Report Discusses POC Testing and Changing Paradigms
|
By LabMedica International staff writers Posted on 20 Jun 2017 |
|
Image: A new report suggests utilization of trained personnel and evaluation of tests will help ensure that best-quality tests are ordered and interpreted correctly to benefit patient care (Photo courtesy of the American Society for Microbiology).
The American Academy of Microbiology has released a new report on the role of the role of point-of-care (POC) and near-patient testing in changing diagnostic paradigms in microbiology.
Technology for diagnosing infectious diseases in patients is rapidly advancing, and new diagnostic tests have the potential to meaningfully improve patient care. Recommendations for the Academy’s report (Changing Diagnostic Paradigms for Microbiology, published May 2017) were based on discussions of a panel of experts. The Academy convened a colloquium October 17-18, 2016, (Washington, DC; USA) to explore the development and implementation of near-patient and POC testing and to provide recommendations for using these tests to improve patient care across clinical settings.
“Rapid diagnostic tests have the potential to deliver timely results, enable treatment decisions by detecting the presence of biomarkers, distinguish between viral and bacterial infections, identify causative organisms, and provide information on drug resistance,” said Melissa Miller, PhD, steering committee chair of the colloquium. The report focuses on the unmet needs for research and development of new diagnostic tests, for ongoing regulatory review of POC tests, and for laboratorian expertise, even in near-patient settings. The participants also discussed the importance of proper interpretation of test results, and linking test results to electronic medical records. They emphasized the need for microbiology experts to guide the development and utilization of tests and ensure proper reporting of results.
“The expertise of clinical microbiologists is essential to maximizing the value and minimizing the risk of POC infectious disease diagnostics, provided that clinical microbiologists adapt their practice to this setting,” said Sheldon Campbell, MD, PhD, Yale School of Medicine, a participant in the colloquium.
The report summarized proper utilization of tests (such as ordering appropriate tests and correctly interpreting results), the need for proper training and education on test usage, and contamination concerns. It also discussed regulation of the tests (reporting issues to FDA, CMS requirements), and the importance of documenting results and reporting to health departments when necessary. For the future, participants agreed that POC tests should be linked to web-based quality and performance matrices that would revolutionize POC testing quality and reach.
A commentary with additional information on advances in diagnostics, Advances Afoot in Microbiology by Mayo Clinic’s Patel R and Karon BS, was published May 24, 2017, in the Journal of Clinical Microbiology.
Technology for diagnosing infectious diseases in patients is rapidly advancing, and new diagnostic tests have the potential to meaningfully improve patient care. Recommendations for the Academy’s report (Changing Diagnostic Paradigms for Microbiology, published May 2017) were based on discussions of a panel of experts. The Academy convened a colloquium October 17-18, 2016, (Washington, DC; USA) to explore the development and implementation of near-patient and POC testing and to provide recommendations for using these tests to improve patient care across clinical settings.
“Rapid diagnostic tests have the potential to deliver timely results, enable treatment decisions by detecting the presence of biomarkers, distinguish between viral and bacterial infections, identify causative organisms, and provide information on drug resistance,” said Melissa Miller, PhD, steering committee chair of the colloquium. The report focuses on the unmet needs for research and development of new diagnostic tests, for ongoing regulatory review of POC tests, and for laboratorian expertise, even in near-patient settings. The participants also discussed the importance of proper interpretation of test results, and linking test results to electronic medical records. They emphasized the need for microbiology experts to guide the development and utilization of tests and ensure proper reporting of results.
“The expertise of clinical microbiologists is essential to maximizing the value and minimizing the risk of POC infectious disease diagnostics, provided that clinical microbiologists adapt their practice to this setting,” said Sheldon Campbell, MD, PhD, Yale School of Medicine, a participant in the colloquium.
The report summarized proper utilization of tests (such as ordering appropriate tests and correctly interpreting results), the need for proper training and education on test usage, and contamination concerns. It also discussed regulation of the tests (reporting issues to FDA, CMS requirements), and the importance of documenting results and reporting to health departments when necessary. For the future, participants agreed that POC tests should be linked to web-based quality and performance matrices that would revolutionize POC testing quality and reach.
A commentary with additional information on advances in diagnostics, Advances Afoot in Microbiology by Mayo Clinic’s Patel R and Karon BS, was published May 24, 2017, in the Journal of Clinical Microbiology.
Platinum Member
Automated Coagulation Analyzer
Hemolumi H6
Gold Member
Blood-Based Protein Biomarker Solution for Alzheimer's Disease
BG-DTi2000.
New
MR-proADM Test
B•R•A•H•M•S MR-proADM KRYPTOR test
New
Fully Automated Urinalysis System
DxU 1800 Fully Automated Urinalysis System
Latest Microbiology News
- Oral and Lung Microbiome Changes Linked to Severe Long Covid Symptoms
- Study Finds Distinct Malaria Parasites Linked to Sickle Cell Trait Protection
- Rapid Urine Test Aids Diagnosis of Invasive Aspergillosis
- Nanodroplet CRISPR Technology Supports Rapid, Multiplexed Mycobacterial Identification
- Genomic Workflow Identifies Fungal Pathogens Before Blood Cultures Turn Positive
- FDA-Cleared Multiplex PCR Test Detects 13 Respiratory Pathogens in a Single Sample
- One-Hour Molecular Panel Expands Bloodstream Infection Testing for Gram-Negative Pathogens
- FDA Clears Rapid Phenotypic Antimicrobial Susceptibility System for Positive Blood Cultures
- New Urine Test Expands Mycotoxin Analysis to 31 Markers for Broader Exposure Assessment
- Collaboration Targets Blood-Based Ebola Detection Outside Central Laboratories
- Study Finds Frequent Overlap in Antibodies to Lyme and Other Tick-Borne Pathogens
- Early-Life Gut Microbiome Changes May Help Assess Type 1 Diabetes Risk
- FDA Breakthrough-Designated Urine Panel Aims to Shorten Pathogen and Susceptibility Testing
- Expanded Newborn Screening Program Increases Detection of Congenital Cytomegalovirus
- Genetic Studies Uncover Mechanisms Driving Drug Resistance in Superbugs
- Magnetic Nanoparticles Enable More Sensitive Beta-Lactam Allergy Testing
Channels
Clinical Chemistry
view channel
Blood Protein May Help Identify Treatment-Resistant Psychosis
Psychotic disorders, including schizophrenia, are diagnosed primarily through assessment of symptoms and behaviors such as hallucinations, delusions, and disordered thinking. Treatment-resistant psychosis... Read more
Electrochemical Biosensor Rapidly Detects Cerebrospinal Fluid Leaks
Cerebrospinal fluid surrounds the brain and spinal cord and helps protect them from physical impact. After severe head trauma or brain surgery, it can leak through skull defects and drain from the nose or ears.... Read more
Molecular Diagnostics
view channel
Whole Genome Sequencing Solution Targets Unsolved Rare Disease Cases
Rare diseases often present persistent diagnostic challenges for patients and families. Many patients undergo years of testing without receiving a diagnosis, and even comprehensive genetic testing can... Read more
Study Shows How Genome Reference Bias Can Mislead Preventive Testing
Whole-genome sequencing is expected to play a growing role in preventive and predictive medicine, but accurate interpretation remains a major diagnostic challenge. The approach requires comparing billions... Read more
Validated Test Predicts Recurrence Risk and Radiation Benefit in Early-Stage Breast Cancer
For women with early-stage invasive breast cancer who undergo breast-conserving surgery, clinicians must assess both the risk of locoregional recurrence and the potential benefit of adjuvant radiation therapy.... Read more
Hematology
view channel
New Donor Genetic Marker May Help Predict Stem Cell Transplant Success
Donor selection for hematopoietic stem cell transplantation plays a major role in relapse risk and survival for patients with blood cancers and other blood disorders. Despite advances in genotyping, uncertainty... Read more
Updated Ferritin Thresholds Improve Detection of Iron Deficiency
Iron deficiency is one of the most common health conditions worldwide, yet its nonspecific symptoms can delay diagnosis for months. Variation in testing practices and ferritin thresholds may contribute... Read more
Immunology
view channel
FDA Approval Adds Automated Testing Option for Parvovirus B19 Serology
Human Parvovirus B19 is a highly contagious erythrovirus transmitted mainly through respiratory droplets and close contact. Diagnosis relies on IgM antibodies to detect active infection and IgG antibodies... Read more
Blood-Based Immune Aging Map Could Help Spot Disease Risk Earlier
Chronological age does not always reflect immune health or future disease risk. Two adults of the same age can have immune systems that age very differently, with some remaining resilient while others... Read more
Pathology
view channel
AI Histopathology Tool Distinguishes Ewing Sarcoma for Diagnosis
Ewing sarcoma is a rare malignant tumor that mainly affects children, adolescents, and young adults. It usually arises in bone but can also develop in soft tissue, where its microscopic appearance may... Read more
Rapid Mass Spectrometry Test May Aid Glioma Margin Decisions
Glioma brain tumors are highly infiltrative and can extend into nearby healthy brain tissue, making tumor margins difficult to define during surgery. Residual tumor cells may contribute to recurrence and... Read more
Genomic Classifier Predicts Benefit From Adding Hormone Therapy to Salvage Prostate Radiation
Men who have undergone prostatectomy for prostate cancer may later develop a detectable or rising prostate-specific antigen, prompting salvage radiation therapy. A key challenge is determining who is most... Read more
Technology
view channel
Laser-Based Swab Analysis Shows Promise for Detecting Disease-Linked Odor Patterns
Disease-related changes in volatile organic compounds can alter body odor, producing measurable patterns in exhaled breath and bodily fluids. Current analytical methods can be complex, time-consuming,... Read more
Laser-Enhanced Assay Boosts Sensitivity for Colorectal Cancer Biomarker Detection
Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related death worldwide. Early detection remains critical, but cancer biomarkers can produce only faint... Read more
Industry
view channel
Multi-Cancer Screening Blood Test Gains FDA Breakthrough Designation
Natera Inc.’s (Austin, TX, USA) multi-cancer early detection (MCED) assay has received Breakthrough Device designation (BDD) from the U.S. Food and Drug Administration (FDA). The assay analyzes cell-free... Read more
European Approval Expands Liquid Biopsy Use in Advanced Breast Cancer Testing
Estrogen receptor-positive (ER+), HER2-negative advanced breast cancer may require molecular testing to guide treatment selection, with blood-based assays offering a way to identify tumor mutations that... Read more
