Home >> Tag Archives: Screening tests (See also Prenatal screening

Tag Archives: Screening tests (See also Prenatal screening

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.

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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.

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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.

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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.

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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.

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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.

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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.”

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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.

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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).

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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).

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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.

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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.

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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.

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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.”

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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.

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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.

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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.  

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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?

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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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.”

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