MultiPlex IFA ANCA Testing Available From Euroimmun US
E uroimmun’s unique technology innovation, BIOCHIP™ Mosaic, has been cleared by the FDA for in vitro diagnostic use and is now available for routine laboratory use. This technology multiplexes the immunofluorescent (IFA) anticytoplasmic neutrophilic assay (ANCA). Using the patented BIOCHIP Mosaic technology, laboratories can simultaneously screen and confirm the patterns associated with c-ANCAs, p-ANCAs, and atypical p-ANCAs.
Each well contains four individual substrates: ethanol-fixed granulocytes, formalin-fixed granulocytes and control wells HEp-2 Cells, and primate liver. The substrates are optimally fixed and then adhered in the same well, preserving the individual substrate’s integrity. The patient sample is screened for c-ANCAs and p-ANCAs, as well as atypical p-ANCAs in the same well and test run, significantly reducing turnaround time. The HEp-2 and primate liver substrates are used as the control substrates to determine if an ANCA reaction is present or coexists with the p-ANCA.
The ability to multiplex the ANCA IFA panel rather than running three to four individually dedicated slides and test systems is a benefit in the laboratory, providing for significantly faster turnaround times, savings in labor and reagent cost, and increased confidence in reading and result reporting. Comprehensive results are available in less than 2 hours.
The ANCA slide may be configured with one, two, three, or four substrates, depending on the laboratory’s needs. The slides are available in a 50-well format for large-volume users as well as the routine 10-well slide.
Specific antigen EIA assays for PR3 and MPO, as well as an ANCA Profile EIA for proteinase 3, lactoferrin, myeloperoxidase, elastase, cathepsin G, and BPI, are also available. In addition, Euroimmun manufactures EUROLine MPO/PR3 Profile EUROLine Membrane for confirmatory testing and offers unique software EUROLineScan for reporting.
The Euroimmun US product menu includes extensive autoimmune and infectious-disease test systems using multiple methodologies, such as IFA, ELISA, Westernblot, and EUROLine. Specialized LED microscopes, EIA processor, Blot processing, and reading and interpretation equipment are also marketed.
(800) 913-2022; www.euroimmun.com
HemoCue Introduces POC Test for WBC Count
HemoCue’s new single-analyte point-of-care (POC) testing system for the determination of total white blood cell (WBC) count can be performed in any physician’s office within minutes. It is designed to be a valuable tool in the diagnosis of bacterial infections.
The new POC testing system for total WBC count, which has not yet been cleared by the FDA, will be used to rapidly diagnose infections and will substantially improve quality in primary care. Instead of sending blood samples to a reference lab, the HemoCue WBC system is designed to provide immediate and reliable results with the same precision and accuracy as a lab test, on-site and within minutes.
Since an increased total WBC count is typically seen in patients with bacterial infections, HemoCue WBC will help physicians decide whether to prescribe antibiotics or not. Today, overprescription of antibiotics is a major concern, resulting in an increasing number of bacterial strains that are resistant to antibiotics.
“Our new point-of-care system for measuring total WBC will help physicians prescribe antibiotics to patients in need of it without unnecessary delay, and will avoid prescribing to patients where it has no effect,” says Stellan Lindberg, director of R&D at HemoCue. “So far, we have presented HemoCue WBC to a small number of experts at large central hospital laboratories and to physicians in primary care settings. They have all been very impressed by the simplicity and accuracy of our system.”
The HemoCue WBC system is based on HemoCue’s proven cuvette technology and is specifically designed to receive waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The system will be tested on a large scale at the beginning of next year by a number of clinics in Sweden and the United States, with an anticipated commercialization in the second quarter of 2007.
“A point-of-care system for the early detection and confirmation of an infection will be an important tool in the treatment of patients. As elevated levels of white blood cells are a typical sign of a bacterial infection, physicians now can assess patients and prescribe antibiotics more accurately,” says Sharon Ehrmeyer, MD, professor of Pathology and Laboratory Medicine and director of the Medical Technology Program, University of Wisconsin in Madison.
(800) 881-1611; www.hemocue.com
ARTEL Introduces PCS plus
To reduce the risk of human error and to enhance efficiency, laboratories can automate management of pipette calibration with ARTEL’s new PCS® plus. Given the critical need for data accuracy and precision, and the consequences of incorrect liquid-delivery devices, regular pipette calibration is mandatory, yet the shortage of trained laboratory technicians stretches resources thin. Launched by liquid-delivery quality assurance provider ARTEL (Westbrook, Me), PCS plus streamlines the calibration process, which facilitates compliance and helps laboratories ensure data integrity. ARTEL introduced the new PCS plus during a press conference at the AACC 2006 Annual Meeting and Clinical Lab Expo in Chicago.
Keeping track of pipettes and ensuring that they are properly calibrated can prove to be significant barriers to laboratory efficiency. ARTEL’s PCS plus reduces human transcription error and speeds up calibration by relying on several unique components: proprietary software, a bar code scanner, and a laboratory-qualified printer. Affixing bar code labels with identification (ID) numbers to each pipette and scanning these labels prior to beginning the calibration process eliminates the need for manual tracking of calibration.
Error risk is further reduced by automatic calculation and documentation of calibration results, accomplished through ARTEL’s robust and portable pipette calibration system (PCS) and ARTEL Pipette Tracker™ software. Based on Ratiometric Photometry™, which uses two dyes to measure volumes, the standardized PCS verifies liquid delivery in minutes. If the PCS verifies that the pipette is performing within laboratory-specific tolerances, PCS plus immediately prints a label with the pipette ID number, technician’s name, and calibration date, indicating that the pipette is in good working order. To maintain legibility in harsh laboratory environments, labels provided by ARTEL are resistant to solvents and water.
With PCS plus, laboratories will also be able to generate trend reports to understand how a pipette is performing over time. A pipette identified as trending out of tolerance can be removed from circulation, allowing laboratories to detect errors before they occur. This will reduce downtime, costly remedial action, and possible liabilities. In addition, PCS plus and Pipette Tracker can be used in a program to build and ensure pipetting technique, which will maintain proficiency test records, including trend and progress reports, of the laboratory’s technicians’ skill levels. Improper technique can be quickly identified and improved to further strengthen accuracy and precision in the laboratory.
“Automation has permeated many aspects of modern laboratories,” says Kirby Pilcher, president of ARTEL. “But until now, pipette calibration was largely managed manually. Now our customers can eliminate risk and inconvenience in calibration, focus resources on their critical laboratory tasks, and ensure optimal clinical outcomes.”
(888) 406-3463; www.artel-usa.com