Bio-Rad Laboratories recently announced the availability of a new Measurement Uncertainty Report in their Quality Control Data Management Software Unity Real Time 2 Service Pack 5 upgrade. Under ISO 15189, Measurement Uncertainty is a mandatory requirement and allows labs to calculate their analytical test dispersion. This new report allows laboratories to calculate their Measurement Uncertainty according to one of three different calculations. The three different calculations include the standard expanded Uncertainty based on the lab’s imprecision (consistent with RCPA and NABL), and two combined expanded uncertainty calculations which contain either the bias or the calibrator uncertainty (consistent with the SH GTA 14 Guideline from France).
Unity Real Time 2 is Bio-Rad’s expert QC Data Management solution for desktop users which facilitates compliance under CLIA and ISO 15189. It provides run validation with real-time bench and supervisor QC data review with comprehensive audit trails. It allows labs to participate in Bio-Rad’s Unity Interlaboratory Program with over 50,000 participating instruments. All QC data can be uploaded from any LIS, middleware or instrument via the Unity Connect software. Users can also reduce non-essential retests with Analytical Goal options and implement the best QC rules with the Westgard Advisor or use Bio-Rad’s latest QC design tool Mission: Control which provides a risk based approach to Quality Control.

http://www.qcnet.com/datamanagement/
Read more

Digitization has revolutionized connectivity by increasing productivity and improving lab efficiency like never before. Thanks to connected devices, technical teams no longer need to remain in front of their workstations, or even in the laboratory.
The secure Connect.One network architecture allows laboratories to benefit from remote monitoring of their automated analysers, meaning Stago can check they are operating correctly and diagnose and analyse any malfunctions as part of a proactive approach.
Designed to meet international data privacy and security guidelines, Connect.One will become a cornerstone for integrating new applications.
Systems connected to Connect.One can also send QC results to My Expert QC (Stago’s externalized IQC platform), as well as activity statistics to simplify the management of “Cost Per Reportable Results” contracts.
Connect.One can track analyser performance and send notifications in case of problems while downloading software improvements from a secure infrastructure.
Using their connected devices, laboratories can increase productivity, efficiency and operational flexibility by receiving a higher level of support and expertise from Stago.

Read more

The Panther Fusion MRSA assay has received CE mark in Europe. This assay, the latest in a growing menu of Panther Fusion and Aptima assays, brings full automation, efficiency and excellent assay performance to MRSA screening. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, and is suitable to any size laboratory. With rising antibiotic resistance in Europe and the threat posed by healthcare-associated infections to public health, the new assay will help customers provide a rapid service to hospitals, so cases of resistance, such as MRSA, are identified and managed quickly and effectively.
The Panther Fusion MRSA assay accurately detects and differentiates Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from ESwab nasal samples. It has broad strain inclusivity including the Bengal Bay clone, and is able to correctly identify empty cassette variants.
The Panther Fusion MRSA assay enables laboratory customers to leverage the benefits of the fully automated Panther Fusion system, which provides random and continuous access to improve laboratory efficiency. Laboratories can combine women’s health, virology, respiratory, hospital-acquired infections, and Open Access tests on the Panther Fusion system, running up to 32 different assays at the same time. In addition, MRSA samples can be loaded directly into the Panther Fusion, saving customers vital time and labour costs and delivering first results in 2.4 hours, considerably faster than commonly-used culture and lab developed tests. In addition, Panther Fusion offers labs the potential to process up to 500 Panther Fusion and Aptima assays in an 8-hour period.
Panther Fusion is available as a full system, or the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities. The Panther Fusion module adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry used in the company’s Aptima brand. Key benefits include the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time, continuous loading, and STAT capabilities. Its ready to use, unit-dose lyophilized reagents, which have 60-day on-board stability, help reduce waste and the need for manual reagent preparation.

Read more

A new ELISA provides parallel detection of anti-Zika virus antibodies of classes IgA and IgM against the highly specific viral non-structural protein (NS-1). Anti-Zika virus NS-1 antibodies of class IgA are a novel alternative indicator of acute infection, and their detection is particularly useful in cases where IgM is not detectable. This can occur, for example, in patients who have had previous contact with a flavivirus through infection or vaccination (e.g. dengue, yellow fever, tick-borne encephalitis, Japanese encephalitis or West Nile viruses). When these individuals become infected with another virus of the genus Flavivirus, in this case Zika virus, the specific IgM response may be absent (secondary immune response). In these cases, determination of specific IgA can facilitate diagnosis of the acute Zika virus infection.
Studies have shown that although not all patients with an acute Zika virus infection exhibit specific IgM and specific IgA antibodies, all tested samples were reactive for at least one of the two parameters. Therefore, combined testing for IgM and IgA is beneficial for reliable diagnosis of acute infections.
In the study, serum samples of 31 patients with confirmed acute Zika virus infections from the Dominican Republic, where Zika and dengue viruses are endemic, and 40 patients from Vietnam with acute dengue virus infection were tested with the new ELISA. The Anti-Zika Virus IgAM yielded a sensitivity of 100% (31/31) and a specificity of 95% (38/40). In comparison, the Anti-Zika Virus IgM demonstrated a sensitivity of 29% (9/31) and a specificity of 100% (40/40). Thus, combined detection of both antibody classes instead of just IgM leads to a threefold increase in the sensitivity for acute Zika virus infections without a significant loss of specificity.
Early diagnosis of acute infections with Zika viruses is particularly important for pregnant women since the virus may interfere with the neurological development of the fetus and can cause microcephaly. However, also in adults the viral infection may have long-term neurological consequences. Therefore, timely recognition of this infectious disease is required.

Read more