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.
Read more

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.
Read more

Measurement of fecal calprotectin allows reliable discrimination of patients with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS), an early detection of relapse in IBD-patients as well as an objective therapy monitoring. RIDASCREEN Calprotectin comes equipped with an economical calibrator for evaluation by 1-point calibration. Each kit additionally contains a set of 5 standards for quantitative determination of fecal calprotectin (FC) by means of a standard curve. The test is validated for manual as well as automated use. Optionally the RIDASCREEN stool collection tubes are available. They are prefilled with extraction buffer which allow for fast, clean and precise sample collection.
Read more

The management and control of anticoagulant therapy and the assessment of pre and post surgical states, among others, require a proper evaluation of the coagulation cascade. Several tests help the physician in the diagnosis of altered coagulation states and management of coagulopathy. Biosystems’ recently launched coagulation reagents line includes the main diagnostic tests: Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen and Thrombin Time. These reagents can be used in semiautomatic and automatic coagulation instruments, independently of the kind of clot detection method (optical and mechanic). Additionally, they are characterized by high stability and a good performance using low volume consumption.
Read more