ORLANDO – Consistent with the giant presence it already is, Abbott Laboratories (Abbott Park, Illinois) rolled out a large-sized package of developments at last week's joint International Federation for Clinical Chemistry (Milan, Italy)/American Association for Clinical Chemistry (AACC; Washington) annual meeting and clinical lab expo, its announcements ranging from a new partnership to new products.
On the instrument front, Abbott reported that it received 510(k) clearance from the FDA for the high-volume Cell-Dyn Sapphire, its latest Cell-Dyn hematology analyzer to incorporate monoclonal antibody tests for additional cellular analysis.
The company said that the Sapphire's blue diode laser offers fluorescence and patented Multi-Angle Polarized Scatter Separation (M.A.P.S.S.) technology to provide analysis of red blood cells, white blood cells and platelets, which helps physicians diagnose and monitor anemia, cancers and infectious diseases.
One advantage of the Sapphire, Amy Woodworth, public affairs manager for Abbott Diagnostics, told Diagnostics & Imaging Week, is that it includes flow cytometry capabilities for its MAb tests, which allows labs that ordinarily might be required to send samples for processing to a specialty lab to be able to do them in-house.
Abbott also introduced two new laboratory software solutions: Accelerator Decision Manager and an enhanced version of Abbott Link.
Accelerator Decision Manager is designed to connect a laboratory's existing information systems to diagnostic instruments, optimizing sample processing and assessment, while AbbottLink monitors is designed to monitor critical instrument operations and produce management reports that are meant to help reduce costs and maximize instrument performance.
"Once installed, these software solutions can provide immediate benefits to increase laboratory productivity and enhance overall patient care," said Douglas Bryant, vice president, Diagnostic Global Commercial Operations, Abbott, in a company statement. "For example, Accelerator Decision Manager uses programmed decision logic and customized rules to enable a lab to quickly and consistently evaluate test results. These results can then be released to physicians upon clearing these criteria, freeing up the technologist's time to focus on more complicated patient samples."
Accelerator Decision Manager also is designed to enable the laboratory to help automate processes such as result verification, sample location and quality control analysis. Abbott said decision rules can be programmed to route samples and evaluate results based on factors such as patient age, past test results, prescribing physician, hospital ward and other parameters. It also has an open interface and is scalable for small to large laboratories, the company said.
Abbott Link, which reviews and captures instrument data in real time, allows Abbott service representatives to correct any technical problems more quickly by being able to remotely view instrument data, logs, files and maintenance records, calibrations and other performance measures.
AbbottLink is available for use with Abbott's AxSYM, Architech and certain Cell-Dyn instruments.
The company also unveiled its expanded Architect family of analyzers at this week's conference. The Architect i1000, Architect c16000 and Architect ci16200 were shown, although they are still in development.
Early on in the session, Abbott reported a new agreement with Nephromics (Chestnut Hill, Massachusetts) for patents related to the development of in vitro diagnostic tests for preeclampsia. It would be the first such test for pregnant women to detect this life-threatening disorder.
"We're in the very early stages now as far as timeline; it's just now in early development," Woodworth told D&IW.
In the agreement, Abbott obtains worldwide, semi-exclusive rights to commercialize products using Neph-romics' patents covering two proteins for both detecting and monitoring preeclampsia. No financial terms of the pact were disclosed.
According to the Preeclampsia Foundation (Bellevue, Washington), this disorder affects 5% to 8% of all pregnant women and occurs typically after 20 weeks of gestation. Preeclampsia is characterized by high blood pressure and the presence of protein in the blood. Among the symptoms are swelling, sudden weight gain, headache and changes in vision.
About 76,000 deaths are expected to occur each year due to preeclampsia, the foundation said.
"Because preeclampsia can strike quickly, potentially causing severe and immediate complications, such as seizures and organ failure, that threaten both the health of the baby and mother unless the pregnancy is induced, early diagnostic tests are needed," said David Barch, MD, medical director of Abbott Diagnostics, in a statement.
Abbott also sponsored a workshop on trends in women's healthcare during the meeting, which focused in part on thyroid disorders in women attempting to become pregnant. It also focused on fluctuating hormones from puberty, through the reproductive years to menopause.
Among Abbott's fertility tests are estradiol, which can be used to test infertility in men and women and the onset of menopause, among other things; FSH [follicle stimulating hormone], LH [luteinizing hormone], progesterone, prolactin, and testosterone.
In a scientific session at the conference, Amitava Dasgupta, PhD, said it is "critical" that laboratory clinicians be able to test for test "disruptors" such as foods, herbs, prescription drugs, over-the-counter drugs or liquids that interfere with lab results.
Dasgupta, of the department of pathology and laboratory medicine at the University of Texas-Houston Medical School, said that some of the common culprits that can disrupt common lab tests – intentionally or unintentionally – are diuretics, herbal medicines, alcohol, prescription medications used to treat routine health issues such as heart disease, and even food.
"Eliminating interferences in routine lab tests is critical to ensure that physicians are provided with the most accurate information," Dasgupta said, adding that laboratorians need to hold "effective consultations" with ordering physicians when they encounter unexpected test results.
It was reported at the closing plenary session that nearly 17,400 attended the five-day IFCC/AACC conference.