News
Ireland Investigates Cervical Cancer Screening Scandal
The Irish government announced on April 30th that it was opening an official inquiry and setting up phone help lines and emergency testing after it emerged that a publicly funded smear test program had mistakenly cleared at least 208 women who later received diagnoses of cervical cancer.
The 208 women received false negatives between 2010 and 2014. At least 17 of these women have since died, Irish officials said, although they added that they could not confirm the causes of death.
Prime Minister Leo Varadkar said Monday that he was “very angry” and “saddened” by the case. He said the government would investigate what he described as “appalling communication failures” and examine the testing process.
The government is contacting all affected, including survivors of the 17 deceased women, to inform them of the mistaken tests and of a 2014 review that identified the lapses but did not become public until recently. The government is also considering a plan to automatically compensate those survivors, so that their families do not have to go through the courts.
The scandal came to light when it emerged from court proceedings that an American company to which some tests had been outsourced, Clinical Pathology Laboratories Inc. of Austin, Tex., had reached a settlement worth 2.5 million euros (about $3 million) with Vicky Phelan, 43, a terminally ill woman from County Limerick.
In 2011, Ms. Phelan was given a negative result after a smear test taken that year was negative, but a second test done in 2014 revealed a diagnosis of cancer. Her previous negative test was then reviewed, in accordance with standing procedure, and was found to have in fact strongly indicated the presence of cancer.
“If she had been diagnosed in 2011, there would have been a 95 percent chance of a cure,” said her lawyer, Cian O’Carroll. “Instead she is left with what is now an incurable cancer.”
In 2014, a review found that 208 women had received false negative results since 2010, but only 46 of those women were informed.
Ms. Phelan only learned of the earlier false result last September. In January, she was told she had only six months to a year to live.
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Lab not leaving Baddeck hospital
The Nova Scotia Health Authority says it’s business as usual at the Victoria County Memorial Hospital in Baddeck. Concerns were raised in recent weeks about the possibility of the local hospital’s laboratory service closing at the end of the year, however the health authority confirmed that won’t be the case.
“There is no intent to take lab services away (at Victoria County Memorial Hospital),” said Shauna Thompson, senior director of pathology and laboratory medicine for the health authority.
“As far as blood collection services for patients, we have no intentions to change any of that and physicians will still have access to testing and will ensure that we provide results in an appropriate turnaround time.”
Although there will be no disruption in blood collection at the Baddeck facility, Thompson said how the health authority delivers the services may look different in the future. “(It will be) behind the scenes (changes), patients using our services for blood collection won’t see any noticeable differences, physicians will still get their results in an appropriate turnaround time and they will still have access to whatever testing that they need,” she said.
“I can use examples from other jurisdictions where we’ve changed their service delivery model in response to shortages of staff, so we put the service in place to ensure that the stat and urgent testing needed to support onsite clinical services are there and available — that’s just an example.”
Laboratory service at the hospital will not be outsourced, but some routine, non-urgent, testing will continue to be referred to the Cape Breton Regional Hospital in Sydney.
All urgent testing required to support onsite clinical services will still be performed at the Victoria County hospital and right now there are no plans to change it.
“It’s really about improving the sustainability and ensuring that into the future that testing needs for the community are provided and for patients that they have access to blood collection services,” said Thompson.
“We’ll ensure that tests are available onsite that need to remain onsite.”
Canadian AMR report urges action, federal leadership
The Canadian parliament has issued a new report that calls on the country's public health agency to speed up development of a plan to address antimicrobial resistance (AMR) and urges more federal leadership and coordination on the issue.
The report from the House of Commons Standing Committee on Health comes after 2 years of study, during which members of the committee heard from government officials, academics, international organizations, and various stakeholders in both human and animal health. It summarizes the scope of the issue in Canada and the challenges the country faces in addressing AMR, and makes recommendations to address those challenges.
"The committee agrees that Canada has made significant efforts to tackle AMR," committee chair Bill Casey writes. "At the same time, the committee stresses that more needs to be done, particularly with respect to federal leadership and coordination and investment in research and innovation."
The recommendations are geared toward the Pan-Canadian Framework for Action, a strategic plan released in 2017 that is intended to serve as a guide for coordinated efforts by the government and human and animal health and agriculture sectors to address AMR. The four main focus areas of the framework are surveillance, infection prevention and control, stewardship, and research and innovation.
Point-of-Care
Point-of-care C-reactive protein testing in community pharmacy to deliver appropriate interventions in respiratory tract infections
Introduction: This pilot study sought to evaluate the potential use of point-of-care (POC) C-reactive protein (CRP) testing for respiratory tract infections (RTIs) in a rural community pharmacy in North Staffordshire, UK, in conjunction with local GP practices. The study was performed between February and August 2017.
Methods: A total of 52 patients were entered into the study. Overall, 25 patients were referred via GP surgeries, 6 by pharmacy staff and 21 self-referred as a result of a consumer awareness campaign. Patients were asked questions by the community pharmacist to establish if a POC CRP test was required or whether referral to another healthcare professional was suitable. In total, 44 patients were determined to be suitable for POC CRP testing. All patients were followed up at three and seven days by the community pharmacist by telephone to assess their course of action following the pharmacist intervention and their satisfaction with the process.
Results: Following the POC CRP test, 6 patients were referred to the GP surgery, 5 were allocated to the ‘watch and wait’ category and 33 were recommended self-care. Of the ‘watch and wait’ and self-care patients (n=38), none of them required subsequent GP referral. Overall, 95% of patients who received the POC CRP test reported that they would have otherwise visited the GP and would have expected to be prescribed antibiotics.
Discussion: Although participant numbers were small, owing to seasonality, this study indicates that community pharmacies and GP surgeries can deliver an effective service together with a high degree of patient satisfaction.
Conclusion: The use of POC CRP testing in community pharmacies has the potential to reduce the number of GP appointments caused by RTIs and, therefore, may help reduce unnecessary antibiotic prescribing.
Transfusion Medicine
UK scientists have managed to edit a blood transfusion
Biologists from Bristol University are one step closer to editing blood for patients with rare blood groups. Researchers have introduced a technology that helps to produce blood cells for transfusion to those patients for whom there was no donor, says Science Alert.
Research Ashley Toya and his colleagues from the University of Bristol in the UK showed that with the help of technology CRISPR can be removed from the cells genes of rare blood groups. The new mechanism has the same function as “find and replace”: the enzyme Cas9 cuts the DNA in the place chosen for the sample. Then specific genes that can cause immune reactions, are removed. It has the potential to help patients with these congenital diseases like thalassemia and sickle cell anemia.
Scientists are still far from growing blood cells in the lab in large enough quantities to use them for blood transfusions. However, once technical obstacles are overcome, the first recipients of such cells are likely to be patients who find it difficult or impossible to find a donor. A new study shows that it is now possible to adapt the antigenic profile of the cell lines of blood to the needs of these patients.
Microbiology
‘Ultrasensitive’ C. difficile assay outperforms current testing options
Singulex’s Clarity C. diff toxins A/B assay could potentially be used as a standalone test for patients with Clostridium difficile infection, according to findings presented at the European Congress of Clinical Microbiology and Infectious Diseases.
As previously reported in pilot studies, when used in conjunction with the Singulex Clarity system, the Singulex assay can detect toxins rapidly and at 100 times lower concentrations than current immunoassays.
In a more recent analysis, Niaz Banaei, MD, associate professor in the department of pathology at Stanford University School of Medicine, and colleagues evaluated the performance of the test on stool samples from 311 patients with potential C. difficile infection (CDI). All samples had been previously tested by PCR (Xpert C. difficile, Cepheid). PCR-positive samples (n = 211) were tested again for free toxins with a rapid membrane enzyme immunoassay, or EIA (C. diff Quik Chek Complete, Techlab). EIA-negative samples (n = 110) were further tested with a cell cytotoxity neutralization assay (CCNA). Of the 110 EIA-negative samples, 31 were found to be positive with CCNA and 79 were negative, according to the study. Samples were considered CDI-negative if PCR was negative, and samples that were positive with EIA or CCNA were considered true-toxin positive.
The stool samples were then tested with the Singulex assay to compare its sensitivity and specificity against current testing options. Of the 132 samples that were positive with PCR, EIA and CCNA, 129 were found to be positive by the Singulex assay, and all PCR-negative samples were similarly found to be negative with the Singulex assay, resulting in 97.7% sensitivity and 100% specificity. The assay also detected toxins in 23% of samples that were positive with PCR but negative with EIA and CCNA. Altogether, the Singulex Clarity C. diff toxin A/B assay may lead to a more precise selection of patients who need treatment, according to the study results.
Medical Laboratory Education
DynaLIFE creates new Student Bursaries for NAIT's Medical Laboratory Technology and Medical Laboratory Assisting programs
DynaLIFE Medical Labs is proud to announce the creation of two Student Bursaries which will provide two deserving students the funding to help pay for their tuition fees to attend NAIT's Medical Laboratory Technology (MLT) and Medical Laboratory Assisting (MLA) Programs . The Bursaries are available to first and second year NAIT Medical Laboratory Students, Grade 12 Students and Adult Learners in good educational standing who will be enrolled in the MLT or MLA Programs within the next calendar year. The Bursary for Medical Laboratory Technology was named in honour of retired DynaLIFE employee Roxanne Bunyan who inspired DynaLIFE employees with her strong leadership skills. The Bursary for the Medical Laboratory Assisting Program was named in honour of Jeanne Irwin who was a strong advocate for Medical Laboratory Assistants during her tenure at DynaLIFE.
Research
Canadian researchers create tiny 'lab on a chip' to test for infectious diseases
Canadian researchers have created a tiny, portable device they say can do the same work as a larger blood testing lab, in a fraction of the time and cost.
Their newly developed “lab on chip” device can quickly perform blood tests and determine whether people living in areas without access to standard laboratories are at risk for measles and rubella.
The University of Toronto researchers have cheekily named their device “Mr. Box,” or MR (measles, rubella) Box. They say it can do on-the-spot tests to check whether people have developed antibodies against measles and rubella -- two diseases that kill or injure hundreds of thousands in developing countries every year.
The device relies on a technology called digital microfluidics. A pinprick drop of blood is placed onto a specially created microchip and then placed into the device, which then moves the blood drop around the chip using electrostatic pulses. As the blood drop moves, the device looks for the presence of antibodies to measles or rubella, which would indicate whether a person has developed an immunity to the disease, either through previous infection or vaccination.
The researchers recently published test results of Mr. Box in the journal Science Translational Medicine and report that the device is not only simple and inexpensive, it offers results much faster than a traditional lab.
The team tested the device by travelling to the Kakuma refugee camp in northwestern Kenya, which had recently undergone a measles and rubella immunization campaign. They tested small blood samples from children and adults to see whether they had developed immunity, and then sent the samples to Kenya’s national laboratory in Nairobi to compare the results. The low-cost device matched the international laboratory-standard reference tests of the Kenyan Medical Research Institute.
“It was 86 per cent for measles and 84 per cent for rubella…these patients wouldn’t even have those results, because they are in a refugee camp,” said Julian Lamanna, a PhD candidate in chemistry who was part of the research team.
The accuracy of the device will continue to improve which could allow quick blood tests to be performed in the field, say researchers.
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