Systemic errors at Canadian forensic laboratory Motherisk make national news and provide another example of consumer interest in accuracy of clinical laboratory testing
Hair tests developed by Motherisk Laboratory and used by the Hospital for Sick Children in more than 16,000 child protection cases throughout Canada (2005 – 2010) have been found to produce flawed results. The hospital, originally backed the validity and reliability of the testing, but has since conducted an independent review which found that they had been misled by the company repeatedly. An enzyme-linked immunosorbent assay test was used to determine if hair samples were positive, however the results were not confirmed against a second screening test method. At least one case has been overturned, in which a Toronto mother had been sent to jail for cocaine-related charges that were later thrown out due to the “validity of the [hair-strand] results”. The retired Ontario Appeal Court Justice Susan Lang, who had been provincially appointed to conduct an investigation, confirmed in her report that the, “…laboratory employed a preliminary screening test that specifically cautioned users about its limitations. Despite this caveat, the laboratory represented that this preliminary test could both identify and quantify drugs in hair. It could not. Also, the laboratory fell short of meeting international forensic analytical standards in other important ways that I describe in my report. Finally, the laboratory lacked expertise in the interpretation of the purported test results, which it frequently misinterpreted or over-interpreted.” The hospital has permanently stopped drug and alcohol hair testing by Motherisk for their cases.
FDA gives emergency approval to 3-in-1 test for Zika, chikungunya and dengue; Microcephaly caused by Zika confirmed
The Centers for Disease Control and Prevention (CDC) announced in a media statement that it will distribute testing kits that can determine infection with Zika, chikungunya or dengue within a single test call the Trioplex Real-time RT-PCR Assay. Facilities associated with the Laboratory Response Network which includes domestic and international lab that respond to public health emergencies will only receive the text at this time.
The CDC and other agencies have made assumptions that the Zika virus has caused microcephaly in newborns but have now released a publication on the findings that a causal relationship does exist. The evidence used to derive this includes: infection time in relation to prenatal development and defects observed, a review of a rare phenotype involving microcephaly and associated brain anomalies in fetuses and infants, and biologic plausibility data including the identification of Zika virus in infected brain tissue.
Theranos Takes a Shot at Redemption by Adding Experts to the Medical Board
Theranos is taking more steps to counter the scathing criticism it has received in recent months for inadequate leadership and inaccurate blood-testing technology. In early April, the company added high profile medical experts to its advisory board as well as opened proprietary data to scientific reviewers – a highly intelligent move if their data can withstand testing.
New members include:
Susan Evans - former president of the National Academy of Clinical Biochemistry,
William Foege, epidemiologist and former director of the U.S. Centers for Disease Control and Prevention,
Ann Gronowski, a professor in the Department of Pathology and Immunology and the Department of Obstetrics and Gynecology at the Washington University School of Medicine in St. Louis.
A total of four medical doctors and six professors will contribute to a board who, now, all have scientific backgrounds. "This group together is really going to help not just Theranos, but all of the scientists out there who are involved, to understand the technology and utilize the technology and science," said David Helfet (co-chair) who is an orthopedic trauma surgeon at the Hospital for Special Surgery and New York-Presbyterian Hospital.
Related Article: Controversial health startup Theranos has barely any medical experts on its board of directors
Donors sue blood service after test failed to detect anemia
Donors to the Irish Blood Transfusion Service (IBTS) are grouping together for legal action against the organization as faulty testing equipment identified them as has having normal hemoglobin levels. Of the 1,700 individuals tested for the development of anemia after donation (2014 - 2015), medical follow-up was conducted and resulted in four donors requiring blood transfusions. A subsequent compensation claim will be made to the equipment manufacture for IBTS costs incurred of over €500,000 due to the situation. The impact of the faulty equipment can be identified in the 12% increase of deferrals based on accurate equipment results.
Safe patient care through competent management and utilization of laboratory test information
Laboratory errors generally occur during test selection (Total Testing Process (TTP) pre-analytical phase) and test result interpretation (TTP post-analytical phase) according to the Institute for Health Care Improvement. “Now more than ever, laboratory professionals must focus their efforts and attention on the fact that these errors can be prevented through appropriate changes in laboratory information systems, health care information systems and strong collaboration between physicians, laboratory professionals and all health care professionals who rely on laboratory test information to provide safe patient care.“ In an Institute of Medicine report titled, “Improving Diagnosis in Health Care”, 8 goals to improve diagnosis and reduce diagnostic errors were established.
The organization recommends that health information used in diagnostic process:
incorporates human factors knowledge
integrates measurement capability
fits well within clinical workflow
provides clinical decision support
facilitates the timely flow of information among patients and health care professionals
assures interoperability to support effective, efficient, and structured flow across care settings
SA Pathology incorrectly refers 68 patients to urologist after prostate cancer screening tests
South Australian Pathology has been involved in two major prostate cancer testing “blunders” this past week. David Swan, SA Health CEO, has ordered the review of these incidences. The first news release announced 100 men, of which some had had their prostate glands removed, were falsely given positive cancer screens associated with prostate specific antigen (PSA) levels. Siemens, who produces the testing kits has denied that they were faulty. In the second occurrence, 68 patients were given inappropriate urology referrals instead of a re-screening recommendation in 6-12 months. It was noted that their tests results were accurate but that the automatic generation of referral timeline statements was faulty. “There are thousands [of] South Australians who are less likely to believe advice when it comes from SA Health,” said Opposition health spokesman Stephen Wade.
Related Article: SA Health staff sacked, disciplined as 21 caught spying on patient records
Blood processing methods affect microparticles and mtDNA linked to transfusion reactions: Research debunks previously held belief that storage of blood is responsible for cellular damage
The Canadian Blood Services' Centre for Innovation lab in Alberta and Blood Systems Research Institute in California have released findings in Vox Sanguinis online. The study examined red blood cells collected from Canadian and American blood donation centers and investigated cellular blood damage via levels of microparticles and mitochondrial DNA (mtDNA).
The nine different red blood cell manufacturing processes showed clear differences in their degree of damage (damage-associated molecular patterns known as DAMPs). The investigation was also able to debunk a long-held belief that higher levels of DAMPs are associated with longer lengths of storage time prior to transfusion. It was concluded that the increased DAMP levels is associated with the manufacturing method, rather than the storage method. However, researchers need to continue studying this phenomenon to isolate the specific causes of the variations in mtDNA and microparticle counts. "We think that our research could lead to finding 'the best' way to manufacture red blood cells," describes Dr. Jason Acker, senior development scientist. "It's clear now that manufacturing methods matter."
13 people identified as immune to genetic diseases, but researchers can't find them
Published in Nature Biotechnology, a study analyzed 589,306 genomes and was able to identify 13 individuals who should have developed a debilitating disease, but were resilient to one of eight diseases: cystic fibrosis, Smith-Lemli-Opitz syndrome, familial dysautonomia, epidermolysis bullosa simplex, Pfeiffer syndrome, autoimmune polyendocrinopathy syndrome, acampomelic campomelic dysplasia and atelosteogenesis. In an unconventional approach, the international team searched for people who were remained healthy despite the potential for disease in comparison to most studies that look for mutations in people who are ill. The implication of this research means that those who inherit the mutation and never go on to develop the disease could have a natural defense mechanism that may permit survival and/or lead to new treatments. Adult data was collected from various sources including 23andMe, the 1000 Genomes Project, and the Ontario Institute for Cancer Research. However, contacting these participants to validate the lack of disease or mild variant is not possible due to a lack of consent for a second contact by researchers. Dr. Ada Hamosh, Professor and Clinical Director at Johns Hopkins University. “[But] because of the inability to confirm the source or validity of the variants and the inability to recontact the individuals, this paper does not constitute a proof of principle.”
Biologists just built a piece of software that can program living cells like a computer
Quote: "What we’re finding over time is that biology isn’t this kind of mysterious unpredictable substrate; it just felt that way because we didn’t really have the tools to see what was going on," said Christopher Voigt, a synthetic biologist and lead researcher. "This is the first example where we’ve literally created a programming language for cells."
A United States based research team has published an article in Science that describes a new computer software that genetically engineers a cell to perform various functions. Contrary to current cell programming in cases like bacteria producing biofuels or antibiotics, the Cello uses programming code to “input your instructions, such as what kind of promoter you want to use and how you want the ‘circuit’ or program to run, and it will spit out a sequence for a DNA plasmid.” In their testing, 92% of the results functioned correctly and 75% (45/60) of the E. coli circuits produced using Cello worked without error. If you want to play around with the program, go to the website for some programming fun!
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