Sep 15, 2017 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Management & Operations
Horseshoe crabs have been utilized by the biomedical industry to save millions of lives around the globe for years. But now researchers fear the practice of bleeding them may be threatening their survival
Many medical laboratory scientists are aware that horseshoe crabs are harvested to get their blue blood and the limulus amebocyte lysate, or LAL (pronounce “el-ay-el”), because it can detect bacterial endotoxins. The popular wisdom has been that the collection procedure does not harm the crabs. However, there are growing concerns that indicate the biomedical industry is having a negative impact on the horseshoe crab population.
More than 600,000 horseshoe crabs are harvested annually for their blood in the United States (US). It is estimated that the blood is worth $60,000 per gallon and the global industry of processing the blue blood is valued at over $50-million per year, according to a CNN article.
The blood of the horseshoe crab is bright blue in color because it is rich in copper. Horseshoe crabs are bled in laboratories for a protein contained in their blood that scientists use to make LAL. This protein can detect bacterial endotoxins in clinical laboratory tests by solidifying when it comes in contact with certain bacteria.
LAL is prized by the biomedical industry because it can detect dangerous bacteria in injectable drugs, implantable medical devices, and on instruments and equipment. Federal law mandates that any medical device that is inserted or injected into a human body must pass the LAL test for contamination.
Capture, Bleeding, Leading to Depopulation of the Species
After the crabs are dredged from the ocean floor, or captured as they come ashore for breeding, they are transported to one of a handful of facilities authorized to perform the bleeding process. Once there, the horseshoe crabs are cleaned and sterilized, suspended upside down and inserted with a needle which extracts approximately one third of their blood. The helmet-shaped creatures are then returned to the sea.
Like all animals, horseshoe crabs have an immune system to protect them from infection due to an injury or presence of bacteria. The immune system of a horseshoe crab uses endotoxin as the major chemical signal that the crab is being infected. Even miniscule amounts of endotoxin will spark a clotting reaction. Types of cells in the blood called amebocytes are separated from all the harvested blood and broken open, or lysated, to release the coagulation properties. (Photo copyright: Popular Mechanics.)
An LAL solution is then concocted to test for endotoxins in medications and on medical supplies. After this solution is combined with a sample from a batch of medication or placed on a piece of equipment, the presence or absence of the clotting reaction signifies whether endotoxin is present or not. There are currently no other tests that can analyze the purity of medications with the same accuracy as the LAL test.
Fisherman Regulated but Not Biomedical Laboratories
The Atlantic States Marine Fisheries Commission (ASMFC) regulates how many horseshoe crabs fishermen can collect for use as bait. However, the biomedical industry is not bound to restrictions because the crabs are returned to the water after the blood is extracted. The number of crabs harvested by the US biomedical industry jumped 86% between 2003 and 2014, according to an article in Scientific American.
In “Changing Global Perspectives on Horseshoe Crab Biology, Conservation and Management”, Thomas Novitsky, PhD, Chief Executive Officer of Cape Cod Biosystems of East Falmouth, Mass., wrote, “Evidence is accumulating that mortality of bled horseshoe crabs is higher than originally thought [29% versus 15%]; that females may have an impaired ability to spawn following bleeding and release; and that bled crabs become disoriented and debilitated for various lengths of time following capture, handling, bleeding, and release.”
In 2012, a horseshoe crab subcommittee was created by the International Union for Conservation of Nature (IUCN), an organization that establishes global standards for species extinction. That subcommittee later determined the Atlantic horseshoe crab is “vulnerable to extinction,” which is just one level from its Red List of Threatened Species. Their report also stated that horseshoe crab populations could decrease by 30% over the next 40 years, the Scientific American article noted.
“I wouldn’t be surprised if they weren’t on the Red List very soon. The [Asian] populations are significantly declining,” stated John Dubczak, Director of Operations at LAL facility Charles River Laboratories in Charleston, S.C. “Between pollution, loss of habitat, and the animals being eaten in Asia, their populations are under a tremendous amount of stress.”
The facilities that perform the bleeding assert they are not harming the horseshoe crabs. Dubczak states his company has procedures in place to ensure the creatures will not be harmed during the bleeding process. They also provide economic incentives to their suppliers to help guarantee the crabs are being handled appropriately outside their facility.
“It reduces the injury, it reduces the stress, it’s better for [sustaining] the population, and it’s better for us,” Dubczak said in the Scientific American article, noting that the mortality rate for crabs used in his operation is just 4%. “One of my suppliers built a water slide to put the crabs back into the water. They love it!”
Christopher Chabot, PhD, Professor of Neurobiology, Physiology and Behavior at Plymouth State University in Plymouth, N.H. questions how the overall health of the crabs is affected by the 24- to 72-hours they spend out of the water during the bleeding process.
“As you might imagine, being an aquatic organism, that probably has an impact on their viability, their health, their mortality, perhaps, as well as their ability to bounce back after this bleeding,” said Chabot. It takes about a month for the horseshoe crabs to replenish the blood that was extracted and they are not very active after they are bled.
Horseshoe Crabs Critical to Marine Ecosystems
The biomedical industry isn’t the only threat to the survival of the horseshoe crab. Fishermen use them for bait to catch eel and conch. Many shorebirds, migratory birds, fish, and turtles dine on horseshoe crab eggs. In addition, developments along the shorelines are destroying their natural habitat and breeding grounds.
Since horseshoe crabs have a vital role in the preservation of marine ecosystems, it is crucial that alternatives to the current bleeding procedure are developed. Practical and cost-effective substitutes for the LAL test that do not require horseshoe crab blood are under development. A synthetic version of the clotting factor called recombinant factor C is made from cloned Deoxyribonucleic acid (DNA). A test called the monocyte activation test (MAT) uses human blood and may have the ability to detect endotoxin bacteria that horseshoe crab blood is unable to expose. At this time, however, the LAL test is the only one approved by the Food and Drug Administration.
These news reports about the shrinking population of horseshoe crabs along the Atlantic coast demonstrate how interconnected environmental issues are with society’s use of natural resources. Clinical laboratory managers and pathologists should take note of the fact that researchers determined that the number of horseshoe crabs harvested nearly doubled between 2003 and 2014. That raises the stakes for researchers to find a substitute for the limulus amebocyte lysate that is produced from the blood of horseshoe crabs and has some many essential uses in medicine and healthcare.
—JP Schlingman
Related Information:
Medical Labs May Be Killing Horseshoe Crabs
The Blood of the Crab
Crab Bleeders
As Horseshoe Crab Populations Steadily Decrease, their Indispensable Medical Use is Threatened
Could the Multi-Million Dollar Industry that Bleeds 500,000 Horseshoe Crabs a Year for Medical Research Drive Them to Extinction?
Sep 11, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
National Health Service estimates 73% of 65-million urine specimens collected annually in the UK are contaminated
Wanting to know why so many female patients that present with urinary tract infections (UTIs) require repeat appointments, Dr. Vincent Forte, a family GP and forensic physician who worked for the National Health Service (NHS) for 26 years, began investigating. He determined that the standard urine specimen collection cup is primarily the cause of poor-quality medical laboratory test results.
Forte realized that the method of collecting the specimens was largely to blame, with the required “start-aim-start” midstream collection technique required by traditional polypropylene specimen cups at the root of the problem.
That realization led to the development of a unique “midstream” urine collection device that eliminates the problem of first-void urine contaminating samples, according to a blog post on the Royal Society for the encouragement of Arts, Manufactures and Commerce (RSA) website written by Forte Medical of London’s Founding Director and Chief Executive Officer Giovanna Forte, Vincent Forte’s sister.
65-million Specimens Deemed Unreliable
Healthcare professionals, whether working in clinical laboratories and anatomic pathology groups or hospitals and out-patient clinics, often are among the first to notice when gaps in the quality or integrity of medical laboratory test results exist. However, in this case, it was a general practice physician rather than a medical laboratorian or in vitro diagnostics (IVD) manufacturer that set out to solve the problem of poor urine specimen collection, which The Daily Telegraph reports results in 73% of the 65-million urine specimens collected annually by the NHS being unreliable. That’s 47.5-million unreliable medical laboratory specimens collected and tested yearly in the United Kingdom.
Accurate Urine Collection Brings Billions in Savings
Vincent Forte concluded that the quality gap in urine specimen collection for his female patients was preventing accurate first-time analysis, diagnosis, and targeted treatment. In 2001, he set out to re-engineer urine collection cups. His first design—“a simple flushable paper funnel, which rejected first-flow urine, collected midstream, and ejected the remainder”—established the underlying design principle behind the patented Peezy Midstream product, Giovanna Forte stated in the RSA blog post.
Giovanna Forte noted that the first version of the device, marketed in 2010, was a “funnel formed by flat-sheet film, with a unique container-acceptor,” with overflow duct and incorporating a compressed sponge that rejects the first 8-10 ml of urine. While the product was well received, Forte says the selling price was too expensive to meet the NHS requirement for cost savings. By 2012, the product evolved into an injected-modeled design, which cut production costs by 50%. By 2014, the ergonomically designed funnel was improved to incorporate the two most common urine collection tubes.
In a Forte Medical presentation, Giovanna Forte predicted that accurate urine collection could result in a £1.2-billion (US $1.56-billion) savings to the NHS.
A Design Week article described the testing process for developing the midstream specimen collection device as “similar to launching a website in beta,” with initial testing resulting in changes such as the creation of a flatter, rounder handle to make the product easier to hold.
“Within the NHS, I was allowed to attend clinics where evaluations were taking place and speak directly to the patients. This allowed me to find out what they thought of everything from instructions for use to the collection system itself,” Vincent Forte stated in the Design Week article. “All the information was fed back into our design engineers, who proposed an improved product made more simply at a lower price.”
The patented Peezy Midstream urine collection system rejects the first (often contaminated) 8-10 ml of urine, isolating and capturing the important midstream and rejecting the rest of the urine into the toilet. The product claims 98.5% accurate urine specimen collection and would improve the accuracy and reliability of the medical laboratory tests performed on urine samples collected with this device. (Photo copyright: Forte Medical.)
Today, Forte Medical offers two midstream urine collection devices used by both men and women:
1. Peezy Midstream PE40, which collects urine into a traditional 30ml universal container; and
2. Peezy Midstream PE50, which collects urine into a lab-friendly 10ml primary tube designed to fit in laboratory analyzers.
“This simple solution … took 10 years and £2.6-million [US $3.38-million] to get right. It was achieved not by a multinational with deep pockets, but by a startup funded largely by friends, family, and a handful of angel investors, along with the goodwill of design and manufacturing partners,” Vincent Forte stated in the RSA blog post.
Specimen Capture Methods Lead to Careless Infection Control
In an article published on News Medical, an online, open-access medical information provider, Giovanna Forte points out another flaw in traditional urine collection systems.
“Thrusting one’s hands willingly into our own urine is hardly common practice. That we are expected to do so in order to capture an important specimen essential to diagnosis hardly chimes with the concept of modern medicine and leads to pretty shabby infection control by any standards,” she stated.
The Peezy Midstream is a Medicines and Healthcare Products Regulatory Agency (MHRA) approved product in the UK, and is FDA listed in the United States. As a Class 1 “Container, Specimen Mailer and Storage, Non-Sterile” device, the Peezy Midstream is “510(k) exempt” and did not require FDA review before being marketed in this country.
Still to come are clinical trials and papers in peer-reviewed medical journals that support the function of this medical device to improve patient care. It is notable, though, that the National Health System in the UK is collaborating with Forte Medical in certain ways to determine how the device can improve patient care. Dark Daily would like to hear from any medical laboratories in the UK and USA that are using this device when urine specimens are collected.
—Andrea Downing Peck
Related Information:
Liquid Gold: Urine Is the Unsung Hero of Modern Medicine and Health Economy
Peezy Mid-Stream Urine (MSU) Usability Study Results Report
What Is a Mid-Stream Urine Sample and Why Do Healthcare Professionals Request Them?
The Peezy: The Tale of an Award-Winning, Rapid-Prototyped, User-Developed Design
How Design Integrity Can Save Lies in Essential Basic Medicine
Aug 30, 2017 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Should this milestone be an indicator that more patients are willing to use telehealth to interact with providers, then clinical laboratories and pathology groups will need to respond with new ways to collect specimens and report results
Telehealth is gaining momentum at Kaiser Permanente (KP). Public statements by Kaiser administrators indicate that the number of virtual visits (AKA, telemedicine) with providers now is about equal to face-to-face visits with providers. This trend has many implications for clinical laboratories, both in how patient samples are collected from patients using virtual provider visits and how the medical laboratory test results are reported.
That this is happening at KP is not a surprise. The health system is well-known as a successful healthcare innovator. So, when its Chairman and Chief Executive Officer Bernard Tyson publically announced that the organization’s annual number of virtual visits with healthcare providers had surpassed the number of conventional in-person appointments, he got the members’ attention, as well as, the focus of former US Senator Bill Frist, MD, who moderated the event.
Tyson made this statement during a gathering of the Nashville Health Care Council. He informed the attendees that KP members have more than 100 million encounters each year with physicians, and that 52% of those are virtual visits, according to an article in Modern Healthcare.
However, when asked to comment about Tyson’s announcement during a video interview with MedCity News following the 13th Annual World Health Care Congress in Washington, DC, Robert Pearl, MD, Executive Director/CEO of the Permanente Medical Group and President/CEO of the Mid-Atlantic Permanente Medical Group (MAPMG), stated, “Currently we’re doing 13-million virtual visits—that’s a combination of secure e-mail, digital, telephone, and video—and we did 16-million personal visits. But, by 2018, we expect those lines will cross because the virtual visits [are] going up double digits, whereas the in-person visits are relatively flat.”
So, there’s a bit of disagreement on the current numbers. Nevertheless, the announcement that consumer demand for virtual visits was increasing sparked excitement among the meeting attendees and telemedicine evangelists.
“It’s astounding,” declared Senator Frist, “because it represents what we all want to do, which is innovate and push ahead,” noted an article in The Tennessean.
Is this a wake-up call for the healthcare industry? Should clinical laboratories start making plans for virtual patients?
Of virtual office visits, Pearl noted in the interview with MedCity News, “Why wouldn’t you want, if the medical conditions are appropriate, to have your care delivered from the convenience of your home, or wherever you might be, at no cost to you, and to have it done immediately without any delays in care?”
Pearl added that one-third of patients in primary care provider virtual visits are able to connect with specialists during those sessions.
“It’s better quality, greater convenience, and certainly better outcomes as care begins immediately,” he noted.
Kaiser Permanente ‘Reimagines’ Medical Care
The virtual visit milestone is an impactful one at Kaiser Permanente, an Oakland, Calif.-based nonprofit healthcare organization that includes Kaiser Foundation hospitals, Permanente Medical Groups, and the Kaiser Foundation Health Plan. It suggests that the KP has successfully integrated health information technology (HIT) with clinical workflows. And that the growing trend in virtual encounters indicates patients are becoming comfortable accessing physicians and clinicians in this manner.
As Tyson stated during the Nashville meeting, it is about “reimagining medical care.”
Bernard Tyson (right), Chairman and CEO of Kaiser Permanente, speaking with former Senator Bill Frist, MD (left), at the Nashville Health Care Council meeting where he announced that the non-profit provider’s number of virtual visits with patients had surpassed its face-to-face appointments. (Photo Credit: Nashville Health Care Council.)
What does “reimagining” mean to the bottom line? He shared these numbers with the audience, according to the Modern Healthcare report:
- 25% of the system’s $3.8 billion in capital spending goes to IT;
- 7-million people are Kaiser Permanente members;
- 95% of members have a capitated plan, which means they pay Kaiser Permanente a monthly fee for healthcare services, including the virtual visits.
The American Telemedicine Association, which itself interchanges the words “telemedicine” and “telehealth,” noted that large healthcare systems are “reinventing healthcare” by using telemedicine. The worldwide telemedicine market is about $19 billion and expected to grow to more than $48 billion by 2021, noted a report published by Research and Markets.
Consumers Want Virtual Health, but Providers Lag Behind Demand
Most Americans are intrigued with telehealth services. However, not everyone is participating in them. That’s according to an Advisory Board Company Survey that found 77% of 5,000 respondents were interested in seeing a doctor virtually and 19% have already done so.
Healthcare systems such as Kaiser Permanente and Cleveland Clinic are embracing telehealth, which Dark Daily covered in a previous e-briefing. However, the healthcare industry overall has a long way to go “to meet consumer interest in virtual care,” noted an Advisory Board news release about the survey.
“Direct-to-consumer virtual specialty and chronic care are largely untapped frontiers,” noted Emily Zuehlke, a consultant with The Advisory Board Company (NASDAQ:ABCO). “As consumers increasingly shop for convenient affordable healthcare—and as payers’ interest in low-cost access continues to grow—this survey suggests that consumers are likely to reward those who offer virtual visits for specialty and chronic care,” she stated.
Telehealth Could Increase Healthcare Costs
Does telehealth reduce healthcare spending? A study published in Health Affairs suggests that might not be the case. The researchers found that telemedicine could actually increase costs, since it drives more people to use healthcare.
“A key attraction of this type of telehealth for health plans and employers is the potential savings involved in replacing physician office and emergency department visits with less expensive virtual visits. However, increased convenience may tap into unmet demand for healthcare, and new utilization may increase overall healthcare spending,” the study authors wrote in the Health Affairs article.
Clinical Laboratories Can Support Virtual Healthcare
Clinical laboratories must juggle supporting consumer demand for convenience, while also ensuring health quality expectations and requirements. How can pathologists and medical laboratory leaders integrate their labs with the patient’s virtual healthcare experience, while also aiming for better and more efficient care? One way would be to explore innovative ways to contact patients about the need to collect specimens subsequent to virtual visits. Of course, the procedures themselves must be done in-person. Nevertheless, medical laboratories could find ways to digitally complement—through communications, test results sharing, and education—patients’ use of virtual visits.
—Donna Marie Pocius
Related Information:
Kaiser Permanente Chief Says Members are Flocking to Virtual Visits
Kaiser’s Tyson to Nashville: Health Care’s Future Isn’t in a Hospital
More Virtual Care Than Office Visits at Kaiser Permanente by 2018
Telemedicine Market Forecasts: 2016 to 2021
What do Consumers Want from Virtual Visits?
Virtual Visits with Medical Specialists Draw Strong Consumer Demand, Survey Shows
Direct-to-Consumer Telehealth May Increase Access to Care but Does Not Decrease Spending
Cleveland Clinic Gives Patients Statewide 24/7 Access to Physicians Through Smartphones, iPads, Tablets, and Online; Will Telemedicine Also Involve Pathologists?
Aug 16, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
Undergoing genetic testing also can impact the cost and availability of life insurance in Australia, not just for the person who underwent the testing, but for their families as well
Concerns about direct-to-consumer genetic testing have led to stricter regulatory requirements for Clinical laboratories that perform genetic tests in Australia.
Starting in July 2017, medical laboratories that perform genetic testing must have accreditation by the National Association of Testing Authorities (NATA). And their tests must meet performance standards established by the National Pathology Accreditation Advisory Council. Manufacturers must also obtain a conformity assessment certificate from the Therapeutic Goods Administration, the organization that regulates medical devices, medicines, blood, and tissue in Australia.
According to the Australian Law Reform Commission (ALRC), there are currently 220 deoxyribonucleic acid (DNA) diagnostic tests available in Australia. There are 44 different laboratories located throughout the country that perform those tests. A database of the available tests and labs is maintained by the Human Genetics Society of Australasia (HGSA).
However, Australian citizens are not limited to just the tests and labs listed by the HGSA. Direct-to-consumer genetic testing kits, which are marketed through retail outlets, mail order, and the Internet, also can be used to obtain genetic information. However, receipt of genetic test results can be problematic and have negative consequences, say some experts.
Genetic Tests Can Cause Confusion; Affect Insurance
A recent paper, authored by researchers at Monash University, outlined apprehension about home genetic testing and how it can have a negative impact on people’s lives and insurance rates. The authors claim the tests can be misleading, noting concerns that the results are often interpreted by people who lack proper training. They cautioned that providers in other countries are not subject to the strict laws that govern genetic testing in Australia. Monash University is Australia’s largest university with facilities and campuses in Australia, Malaysia, South Africa, China, India, and Italy.
“In the age of individuality and consumer empowerment, some people want to take things into their own hands, but that’s not without its risks,” stated Ken Harvey, MBBS (Bachelor of Medicine, Bachelor of Surgery), in a Special Broadcast Service (SBS) article. Dr. Harvey is an FRCPA (Pathologist) and Associate Professor in the Department of Epidemiology and Preventive Medicine at Monash University, and one of the authors of the paper. “If you’re getting something over the internet it can be really difficult to assess whether that test has been accredited by a reputable independent authority.”
The chart above tracks the collective annual test volume of just three direct-to-consumer (DTC) providers of genetic test in the US. It illustrates the steep rise in DTC genetic test usage among US-based healthcare consumers. Clinical laboratories could chart a similar progression tracking the increase in DTC genetic testing they have performed in just the past few years. (Image copyright: University of Iowa Wiki.)
In addition, the results of home genetic tests have to be translated and explained to consumers by a medical professional, often a General Practitioner (GP), which, according to the Australian researchers, can lead to confusion.
“Though the results would go back to the GPs, many GPs really had no idea what to do with these results when they got them”, Harvey noted in the SBS article. “I’ve had GPs tell me one of their patients comes in clutching a handful of printouts about their genetic tests, and they say, ‘what am I meant to do with this?’”
Why Genetic Testing is Important
One person who understands the urge to try genetic testing is Heather Renton, Founder and President of Syndromes Without a Name (SWAN) Australia, a not-for-profit incorporated association and charity that works to increase awareness and understanding of the impact and prevalence of undiagnosed genetic conditions.
After being misdiagnosed multiple times, it was discovered that Renton’s daughter had the rare FOXP1 gene. Individuals with the FOXP1 genetic disorder have delayed speech and learning issues, sometimes with signs of autism. Symptoms of the condition include:
- Speech and learning disabilities;
- Immune system issues; and
- Behavioral abnormalities.
“People are sometimes so desperate for answers, [but] who’s to know that it’s credible—you might think you’ve got this gene and it might turn out that you don’t,” Renton stated in the SBS article.
“You might have a gene susceptible to breast cancer the older you get, but as a 20-year-old you have no idea you’ve got that,” she continued. “Life’s a lottery game.”
Why Genetic Testing Can Cause Problems
Nevertheless, some individuals may not welcome the results that genetic testing could reveal.
“If you get one of these batteries of genetic tests, the implication is these are genetic conditions that can be inherited; the results are not just important or significant to you, but to your family members, your children, etc.,” Harvey stressed. “The implications go beyond a particular person—and not everyone wants to know.”
“For some families, it’s been life shattering to find out they’ve actually passed this condition on to their child, and they carry this guilt,” Renton added.
Genetic Test Results Can Affect Insurance Premiums/Availability
Results of genetic tests also could affect the costs and availability of life insurance policies in Australia that went into effect after July.
Under the Insurance Contracts Act, Australians applying for life insurance are required to disclose:
- Their medical history;
- Information about the health of first degree relatives (parents, siblings, and children); and
- The known results of any genetic testing.
Life insurance policies in Australia are guaranteed renewable. This means consumers do not have to inform insurers of changes in their medical conditions after policies have been issued. It is forbidden for insurers to demand that consumers have any genetic testing performed. However, if a consumer has had a genetic test performed and knows the results before the policy is issued, those results must be divulged to the insurer. That information can then be used to determine policy rates or deny coverage.
Could This Happen In the US?
In the United States, some genetic testing is regulated by the Food and Drug Administration (FDA) under the processes that oversee medical devices. The FDA has proposed regulating laboratory-developed tests (LDTs), which would bring more genetic testing under the agency’s scrutiny. As direct-to-consumer genetic testing becomes more advanced and is marketed to the public, it is probable that regulatory oversight of labs performing these tests also will increase in an effort to protect the public. Thus, clinical laboratories and pathology groups are advised to monitor this situation in Australia. Similar regulatory actions could be taken in the US as well.
—JP Schlingman
Related Information:
‘Not Everyone Wants to Know’: Warnings Over Genetic Tests
Warning Over Direct-to-Consumer Genetic Tests
Retail Genetics
Growth in DTC Genetic Testing
Thinking About Life Insurance Through a Genetic Lens
Life Insurance Products and Genetic Testing in Australia
British Health Authorities Criticize Medical Laboratory Tests for Consumers
Medical Laboratory Tests for Consumers Under Investigation on Two Continents
Aug 9, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Additionally, the device also could help reduce antibiotic-resistant infections and other HAIs and HACs, though this result was not part of the study
Research findings indicate how a new system-in-a-box device that phlebotomists and clinical laboratories would use when drawing blood could reduce contamination of blood cultures and lower patients’ use of antibiotics. In a study involving 1,800 blood cultures done on 904 patients at the University of Nebraska Medical Center (UNMC), use of the device was attributed to an 88% reduction in the blood culture contamination rate.
Developed by Magnolia Medical Technologies, the SteriPath Initial Specimen Diversion Device (ISDD) is compatible with standard BD and bioMérieux blood collection tubes and culture bottles, and has been approved by the US Food and Drug Administration (FDA) for marketing in the United States.
According to a press release by researchers at UNMC who studied the device, “With traditional blood draws, about 30% to 40% of patients with contaminated blood cultures are prescribed antibiotics unnecessarily. This contributes to antibiotic resistance and undermines nationwide efforts to improve antimicrobial stewardship.” The researchers reported their findings in an article published in the Oxford Academic journal Clinical Infectious Diseases (CID).
Blood Culture Contamination Harms Patients and Increases Cost of Care
The UNMC researchers noted that, during a blood draw, a significant percentage of blood cultures become contaminated when skin fragments containing bacteria are dislodged and mix with the patient’s blood. For the thousands of patients each day who have their blood drawn, contaminated blood cultures, which lead to false positive results for sepsis, often result in unnecessary antibiotic treatment. This in turn can lead to serious and deadly antibiotic-resistant infections with various multi-drug-resistant organisms such as Clostridium difficile infection (C. diff), as well as, other hospital-acquired infections and conditions (HAIs & HACs) due to unnecessary extended length of stay, according to Mark Rupp, MD, Professor, Department of Internal Medicine, Section of Infectious Diseases, and Medical Director, Department of Healthcare Epidemiology-Infection Control at UNMC.
In the CID article, Rupp and colleagues reported on a prospective, controlled trial conducted in the emergency department (ED) at UNMC’s partner hospital Nebraska Medicine. Results of the trial showed that the SteriPath ISDD diverts and sequesters the first 1.5 to 2 mL portion of blood. The researchers presumed that these initial drops of blood would contain the contaminating skin cells and microbes.
SteriPath is a self-contained, preassembled, sterile blood collection system. It provides proprietary vein-to-bottle technology that significantly reduces blood culture contamination, according to Magnolia Medical Technologies. This could be useful for helping phlebotomists and clinical laboratories improve the quality of specimens collected for use in blood culture testing. Click on the image above to view videos on the SteriPath ISDD. (Photo copyright: Magnolia Medical Technologies.)
The researchers tested the SteriPath ISDD during standard phlebotomy procedures in patients requiring blood cultures. After drawing 1,808 blood cultures from 904 study subjects, the researchers concluded that the ISDD significantly reduced blood culture contamination compared with standard phlebotomy procedures. The blood culture contamination among phlebotomists who used the ISDD decreased by nearly 90%, compared to phlebotomy procedures conducted by nurses who did not use the ISDD.
“We were able to decrease the false positive rate significantly through use of this device—from 1.78% down to 0.2%, which represents an 88% reduction,” Rupp noted in the UNMC press release. “The 1.78% baseline rate of contamination may seem small, but we should strive to decrease adverse events to the lowest possible level, because of the impact to the patient and the burden to our healthcare system.
“The device is innovative in that it diverts the first couple of milliliters of blood into the sequestration chamber,” Rupp explained. “That’s where we think the contaminants are. The remaining blood being drawn is then diverted into the sterile pathway into the blood culture vial, thereby preventing the contamination.”
Billions of Healthcare Dollars Could Be Saved with SteriPath’s ISDD
During a conference call with reporters, Rupp admitted that cynics might scoff at such a low rate of improvement. “Many of those folks don’t understand that we do tens of millions of blood cultures in this country every year,” he explained. “Every year, we do about 30 million or so blood cultures. That many cultures means a 2% contamination rate equates to somewhere in the neighborhood of about 600,000 contamination events. And 2% is a very respectable level. Usually clinicians are satisfied anywhere below about 3%, which is about 900,000 events each year.”
For about 40% to 50% of patients whose blood is contaminated, physicians will prescribe antibiotics, order another blood test, and require patients to stay several days in the hospital, he added. “All of this results in thousands of extra dollars being spent,” he declared. If each blood contamination case costs about $4,000, then reducing such contamination in potentially 600,000 cases each year could save more than $1 billion healthcare dollars.
According to the researchers, costs associated with blood culture contamination ranged from $1,000 per patient in 1998 to $8,700 per patient in 2009. “If a midpoint cost estimate of $4,850 is used, and the added cost of the device is not taken into account, it equates to a cost avoidance of $1.8 million per year at our institution alone,” Rupp stated. “If the low rate of contamination that we observed in the study, 0.22%, was applied to all blood cultures throughout the country, billions of dollars of excess costs could be avoided.”
This clinical study offers strong evidence that the SteriPath ISDD might prove to be a useful tool that clinical laboratories could use to help prevent unnecessary exposure to antibiotics and hospital stays, lower healthcare costs, and improve patient test outcomes. If the UNMC clinical study outcomes are replicated in future studies, then it is a technology and a solution that has the potential to be adopted by phlebotomists in medical laboratories and hospitals.
—Joseph Burns
Related Information:
Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device
Study Shows Device Reduces Blood Draw Contamination
Novel Device Significantly Reduces Blood Draw Contamination, Reduces Risks to Patients, Study Shows
Better Care by Reducing Blood Culture Contamination: Sepsis, SteriPath and Antimicrobial Stewardship
Study by Mark Rupp, MD, in Clinical Infectious Diseases: Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device (SteriPath)
Aug 7, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
Phenotypic data combined with artificial intelligence provides a new biomarker for genetic laboratories to use when diagnosing disease
Researchers are demonstrating that facial analysis and facial recognition technology can play a useful role in helping pathology and medical laboratory scientists diagnose disease. This is just the latest example of how advances in different technologies can add new sources of biomarkers for clinical laboratories.
Biomarkers used by clinical laboratories and anatomic pathologists are usually biological substances or states that can be measured during testing either in vivo or in vitro. However, clinical laboratories may soon be working with biomarkers based on measurable aspects of external human anatomy. One such biomarker employs facial analysis and facial recognition technology to produced phenotypic data that could help pathologists diagnose rare genetic disorders. A human phenotype is data comprised of a person’s “observable characteristics or traits.”
Phenotypic Data from Photographs
Three genomics companies: FDNA, GeneDx, and Blueprint Genetics, are collaborating on a unique project, dubbed Face2Gene Labs. They are using a facial recognition application called Face2Gene developed by FDNA. The application uses artificial intelligence (AI) and phenotyping technology to extract data from facial photographs of patients. The data is then examined and compared to a database of hundreds of thousands of patterns that were generated from photos of patients with known rare genetic disorders. The algorithm then compiles a list of possible diagnoses. The goal is to produce phenotypic data that clinicians can transmit in real-time directly to medical laboratories for analysis.
“Trying to diagnose patients with genetic sequencing is like searching for a pin in a 22,000-needle haystack,” stated Dekel Gelbman, CEO, FDNA, in a news release. “By providing accurate phenotypic and clinical data to the lab directly at the point of genetic interpretation, we are truly realizing the promise of precision medicine. And, with the power of artificial intelligence behind it, clinicians will be pointed toward potential diagnoses that they may have never otherwise considered.”
The Face2Gene application developed by FDNA uses artificial intelligence to compare digital photographs of patients’ faces against hundreds of thousands of stored patterns to help clinicians identify genetic disorders in children. (Photo copyright: FDNA.)
Solomon goes on to praise GeneDx and Blueprint Genetics as examples of innovative and renowned labs adopting technology that will lead the way in pinpointing rare disease and promote further medical advancements.
“This is an important collaboration for several reasons,” states Ben Solomon, MD, a Clinical Geneticist and Managing Director of GeneDx, in the news release. “It’s a great way to leverage clinical and genetic information and machine learning approaches to find answers for the clinicians, patients, and families GeneDx serves. Aside from providing answers, this integration will make the diagnostic testing process easier, smoother, and more enjoyable for clinicians.”
85% Increase in Diagnostic Yield with Addition of Phenotypic Data
A recent multi-center study called PEDIA (short for Prioritization of Exome Data by Image Analysis) looked into the accuracy of genetic testing when using FDNA’s Face2Gene tool. The study, conducted by researchers at the Berlin Institute of Health and Charité University of Medicine in Berlin, showed promising results of the collaboration.
“We estimate that the addition of phenotypic features [encoded in HPO terms] increases the diagnostic yield to about 60% [from 25% without],” stated Peter Krawitz, MD, PhD, and Principal Investigator for PEDIA. “When adding facial analysis, FDNA’s technology, to that process, the diagnostic yield increases to more than 85%,” he explained in the FDNA news release.
The Rarity Paradox and Diagnosing Genetic Disorders in Children
According to Global Genes, a rare disease patient advocacy non-profit organization, one in 10 Americans (approximately 30 million people) suffer from a rare genetic disorder. These disorders also affect the same percentage of people worldwide, or about 350 million people. There are more than 7,000 distinct rare diseases known to exist and approximately 80% of those illnesses are caused by faulty genes. In addition, about half of the people affected by rare genetic illnesses are children.
“We call it the rarity paradox,” stated Gelbman in an article published in Wired. “Each rare disease in itself affects very few people, but on aggregate the effect is pretty staggering.”
The three companies hope their collaboration will help clinicians determine faster, more accurate diagnoses, while diminishing anxiety among patients and their families regarding the unknowns of rare genetic disorders.
“Since 2012, Blueprint Genetics has been developing technological innovations in sequencing and clinical interpretation to improve the quality and performance of rare disease diagnostics,” noted Tero-Pekka Alastalo, MD, PhD, President, Chief Medical Officer of Blueprint Genetics, in the FDNA news release. “It’s great to see how these innovations are now helping the genetics community and patients suffering from inherited disorders. Combining these technological innovations with our transparent approach to diagnostics and next generation phenotyping tools like Face2Gene represents the next steps forward in molecular genetic diagnostics.”
Pathology groups and clinical laboratories are advised to monitor this exciting development in genomic research. It illustrates how unrelated technologies, such as facial analysis software, could soon be used for diagnostic purposes to detect the presence of genetic disorders, and to determine the best therapies for patients. Labs will want to be prepared to engage with clinicians who adopt this technology and to answer patients’ questions about it.
—JP Schlingman
Related Information:
FDNA Announces Collaboration with GeneDx and Blueprint Genetics in the Launch of Face2Gene LABS
FDNA Expands Facial Analysis Reach to 2,000 Syndromes
Groups Explore Facial Analysis Software for Inherited Disease Diagnosis, Research
Your Face Could Reveal if You Have a Rare Disease
Face2Gene: Take a Headshot – Get a Diagnosis
