Tag Archives: AACC meetings/conferences

October 2023—Orders for cerebrospinal fluid testing for Alzheimer’s disease have grown at Mayo Clinic since spring 2020, when testing was first offered. When aducanumab was approved in May 2021, test orders jumped.

September 2023—For the tickborne and mosquito-borne arboviruses, which are frequently more transient in blood and tissue than other pathogens, both molecular and serologic testing have a place in the diagnostic toolkit.

September 2023—A casual comment made in a routine exchange in an Avera McKennan Hospital laboratory sparked a five-year campaign to bring down the urine culture contamination rate. “I feel like all I do is report contaminated cultures,” a microbiology technologist said in 2016.

June 2023—For HIV and HCV algorithmic testing, the workflow options have risks to consider. Molecular testing performed as an automatic reflex on the same sample used for the serologic testing risks carryover contamination, and requiring a dedicated sample for the molecular assay risks incomplete testing.

June 2023—Transporting specimens to the laboratory, and processing and distributing them within the lab, will be what AACC meeting-goers hear about in a session next month.

May 2023—Of the five methods used to measure HbA1c—immunoassay, boronate affinity, enzymatic, capillary electrophoresis, and ion-exchange HPLC—only the latter two can alert the laboratory and physician to the presence of a suspected hemoglobin variant. Even so, there are reasons to be cautious.

April 2023—Traumatic brain injury triage in the emergency department is badly in need of biomarkers—and ones that can change practice. “If biomarkers don’t change practice, they’re a waste of time,” said W. Frank Peacock IV, MD, professor of emergency medicine, vice chair of research, and research director, Department of Emergency Medicine, Baylor College of Medicine.

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.

February 2023—Traditional algorithm? Or reverse? Elitza Theel, PhD, D(ABMM), of Mayo Clinic, in an AACC session last year walked through the two primary diagnostic algorithms for syphilis, explaining where the complexities lie and how her laboratory uncovered inappropriate testing for neurosyphilis.

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.

December 2022—In toxicology testing, cross-reactive compounds, incomplete medical records, immunoassay performance, calibrator drift, and human error all play into unexpected positives.

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.”

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.

October 2022—William E. Winter, MD, D(ABCC), is blunt about whether to report a corrected sodium: He would worry if his name were on such a report. “I think you have to be careful about formulas,” he said in his “hot topic” talk at the AACC meeting in July.

September 2022—Which biomarker for heart failure should be used—BNP or NT-proBNP—and does it matter? That’s the question Christopher W. Farnsworth, PhD, set out to answer in his “hot topic” talk (one of a trio) at the AACC meeting in July.

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.

June 2022—The effects of acute cannabis on driving performance and how impaired drivers can be detected will be reported at the AACC annual meeting July 24–28. Sessions on serum COVID-19 antibodies and lab workforce solutions are two more of the many that await attendees in Chicago.

May 2022—Studies show promise for new approaches to biomarkers for myocarditis diagnosis, one of which is circulating micro­RNA mmu-miR-721. Another biomarker, sera soluble ST2 (sST2), which has been found to be clinically useful in predicting heart failure, could be added to existing biomarkers used to diagnose patients with myocarditis, interpreted according to sex and age. And serial high-sensitivity troponin measurements might be another approach to diagnosing and monitoring myocarditis.

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.

November 2021—The guidelines for laboratory analysis in the diagnosis and management of diabetes mellitus are being revised and will be released next year. In a virtual session at the AACC meeting in September, laboratorians got a look at some of the recommendations to come.

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.

August 2021—Pharmacogenetic testing is not standard of care at most transplant centers, nor do the FDA or others mandate it. But “transplant medicine is ripe for observing the benefits of pharmacogenetics,” said Gwendolyn A. McMillin, PhD, D(ABCC), in an AACC virtual session last year.

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.

March 2021—Synthetic cannabinoids. Toxic house­hold substances. Over-the-counter medicine. These and other drug and non-drug substances are favored by adolescents and young adults and tough to detect, and the pandemic has exacerbated their use. “Many drugs that are of interest for this age group are household substances, things they can get their hands on easily, and often those tests are not available as immunoassays,” said Sarah E. Wheeler, PhD, medical director of the automated laboratory, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh, and assistant professor of pathology, University of Pittsburgh, in a session on adolescent and young adult substance abuse testing at AACC’s virtual annual meeting last year.

November 2020—Point-of-care testing for sexually transmitted infections, toxicology investigation, and biosafety practices are three of the hundreds of topics that will come online next month during AACC’s virtual annual meeting.

April 2020—Bypassing immunoassays as the first step in toxicology testing can minimize clinician calls to the laboratory about negative toxicology reports for apparently overdosed patients and save diagnostic time. Read more.

March 2020—Standardizing indirect immunofluorescence testing for antinuclear antibodies is a critical task for the laboratory community, and it’s more urgent now that new classification criteria make positive ANA a key factor in diagnosing lupus, said Mark H. Wener, MD, in a session at last year’s American Association for Clinical Chemistry annual meeting.

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.

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.”

November 2019—Current sex-specific intervals can be used to interpret hematology results for transgender people using their affirmed gender, say authors of a study published earlier this year.

October 2019—Chlorinated lipids have been shown to be new potential biomarkers for sepsis, and continuing research into their role could lead to faster diagnosis, said David A. Ford, PhD, of Saint Louis University School of Medicine, at this year’s AACC annual meeting. Dr. Ford, a professor of biochemistry and molecular biology, discovered chlorinated lipids in 2002, and at the AACC meeting he shared recent research on the association between chlorinated lipids and lung injury and death in sepsis patients.

October 2019—How well can analytics predict the risk for sepsis? T. Scott Isbell, PhD, DABCC, director of clinical chemistry and point-of-care testing, SSM Health, Saint Louis University Hospital, at this year’s AACC annual meeting shared his hospital’s experi-ence with Epic’s sepsis predictive tool. Launched in 2017, the tool uses predictive analytics to produce a sepsis score for ad-mitted patients based on regular scans of key data elements in the electronic health record.

February 2019—A forgotten creditor. A poor relation. An envious rival. In the theater, one of these characters often emerges from the woodwork, ready to supply a plot twist just when the protagonist is riding highest.

February 2019—Mass spectrometry has been proved to be an essential and powerful platform for clinical diagnostics. The value it adds to health care has increased steadily in the past decade.

January 2019—Medicare hospital readmission rates are down under the Centers for Medicare and Medicaid Services readmissions reduction program, though hospitals are still paying millions in penalties, in part because new conditions are included in the calculations.

November 2018—Food component testing offers improved specificity for distinguishing IgE sensitized from truly allergic patients, and the menu for allergen components may soon expand.

October 2018—How pregnancy affects normal thyroid function and thyroid function tests, and screening for thyroid disease during pregnancy, were the focus of a session at this year’s AACC annual meeting.

September 2018—Qualitative or quantitative testing. Hydrolyze or don’t hydrolyze. Use or don’t use standard cutoffs. These and other decisions in toxicology testing have taken on new urgency amid the opioid crisis, which is driving laboratories to change test methods to assess prescription drug compliance and illicit drug use.

February 2018—The modern analytical technologies of mass spectrometry continue to garner prominence and broader utility in clinical diagnostics. This was showcased at the 7th Annual American Association for Clinical Chemistry Conference on Mass Spectrometry and Separation Sciences for Laboratory Medicine, held last fall in Philadelphia. Representatives of academia, industry, and regulatory bodies came together to share information about the technology and best practices, the aim of which is to strengthen clinical diagnostics for the betterment of patient care. In opening remarks, then CAP president Richard Friedberg, MD, PhD, shared his hopes for the future of mass spectrometry in anatomic pathology.

January 2018—Using point-of-care glucose meters in critically ill patients can feel like tiptoeing through a regulatory minefield. Perhaps your preferred meter hasn’t been cleared by the FDA for use in this population. Or maybe you’re not sure which assay performance requirements should be regulating the performance of your meters. Or perhaps you’re still trying to define “critically ill.”

June 2017—Mass spectrometry has been gaining acceptance for routine assays in clinical laboratories. The 6th Annual AACC Conference on Mass Spectrometry and Separation Sciences for Laboratory Medicine, held in fall 2016, spotlighted best practices in the use of mass spectrometry testing for patient-centered care.

October 2016—Surprises might work for birthday parties—and even then they’re not everyone’s cup of tea—but not in drug screening programs. Perhaps the most common reason for doing a toxicology consultation is when a urine drug screen yields an unexpected result, either positive or negative, says Nicholas Heger, PhD, assistant director of clinical chemistry at Tufts Medical Center and assistant professor of anatomic and clinical pathology, Tufts University School of Medicine, Boston.

October 2016—ET Healthcare presented two posters at the meeting. Data from the abstract “A whole blood high-sensitivity cardiac troponin assay for POCT” showed that the Pylon cTnl assay met the definition of a fourth-generation high-sensitivity cardiac troponin I assay, with less than 10 percent CV at the 99th percentile and detection in greater than 95 percent of the reference population.

October 2016—Telcor’s QML eLearning interface performs tasks vital to managing point-of-care-testing operators while storing recertification data, such as competency and samples performed together in the company’s QML software for CAP/CMS/JCAHO inspections.

October 2016—Waters Corp. showcased its newest IVD medical device for clinical laboratories, the Acquity UPLC I-Class/Xevo TQ-S micro IVD system. The Xevo TQ-XS is a high-performance tandem quadrupole instrument that aims to expand the scope of ultimate sensitivity analysis.

October 2016—Roche launched its presence by featuring several next-generation diagnostic testing platforms and a virtual reality experience that was designed to give attendees an “under the hood” look at a lab of the future and a concept Roche calls the “Roche connected lab.”

October 2016—Products on display in Ortho Clinical’s booth included the company’s flagship Integrated Clinical Chemistry and Immunodiagnostic Systems and the Nephrocheck Test. The Ortho Vision Max transfusion medicine instrument (shown below), which is pending 510(k) clearance, was highlighted as well.

October 2016—Wheaton launched its DualFusion Vial, which combines properties of plastic and glass into one container. Using plasma enhanced chemical vapor deposition (PECVD) technology, an organosilicate protective layer is fused with a silica-like (SiO2 barrier) layer that is fused to a cyclic olefin polymer (COP) shell to form a robust, covalently bonded material.

October 2016—Streck and Diesse Diagnostica Senese S.p.A., an Italian manufacturer of in vitro diagnostic systems, are introducing the Diesse Mini-Cube, an automated instrument for erythrocyte sedimentation rate testing in EDTA tubes. Streck will be the exclusive distributor of the Mini-Cube in the United States and Canada.

October 2016—Visiun showcased its predictive analytics and population health reporting, which was added to its flagship product, Performance Insight. The predictive analytics, added to the comprehensive test-use module, are designed to enable laboratories to identify high-risk patients with both elevated patient risk and care gaps.

October 2016—Sekisui Diagnostics and Qualigen announced a strategic partnership encompassing current business and future collaboration opportunities. Sekisui Diagnostics has assumed commercial activities and distribution management for the FastPack IP System and associated products in U.S. and international markets.

October 2016—Gold Standard Diagnostics announced a strategic alliance with R-Biopharm AG (Darmstadt, Germany) to collaborate on multiple technology and marketing initiatives that will leverage the companies’ respective strengths in expanding product offerings and geographic sales coverage.

October 2016—Thermo Fisher Scientific exhibited its expanded offering of new assays, instruments, and software designed specifically for customers working in research and clinical settings. The Thermo Scientific DRI Hydrocodone assay detects hydrocodone in specimen samples and is FDA 510(k) cleared.

October 2016—BrandTech Scientific featured its line of Brand liquid handling products, including the Transferpette S single and multichannel pipettes optimized for handling sensitive clinical samples. The pipettes are designed for ergonomic, one-handed volume adjustment, are completely user serviceable and fully autoclavable, and are CE-IVD compliant.

October 2016—Siemens Healthineers unveiled the Atellica Solution, a flexible immunoassay and clinical chemistry solution featuring patented bi-directional magnetic sample-transport technology that is 10 times faster than conventional conveyors, according to the company.

October 2016—Boston-based Oncolab’s AMAS test detects circulating antibodies to a specific antigen (protein) produced by most types of cancer. The AMAS test can be used as a diagnostic aid in cancer occurrence and recurrence. More than 60,000 tests have been performed, and both its sensitivity and specificity are over 90 percent.

October 2016—Fio Corp. exhibited the Fionet platform, a cloud-based connectivity and reporting platform that enables real-time oversight, fragile network connectivity, and actionable insights for medical device manufacturers and health care providers.

October 2016—Binding Site’s Immunological Group announced the addition of two rubella antigens and a cytomegalovirus antigen along with the availability of special protein reagents to in vitro diagnostic manufacturers. The rubella antigens are derived and sourced from infected cells, via culture, which are then treated by UV irradiation to inactivate the pathogenic components. The ultra-purified and ultra-sensitive variant is ideal for the detection of IgM antibodies. The antigens are designed to benefit the needs of biopharmaceutical, clinical, and life science researchers, as well as manufacturers of IVD test kits, and exhibit exceptional purity levels as a result of cross-flow, ultra-filtration and centrifugation techniques.

October 2016—GlycoMark has partnered with Diazyme Laboratories to offer a diabetes panel to test three different measures of glycemic control on one specimen. The panel includes assays that measure both intermediate- and long-term glucose averages (Diazyme’s Glycated Serum Protein/GSP and Enzymatic HbA1c) along with the GlycoMark test.

October 2016—DRG International showcased its Aldosterone ELISA kit for the measurement of aldosterone in serum, plasma, and urine. Aldosterone regulates levels of sodium and potassium in the body and controls blood pressure as well as fluids and electrolytes in the blood. Measurement of aldosterone levels in serum in conjunction with plasma renin levels (aldosterone/renin ratio) can be used to differentiate between primary and secondary aldosteronism, which is vital in the treatment and management of the disease. The kit is available worldwide and is for research use only in the United States.

October 2016—Beckman Coulter, an operating company of Danaher, and Augusta University (Ga.) Medical Center signed a 15-year master service agreement. The alliance aims to create innovative models of care using technology and process improvement methodologies in the laboratory setting, ultimately providing enhanced patient care and significant long-term cost savings for the medical center.

October 2016—U.K.-based Angle plc presented a poster by researchers from the University of Texas MD Anderson Cancer Center describing clinically relevant results from a study using Angle’s Parsortix cell separation system to harvest breast cancer cells in blood for subsequent molecular characterization. The research team, led by James M. Reuben, PhD, professor, Department of Hematopathology, MD Anderson Cancer Center, confirmed the ability to perform advanced molecular analysis on breast cancer cells isolated from blood samples using the Parsortix liquid biopsy technology. The researchers note the ability of the Parsortix method to harvest circulating tumor cells without the use of antibodies.

October 2016—Bio-Rad Laboratories launched Amplichek II quality control, which was issued a de novo clearance from the FDA. Amplichek II is the first in a series of infectious disease controls that the company is introducing to the molecular diagnostic testing market. It is an independent, multianalyte quality control that monitors the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of health care–associated infections.

October 2016—Abingdon Health announced the CE marking and FDA registration of its immunoassay reader, the ADxLR5, as a class I medical device. The ADxLR5 lateral flow device reader is designed to offer the most up-to-date features required for rapid testing, including a touchscreen user interface, barcode sample identification, stored calibration curve processing, and Wi-Fi or wired connectivity.

October 2016—Abbott introduced Alinity, its harmonized family of next-generation systems across immunoassay, clinical chemistry, point-of-care, hematology, blood and plasma screening, and molecular diagnostics. Each Alinity platform will include a number of features to help institutions, clinicians, and laboratorians better navigate through the health care environment.

October 2016—Instrumentation Laboratory introduced several innovations in hemostasis at the meeting, including the FDA 510(k)-cleared HemosIL HIT-Ab(PF4-H) assay for use on ACL Top Family Hemostasis Testing Systems. The fully automated, on-demand assay for heparin-induced thrombocytopenia detects antibodies associated with HIT on a hemostasis testing system.

October 2016—Advanced Instruments launched its GloCyte Automated Cell Counter System. The company announced in July that it received 510(k) clearance from the Food and Drug Administration to market its GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls.

September 2016—When nephrologist Katherine Tuttle, MD, first saw the photo of two women holding young children, she thought it captured the mother of the boy and girl sitting on a couch with the children’s grandmother.

August 2016—As optimists like to point out (in their annoying way), showing up is half the battle. But it’s still only half, as other, equally clear-eyed folks might point out. That leaves plenty to do. And in drug testing for chronic pain management, the work facing laboratories may seem like even more than 50 percent.

November 2015—Tim Skelton, MD, PhD, knows a fair amount about how to enhance the clinical value of urinalysis. It’s a subject that, as medical director of the core laboratory and laboratory informatics at Lahey Hospital and Medical Center in Burlington, Mass., he’s been focused on for the past three years. But he didn’t exactly set out to become an expert in that particular area. He was mainly trying to figure out why his laboratory was experiencing repeated urinalysis quality assurance failures.

November 2015—Cardiologist James Januzzi Jr., MD, sounds like he could be running for political office. Are you going to settle for something different? Or is it time to demand something better?

September 2015—This year’s meeting of the American Association for Clinical Chemistry saw soaring temperatures in the host city of Atlanta and a lofty number of attendees. Nearly 18,000 laboratory professionals took part in the five-day extravaganza, which featured hundreds of educational sessions and poster presentations, along with 720 exhibitors that filled the expo floor. A selection of company news released at the meeting is included in this special section.

MedCompGx, a division of MedComp Sciences, announced the installation and implementation of UniConnect’s Precision MDx laboratory information management system for its new genetic testing lab. The system provides automation of all processes while integrating with multiple systems under one umbrella.

Sysmex announced its Beyond a Better Box product and services model to deliver a comprehensive and intuitive ecosystem that aims to add value to laboratory hematology operations through next-generation diagnostics, advanced tools and technologies, process optimization, and harmonized support known as BeyondCare.

New products featured by Streck this year included CD-Chex CD103 Plus, a flow cytometry control. It includes CD103, CD30, CD38, CD56, CD138, and cytoplasmic lambda in a single control and provides reference values for CD38. The control includes rare leukemia and lymphoma CD markers that are absent in normal whole blood.

Siemens Healthcare Diagnostics revealed its latest IVD solutions, including the Advia Centaur XPT Immunoassay System. Recently FDA-cleared, this high-throughput analyzer is designed to provide continuous operation and seamless connectivity, including to Aptio Automation. The XPT is not available in the U.S.

The family of Phadia instruments from Thermo Fisher Scientific now includes the Phadia 2500E Laboratory System for laboratories meeting high demands. Phadia Laboratory Systems are fully automated instruments for running assays that detect and quantitatively determine clinically relevant antibodies in the blood.

The BBI Group developed, in collaboration with the Defence Science and Technology Laboratory, a rapid test for Ebola that is in the process of being verified to allow EUA submission. Using lateral flow technology, BBI’s assay will make testing simpler and quicker than assays that require technical infrastructure.

Cepheid unveiled the GeneXpert Omni, a portable molecular diagnostics system enabling access to accurate, fast, and potentially life-saving diagnosis of tuberculosis, HIV, and Ebola in even the most remote areas of the world.

Medical Electronic Systems released its new automated sperm quality analyzer, the SQA-Vision. Developed based on 10 years of market feedback, the SQA-Vision is positioned to augment Medical Electronic’s line of SQA-V and QwikCheck semen analyzers with a top-of-the-line solution.

The Diatron Group displayed its new walkaway clinical chemistry analyzer, the Pictus P500. This medium-throughput system (215 tests per hour on a typical sample mix) is ergonomically designed and user-friendly. The advanced, intuitive Windows-based software and smart architecture means the P500 offers many features on an accessible platform including uninterrupted workflow, enhanced walkaway operation, and remote-access diagnostics.

Festo displayed the EXCM mini H-gantry, its high-speed automated handling system for clinical laboratories. The planar surface gantry system is fast, accurate, modular, and flexible. This plug-and-play system can be used for dosing, barcode-based sample identification, liquid dispensing/pipetting with the addition of a Z-axis, and more. The desktop system moves vials on a planar X/Y axis with absolute positioning accuracy.

Nuclea Biotechnologies will begin offering more than 50 research-use-only mass spectrometry–based biomarker tests as part of its laboratory services. The tests detect and quantify protein biomarkers in human serum or plasma and are available to pharmaceutical companies for clinical trials, to researchers, and as companion diagnostics.

Swisslog Healthcare Solutions announced the launch of its Nexus Station. As the next generation of pneumatic tube stations, the Nexus Station provides quiet delivery of PTS carriers and improved carrier management through a carousel that handles both send and receive actions.

Diadexus and Mayo Clinic signed an agreement to collaborate in the areas of education, research, and innovation on the PLAC Test for Lp-PLA2 Activity. The FDA-cleared test is used to identify risk for coronary heart disease in patients with no history of cardiovascular events.

Beckman Coulter Diagnostics’ boothBeckman Coulter Diagnostics’ booth showcased its portfolio of high-productivity analytical and workflow systems. Solutions featured in the booth included the Power Express automation solution, the new DxH Connected Workcell, and IRIS International urinalysis solutions for automated urinalysis.

The Binding Site announced the formation of its new Immunologicals Group. Formerly known as OEM, this new team will have a broad remit to encompass the sales, marketing, and support of specialist antibodies, antigens, disease state sera, and services to IVD manufacturers, research scientists, and academic facilities.

BioMérieux announced the FDA 510(k) clearance and commercial availability of Vidas 3, the new generation of Vidas. Vidas 3 features enhanced automation, in particular the preanalytical section from the barcoded primary tube including dilution, improved traceability, and new software capabilities, as well as a quality control program in compliance with laboratory certification standards. Vidas 3 is CE marked and registered at the Chinese Food and Drug Administration.

EKF Diagnostics launched its Altair 240 clinical chemistry analyzerEKF Diagnostics launched its Altair 240 clinical chemistry analyzer, a benchtop platform that is EKF’s first fully integrated chemistry system for the global market. The fully automated system has LIS bidirectional connectivity, and double arm functionality yields up to 480 tests per hour.

ELITechGroup Molecular Diagnostics Precision System Science and announced the upcoming CE-IVD marking of ELITe InGenius for IVD applications in Europe and the expected availability of the instrument as laboratory use equipment in the U.S.

Roche introduced next-generation diagnostic testing platforms and an educational initiative that demonstrates how it’s partnering with customers to redefine the value of the laboratory.

September 2014—Ohaus will launch in September its Adventurer line of analytical and precision balances for standard laboratory weighing. Adventurer has nine application modes, including weighing, percent weighing, counting, check weighing, dynamic weighing, totalization, formulation, density determination, and display hold.

September 2014—EKF Diagnostics highlighted its expanding product portfolio at its subsidiary’s booth, Stanbio Laboratory. DiaSpect Tm, which previewed at the meeting, is a palm-sized hemoglobin measurement system that gives laboratory-quality performance for anemia screening. Delivering results in one to two seconds, this analyzer is CE marked and currently undergoing FDA approval.

February 2015—Like a modern-day Pericles, Tracy George, MD, had much to traverse in her overview of leukocytosis, thrombocytosis, and erythrocytosis during a course on diagnostic hematology at last year’s AACC meeting. Unlike Shakespeare’s Pericles, however, Dr. George navigated the many twists of her topic with the efficiency and near-encyclopedic knowledge of an experienced tour guide.

September 2014—Immucor’s PreciseType HEA test is an FDA-approved molecular assay designed to provide clinicians and blood banks with the detailed genetic matching information they need to reduce the risk of alloimmunization and serious hemolytic reactions, which is especially problematic for patients receiving frequent blood transfusions.

September 2014—Wheaton’s CryoElite Tissue Vials are designed for the safe, secure, and effective cryopreservation of biological tissue specimens and are able to maintain sample integrity while maximizing storage capacity and organization. CryoElite Tissue Vials were developed for the high-performance tissue banking requirements of anatomical pathology departments, clinical trial organizations, and biorepository and biobanking facilities.

September 2014—AutoSorter 2000BB is Yaskawa Motoman’s new high-speed bulk sorter for high-volume commercial laboratories. AutoSorter 2000BB provides specimen throughput of up to 2,000 tubes per hour. It minimizes manual handling of specimens through bulk loading and unloading, and reduces sequential sorting by fine sorting in one step.

September 2014—Beckman Coulter Diagnostics showcased five laboratory solutions in its booth, which was themed “New Laboratory Challenges Require New Thinking”: the Power Express automation solution consolidates immunoassay, hematology, and coagulation; the DxH Connected Workcell offers labs workflow management while delivering comprehensive and accurate patient results; the latest addition of the IRIS International urinalysis portfolio; the Remisol Advance enterprise data management system; and its immunoassay diagnostic testing menu, which includes AccuTnI+3 troponin I in the cardiac panel, the Prostate Health Index (phi) as part of the men’s health panel, and a complete reproductive panel.

September 2014—Rheonix displayed its Chemical and Reagent Device, CARD, and EncompassMDx molecular testing platform at AACC. The Rheonix CARD is a disposable cartridge the size of a credit card that runs multiple samples simultaneously without user intervention.

September 2014—New products featured by Roche this year include analyzers, an automated workflow series, and assays. The Cobas u 601 urine analyzer is a fully automated solution for urine strip testing in mid- to high-volume labs that delivers high-quality results through reagent test strips. This analyzer is not available for sale in the U.S.; a 510(k) submission is pending.

September 2014—Currently in development from Abbott is the Iridica platform, targeted for release in CE-marked European countries within 12 months, to test for and identify hundreds of bacteria and candida, fungi, and viruses from a direct patient specimen.

September 2014—NanoComposix unveiled its BioReady Gold line of products that include new surface chemistries for covalent attachment to gold nanoparticles and gold nanoshells.

September 2014—Atomo Diagnostics introduced the AtomoRapid all-in-one blood test. It can accommodate test strips for a variety of conditions, from celiac disease and allergies to infectious diseases, such as malaria and HIV.

September 2014—Multisorb’s QbD-based Calculations through Operations program provides an effective and efficient solution for ensuring the chemical and physical stability of IVD devices through their desired shelf life.

September 2014—Medical experts representing Vermillion, a multivariate diagnostics company focused on gynecologic cancers and women’s health, presented on Aspira Labs, its new CLIA-certified reference laboratory. Aspira Labs provides expert diagnostic services, including OVA1 and Longitudinal CA 125 testing, which support clinical decision-making and personalized treatment plans.

September 2014—Sysmex America displayed four new products at its booth. The DI-60 Integrated Slide Processing System provides automation of manual WBC differential process in a stand-alone configuration, offering a cell image analyzer for any type of laboratory or budget.

September 2014—The Binding Site announced an enhancement to its Rheumatoid Factor/Immunoglobulin-G Absorbent Reagent specifically designed for use in conjunction with infectious disease immunodiagnostic procedures. The RF/IgG Absorbent Reagent can now be used to equally test and analyze serum and plasma samples without compromising test results.

September 2014—Orchard Software has introduced Orchard Sequoia, a laboratory information system for the enterprise-wide lab. Sequoia is “designed to be scalable and to address the needs of the largest clients,” says Rob Bush, president of Orchard Software. The product’s three-tier design accommodates the needs of high-volume laboratories across multiple locations and departments, including clinical, molecular, anatomic pathology, and microbiology.

September 2014—UniConnect announced the release of its PrecisionMDx System for molecular laboratories. The system has been developed for laboratory professionals seeking a focused solution for CAP- and CLIA-certified molecular laboratory operations, and the software platform is ideal for MDx, CDx, and PGx pursuits.

September 2014—Pall Life Sciences’ Acrodisc WBC premium syringe filter is a filtration device designed specifically for use in the capture and recovery of leukocytes and the separation of red blood cells. The Acrodisc WBC filter contains the company’s patented Leukosorb media.

September 2014—Biofortuna announced the expansion of its freeze-dried production service. Biofortuna invested in a new, state-of-the-art freeze-drier and additional climate-control units to meet the increased demands of companies that are outsourcing their freeze-dried production of diagnostic kits. The additional freeze-drier and infrastructure almost doubles the company’s production capacity.

September 2014—Eco-Tek products by Kem-En-Tec, distributed in the U.S. by Rainbow Scientific, reduce the environmental impact of ELISA, blotting, or immunohistochemistry applications by eliminating biological and chemical hazards commonly found in diagnostic assay components, including bovine serum albumin, sodium azide, and harmful organic solvents, without compromising quality, reliability, or stability.

September 2014—The Mix&Go product is a proprietary surface coating for use in diagnostic testing from Anteo Diagnostics. Mix&Go incorporates a type of molecular Velcro that provides a novel approach for attaching fragile proteins to synthetic surfaces distinct to the traditional methods, enabling the development of sensitive and affordable diagnostics.

September 2014—Diagnostica Stago celebrated the success of its newest instrument line with the competitive conversion placement of its 100th Compact Max in six months. The Compact Max, an intelligent, user-friendly platform for coagulation testing, is the first of the Max line of instruments that will be rolling out to laboratories worldwide over the next couple of years.

September 2014—The promises and perils of big data and mobile health were among the hot topics at this year’s meeting of the American Association for Clinical Chemistry.

September 2014—Newly reported survey data that show widely varying international practices on managing critical values may demonstrate the need for a new guideline—already in development—to help laboratories formulate evidence-based policies. The new data from European labs were presented during a session at the American Association for Clinical Chemistry’s Annual Meeting and Clinical Expo in Chicago (“Critical Result Management Practices: Global Perspectives and Recommendations for Best Practices”). The session also provided a preview of a forthcoming draft guideline from the Clinical and Laboratory Standards Institute that represents the organization’s first formal attempt to advise laboratories around the world on critical values reporting.

December 2013—Quality systems and quality management plans can be as solid as a laboratory can make them and still lab errors will occur. And as laboratories become more automated and test volumes grow, the potential for large-scale errors grows too.

November 2013—There’s nothing flashy about specimen tubes, which may look like the most mass-produced, commonplace items in the laboratory, but appearances can be deceptive. All tubes are not created equal. “We know that preanalytical errors account for the majority of errors in the laboratory, and many of those errors derive from the tube type in which you collect your sample,” says Leslie J. Donato, PhD, co-director of the hospital clinical laboratory and point of care at the Mayo Clinic in Rochester, Minn.

Multisorb Technologies offers its Quality by Design (QbD)-based Calculations through Operations Program. Multisorb’s scientists use the program to determine the optimized sorbent for the application and to manage placement of that sorbent during packaging operations, when required, with the use of a sorbent-specific dispenser. The program and use of a Multisorb system provide an effective solution for ensuring chemical and ...

SISCAPA Assay Technologies (SAT) announced publication of a study in Clinical Chemistry demonstrating that one of the company’s MALDI-TOF assays for protein C inhibitor can help identify patients at risk for recurrence of prostate cancer after radiotherapy. The assay measures a proteotypic peptide of protein C inhibitor enriched from tryptic digests of patient serum by anti-peptide antibodies (the SISCAPA, or ...

Sagentia has completed initial alpha prototype development of the Resolution microbial genotyping system that it is developing for PathoGenetix. Sagentia has worked with PathoGenetix for the past two years across the full product development life cycle, helping to combine two bread board systems into an intuitive, usable system with a smaller footprint. The Resolution system is based on PathoGenetix’s Genome ...

AACC 2013 AB Sciex has introduced its Sciex IVD-MS kits, which are a new series of reagent kits for in vitro diagnostic use in conjunction with mass spectrometry instrumentation for clinical analysis in Europe. The first kit is focused on vitamin D analysis and is CE-Marked to meet European regulatory requirements. The Sciex IVD-MS kit for 25-OH vitamin D analysis ...

AACC 2013 AB Sciex has launched in Europe its 3200MD CE-IVDD series, which includes the API 3200MD and 3200MD QTRAP LC/MS/MS systems. The systems are now CE-Marked. AB Sciex, 800-343-1346

AACC 2013 AB Sciex’s MPX TF 1.0 software is designed to accelerate drug screening, with accurate mass-based technology for laboratories performing clinical research. The software delivers faster turnaround times, increased sample throughput, and lower costs compared with single-stream, mass spectrometry (MS) methods. With the MPX TF software, researchers can increase throughput by as much as twofold. This is made possible ...

The Binding Site now offers a specifically formulated and optimized ELISA procedure for the quantitation of intact human IgG from matrices containing non-human proteins. The assay is for clinical, biopharmaceutical, and medical researchers. The ELISA uses sheep polyclonal antibody, specific to the Fc and light chain regions of human IgG for capture and detection respectively, ensuring that only intact human ...

The Binding Site now offers a substrate-chromogen containing 3,3’,5,5’-tetramethylbenzidine (TMB). Designed for use as an integral component in peroxidase-based, colorimetric techniques, the TMB chromagen-substrate is for use in enzyme immunoassay test procedures. The TMB substrate-chromagen demonstrates decreased sensitivity to light when compared with other peroxidase chromogens and can be developed without any special precautions. Offered in a liquid-stable, ready-to-use format, ...

The Binding Site now offers a specialized line of anti-human serum protein antibodies. Through the use of a patented technique, which yields highly specific antibodies, all available products display a high degree of purity, shelf-life stability, and lot-to-lot consistency. The range of specialized antibodies includes those involved in blood coagulation, complement activation, acute-phase reactants, immunoglobulin response, and others. The antibodies ...

Thermo Fisher Scientific has launched its Barnstead GenPure xCAD Plus water purification system, which has technology that allows simultaneous dispensing from three remote dispensers for exceptional flexibility and ease of use in shared laboratory environments. In addition to its advanced dispensing technology, the Barnstead GenPure xCAD Plus is easy to use and comes with leak detection, feed water monitoring, and ...

The FDA in June approved a workflow process for Roche Diagnostics’ Cobas HPV test that allows sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing. The approval allows labs to load the same vial used for a ThinPrep Pap test directly onto Roche’s Cobas 4800 system for high-risk HPV and individual HPV ...

Roche’s Cobas 8100 automated workflow series is an advanced system designed to automate many routine tasks to help diagnostic laboratories increase efficiency, reduce expenses, and maximize patient safety. Through intelligent robotics, the Cobas 8100 series automatically prepares blood samples for immediate testing and post-analytical processing, providing high-speed processing of up to 1,100 samples per hour. The system offers dynamic and ...

Tosoh Bioscience’s ST AIA-Pack 25-OH vitamin D assay is for use on most Tosoh AIA system analyzers. Vitamin D measurement is intended as an aid in the determination of vitamin D sufficiency. Using Tosoh’s unit-dose test-cup reagent technology, ST AIA-Pack 25-OH vitamin D has an assay time of about 40 minutes. Single, unitized test cups require no premixing, no premeasuring, ...

Samsung Electronics presented details of the first peer-reviewed report of a pilot conducted with the National Health Service in Scotland, Borders General Hospital, the Scottish Ambulance Service, and the Scottish Centre for Telehealth and Telecare on the use of the company’s Labgeo IB10 portable blood analyzer to diagnose cardiac patients in transit to the hospital. Conducted in the sparsely populated ...

Cepheid has received FDA market authorization for its Xpert MTB/RIF test, which provides results in about two hours. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be downclassified and brought to market. Xpert MTB/RIF is for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens ...

September 2013—Abbott has received FDA approval to expand the use of its RealTime HIV-1 assay to run on the company’s mPlus system. In April, Abbott introduced mPlus capability for its RealTime m2000 system to enhance the system’s flexibility and make molecular testing easier and more efficient for laboratories.

AACC 2013 Abbott announced results from a study evaluating its high sensitive troponin-I (hsTnI) assay. The study, conducted by researchers at Brigham and Women’s Hospital, demonstrated that Abbott’s Architect stat hsTnI test may help doctors predict which patients presenting with symptoms of a heart attack are at a higher risk for having a heart attack 30 days after presentation. Researchers ...

Eppendorf North America offers a new generation of its ThermoMixer and ThermoStat incubators. The excellent mixing results of the ThermoMixer C, F1.5 and FP (two-in-one instruments for combined mixing and incubating) are due to the company’s two-dimensional mix-control technology, which ensures fast and efficient mixing in seconds. Through controlled circular movements, liquids in small volumes are thoroughly mixed, while anti-spill ...

Seegene has launched its multiple mutation detection technology to accelerate the development of companion diagnostic tests. The technology transforms conventional real-time instruments into powerful systems to simultaneously detect multiple mutation targets in a single channel. Seegene has extended the capabilities of its real-time PCR technology to simultaneously detect more than 20 different mutations, including insertions, deletions, and point mutations, in ...

Greiner Bio-One’s Vacuette Tube-Touch passive safety device has a passive safety shield that activates upon tube insertion, reducing the risk of exposure to bloodborne pathogens from a needlestick. The product comes to the customer completely assembled with a needle, safety shield, and tube holder. Greiner Bio-One, 888-286-3883

Streck’s A1c-Cellular Linearity, an HbA1c linearity/calibration verification material with intact red blood cells, is now assayed for Roche Diagnostics’ Cobas c 311. It is a five-level assayed linearity material used to assess instrument accuracy and verify the patient reportable range of the HbA1c parameter. The product does not require reconstitution, which reduces the potential for human errors and saves time. ...

Radiometer America offers its “Avoid Errors” application for the iPhone. The app allows users to identify typical preanalytical errors in blood gas testing. The content of the “Avoid Errors” application is threefold, with tips on how to prevent errors, a troubleshooting section, and a skill test. A handbook section in the app contains videos that show how to properly collect ...

Mercy Medical Center in Canton, Ohio, has implemented advanced clinical laboratory diagnostic technology for conducting on-demand HbA1c diabetes testing, as well as analysis of red blood cell, white blood cell, and platelet counts. Mercy did this by installing Sysmex America’s XN-9000 Lavender Top Management configuration. As North America’s first installation of its kind, the Sysmex Lavender Top Management system, designed ...

NorDx, a large reference laboratory in Maine that is a member of MaineHealth, has acquired Sysmex America’s XN-3000 automated hematology analyzers. The XN-3000 configuration enables enhanced diagnostic capabilities and greater efficiency that transforms NorDx into an accountable care laboratory model. The Sysmex XN-3000 has a menu of advanced clinical parameters that allows NorDx and MaineHealth to conduct cellular studies that ...

Ontario-based Brockville General Hospital and Sysmex Canada announced the hospital’s installation and implementation of a Sysmex XN-2000 automated hematology analyzer. This is the first Sysmex XN series analyzer to be installed in Canada. The compact automated hematology analyzer provides the hospital’s clinical laboratory with expanded clinical and operational capabilities to meet changing workload demands and testing complexity that may accompany ...

EKF Diagnostics offers a novel test to accurately identify diabetic patients at high risk of progression to end-stage renal disease (ESRD) up to 10 years before currently available tests can. EKF’s sTNFr1 test is an ELISA assay that has the potential to significantly improve diabetic patient management and outcomes. The test accurately detects circulating levels of soluble tumor necrosis factor ...

EKF Diagnostics offers its Stat-Site M Hgb strip-based test for quick and easy hemoglobin analysis for rapid anemia determination. Stat-Site M Hgb is a portable handheld analyzer. The pocket-sized device delivers accurate hemoglobin analysis results within 30 seconds from 15 µL of fingerstick whole blood. This hemoglobin photometer is maintenance-free and includes intuitive, step-by-step on-screen instructions to minimize operator training. ...

EKF Diagnostics’ Stat-Site M β-HB is a strip-based test for β-hydroxybutyrate that provides a quick and easy assessment of diabetic ketoacidosis (DKA), delivering results in less than 80 seconds. The presence and degree of ketosis can be assessed rapidly at the point of care by accurately measuring blood levels of β-HB, which accounts for 78 percent of the three ketone ...

EKF Diagnostics offers its EKF Molecular Diagnostics’ PointMan DNA enrichment kits. The three kits are for enriching mutations in BRAF, KRAS, and EGFR T790M genes associated with skin melanoma and colorectal and lung cancers. PointMan kits provide highly specific and ultrasensitive enrichment of mutant genes in a background of wild-type (normal) genes. PointMan real-time PCR technology provides reliable and extremely ...

The IVD Industry Connectivity Consortium (IICC) has developed a laboratory analyzer workflow (LAW) interface, which is a global interface based on a common set of clinical laboratory communications that unambiguously define communication protocols. In 2012, four diagnostic and three IT companies successfully validated 129 LAW tests. Since then, IICC has refined these interfaces and is asking more manufacturers to adopt ...

Cerilliant offers seven new certified spiking solutions of bath salt metabolites. The new products are 1.0 mg/mL (as free base) in methanol for the primary urinary metabolites of bath salt cathinones, mephedrone, buphedrone, pentedrone, flephedrone, N-ethylcathinone, and 4-methylethcathinone. For GC/MS and LC/MS methods that quantify concentrations of synthetic cathinone metabolites, the company also offers the corresponding deuterium-labeled internal standard. Cerilliant ...

Cerilliant offers certified Snap-N-Spike solutions of thyroid hormones T4, T3, and reverse T3 at concentrations of 100 µg/mL in 0.1 N ammonia in methanol for each solution standard. These certified spiking solutions are for use as critical starting materials in the preparation of calibrators, controls, or linearity standards for analytical testing including LC-MS/MS analysis of free and total thyroid hormone ...

Life Technologies in February received FDA 510(k) clearance for its 3500 Dx genetic analyzers and SeCore HLA typing kits. The company’s 7500 Fast Dx real-time PCR system was cleared for diagnostic use with the CDC’s H1N1 assay in 2008. The Applied Biosystems 3500 Dx/3500xL Dx CS2 genetic analyzers, Invitrogen SeCore HLA sequencing kits, and uType Dx HLA sequence analysis software ...

March 2013—When Bobbi S. Pritt, MD, director of clinical parasitology and virology in the Division of Clinical Microbiology at Mayo Clinic, set out to improve test utilization among the physicians for whom her laboratory performs assays, she figured that knowledge was power. Simply educate the clinicians, she thought, and surely they would begin to order the most appropriate tests for their patients.

February 2013—The list of anticoagulants has grown in recent years, which means there’s more to know about whether, when, and how to monitor. Last month in CAP TODAY, Michael Laposata, MD, PhD, spoke briefly about the newer drugs and explained how the older ones—warfarin, heparin, and low-molecular-weight heparin—work, and what that means for labs. This month, he returns to the newest of the major anticoagulants.

January 2013—When to monitor and how? These questions were simpler when the list of anticoagulants patients were given was two or three deep—warfarin and unfractionated heparin, and maybe low-molecular-weight heparin. But the number of anticoagulants has grown and so has the complexity. Old and new—Michael Laposata, MD, PhD, covered the major anticoagulants and antiplatelet drugs in a recent AACC webinar and again at the CAP ’12 annual meeting in September. Here, this month, is an edited transcript of what he said in the webinar about warfarin and heparin and briefly about the newer drugs. In the February issue: a close-up look at fondaparinux, bivalirudin, rivaroxaban, dabigatran, lepirudin, and argatroban.