News
Rutgers new lab on a chip reads your blood from your wrist
Looking like a piece of jewelry from a Steampunk convention, a new wrist sensor is coming out of Rutgers, the State University of New Jersey that can measure the cell count of your blood.
Researchers developed the wearable, which was made by wrapping a wide piece of circuit board around the wrist and studding the surface with gold electrodes instead of jewels. The entire wristband works to get information to doctors via Bluetooth through an Android application on a smartphone. Anyone interested in donning this wired cuff should be aware, however, that they need to play a role in collecting their own data.
Wearers have to actively prick their own skin to draw blood and then put the sample into micro chambers on the device. Ultimately, though, researchers say they imagine automating that process by "fabricating minimally invasive microneedle or catheter-based impedance sensors" which could then "continuously sample venous blood using a wearable cytometry platform for readout."
While the initial research for the device from Rutgers University studied the number of blood cells in a single reading, researchers say the wearable could be tuned to read "a wide variety of biomarkers," they wrote in the "Microsystems & Nanoengineering" publication, which published their work.
The revolution that’s about to transform blood testing
Three Israeli startups aiming to revolutionize and democratize how blood tests are done.
RevDx by Engineering for All (EfA)
Engineering for All (EfA) is developing a handheld programmable device that performs automated blood analysis and diagnostics at the point-of-care. RevDx (Revolution Diagnostics) is meant for anyplace without reliable access to a lab, electricity or Internet connection, says founder Yoel Ezra, former chief commander of an IDF technological unit.
The digital platform — combining opto-mechanics, electrochemistry and bioengineering technologies — will initially be programmed to do a blood count and diagnose malaria, two major identified needs. Future applications could support additional blood and urine analyses.
“My vision is that in a few years our product will be an essential tool in every healthcare worker’s bag for home visits, emergencies, point-of-care, remote locations and more,” Ezra says.
Sonorapy
Sonorapy is developing a technology to replace standard diagnostic blood tests with a noninvasive soundwave diagnostic tool to detect pathogens (viruses or bacteria) from a single blood sample.
“Our product is a one-of-a-kind sensor that sends very high-frequency soundwaves into an organism and listens to the acoustic sounds resonating back. Each pathogen is known to have a unique sound signature but there was never a machine capable of reading them,” explains cofounder Noemie Alliel.
A unique algorithm will identify the pathogen using a massive database of harmonic resonance peaks for each disease. In seconds, easy-to-read test results will be available at the point-of-care. Sonorapy’s device theoretically could even scan the patient’s body rather than a blood sample, making the diagnostic process 100 percent noninvasive.
Sight Diagnostics
Sight Diagnostics of Tel Aviv recently launched OLO, an AI-based blood diagnostics device that does lab-quality complete blood count (CBC) tests from finger prick samples at the point-of-care. Sight’s patented process for “digitizing” the blood sample into a set of specifically colored microscope images begins with placing the sample on a pocket-sized test cartridge and inserting it into the system. OLO then applies proprietary machine-vision algorithms to these images to analyze 19 CBC parameters. Results are delivered in just 10 minutes.
“The technology to provide full-spectrum analysis with only a finger prick of blood is seen by many as a holy grail in this space, and it’s no secret that others have tried,” said CEO Yossi Pollak, who cofounded Sight Diagnostics in 2010. “After implementing our malaria-detection technology in India and several African countries and exceeding expectations in multiple clinical trials, we were encouraged to explore our technology’s ability to enter the $50 billion market of CBC testing.”
Pot Breathalyzer: California Company Creates THC-Detecting Breathalyzer For Safer Roads
A California company, Hound Labs, has developed what they call the “world’s first marijuana and alcohol breathalyzer.” The device is much like the typical breathalyzer currently being used by police officers across the country, except that it detects both alcohol and THC levels. THC is the psychoactive component of marijuana.
As a breathalyzer, the device can collect samples without having to collect urine, oral fluid, and blood. It is quick, as it releases results in just minutes, and can determine marijuana use in the last two hours. It also automatically collects two samples for testing: the first sample for immediate processing, and a second sample for processing later on.
The current tests in the market often require blood or urine and may take days to process. They also do not really determine whether the marijuana was smoked hours or days before, which is quite problematic since THC tends to stay in the system for up to a month after use.
Pre-Analytical
Positive patient ID for phlebotomy: Improving safety when drawing blood
A new system being introduced at St. Michael’s Hospital, called positive patient ID, is getting rave reviews for “how convenient and simple it is,” said medical laboratory technician, Leah Jaikaran, who said it took the team a couple of days to get used to going electronic.
With the introduction of positive patient ID, medical laboratory technicians are now starting to carry mobile devices and portable printers. The device can scan a patient’s wristband to confirm the technician is drawing blood from the right person for the right test. The mobile device tells them what test is required, what tubes are needed and what time blood needs to be drawn. The portable printer then spits out a label on the spot and all of the relevant information is digitally submitted in real time to the laboratory.
“We take patient safety very seriously,” said information technology coordinator Drake Yip. “Using positive patient ID adds an extra check to reduce the potential for mixing up patient samples. And it’s making the whole process quicker and more efficient.”
Another benefit of the system is that any urgent requests can be flagged on the technician’s mobile device – they flash on the screen and show up in red compared to the routine tests in black and timed tests in blue. “The system updates every 30 seconds, which is especially helpful if someone needs a blood draw quickly – we see it immediately and can respond right away,” said Jaikaran.
The new system launched mid-June and is currently supporting technicians drawing blood at the bedside. The next step is to use the same process for blood transfusions, by scanning patients’ wristbands as well as the blood products they’re receiving to enhance patient safety.
Over-the-counter drugs, dietary supplements and their effect on lab test results: Patients' reluctance to disclose OTC drug use can lead to inaccurate test results
The use of various OTC drugs and dietary supplements is highly prevalent in Europe and patients are often not willing to disclose this information to laboratory staff and the ordering physician as a survey published in Clinical Chemistry and Laboratory Medicine, published by De Gruyter in association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), shows.
The study reports on the results of a survey of patients in 18 European countries which shows that those taking OTC products and dietary supplements are not aware of the potential effects on laboratory test results they may have. In addition, patients do not believe that they need to disclose this use to medical and/or laboratory staff.
The study shows that dietary supplements and OTC drugs are more frequently used by middle-aged patients -- especially women -- with the most common being multivitamins, multiminerals, cranberry and aspirin. All of these compounds, if consumed shortly before blood sampling, may cause changes in lab test results, thus leading to interpretation difficulties and possibly incorrect diagnoses.
Although more data is needed about the frequency of the consumption of various dietary products, vitamins or OTC drugs, the authors believe that a multifaceted approach is necessary to draw attention to the issue using educational interventions which target both healthcare professionals and patients.
"We hope that our survey helps to raise awareness about this need to educate patients about the potential effect of OTC drugs and dietary supplements on lab test results, and we would encourage clinicians and lab staff to engage more with their patients and ask them direct questions about the use of various self-prescribed products," said Professor Ana-Maria Simundic of the Sveti Duh Clinical Hospital in Zagreb, Croatia, and the corresponding author of the article.
Clinical Chemistry
Thyroid Testing Algorithms in Pregnancy
Fetal and placental growth depends on maternal thyroid hormones (TH) early in pregnancy. As a result, pathological processes that alter maternal TH status can result in adverse outcomes for both mother and baby. Given the complicated nature of thyroid function testing in pregnancy, laboratories should implement reflex testing algorithms that incorporate appropriate tests, methods, and reference intervals to guide screening of high-risk patients. Implementing guideline-driven algorithms for thyroid function testing in pregnancy is critical to improve quality of care for these women.
Overt thyroid disease in pregnancy is associated with several negative outcomes. Untreated overt hypothyroidism can result in preterm birth, low birth weight, miscarriage, stillbirth, placental abruption, preeclampsia, heart failure, and impaired neurocognitive development.
Selecting the best assays:
Changes in thyroid biochemistry during pregnancy lead to several challenges for both testing and interpreting the results of thyroid function tests. TSH and fT4 concentrations differ over the course of pregnancy, so results should be evaluated in the context of trimester-specific reference intervals (TSRI). Further, pregnancy-induced changes in binding protein concentrations and glycosylation status affect some testing methodologies for TSH and fT4. The gold standard assay for assessing fT4 during pregnancy is equilibrium dialysis liquid chromatography-tandem mass spectrometry (LC-MS/MS). This methodology is impractical in most hospital laboratories, so immunoassay methods (IA) are used instead.
Be sure to click on the article title above to read the full article including information on developing a diagnostic testing algorithm.
Microbiology
Bloodless Test for Malaria Wins Africa Prize
A 24-year-old Ugandan computer scientist whose own malaria was missed by traditional clinical laboratory blood tests has developed a device that detects signs of the disease using a beam of light directed onto a patient’s finger. The light highlights and detects changes in the color, shape, and concentration of red bloods cells affected by disease.
Brian Gitta, CEO and co-founder of computer software company thinkIT Limited, became the youngest winner of the UK’s Royal Academy of Engineering Africa Prize for Engineering Innovation. His eHealth solution is called Matibabu, which means “treatment” in Swahili.
Gitta and his team are developing a low-cost, reusable device that clips onto a patient’s finger and provides malaria test results within 60 seconds through a mobile phone app, UPI.com reported. The latest Matibabu prototype uses a ‘hybrid of magnetic-optic technology and electro-impedance technology’ to detect the disease,” according to a blog post on the thinkIT website.
“Our next step is to determine the validity and reliability of the Matibabu device compared with the gold standard microscopy and RDT by conducting field tests with malaria patients in selected health facilities in order to obtain information that will be used to improve the device, and eventually roll it out to the market,” the blog post states.
Trained dogs can detect C. difficile in stool
Dogs trained to sniff out Clostridium difficile in human stool samples were able to identify cases with up to 92.6 sensitivity and 85.1 specificity, according to recent study findings.
However, Maureen T. Taylor, physician assistant in infectious diseases at Michael Garron Hospital in Toronto, and colleagues said wide variability in the dogs’ performance restricts their use in point-of-care testing.
“The inconsistency in each dog’s ability to correctly allocate specimens is a major limitation to the widespread use of dogs to detect toxigenic C. difficile in clinical settings,” they wrote in Open Forum Infectious Diseases.
Dogs are increasingly being assessed as diagnostic tools in medicine, according to Taylor and colleagues. They noted two studies previously conducted in separate countries that found that trained dogs can accurately detect C. difficile in human stool samples. Neither study, however, investigated the inter-rater reliability of canine C. difficile detection because only one dog was included in each trial.
For their study, Taylor and colleagues examined the diagnostic accuracy and inter-rater reliability of two rescue dogs — a German shepherd and border collie pointer mix, both aged 3 years — that underwent training for C. difficile detection.
The diagnostic accuracy of the dogs was formally tested with 300 samples, 30% of which were positive for C. difficile. The dogs identified positive samples with sensitives of 77.6 and 92.6 and specificities of 85.1 and 84.5. The positive predictive value of each dog was 45.2% and 49.6%, whereas the negative predictive value was 96.1% and 98.7%.
Research
Heart Attacks Ruled Out Three Times Faster with New Blood Test
Investigators at the University of Texas (UT) Southwestern Medical Center have published new data assessing a novel test that can rule out heart attacks three times faster than conventional methods. Findings from the new study were published recently in Circulation through an article titled “Evaluation of a Novel Rule-Out Myocardial Infarction Protocol Incorporating High-Sensitivity Troponin T in a US Hospital.”
“An observational study of unselected patients undergoing MI rule-out was performed to evaluate the safety of the protocol and its potential impact on patient disposition,” the authors wrote. “The proportion of patients who would have been eligible for early rule-out with the new protocol incorporating hs-cTnT was compared with existing practice in which the conventional fourth-generation cTnT assay was tested at baseline and ≥3 hours after presentation. The negative predictive value was calculated to assess safety.”
The hs-cTnT protocol is already used in Europe and has been recently approved by the FDA. The UT Southwestern researchers developed a procedure for assessing the results of the new test and compared it to existing practice using a conventional troponin test, which takes three hours to complete. Study participants were 536 patients admitted to an emergency room with heart attack symptoms, including chest pains and shortness of breath.
“We did not miss any heart attacks using this test in this population," notes lead study investigator Rebecca Vigen, M.D., a cardiologist at the UT Southwestern Medical Center. "The test also allowed us to determine faster that many patients who had symptoms of a heart attack were not having a heart attack than if we had relied on the traditional test."
The new procedure successfully "ruled out" 30% of patients immediately and an additional 25% at one hour. By three hours, the new procedure ruled out heart attack in 83.8% of patients compared with 80.4% using the conventional test.
Historical
The first Porcupine blood bank
Long before the establishment of OHIP in 1959, miners in the Timmins area and their families enjoyed a unique, yet invaluable health service. In 1942, Robert Dye, manager of the Dome Mine, instituted a medical plan for his mine’s employees and their families. Following this success, in 1944, the Porcupine Mines Managers group started a similar plan that provided medical care for all area miners and their families. At its peak, there would have been at least 17 mines involved. It was called the Porcupine Mines Employees’ Medical Services Association, known as the PMEMSA. Each month, the programme was funded by payroll deduction and there was a 50-cent user fee for each doctor’s visit.
As a partial answer to the blood transfusion problem, the Dome Mine devised a plan in 1944. They had just joined the Porcupine Mines Employees Medical Service Association. Two of the Dome Mine’s First Aid men, Ron Mansfield and John Newman, began the arduous task of typing the blood of over 1,100 people, in order to establish the first “Walking Blood Bank” for this area. The two men spent many volunteer hours over the next two years helping to complete the task.
Should someone require a particular blood type for a transfusion, the records of those 1,100 prospective donors was available to the two local hospitals of the time. (Porcupine General Hospital and St. Mary’s Hospital) This made the search much faster, especially in a time of critical importance.
The Timmins Lions Club realized the seriousness of this situation and determined to do something about it. They appealed to the public for funds which they used to purchase two suitable, fast-freezing refrigerators and the necessary bottles, needles, tubing, chemicals and other equipment necessary for setting up a blood bank.
Staff would be required to control and operate the proposed bank and a suitable location was also needed. The Porcupine Health Unit (which was the first Health Unit in Ontario, and started by Dr. Graham B. Lane, himself a member of the Lions Club) had premises within the Timmins Municipal building. Funding for the part time services of a Registered Nurse was paid for by the Timmins Lions Club, and the Town of Timmins provided the location for the first Blood Bank in the Porcupine.
The Bank was opened in the fall of 1946 and volunteers of all ages immediately responded with more than 150 donors giving approximately 300 pints of blood in the first two years of its operation.
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