Throughput: 480 tests/hour 580 tests/hour with ISE
Test items on board: 36 items + ISE 3 items
Reaction volume: 120– 300 micro-liter
Patient samples on board: 72 patient samples, 30 STAT samples
Reaction volume: 140– 300 micro-liter
Test items on board: 24 items + ISE 3 items / 36 items + ISE 3 items
Patient samples on board: 30 patient samples
Throughput: 270 tests/hour 450 tests/hour with ISE
R1: 140 ～ 300μl (1μl step）
R2: 20 ～ 260μl (1μl step）
News and Announcements
The diagnosis of multiple myeloma, a cancer affecting plasma cells, traditionally forces patients to suffer through a painful bone biopsy. Doctors insert a bone-biopsy needle through an incision to get a bone marrow sample or make a larger incision and remove a section of bone via surgery.
However, the days of using bone biopsies to guide treatment for multiple myeloma and other cancers, such as many types of leukemia, may be numbered. A low-cost, reliable blood test that uses a small plastic chip about the size of a credit card that can deliver the same diagnostic information as a bone biopsy, but using a simple blood draw instead.
Scientists collaborating with those at the University of Kansas (Lawrence, KS, USA) took blood samples from patients with plasma cell disorders, which were analyzed for the presence of circulating plasma cells (CPCs) using a microfluidic device modified with monoclonal anti-CD138 antibodies. CPCs were immuno-phenotyped using a CD38/CD56/CD45 panel and identified in 78% of patients with monoclonal gammopathy of undetermined significance (MGUS), all patients with festering and symptomatic multiple myeloma (MM), and none in the controls.University of Kansas
Beta Trace Protein (BTP) is a promising marker of glomerular filtration rate (GFR) as it was reported to be increased in the serum of patients with renal disease. Some evidence suggests that it is more sensitive than creatinine (Cr) at detecting early changes in GFR. Unlike Cr, very little is known about the origin and metabolism of BTP. BTP is a heterogeneous glycoprotein with multiple isoforms and is present in various fluid compartments including blood, urine and cerebral spinal fluid (CSF). The impact of hepatic dysfunction on serum BTP concentrations has recently been investigated.
Scientists at Queen’s University (Kingston, ON, Canada) and their colleagues conducted a case-control study between June to October 2014 of 99 cirrhotic subjects and matched controls. The diagnosis of cirrhosis was confirmed by the hepatologists according to standard clinical criteria including non-invasive testing estimating F4 fibrosis in an individual with known chronic liver disease. Basic demographic, clinical and laboratory data were collected including diabetes status, etiology of cirrhosis, presence of ascites or encephalopathy, INR, albumin and bilirubin. The team measured Cystatin C (cysC), BTP using nephelometry assays and Cr using a Vitros Chemistry enzymatic assay. The BTP/cysC ratio was calculated for each subject. The BTP/cysC ratio was chosen in lieu of the BTP/Cr ratio due to the well-recognized inaccuracy of serum creatinine as a marker of GFR in the setting of hepatic dysfunction.Read More Here
Heart disease remains the leading cause of death in men and women in the USA, and each year 735,000 Americans have heart attacks that damage the heart muscle, and of those, an estimated 120,000 die. About one in five heart attacks are "silent," yielding no symptoms, but symptoms such as chest tightness or pain, dizziness, nausea and fatigue are good reasons to seek immediate evaluation. Among the diagnostic tools to detect heart attacks are blood tests that measure levels of various proteins released into the bloodstream when heart cells are injured. Two of these are cardiac troponin and creatine kinase-myocardial band (CK-MB).
Scientists at the Johns Hopkins University School of Medicine (Baltimore, MD, USA) and the Mayo Clinic (Rochester, MN, USA) have compiled peer-reviewed evidence and crafted a guideline designed to help physicians and medical centers stop the use of a widely ordered blood test that adds no value in evaluating patients with suspected heart attack. The clinical and financial implications of institutions continuing CK-MB testing are significant, say the authors, who estimate that all blood tests for diagnosing heart attacks add USD 416 million each year to the cost of care. The team also cites studies showing that in addition to its diagnostic value, troponin testing is a more definitive predictor of in-hospital mortality and severity of disease. Professional guidelines concluded that CK-MB provides no additional diagnostic value for diagnosing heart attacks. It was found that 77% of nearly 2,000 laboratories in the U.S. still use CK-MB as a cardiac damage biomarker.
Jeffrey Trost, MD, an assistant professor of medicine and the corresponding author of the study, said, “This article is the first in a series of collaborative multi-institutional publications designed to bridge knowledge to high value practice. We present multiple quality improvement initiatives that safely eliminated CK-MB to give providers reassurance about trusting troponin levels when managing patients with suspected acute coronary syndrome.” The study was published on August 14, 2017, in the journal JAMA Internal Medicine.Related Links: LabMedica
Researchers have developed a highly portable, low-cost immunoassay technology that enables low limits of detection (LoD) by combining solid-phase microextraction membranes, gold nanoparticle labels, and surface-enhanced Raman scattering. Their prototype device successfully measured a liver cancer biomarker at LoD within only ~2 minutes. The team is also working to lower the cost to ~ USD 3 per test. The assay can likely be easily modified to detect infectious diseases such as tuberculosis, malaria, and dengue fever.
Currently, testing for liver cancer involves lab-based blood tests and ultrasound imaging, both of which require traveling to major cities and can often cost more than a month’s salary in low- and middle-income countries. The research team, led Prof. Marc Porter and surgeon and Prof. Courtney Scaife of University of Utah (Salt Lake City, UT, USA), developed a test for hepatocellular carcinoma that doesn’t involve sending a specimen to a blood lab and cuts the wait time for results from 2 weeks to 2 minutes. This inexpensive test can be administered wherever the patient is, which would be particularly valuable in developing nations with little access to hospitals.
The new test measures alpha-fetoprotein (a widely-used marker used to screen individuals for hepatocellular carcinoma) directly from human serum at an estimated LoD of 3 pg/mL. The device uses a small domino-sized plastic cartridge containing a paper membrane that selectively traps protein biomarkers from biological fluids. A small droplet of blood, saliva, or urine, or even a teardrop, from the patient is dropped onto the membrane. This is followed by the droplet of gold nanoparticles, which tags the biomarkers trapped in the membrane. If the biomarkers are present, a red spot appears, signaling the patient has the disease and should seek additional testing and possible treatment.
“The concept is similar to a home pregnancy test, but instead of flowing laterally, it flows through the membrane,” said paper first-author Jennifer Granger, research associate at U. Utah. The idea for the test is a spinoff of a similar test Prof. Porter developed years ago that astronauts on the International Space Station used to test the cleanliness of their drinking water. “This is a smarter offshoot of that,” said Prof. Porter. Now that the team has proven the concept with liver cancer and built a prototype test kit, researchers plan to evaluate the technology in Mongolia in spring of 2019. The East Asian country has the highest rate of liver cancer in the world.
A handheld spectrometer manufactured by project collaborator B&W Tek (Newark, DE, USA) can analyze the membranes and measure the amounts of biomarkers present, which in the future could help determine disease severity or monitor how a patient is responding to treatment. Utah-based nutritional supplement company USANA is interested in using a form of the test for customers with certain vitamin deficiencies. “USANA has a keen interest in the ability to measure certain vitamins and biomarkers in various bodily fluids that can be related to a person’s health status,” said Mark Brown, executive director of Laboratory Sciences at USANA, “Rather than taking a blood sample and sending it off to lab for analysis, this technology could make it possible for people to do their own analysis in the comfort of their own home. Small sample size and simplicity of use are crucial components of making this a reality, and this research is a step closer to that end.”Read More Here
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