The EDAN i15 portable blood gas and chemistry analyser is specifically designed for quickly measuring various panels of time sensitive tests in critical care settings, e.g. emergency room, intensive care units, anesthesia, respiratory and the operating room. The key features and advantages of the state of the art system include zero maintenance, automatic aspiration of sample, colour graphic display and touch screen intuitive user interface, on-board 2D barcode scanning for patient ID, operator ID, cartridges and QC control information and WIFI network connectivity to HIS/LIS facilities, making it an ideal solution for point of care testing.
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As Europe’s first non-invasive molecular diagnostic blood test for the determination of fetal chromosomal aneuploidies from maternal blood, PrenaTest has now successfully been validated for use in multiple pregnancies. It is the only blood test that can be used without any restriction following all methods of fertility treatment, such as IVF or egg donation, after the 9th week of gestation. The number of multiple pregnancies has steadily increased over the last years due to an increased use of fertility treatments especially with women of higher age. For these, PrenaTest is a valuable and risk-free improvement for the determination of fetal chromosomal aneuploidies given the significantly increased risk for miscarriage following an invasive diagnostic procedure like amniocentesis, compared to such risk in case of singleton pregnancies. In addition, conventional non-invasive examinations such as first trimester screening show a two to three fold increase with respect to the false positive rate. In addition, the innovative PrenaTest express is now available in other European countries, too. Th is express version of the PrenaTest provides the test results in one week and thus shortens the stressful waiting period for pregnant women to a minimum. PrenaTest determines the fetal trisomies 21, 18 and 13 from maternal blood reliably, rapidly and safely. It has successfully been validated in a total of 870 samples from singleton and multiple pregnancies in several studies and provides a clear result in 99.8 % of all performed analyses. With its low false positive rate of 0.1% it further clarifies early diagnosis of fetal malformation and therefore reduces the number of unnecessary invasive examinations of non-affected pregnancies. PrenaTest is for pregnant women who are in the 9th week of gestation (W 9 + D 0) and who have an elevated risk of trisomies in the unborn child. Several statutory as well as private health insurance funds in several countries already cover the costs for the analysis. The PrenaTest analysis is exclusively performed in Germany (Constance) in strict compliance with the high quality standards required by the European In Vitro Diagnostic Directive.
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Having recently received U.S. Food and Drug Administration (FDA) 510(k) clearance, the Access Total βhCG (5th IS) assay is the first βhCG assay standardized to the highly purified World Health Organization (WHO) 5th International Standard (IS) for chorionic gonadotropin, a glycoprotein hormone most commonly measured for pregnancy determination. The assay is critical in routine and emergency diagnosis as it is frequently ordered on women of childbearing-age who require treatment which could potentially be harmful to a fetus. The assay features a broad dynamic range with automatic onboard dilution capability, reducing the need for manual sample dilutions. As a part of the standardization, reference ranges have been updated to include additional populations that cover women over the age of 40 and post-menopausal women. Additionally, in response to changing laboratory environments and the challenges faced in collecting serum samples, the Total βhCG (5th IS) assay has been improved to make it more resilient to pre-analytical factors. Access reproductive solutions are part of a comprehensive assay menu featured on the Access and UniCel Immunoassay Systems.
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Early detection and treatment of inherited metabolic disorders in newborns can lessen the severity of health problems, which could cause mental and physical disabilities or death, if undetected. The window of opportunity to determine if a baby is at risk of a serious or life-threatening condition before symptoms begin is small; therefore, test results for indicators of these disorders must be accurate, comprehensive and timely. To address this challenge, a newborn screening assay is now available in Europe only and is specifically designed for in vitro diagnostic use in conjunction with AB SCIEX mass spectrometry instrumentation for clinical analysis. With the new SCIEX IVD-MS kit for newborn screening, clinical diagnostic laboratories in Europe will be able to analyse panels of amino acids and acylcarnitines simultaneously – rather than one by one, as commonly done in hospitals today – and obtain information about indicators of multiple metabolic disorders from the same sample in a single run. Tandem mass spectrometry makes it possible to detect extremely low concentrations of compounds that can be used to indicate whether a baby is likely to have an inborn metabolic disorder. For example, mass spectrometry can be used to measure the markers for early screening of Phenylketonuria, or PKU. Babies diagnosed with PKU by their physician can be treated with a special diet of limited amounts of phenylalanine (Phe) to avoid build up in the blood and brain, which reportedly leads to mental disability. PKU reportedly occurs in nearly one out of every 10,000 newborns in most of Europe. With an accurate diagnosis, early treatment significantly decreases the severity of symptoms the child will experience as he/she grows up. Another example is the use of mass spectrometry-based newborn screening to find indicators of Medium-chain acyl-Coenzyme Dehydrogenase deficiency (MCAD). Twenty-five percent of children with undetected MCAD die the first time they have an illness. However, if the disorder is detected within days of birth, a treatment as simple as frequent meals and avoidance of fasting would set the child on a path to good health. Studies have shown that MCAD is most common among Caucasians from Northern Europe and includes numbers potentially as high as one out of every 4,900 in Northern Germany. The SCIEX IVDMS kit for amino acid and acylcarnitines in dried blood spots will be a fully validated mass spectrometry method with all the reagents necessary to prepare the sample for MS injection. Using these kits, healthcare professionals will be able to test dried bloodspots from a heel prick on newborns and run the test on an AB SCIEX 3200MD CE-marked IVD system where measurements of the analytes are translated into clinically relevant results, generated with easy-to-use software.
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New M. pneumoniae + C. pneumoniae Duplex Real-Time PCR kit allows rapid and accurate detection of these pathogens in less than an hour run time and with <10 copies sensitivity.

Labsystems Diagnostics combines detection of C. pneumoniae and M. pneumoniae in a multiplex kit for simultaneous detection of both bacteria in a single tube reaction. Detection of a genomic DNA target is included in all kits as an internal control for sample validity, extraction and amplification. A separate positive control is included as well.

The assays have shown no cross-reactivity with other respiratory pathogens such as B. pertussis, B. parapertussis, H. influenza, L. pneumophila, S. pneumoniae, M. tuberculosis, Influenza A/B or M. genitalium, M. bovis, M. fermentas, M. arginini and C. trachomatis.

Suitable sample types are sample transfer medium, nasal aspiration biopsy, respiration biopsy, nasal swab and BAL.

The new assay is adaptable to most Real-Time PCR instruments with commonly used fluorescence channels.
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