Bio-Rad Mission: Control is the first objective risk management soft ware to help laboratories identify the best QC rules and the right QC frequency to develop a customized quality control plan to deliver reliable test results. Bio- Rad Mission: Control uniquely quantifies a laboratory’s risk tolerance, going beyond traditional subjective risk assessments. It allows a lab to establish a QC plan that is consistent with the CLSI EP23-A guideline and better assess the risk of reporting incorrect patient test results back to the physician.
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Serological tests for Zika virus (ZIKV), dengue virus (DENV) and chikungunya virus (CHIKV) allow differential diagnosis of infections, especially beyond the short viremic phase when direct detection is no longer effective. These infections are difficult to tell apart clinically, as they manifest with similar symptoms and are endemic in much the same regions. Antibodies against DENV, ZIKV and CHIKV are detectable from around day four to seven after symptom onset. Primary infections are characterized by the occurrence of IgM antibodies, with IgG appearing shortly afterwards. In a secondary flavivirus infection, IgM may be delayed, of reduced intensity or not detectable at all. In these cases a significant increase in the IgG concentration is indicative of an active infection.
ZIKV antibodies can be detected specifically using ELISA based on recombinant ZIKV NS1 protein. This highly specific antigen avoids cross-reactivity with other flavivirus antibodies which may be present from previous infections or vaccinations, e.g. DENV, West Nile, yellow fever, tick-borne encephalitis and Japanese encephalitis viruses. A combination of Anti-ZIKV IgM and IgG ELISA provides an overall sensitivity of 97% at a specificity of 100%. In DENV infections, detection of the highly specific early antigen NS1 by ELISA serves as a first-line screening test in both acute primary infections and re-infections with another DENV serotype. Antibodies against DENV serotypes 1 to 4 are detected using ELISA based on highly purified virus particles, while CHIKV antibodies are determined using ELISA based on a virus-specific structural protein.
Indirect immunofluorescence tests (IIFT) with virus-infected cells are also suitable for detection of DENV, ZIKV and CHIKV antibodies. However, cross reactions between flavivirus antibodies should be taken into account. Arbovirus BIOCHIP mosaics combine different substrates in one test field and aid clarification of cross reactivities, supporting differential diagnosis.

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Orion GenRead, the small benchtop system for pathogen detection, brings fast and accurate results within reach of a wide range of laboratories. The small sized instrument is portable and allows also mobile use as it can be battery operated. This easy to use solution combines reliability with user friendliness for flexible daily routines in laboratories.

The Orion GenRead system is based on SIBA^® technology, Orion Diagnostica’s proprietary isothermal nucleic acid amplification technology. SIBA technology allows accurate detection of pathogens and brings molecular testing outside of conventional PCR laboratories. The first test kit targets C. difficile. Results are displayed as soon as they are ready, for strong positive samples already in 15 minutes and for all results in less than one hour. Next tests are targeted for other pathogens causing gastrointestinal disease, Salmonella and Campylobacter.
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Like the previous version, the new (unified) GastroPanel is a quantitative ELISA test panel that measures the blood plasma concentrations of four stomach-specific biomarkers: pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17) and Helicobacter pylori IgG antibodies. In the new test version, all four biomarkers are processed under uniform reaction conditions and using common reagents, increasing its acceptance among users, while making the test less labour-intense and reducing the overall processing time. The main indications for use of the GastroPanel remain unchanged. The test is designed for the diagnosis of (1) H. pylori infection (2) atrophic gastritis (AG), and (3) functional disorders among symptomatic (dyspeptic) patients as well as for screening of asymptomatic subjects for gastric cancer risk. Also, the interpretation algorithm has been revised, and is now based on 8 distinct biomarker profiles, 5  of them reflecting morphological abnormalities and 3 others a functional disorder.   

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The Iris iRICELL workcell integrates urine chemistry and microscopy into a fully automated walk-away urinalysis system that is easy to use and maintain. The integrated workcell combines the iQ200 Series automated microscopy system with the iChemVELOCITY automated urine chemistry system. The iQ200 Series delivers clear, clinically relevant urine particle images that are auto-classified for more objective and consistent results. This automated microscopy system is designed for all volume workloads, delivering a shorter turnaround time and standardizing results. The iQ200 Series are available either as a stand-alone system or connected to an iChemVELOCITY urine chemistry analyser to form an automated iRICELL workcell. The iQ200SPRINT is one of the fastest automated systems on the market, meeting high-volume productivity and workload requirements. It can handle 101 microscopic samples an hour. The IQ200ELITE manages medium- to high-volume workloads running 70 microscopic samples an hour; with the iQ200SELECT more suitable for lowvolume workloads running 40 microscopic samples an hour. iChemVELOCITY provides a fully automated, high-capacity urine chemistry analysis with excellent low-end sensitivity. The system delivers a high throughput of 210 samples an hour, with the continuous strip loading and a capacity of 300 strip loads. It has a pad on the strip designed to detect and measure the presence of ascorbic acid. This provides clinically significant information about potential interference with key chemistry assays. The system evaluates all standard urine chemistry parameters, including glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocyte esterase.

<sup>Utility of reflex urine culture based on results of urinalysis and automated microscopy


Specimens submitted for urine culture in hospital settings are frequently negative for bacteria. Various approaches have been developed to select urine samples in the laboratory to improve the efficiency of handling these samples. At a time of concern for cost containment, utilization of a reflex testing policy using specific screening criteria would be beneficial to eliminate unnecessary urine cultures. With this in mind, an evaluation of Beckman Coulter’s IRIS iQ200 system (urinalysis and automated urine microscopy) was carried out in the US at the Johns Hopkins Bayview Medical Center (JHBMC) clinical microbiology laboratories. The study prospectively collected and reviewed 1248 clinical urine specimens submitted for urinalysis and/or urine culture. It investigated the IRIS iQ200’s utility in aiding a predictive algorithm for the implementation of reflex urine cultures. Findings showed that these test parameters, separate or combined, may be a useful screening method to determine the need for a reflex urine culture.</sup>
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