January 2024—Thrombophilia testing has been shown to be performed far more often than indicated in thromboembolic events, at significant cost to the patient and hospital.
Read More »Panelists on viscoelastic and other coag assays
January 2024—Viscoelastic assays and other coagulation tests were front and center when CAP TODAY publisher Bob McGonnagle on Nov. 20 convened seven people in an online roundtable. Oksana Volod, MD, and Eric Salazar, MD, PhD, and five company representatives weighed in on, among other things, appropriate test use, automation, and laboratory-developed tests. What they said begins here.
Read More »New guidance on lab analysis in diabetes
December 2023—The third and latest edition of recommendations for laboratory analysis in diagnosing and managing diabetes mellitus, released this summer, provide guidance on, among other things, ketone testing, glycolysis, and point-of-care testing. The last such recommendations were published in 2011.
Read More »Tests for paraneoplastic syndromes in neurology
September 2023—Laboratory testing for paraneoplastic neurologic syndromes is neither commonplace nor cheap. It also comes with its own enigmatical math, as Michael Levy, MD, PhD, recently experienced. As the director of the Neuroimmunology Clinic and Research Laboratory in Massachusetts General Hospital’s Department of Neurology, Dr. Levy keeps an eye on PNS laboratory testing (which is performed at Mayo Clinic) at his institution.
Alzheimer’s biomarkers: CSF reports, plasma prospects
May 2023—For fluid biomarkers in the diagnosis of Alzheimer’s disease, the pace of research and related industry and regulatory developments in the past year has been brisk.
Read More »Putting in place a molecular panel for pneumonia
March 2023—When it comes to molecular syndromic panels for pneumonia, there’s both upside and downside, says Neil W. Anderson, MD, D(ABMM), associate professor, Department of Pathology and Laboratory Medicine, Washington University School of Medicine in St. Louis.
Read More »Ins and outs of von Willebrand factor activity assays
January 2023—Guidelines for the diagnosis of von Willebrand disease, published in 2021, have raised questions about which von Willebrand factor activity assay laboratories should use.
Read More »For blood cultures, a lab’s new system and incubation time
January 2023—For the central microbiology laboratory serving Barnes-Jewish and four other hospitals in the St. Louis area, validating and implementing a new blood culture system and moving to a shorter incubation time came at a perfect time: right before the pandemic.
Read More »In fee schedule, an increase to pathology clinical labor rates
December 2022—The Centers for Medicare and Medicaid Services published on Nov. 1 its final 2023 Medicare physician fee schedule with payment rates and new policies set to take effect next year.
Read More »In toxicology, unraveling the unexpected positives
December 2022—In toxicology testing, cross-reactive compounds, incomplete medical records, immunoassay performance, calibrator drift, and human error all play into unexpected positives.
Read More »Is apolipoprotein B the best measure of CVD risk?
November 2022—The evidence in favor of measuring apolipoprotein B routinely, with other lipid parameters, is now so overwhelming, says cardiologist Allan Sniderman, MD, that he believes it’s unreasonable to deny patients the advantage of apoB. “If evidence is what counts,” he says, “then the care Americans receive should include apoB.”
Read More »In toxicology, puzzling out the unexpected negative
November 2022—In cases of unexpected negative results in toxicology testing, avoid overinterpretation, know your assays and providers, and don’t put off definitive testing when it’s needed, though it’s not a panacea.
Read More »The who, what, and when of respiratory virus testing
November 2022—In mid-October, flu was picking up, with high levels of activity in Texas, Georgia, the District of Columbia, South Carolina, Tennessee, and New York. Elsewhere, it was still on the lower side, with less known about what was to come but plans in place. And questions, too, about laboratory testing as it relates to SARS-CoV-2, “which is going to be a challenge,” says David Peaper, MD, PhD, D(ABMM), a member of the CAP Microbiology Committee.
Read More »Highs, lows of tumor mutation burden testing
September 2022—It may not be the oldest story in the world, but in clinical laboratories it’s an oft-told tale: Tumor meets biomarker; drug meets companion diagnostic; both meet FDA approval; clinicians meet with patients offering new hope—and those in the lab are left trying to figure out how to make it all work. That story is playing out again in the realm of measuring tumor mutational burden. In mid-2020 the FDA approved pembrolizumab as a new treatment option in adult and pediatric patients with TMB-high (≥10 mutations/megabase) solid tumors, as determined by the FDA-approved FoundationOne CDx assay. “That doesn’t sound too controversial, right?” says Alain Borczuk, MD, vice chair of anatomic pathology and director of oncologic pathology, Northwell Health Cancer Institute. “It’s not the only way in, but it’s one of the ways in. If you’re arguing for your patient that this is the biomarker that makes them eligible for the drug, then the next questions will be, What was the number? And what was the test?” And it’s off to the races.
Read More »New data on rapid rule-out using high-sensitivity cTnT
September 2022—A single high-sensitivity cardiac troponin T measurement below the limit of quantitation of 6 ng/L is a safe and rapid method to identify a substantial number of patients at low risk for acute myocardial injury and infarction, say the authors of a recently published study.
Read More »A practical approach to borderline melanocytic neoplasms
August 2022—In cases of borderline melanocytic neoplasms, which have overlapping histopathologic features of benign and melanocytic lesions, additional immunohistochemical studies sometimes help to differentiate the two. But a subset of lesions will show overlapping features.
Read More »Emergency department tests HIV screening strategy
July 2022—Thanks to more than two years’ experience with SARS-CoV-2, perhaps at no point in U.S. history has the general public been as aware of antigen and PCR testing, and the difference between them, as it is now.
Read More »Breast cancer breakthrough sparks HER2 quest
June 2022—The latest advance in breast cancer treatment is a big one—the promising antibody drug conjugate fam-trastuzumab deruxtecan-nxki, or T-DXd (Enhertu). The drug was granted breakthrough therapy designation this spring for patients with HER2-low metastatic breast cancer, and the drug and trial on which the decision was based were the focus of the plenary session at the ASCO annual meeting in early June. “This drug in particular is a variant of a drug we are all very familiar with—Herceptin, or trastuzumab,” says David Rimm, MD, PhD, the Anthony N. Brady professor of pathology, professor of medicine (oncology), director of the translational pathology and Yale pathology tissue services, and director of the physician scientist training program in pathology, Department of Pathology, Yale University School of Medicine. Also familiar: the IHC test to determine eligibility for the drug, a companion diagnostic developed decades ago. But that’s where easy familiarity ends.
Read More »Fluid cytology—key features and ancillary testing
June 2022—What to look for in serous fluid cytology is what Eva M. Wojcik, MD, of Loyola University in Chicago, and Xiaoyin “Sara” Jiang, MD, of Duke Health, set forth in their CAP21 session last year.
Read More »Integrating NGS into the cytopenia workup
May 2022—Myelodysplastic syndromes are often challenging to diagnose, and it’s the exceptions to the rules that make it so, said Phillipp W. Raess, MD, PhD, associate professor of pathology and laboratory medicine, Oregon Health and Science University, speaking at CAP21.
Read More »Liver pathology: autoimmune hepatitis, PBC, or overlap?
April 2022—Don’t be afraid of livers. Maryam K. Pezhouh, MD, offered that advice in a CAP21 presentation on autoimmune hepatitis, primary biliary cholangitis, and overlap syndrome, part of a session on common queries in liver pathology. “You don’t need to know everything when you’re looking at the liver,” said Dr. Pezhouh, associate clinical professor of pathology at the University of California, San Diego. “But you need to know what your clinician and your patient are asking.”
Read More »The impact of diagnostics on antimicrobial decisions
April 2022—A study published last fall examined antimicrobial prescribing in gram-negative bloodstream infections based on three rapid diagnostic panels and using what’s known as the DOOR-MAT framework. The study’s findings were explained in a CAP TODAY webinar on stewardship interventions to optimize the management of gram-negative bacteremia. It was presented last December and made possible by a special educational grant from BioFire.
Next-level testing for allergy, autoimmune disease
March 2022—Recent years have seen new releases in allergy and autoimmune disease testing that move the fields forward. “On average we’re looking at six to 10 years of a patient going through the process of seeing specialist after specialist and finally reaching a diagnosis,” Veena Joy, MSc, PhD.
Read More »After the switch: high-sensitivity troponin
February 2022—Like growing old gracefully, moving to high-sensitivity cardiac troponin is both easier and more complex than it often appears. Stacy Beal, MD, thought clinical colleagues might be intimidated by switching assays. Dr. Beal was fully prepared to field worries about increased admissions, more consults, and other disaster scenarios. Instead, what surprised Dr. Beal, a member of the CAP Quality Practices Committee, was the ease with which some thought change could occur. “We heard people saying, ‘Just move the decimal point over two spots,’” she recalls. “I think we started hearing that from the day we started talking about it.” Could simply moving the decimal work? As Dr. Beal notes, “It’s hard to argue with that method, but we truly tried to tell them not to—that they needed to interpret this in a totally different way, and to view the different units as a new assay that’s very different from our previous assay.” “Maybe it’s our own fault,” Dr. Beal concedes. When the lab presented its correlation data, the new units were presented on one axis, while the old ones appeared on another.
Read More »Why yearly TB testing of health care workers is a waste
January 2022—The United States and the rest of the world can expect to see an uptick in active tuberculosis cases brought about by impaired access to care and delays in diagnosis and treatment during the pandemic, says Wendy Thanassi, MD, MA.
Read More »Parsing the role of race in Alzheimer’s biomarkers
October 2021—It’s not quite six degrees of Kevin Bacon, but the connection between Alzheimer’s disease biomarkers and equity in medicine is real (and far more important). It’s a trail researchers have been following for some time, but which has gained more prominence with the recent approval of a new drug for treating the disease (aducanumab) and the acknowledgment of racial disparities in CSF amyloid and tau biomarkers and their associated cutoffs.
Read More »Metagenomic NGS: More pros than cons?
September 2021—A stem cell transplant patient at Lurie Children’s Hospital in Chicago had a disseminated fungal infection by every clinical criterion, but no conventional method had detected it.
Read More »CSF biomarkers in ‘a new era’ for Alzheimer’s
August 2021—The FDA’s approval in June of a new drug to treat Alzheimer’s disease has incited motley responses, a sort of Grand Tour of emotions and reactions. As with any stormy action, the aftermath becomes clear only over time, during the hard work of cleaning up. What comes next?
Read More »Testing for platelet function using whole blood
August 2021—Platelet function testing using platelet-rich plasma is the gold standard, but whole blood platelet aggregation has its advantages, with less risk for preanalytic error among them.
Read More »Coag issues occupy COVID’s central stage
July 2021—The pandemic’s reach has often been portrayed in shades of red, signaling surging COVID-19 cases across states and countries. Vaccination maps, on the other hand, tend to render progress in more soothing tones, typically in the green family. But in coagulation laboratories, one small portent is colored blue—specifically, blue-top sodium citrate tubes. In recent months, laboratories began voicing concerns about tightening supplies. They’ve spoken with their vendors; some have reached out to new ones. And though no one wants to think about limiting testing if supplies truly become scarce, it wouldn’t be the first time labs have had to steer through these waters. The tubes are a functional symbol of the continued complexities of COVID-19-related coagulopathy, as physicians try to understand and respond to the pathophysiology of infection that leads to a thrombotic event. As the pandemic has churned on, much has started coming into sharper focus. Prepublication persists, but physicians have begun to sort through the past 18 months and, as many have put it, to “do the science.”
Read More »A few years in, a new picture for liquid biopsy
July 2021—Liquid biopsy has entered a more confident era, with two FDA-approved next-generation sequencing assays for comprehensive tumor mutation profiling, evidence of its clinical utility, and broadened patient access.
Read More »Testing for platelet function using platelet-rich plasma
July 2021—Identifying severe disorders of primary hemostasis is relatively straightforward for most coagulation laboratories, but the more prevalent disorders with less severe bleeding and less overt diagnostic abnormalities are trickier, and platelet function testing using platelet-rich plasma remains the gold standard. Geoffrey Wool, MD, PhD, in an AACC virtual session last year, presented some of his laboratory’s cases to illustrate the use of light transmission aggregometry and a modification called lumi-aggregation.
Read More »Higher stakes in systemic mastocytosis
June 2021—Mastocytosis is not for quitters. Not at any point, from considering the possible diagnosis, to doing a complement of stains, to looking for mutations beyond KIT D816V, to being curious about the presence of mast cells even after making a diagnosis of another myeloid disease. Patients have already learned this grueling lesson. They can easily spend years seeking answers before their disease is properly identified. Pathologists can speed up that process—and the time to do so is now, says Tracy George, MD, chief medical officer and incoming president of ARUP Laboratories, and medical director of hematopathology. Notes Dr. George: “There’s some exciting stuff going on with systemic mastocytosis.” New targeted KIT inhibitors appear to be quite effective, including at least one agent for advanced systemic mastocytosis that has been submitted to the Food and Drug Administration. “We anticipate there’s going to be approval by the FDA this summer,” says Dr. George, who’s been involved in the clinical trials for avapritinib (Blueprint Medicines).
Read More »1- or 2-step: Outcomes studied in GDM screening
June 2021—If screening for gestational diabetes mellitus were a dance competition, it might have a contest between quickstep and paso doble as its signature event. That tournament could pit the one-step testing protocol (twice as likely to diagnose GDM) against the two-step testing protocol (significantly easier for pregnant women to adhere to).
Read More »Puzzling out platelet function disorders
June 2021—In an AACC virtual session last December, Catherine P. M. Hayward, MD, PhD, of McMaster University, set out the stepwise approach to testing for platelet function disorders, explained the methods used to assess platelet aggregation response, and reported what most clinical labs do.
Read More »ED, lab views on point-of-care cardiac troponin
June 2021—Point-of-care cardiac troponin testing got a fresh look last December when an emergency medicine physician and a clinical chemist came together to talk about the use of both conventional POC troponin assays in a high-sensitivity era and high-sensitivity POC troponin testing when it becomes available.
Read More »B- and T-cell neoplasm features and fine points
June 2021—A case of monoclonal B-cell lymphocytosis and a tour of B- and T-cell morphologies were at the heart of a CAP20 virtual presentation on neoplastic lymphocytosis. Kyle Bradley, MD, associate professor of hematopathology and director of surgical pathology at Emory University, spoke last fall on reactive (CAP TODAY, May 2021) and neoplastic lymphocytosis, with Olga Pozdnyakova, MD, PhD, who addressed neutrophilia and monocytosis (CAP TODAY, February and March 2021). Together they took attendees through a morphology-based approach to hematopoietic neoplasms presenting with an abnormal WBC differential.
Read More »A transparent lens on estimated GFR
May 2021—Forget about who’s buried in Grant’s Tomb (though for the record it’s Grant, his wife, and their dog). For laboratories, the deceptively simple question now under scrutiny is, What is estimated GFR? It is indeed an estimate, for starters—an approximation of glomerular filtration rate, which in turn is a physiological parameter that’s actually difficult to measure, says Greg Miller, PhD. Even so-called measured GFR values are not very precise in individual patients. It’s been carried along by several equations over the decades: Cockcroft-Gault, MDRD, and CKD-EPI, all of which (to the consternation of some) are still in use. It guides clinical care, including referrals to specialists and placement on kidney transplant lists, as well as dosing of medications such as metformin. Some call it a workhorse. But estimated GFR (eGFR) has also long been saddled with a race-based component, a coefficient that adjusts for better kidney function for Black patients compared with other patients.
Read More »Problems, solutions at core of UTI, C. diff modules
April 2021—Urinary tract infections and Clostridioides (Clostridium) difficile testing are the topics of two of the modules released recently in the CAP Test Ordering Program. The Laboratory Workup for Urinary Tract Infections module became available online in January, and C. difficile Testing in October 2020 (www.cap.org/member-resources/test-ordering-program). The program is free to CAP members.
Read More »In SARS-CoV-2, small steps but big wins
December 2020—By its very nature, the global pandemic has forced laboratories to look far and wide, to bring binoculars, in essence, to their views of supply chains, testing platforms, personnel, and the like. As COVID-19 churns on, some labs are looking through a tinier lens as well. These labs aren’t trading their binoculars for a jeweler’s loupe, exactly, but they have found small and significant success stories closer to home. Like so many others, Erin Graf, PhD, D(ABMM), has confronted a spinning roulette wheel since the pandemic’s start. In a talk she gave in an AMP webinar in October, Dr. Graf posted a vibrantly colored wheel titled, “Which supply chain issue will impact us this week?” Each segment contained a phrase familiar to everyone in 2020, ranging from “swabs” and “sheep blood agar” to “pipette tips” and “chlamydia and gonorrhea tests.” As she surveys these continuous claims on her attention, Dr. Graf says, “I think none of us could have ever thought that COVID would have an impact on all these arms of the testing that we do.”
Read More »Journeys to alternative SARS-CoV-2 strategies
December 2020—In Colorado, Joan Coleman, MBA, MT(ASCP), and her UCHealth colleagues launched an expansive pooled testing program this summer that, after much work, worked well—until it didn’t, thanks to rising positivity rates in October.
Read More »Making peace with saliva, pooled testing
November 2020—Adam Barker, PhD, D(ABMM), was ready to call it quits. For weeks, he had been working to bring saliva-based SARS-CoV-2 testing to ARUP Laboratories and the University of Utah. Dr. Barker, director of ARUP’s COVID-19 rapid response lab, and his colleagues had done studies comparing saliva with nasopharyngeal swabs, which seemed to be following the flight of the passenger pigeon out of existence. They had wrestled with the FDA over emergency use authorization. They’d developed their own transport media, since that supply was also becoming extinct. He had begun building kits for saliva collection and figured out what sample size worked best. Kits had been delivered to collection sites on campus, and staff were being trained in their use. He was, in other words, creating a laboratory success story, one of the many that have been written since March. He was not basking in this fact. “I have to tell you: I lost so much sleep because of saliva,” says Dr. Barker, who is also director, ARUP Institute for Clinical and Experimental Pathology.
Read More »Fewer urine cultures — series of changes add up
November 2020—Five years after putting in place a urine reflex algorithm at Barnes-Jewish Hospital in St. Louis, and many tweaks later, Melanie Yarbrough, PhD, D(ABMM), D(ABCC), has tips to share on how to increase the odds for success in reducing the number of urine cultures.
Read More »At POC and in lab, 2 new checks on SARS-CoV-2 testing
November 2020—The CAP released in September its proficiency testing program for SARS-CoV-2 antigen testing, with the first shipment to laboratories set for Nov. 30. It also introduced recently a Quality Cross Check program that makes it possible for labs performing nucleic acid amplification testing for SARS-CoV-2 to monitor performance across multiple instruments, in compliance with the CMS directive prohibiting proficiency testing on multiple instruments.
Read More »Compass on COVID: What test for whom and when—lab leaders talk
November 2020—Testing saliva, stocking up, and expanding capacity were top of mind when members of the Compass Group convened by Zoom on Sept. 1 for a second COVID-19-related call with CAP TODAY publisher Bob McGonnagle. Antigen testing, too, came up, and the question to answer there, said Susan Fuhrman, MD, of OhioHealth, is why the test is performed and what will be done with the result. That and more—testing for patients undergoing treatment for cancer, flu season—were up for discussion. Others on the call were Greg Sossaman, MD, of Ochsner; Lauren Anthony, MD, and Heather Dawson of Allina; Sarah Province and Julie Hess of AdventHealth; James Crawford, MD, PhD, of Northwell; Stan Schofield and Robert Carlson, MD, of MaineHealth; Sterling Bennett, MD, MS, of Intermountain; John Carey, MD, of Henry Ford; and Pamela Murphy, PhD, APRN, of MUSC Health. The Compass Group is an organization of not-for-profit IDN system lab leaders who collaborate to identify and share best practices and strategies. (For our coverage of their first call with CAP TODAY, see “Compass points chart the pandemic,” September 2020.) Here is what they told us on Sept. 1.
Read More »Flu mounts COVID’s bustling stage
October 2020—Barely a half year into the pandemic’s presence in the United States, history has already begun pressing down on SARS-CoV-2 testing. Like an actor playing Hamlet, it’s been difficult not to feel the burden of past performances when preparing for the months ahead. Now, at the start of fall, that also means readying for the return of influenza. Here, even longer experience has shown that each new season is, indeed, a new season. As in the theater world itself these days, planning for what lies ahead feels tempest-tossed. Plans are being laid. Discussions continue. Creativity abounds, and hard work persists. The season shall unfold. But no one knows how it will look until the curtain—or whatever is passing for one this year—goes up. Poor Hamlet is troubled enough to fill the stage for hours—it is, in fact, Shakespeare’s longest play. Yet he’s just one man. Laboratories this fall are absorbing the slings and arrows of two roles simultaneously. Can they prepare for both parts (think Richard II and III sparring on the same stage) with confidence?
Read More »To fast or not to fast? Fat is the question
October 2020—For nearly five decades, clinicians and laboratories aiming to screen LDL cholesterol (LDL-C) in adults to assess cardiovascular disease risk have contended with a problem generally beyond their control: lack of assurance that patients told to fast before a blood specimen is collected for lipid testing have indeed fasted.
Read More »Uncharted season forges new paths for all hands
October 2020—Planning for respiratory season is always tricky but never more so than this year. “Uncharted territory for influenza” is how Frederick Nolte, PhD, D(ABMM), of the Medical University of South Carolina, describes the prospect of testing for influenza at the scale labs have been testing for SARS-CoV-2.
Read More »Compass points chart the pandemic
September 2020—Between a rock and a hard place. Trying to stay ahead, trying to build inventory. Chasing multiple new testing requests. Anticipating influenza. That’s where laboratory leaders said their labs were in early August when CAP TODAY publisher Bob McGonnagle convened members of the Compass Group on Zoom to share their pandemic experiences. They shared surprise, too, that the situation is what it is: “Not a clue in my mind that this would go past the springtime,” said Stan Schofield, president of NorDx and senior VP, MaineHealth. McGonnagle asked them about the diversion of supplies, the coming flu season, IT support, lessons and long-term changes, and more.
See current issue below for additional COVID-19 coverage or access all COVID-19 articles here.
Oh, the places you’ll go when flu season hits
September 2020—The twinned challenge of testing for SARS-CoV-2 and the upcoming influenza season has a bit of The Cat in the Hat energy running through it. How does one manage to keep Thing One and Thing Two from creating unmitigated chaos? Maybe one doesn’t, not completely. A pandemic-based flu season will by its very nature be protean.
Read More »The laboratory tests of pandemic summer
August 2020—In March, the COVID-19 pandemic came in like a lion—and has yet to leave, like a lamb or anything else. Instead, it roared through April and May in early hot spots like New York City and New Orleans. As lockdowns took hold, the cautious hope was that by summer the virus would be tamed (if not simply go away “like a miracle” or “as the heat comes in,” per several infamous predictions), giving health care providers a chance to exhale before a likely second wave in the fall. Instead, June and July saw other cities and states hit hard in turn, while many places that appeared to have flattened the curve were starting to see concerning upticks in cases.
Read More »Targeting microbiology lab efficiency with AI
August 2020—Bringing an automated culture plate reading system into the Hennepin County Medical Center microbiology laboratory was never a question of if but when. “We need artificial intelligence to help us with active decision-making processes in the lab,” says Glen Hansen, PhD.
Read More »Lab with Ebola experience: COVID more complicated
August 2020—If there’s one thing scarier to experience than COVID-19, it’s Ebola. Or so you might think. “Ebola was easier,” says Beverly Dickson, MD, medical director of the clinical laboratory at Texas Health Presbyterian Hospital Dallas.
Read More »Steps to verifying SARS-CoV-2 antibody assays and what’s known about protective immunity
August 2020—The CAP treats emergency use authorization assays similar to FDA-cleared assays and thus requires full verification. In a June 4 CAP webinar, Neil Anderson, MD, D(ABMM), assistant director of clinical microbiology, Washington University School of Medicine in St. Louis, walked through how to approach verification for SARS-CoV-2 assays. Co-presenter Elitza Theel, PhD, D(ABMM), director of the infectious diseases serology laboratory at Mayo Clinic, reported what’s known about protective immunity against SARS-CoV-2.
Read More »At the pandemic’s serologic frontier
June 2020—The arrival of a pandemic has shown—among many, many other things—that anyone who talks about it typically starts by saying, “This is a pandemic.” The next sentence tends to be, “It’s a completely different situation,” whether the focus is grocery shopping, exercising (or not), voting, or practicing medicine. Pointing to the pandemic is a polite way of saying, “All bets are off.” For many, it’s been a springboard to innovation and breakthroughs, even in the midst of considerable anguish. For clinical laboratories, however, much has felt unsettling, especially when the conversation turns to serology testing for SARS-CoV-2. It’s a topic stuffed to overflowing with interest, enthusiasm—and, early on, antibody tests themselves.
Read More »Published in July: Reading COVID-19’s signature: lung tissue injury Alain Charles Borczuk, MD, began his practice of pathology as a resident 28 years ago and has spent quite a bit of his career doing autopsies. But it is this year, during the pandemic, that he’s finding some of the best applications of his autopsy work as he seeks to understand the lung injury patterns in SARS CoV-2, or COVID-19 patients. Read more.
Read More »Biomarker screen makes case for MODY genetic testing
February 2020—Cost-effectiveness analysis of health care diagnosis and treatment, unfortunately connoting quotas and spartan budgets, may not have the best reputation among the general public.
Read More »D-dimer trifecta: clarity on units, values, and use
January 2020—D-dimer has a problem. Several problems, in fact. Many, some might say. Let’s start with the basics regarding D-dimer assays: unit and magnitude. Setting up the equation is easy, and the digits are small: 2 × 4. When applied to D-dimer testing, however, the answer often means far-flung problems for laboratories and clinicians. Parsed out (for fans of James Thurber, this means channeling schoolmarm Miss Groby), D-dimer has two different units of measure. Some assays report fibrinogen equivalent units (FEU), and others measure D-dimer units (DDU).
Read More »No-blot testing charts new course for Lyme Dx
January 2020—“You can eliminate blots altogether!” may sound like a pitch for a cleaning product. But it’s a line from a webpage of Zeus Scientific touting the new algorithm for Lyme disease testing that ditches Western immunoblot in favor of a two-enzyme immunoassay test sequence. The new algorithm, which the CDC recommended last year, is the first approved alternative to the standard algorithm in 25 years.
Read More »For gestational diabetes, one step or two?
December 2019—The controversy surrounding the approved methods for screening gestational diabetes mellitus took the form of a debate at this year’s AACC annual meeting, with two speakers defending the one-step or two-step method.
Read More »Diagnosing GDM in the first trimester
December 2019—“If you thought that diagnosing gestational diabetes at 24 to 28 weeks was unsettled, you haven’t seen anything yet.” That was David B. Sacks, MB, ChB, of the National Institutes of Health, speaking this year in the AACC session on gestational diabetes mellitus (GDM) with his co-presenters who debated the use of the one-step and two-step methods for diagnosing GDM in the second and third trimesters (see story, page 1). His talk: “Let’s Not Wait: Diagnosing GDM in the First Trimester.”
Read More »NTRK fusion testing: ups, downs of four methods
November 2019—With two inhibitors approved by the FDA for the treatment of NTRK-fusion-positive solid tumors, the next step is to determine whom to test and how. If the efficacy of the compounds—larotrectinib and entrectinib—were the only thing to consider in implementing a testing algorithm, knowing whom to test would be easy.
Read More »CDC reports on two alternative HIV testing algorithms
August 2019—For HIV testing, a three-step algorithm that differs from the one recommended since 2014 can potentially reduce the number of tests performed and speed up the availability of viral load results, according to a CDC analysis presented at the HIV Diagnostics Conference in March.
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