC Davis' Foods for Health Institute.

...Currently, pneumonia is diagnosed by a combination of clinical symptoms, X-rays and analysis of a patient's blood or sputum by bacterial culture. Such tests usually take more than 36 hours to complete and tend to yield a high rate of false-positive results. Previous studies have shown that more than 80 percent of patients admitted to the hospital with pneumonia are misdiagnosed, leading to delays in treatment with the appropriate antibiotic.

OK, let's not overstate the case, here. The only way they're arriving at a figure of 80% misdiagnoses (which isn't discussed in the paper) is if they're looking at a chest x-ray and history and trying to guess the causative organism, which is notoriously difficult and never used as a basis for treatment. Instead, broad-spectrum antibiotics are started while maybe blood and/or sputum cultures are cooking. In many, many cases, the patient improves and cultures don't compel a change in antibiotic regimen.

Where Slupsky's urine-checker might one day fit in is if a patient has a story and X-ray consistent with Strep pneumo and a urine test shows Strep pneumo metabolites, a clinician may consider a more narrow-spectrum regimen (which might be better for society as it would discourage antibiotic resistance). But we'd have to see a lot of impressive data on the safety and efficacy of this urine-based approach before we considered changing the current standard of care.

More from Dr. Slupsky's paper...

Press release: Fast, Accurate Urine Test for Pneumonia Possible, Study Finds

Image credit: Flickr user Ritalin

Out of Indianapolis comes FAST Diagnostic's new medical device:

FAST's technology measures the body's kidney function, known as glomerular filtration rate, or GFR, by monitoring inert markers that have been injected into a patient's bloodstream. A fiber optic device inserted into a vein through a catheter tracks the markers, measuring how effectively the body filters waste giving an accurate filtration rate reading in only 40 minutes. There is currently not available any way to accurately and quickly measure GFR. Current estimates, which are not useful in Acute Kidney Injury, have accuracy limitations, and can take up to 24 hours for a reading.

They've been winning awards and funding and today announced a faster (ok, "expedited") review by the FDA:

"Our team is thrilled with the expedited review status granted by the FDA," said Joe Muldoon, chief executive officer of FAST. "It was especially gratifying that the FDA determined we had demonstrated that this is 'breakthrough technology' that may provide a clinically meaningful advantage. This will help accelerate our pursuit of human trial data, and eventual market launch."

Originally developed by researchers at the Indiana University School of Medicine, FAST is partnering with Purdue University to assist in pre-clinical trials, and the Rose Hulman Institute of Technology for continued development of the device. A pilot human trial of the technology could begin as early as 2010, with full commercialization anticipated by 2012.

We think it's releated to this research out of MGH but cannot for the life of us figure out what FAST stands for. Or find a website to point you to. Is there such thing as developing TOO fast?

Graduate student Adam Whiton, who is working on the sensory clothing with collaborator Yolita Nugent, an apparel designer, said the idea for their project sprang from a discussion on how much more vulnerable she felt walking alone at night than he did.

Clothing, they realized, was a factor. Running from a pursuer in high heels “is near impossible,’’ Whiton said.

They began brainstorming on how clothing could be made not only to leave women unhindered, but to aid them.

More from Boston Globe...

Dr. Simon Scarle, a University of Warwick researcher, has detailed his work in using the Graphical Processing Unit (GPU) of an Xbox 360 to model and simulate cardiac arrhythmia in the hopes of understanding their initiation and propagation, so as to develop better treatments. While computer modeling has been around for decades, the breakthrough in this work is using a faster, cheaper, and commercially mass produced computer to accurately model the complex cardiac electrical system. Normally this type of modeling is constrained to supercomputers and must compete for computational time with a whole host of other important scientific modeling applications.

Scarle undertook this work while a software engineer at Microsoft's Rare Studio and modified the GPU to display tracking data of how electrical signals in the heart move around damaged cardiac cells. This creates a visual model of tissue to allow clinicians to identify cardiac conditions such as arrhythmia.

"These game consoles aren't just glorified toys. [They] are pieces of very powerful computing hardware," Scarle says. "I can see this ... being most useful for students and early-career scientists to just quickly and cheaply grab that extra bit of computing power they otherwise wouldn't be able to get."

Scarle developed this project as a fusion of his background as a software engineer in gaming and his past experiences with performing electrocardio-dynamics research at the University of Sheffield. He says that the idea for this heart-modeling project came from a "little shooter game" he developed while at Microsoft in which the player would gun down enemies in an arena that resembled a heart.

Now, if you will excuse us, we will be getting back to our ground breaking cancer research by playing HALO...

University of Warwick press release: Researchers using parallel processing computing could save thousands by using an Xbox...

Time : How Xbox Can Help Fight Heart Disease...

Microsoft Research : Implications of the Turing Completeness of Reaction-Diffusion Models, informed by GPGPU simulations on an XBox 360: Cardiac Arrhythmias, Re-entry and the Halting Problem...

Flashback : Dr. Halo: XBox Based "Care Consoles" to Invade Hospitals

From the product page:

The MicroEye is intended for intravenous use for periods of up to 48 hours and is inserted via an 18G blood catheter. The range of substances that can be monitored using the MicroEye is vast including:

Electrolytes (such as potassium, magnesium etc.)

Energy metabolites (e.g. glucose, lactate, pyruvate, etc.)

Amino acids (glutamate, GABA, etc.)

Hormones and neurotransmitters (such as dopamine, serotonin (5-HT) etc.)

Inflammatory mediators and growth factors (e.g. cytokines, etc.)

Drugs and their metabolites (unbound 'free' fraction and / or total)

Product page: MicroEye...

(hat tip: The Engineer Online)

From a statement by McMaster:

The process involves formulating an ink like the one found in computer printer cartridges but with special additives to make the ink biocompatible. An ink comprised of biocompatible silica nanoparticles is first deposited on paper, followed by a second ink containing the enzyme, and the resulting bio-ink forms a thin film of enzyme that is entrapped in the silica on paper. When the enzyme is exposed to a toxin, reporter molecules in the ink change colour in a manner that is dependent on the concentration of the toxin in the sample.

This simple and cost-effective method of adhering biochemical reagents to paper is expected to bring the concept of bioactive paper a significant step closer to commercialization. The goal for bioactive paper is to provide a rapid, portable, disposable and inexpensive way of detecting harmful substances, including toxins, pathogens and viruses, without the need for sophisticated instrumentation. The research showed that the printed enzyme retains full activity for at least two months when stored properly, suggesting that such sensor strips should have a good shelf life.

Portable bio-sensing papers are expected to be extremely useful in monitoring environmental and food-based toxins, as well as in remote settings in less industrialized countries where simple bioassays are essential for the first stages of detecting disease.

Press release: Toxin detection as close as an inkjet printer ...

Abstract in Analytical Chemistry: Development of a Bioactive Paper Sensor for Detection of Neurotoxins Using Piezoelectric Inkjet Printing of Sol-Gel-Derived Bioinks ...

Image: This is topography of inkjet-sprayed PVAm, and AChE (50 U/mL) and DTNB doped sodium silicate (SS) thin films on paper. Credit: McMaster University

In initial testing, the Ingber lab combined Candida albicans with blood and the antibody coated iron beads. The solution was then filtered through their system, a dialysis like device with electromagnets and up to 80 percent of the bead-pathogen complex were removed.

Image from Yung, C. W., et al, "Micromagnetic-microfluidic blood cleansing device" Lab Chip, 2009, 9, 1171-1177

This chart shows (a) the multi-fluorescence labeling of magnetic beads coated with antibodies for Candida albicans and (b) the effectiveness of the filtration of the bead-pathogen complex.

These types of microfluidic filter systems have the advantage of selective separation of the pathogen complexes from the flowing blood without the need for a filter membrane which can restrict flow and induce clotting while providing a large surface area to increase the efficiency of the entire prcoess. Dr. Don Ingber MD PhD, lab director, reports that animal testing is to commence this fall.

Popular Science : A Magnetic Machine Plucks Pathogens from Blood...

Lab Chip : Micromagnetic-microfluidic blood cleansing device...

Harvard Medical School and Children's Hospital : The Ingber Lab

Flashbacks: Sepsis Microfilter Being Developed ; Manipulating Cellular Signaling with Magnetic Fields

(hat tip: Gizmodo)

"With conventional technology, you have to design the individual layout of the chip, fabricate it, test it and then redesign it when testing uncovers problems," Wereley [Steven T. Wereley, associate professor of mechanical engineering at Purdue] said. "You are talking about a lot of time, effort and expense that could be dramatically reduced by having a multipurpose programmable chip."

For the life scientists who primarily use the technology, the devices are labor-intensive to develop and use.

"Imagine if running a word processing application on your computer required you to go to the lab and design your own microprocessor for that specific application," Amin [doctoral student Ahmed Amin] said. "Instead, wouldn't it be better if you could just buy a multipurpose chip and download the software you needed? That's what we're going to do -- make it easier to use so that the life scientists using the chips can concentrate on their own work instead of chip design."

Researchers at the Massachusetts Institute of Technology first suggested the idea of applying computer programming concepts to lab-on-a-chip technology in 2004.

"They have focused on programming-language aspects, while we're taking the idea to realization by focusing on the hardware and the software-hardware interface," Amin said. "We have developed the software compiler and the runtime system that would automatically understand a program and convert it into signals to control more complex chips."

The new chip is made out of a rubber-like polymer, called polydimethylsiloxane, instead of the rigid glass or silicon wafers often used. The flexible material is needed because pumps used to direct the flow of fluid operate with moving diaphragms.

Most other chips have the polymer layer sandwiched between two glass layers.

"We chose to build the whole chip out of the PDMS polymer, which makes it easier to fabricate and reduces cost over other alternatives, such as silicon or glass," Chuang [doctoral student Han-Sheng Chuang] said.

The Purdue-designed chip is able to mix, store, heat and sense what the sample is made of, whereas previous programmable chips have been limited to mixing and storing samples.

The researchers have demonstrated how the chip works using a mock sample and reagent dyed with food coloring.

The programmable chips are likely to be commercially available within five years, said Amin, a student in the School of Electrical and Computer Engineering who developed the programming language and "architecture," or interface between the hardware and software.

The language enables the "assay protocols" required for specific tasks to be downloaded to the chip.

Purdue has applied for a provisional patent on the technology.

"What we eventually aim to do is create different classes of chips, where each class can run multiple assays from a few related life-science domains," Amin said.

Press release: Innovation could make lab-on-a-chip devices easier to use, cheaper to make ...

From University of Washington:

Results showed that malaria antibodies dried in sugar matrices retained 80 percent to 96 percent of their activity after 60 days of storage at elevated temperatures.

The goal of the long-term project is to develop a system with which a clinician can spot a drop of a patient's blood onto a card and feed it into an instrument that gives a yes/no answer for a panel of infectious diseases in 20 minutes or less. Tests with the prototype malaria card reached a result in less than nine minutes using an immunoassay, or antibody-based, approach.

The malaria-test card is being developed as part of an automated diagnostic system informally called the DxBox, the Dx being medical shorthand for diagnosis. The DxBox team is led by Yager and includes UW bioengineering professor Patrick Stayton; collaborators at PATH, a Seattle-based nonprofit focused on global health; Micronics Inc. of Redmond, Wash.; and Nanogen Inc. of San Diego.

The DxBox consists of a portable, fully automatic reader being developed by Micronics that will process the card-based disposable tests. The UW prototype cards look for the presence of malarial proteins, but the team is also working on other kinds of protein tests as well as a second kind of test for each disease that looks for the pathogen's DNA or RNA.

The UW's malaria cards use features of common lab tests and take into account portability, automation and easy storage. The cards rely on microfluidics, the manipulation of liquids at very small scales. Thin channels crisscross the Mylar sheets, and syringes are used to pump different liquids for the tests through the channels. "It's like plumbing, only the pipes are less than a millimeter wide," Yager said.

Microfluidics not only save space and resources, but working with liquids on such a small scale allows the researchers to do more. "It's not just about making big things small," Yager said. "It's also about doing things that are only possible at that very small scale." The diagnostic tests in the DxBox system run much faster than conventional tests in part because the liquids involved behave differently, a key factor for clinicians who have limited time to spend with their patients.

Currently, the researchers look for colored spots on the card that indicate the presence of malaria proteins. The hue of the color indicates the intensity of the disease. The DxBox can read these small spots automatically, reducing the chance for human error.

While the prototype developed by the UW researchers only tests for malaria, Yager and his collaborators are working towards cards that also will test for five other diseases that, like malaria, cause high-fever symptoms: dengue, influenza, Rickettsial diseases, typhoid and measles.

Press release: 'Astronaut food approach' to medical testing: Dehydrated, wallet-sized malaria tests promise better diagnoses in developing world