News
We complete the picture
This is the statement of celebration for this year's National Medical Laboratory Week; April 22-28, 2018.
Since 1985, The Canadian Society for Medical Laboratory Science (CSMLS) has sponsored this special week to highlight the vital role of medical laboratory professionals in Canada's health care system and shine a light on the dedicated women and men in this health care field.
"Lab professionals are critical to the whole health care picture, yet since their work is not visible to the public, mostly conducted behind the closed doors of the lab, there is not a great understanding for the role they play" says Lisette Vienneau, CSMLS President.
As part of the Lab Week campaign, lab professionals are encouraged to raise public awareness and provide education on their role and its impact on patient care. The CSMLS creates tools to help with these initiatives, including videos that take viewers behind the scenes of a lab. Each video gives an overview of a lab test and meets the people who work in that discipline.
"National Medical Laboratory Week is a highlight of the year for many lab professionals. With many labs experiencing staff shortages the added stress can really weigh on individuals, so a week like this can really boost morale," says CSMLS Chief Executive Officer, Christine Nielsen. "It's important to celebrate the hard work and recognize these health professionals' contributions to patient care."
B.C. health authorities identify problem with early colon cancer test
Provincial health authorities have once again discovered a problem with a laboratory test designed for people considered at average risk of colon cancer.
B.C. Laboratories and B.C. Cancer Agency say recent fecal immunochemical test (FIT) results are showing a spike in the number of positive screens being returned — more patients are testing positive than is typical.
On average, 15 per cent of patients screen positive and require further testing, but the Provincial Health Authority says an additional five per cent of patients who would have previously had a borderline negative result can expect to screen positive.
“We are working diligently with our partners on a long-term resolution that will ensure British Columbians are able to continue to have trust and confidence in this very important early cancer screening tool,” said Dr. Jim Cupples, vice president of the B.C. Agency for Pathology and Laboratory Medicine. “We are working with our partners including B.C. Cancer and the Ministry of Health to resolve the issue as quickly as possible.”
A spike in positive tests last October led to the B.C. Cancer Agency suspending all stool sample collection testing for three months.
The test sensitivity problem was blamed on a liquid solution, known as a reagent, used to test the fecal samples in the labs. A new reagent, which has been in use since mid-December, was performing to expected standards until very recently.
The Provincial Health Services Authority says, despite the recent spike, testing will continue and a higher percentage of patients than normal will be referred for a follow-up colonoscopy.
Quality
Error rate for cancer test results slim, but can it be devastating for patients
The odds are very slim — typically less than 2 percent — of an individual getting a misdiagnosis from a hospital pathology laboratory test for cancer, according to national research studies.
A national study of 6,000 cancer patients by researchers at Johns Hopkins Hospital found an error rate of 1 in every 71 histopathology test results. Histopathology is the study of changes in tissues caused by diseases, such as cancer.
With about 1.3 million Americans receiving a diagnosis of cancer each year, even a 1.2 percent error rate on cancer lab tests can mean about 14,300 faulty results. Other studies suggest the error rate could be as high as 10 percent.
In the case of an unidentified Wake Forest Baptist Medical Center patient, a misdiagnosis of breast cancer last year led her to undergo first a lumpectomy and then she “chose to undergo the more aggressive route” of a bilateral (double) mastectomy, according to a federal Medicare investigation of the medical center’s pathology lab. She didn’t receive radiation therapy.
An external review of the patient’s case, received by Wake Forest Baptist on Dec. 15, “found that the diagnosis of breast cancer was incorrect,” the Medicare report determined. The patient was told of the misdiagnosis, but what happened since is unclear because of patient health privacy laws.
Analytical Variables: Small Mistakes Lead to Major Safety Concerns
The clinical laboratory plays a significant role in the effective diagnosis and treatment of patients. Recent recommendations from the Institute of Medicine (IOM) suggest that patient safety can be improved through the reduction of diagnostic errors. According to the IOM, diagnostic errors include delays in diagnosis, as well as the provision of “unnecessary or harmful treatment.” From a clinical laboratory standpoint, the delivery of timely and accurate test results ensures that providers have the information needed to formulate a correct diagnosis and treatment plan.
While most laboratory errors arise during the pre-analytical and post-analytical phases of testing, errors occurring in the analytical phase can have a detrimental effect on patient care. The analytical phase of testing is described as activities occurring from the time of specimen preparation to result verification. Approximately 7-13% of laboratory errors occur during the analytical phase of testing. There are multiple areas of concern regarding the analytical phase, including interfering substances, reagent stability, calibration, performance and monitoring of quality control, instrumentation malfunction, as well as failure to follow standard procedures for both patient testing and equipment maintenance.
Transfusion Medicine
Gene therapy for blood disorder ends need for transfusions
Gene therapy for transfusion-dependent thalassemia, an inherited blood disorder, produced positive outcomes in an interim analysis of two international Phase 1/2 clinical trials, according to the results published in New England Journal of Medicine. Out of 22 patients aged 12 - 35 years, 15 patients achieved transfusion-free status, while others needed transfusions less often.
The studies used the patient's own stem cells that were treated in the lab with a modified virus to replace the gene that is defective in thalassemia. The patient needed to undergo chemotherapy before the new cells could be infused. Patients typically reached peak production of hemoglobin in nine to 12 months after infusion. They were then monitored for 15 - 42 months after receiving the new cells. Treatment-related adverse events were typical of autologous stem cell transplantation. No safety issue could be attributed to gene therapy in either of the studies. Researchers plan to continue follow-up with all patients for 15 years.
"While these gene therapy trials were the largest for thalassemia to date, we need to evaluate effectiveness in a much larger population," said leading author Alexis Thompson, MD, Head of Hematology and Director of the Comprehensive Thalassemia Program at Ann & Robert H. Lurie Children's Hospital of Chicago, as well as Professor of Pediatrics at Northwestern University Feinberg School of Medicine. "Since we saw such positive results, we are now enrolling patients as young as 5 years old on a Phase 3 trial of gene therapy for transfusion-dependent thalassemia."
Microbiology
Sensitive new assay detects hepatitis B infection in single liver cells and serum
Chronic hepatitis B virus (HBV) can progress to cirrhosis and hepatocellular carcinoma (HCC). A study published in The Journal of Molecular Diagnostics describes a new HBV assay that offers advantages over currently used methods because it has the capability to detect closed circular DNA (cccDNA) in serum, single cells, and preserved tissue samples. This assay can be used to diagnose HCC at an earlier stage to manage treatment more effectively.
"The development of HCC is strongly associated with HBV. Recently, several new antiviral strategies targeting cccDNA have been established to improve HBV clearance. It is of great clinical significance to provide an accurate and sensitive approach for cccDNA detection. With this method, more and more patients with chronic HBV will have precision treatment available to prevent or delay HCC occurrence, and HCC in patients could be diagnosed at an earlier stage," explained lead investigator Song-Mei Liu, MD, PhD, of the Center for Gene Diagnosis, Zhongnan Hospital of Wuhan University, Wuhan, China.
The new assay utilizes droplet digital PCR (ddPCR), which is highly sensitive and accurate for detecting trace molecules such as viruses. By combining ddPCR with PCR, the researchers were able to detect cccDNA in serum, single cells, and formalin-fixed, paraffin-embedded tumor issues. Southern blotting, currently considered the gold standard for this purpose, and other assays have important limitations like less sensitivity than ddPCR in detecting low copy numbers of cccDNA. Other methods require obtaining liver tissue through liver biopsy. "Compared to liver biopsy, serum can be obtained noninvasively, is widely used for clinical diagnostic purposes, and has a homogenous cccDNA distribution. The assay also improves the limit of detection of cccDNA," noted Dr. Liu.
Research
Turn your bathroom into a medical lab
A startup called Confer Health wants to put a medical test lab on your bathroom counter. And a group of venture capital firms have just supplied $9.5 million to help it do that.
The Boston company is building a diagnostic device — target price, $100 — that will be able to perform a range of health-related tests at home. The Confer Analyzer is about the size of a stack of six salad plates. Each test will use a disposable plastic tray that you insert into a slot in the analyzer; those will sell for between $5 and $20 each. Test results can be remotely reviewed by a doctor, who would decide what action needs to be taken — like a prescription for an antibiotic, in the case of strep. The company’s first product will help women who are trying to conceive monitor their fertility, and find out when they’re pregnant. Confer says it will be able to deliver results on a pregnancy test up to two days sooner than the best drugstore tests now on the market. Pending the results of a clinical trial next year, Confer hopes to get clearance from the Food and Drug Administration to begin selling the device and accompanying tests before 2019 is out.
Google develops AR-powered microscope for cancer detection | GulfNews.com
A team of Google researchers has developed a Machine Learning (ML) and Augmented Reality (AR)-powered microscope that can help in real-time detection of cancer and save millions of lives.
In the annual meeting of the American Association for Cancer Research (AACR) in Chicago, Illinois, Google described a prototype Augmented Reality Microscope (ARM) platform that can help accelerate and democratize the adoption of deep learning tools for pathologists around the world.
The platform consists of a modified light microscope that enables real-time image analysis and presentation of the results of ML algorithms directly into the field of view. The ARM can be retrofitted into existing light microscopes around the world, using low-cost, readily-available components, and without the need for whole slide digital versions of the tissue being analysed.
"At Google, we have also published results showing that a convolutional neural network is able to detect breast cancer metastases in lymph nodes at a level of accuracy comparable to a trained pathologist,” the post said.
However, because direct tissue visualisation using a compound light microscope remains the predominant means by which a pathologist diagnoses illness, a critical barrier to the widespread adoption of deep learning in pathology is the dependence on having a digital representation of the microscopic tissue.
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