Oct 14, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Using 3D printing and a chemical heat source, University of Pennsylvania researchers have created a proof-of-concept for an affordable Zika test that returns results in just 40 minutes
There’s a gap in Zika virus testing that researchers at the University of Pennsylvania hope to fill. That gap is a point-of-care test for the Zika virus that can produce a fast and accurate result, whether in developed nations or in developing countries that don’t have many state-of-the art clinical laboratories.
Although numerous Zika virus tests have earned Emergency Use Authorizations from the US Food and Drug Administration (FDA), gold standard detection is still limited to medical laboratories. To date, the FDA’s list of current and terminated Emergency Use Authorizations include no point-of-care options to help medical professionals quickly screen patients for Zika infection.
As noted by the Center for Disease Control and Prevention’s “Interim Guidance for Interpretation of Zika Antibody Test Results,” the antibodies that indicate Zika virus activity also share similarities with other flavivirus viruses. Of particular note is similarities with Dengue virus—a virus prevalent in many of the areas in which Zika is found. (more…)
Aug 26, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
FDA issues press release following clearance of a clinical lab test to detect genetic markers that indicate the presence of Carbapenem-resistant Enterobacteriaceae
Clearance by the US Food and Drug Administration (FDA) of a new rapid, multi-marker genetic test designed to identify bacteria that are resistant to Carbapenem antibiotics was considered significant enough that the federal agency issued a press release announcing that the test was cleared and now available for use by physicians and clinical laboratories in the United States.
In the race to develop molecular assays and genetic tests for infectious disease that deliver improved sensitivity and specificity with a faster time-to-answer, this new test offers all three benefits. Results are available in just 48 minutes, for example.
It was on June 29, 2016, that the FDA cleared Cepheid’s Xpert Carba-R rapid-diagnostic test for marketing in the United States. This is the first clinical laboratory test cleared for market by the FDA that detects healthcare-associated infections (AKA, hospital-acquired infections or HAIs) through the use of genetic markers taken directly from clinical samples. The assay tests for genetic markers that indicate the presence of Carbapenem-resistant Enterobacteriaceae (CRE). (more…)
Aug 15, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
New vaccine has potential to reduce volume of clinical laboratory testing for bacterial and viral infections
By now, nearly all pathologists and clinical laboratory scientists acknowledge that advances in molecular diagnostics and genetic testing are contributing to significant improvements in patient care. Now comes news of a comparable breakthrough in another field of medicine with the potential to protect many individuals from pneumonia and similar infectious diseases.
A new way to develop vaccines made the news recently. Researchers at the University of Buffalo (UB) in New York have found a new way to reduce infections of specific and widespread Streptococcus pneumoniae (pneumococcus) diseases.
This cutting-edge pneumococcal vaccine allows Streptococcus pneumoniae to colonize and live inside the body as long as there is no risk to the host. When a threat is detected, the vaccine establishes an immune system response to annihilate the disease-causing bacteria. (more…)
Jun 29, 2016 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
An earlier Johns Hopkins study looked at diagnostic errors and determined that such errors were the leading cause of malpractice payouts. Can clinical laboratories help?
At a time of heightened transparency in healthcare outcomes, a Johns Hopkins University School of Medicine (Johns Hopkins) study makes a startling conclusion: medical errors are an under-recognized cause of patients’ deaths in the United States. In fact, medical errors rank third—after heart disease and cancer—in causing patients’ deaths, according to a Johns Hopkins statement.
This finding has many implications for pathologists and clinical laboratory managers. Often, medical errors are associated with the failure of physicians to order correct medical laboratory tests at critical junctures. Alternatively, a medical error can result if the physician fails to take appropriate action after getting an accurate lab test result. Thus, any effort within the health system to reduce medical errors will probably bring pathologists and medical laboratory scientists into closer consultation with clinicians.
What the researchers at Johns Hopkins also learned during their study is that medical error is not reported as a cause of death on death certificates. Further, the Centers for Disease Control and Prevention (CDC) has no “medical error” category in its annual report on deaths and mortality, The New York Times (NYT) reported. (more…)
May 9, 2016 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing
Latest calls for easier public access to information on physician performance and quality is a reminder to clinical laboratories and pathology groups of the trend to greater transparency on provider outcomes
If any clinical laboratory executive or pathologist still doubts that more transparency of provider outcomes is a topic of interest to patients, they have only to look at Consumer Reports, well-respected for its advocacy on behalf of consumers. Consumer Reports is using multiple ways to educate their readers about medical errors and how the medical community makes it difficult for consumers to learn about physicians who have been involved in state medical board investigations.
One example is the Consumers Union, which is the policy and advocacy arm of Consumer Reports. Through its Safe Patient Project, the Consumers Union seeks to eliminate medical harm in healthcare.
Consumers Union advocates for increased public disclosure of information about such issues as: (more…)
