Oxcarbazepine is a pro-drug indicated for treatment of partial seizures, a form of epilepsy. Serum concentrations (3-35 mg/L) of the active monohydroxy derivative (MHD) metabolite are associated with clinically effective control of partial seizures. Toxic side effects may occur more commonly at concentrations greater than 35 mg/L. Therapeutic drug monitoring (TDM) is justified when changes are expected that might alter MHD clearance including pregnancy, concomitant use of liver enzyme inducing drugs, or renal insufficiency. The ARK Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of MHD in human serum on automated clinical chemistry analysers. The ARK Oxcarbazepine Metabolite Assay is available for export outside the US. It has not received clearance/approval by the U.S. FDA.
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The Endura MD mass spectrometer LC-MS for in vitro diagnostic use delivers excellent sensitivity for a wide range of compounds and matrices and minimizes signal noise by removing more solvent vapour and blocking neutrals. The instrument provides five orders of dynamic range for accurate quantitation of even low-concentration or limited samples and features ultrafast selected-reaction monitoring (SRM) so more transitions can be monitored for greater confidence. It accommodates both HESI and APCI probes, which can be operated in either positive or negative ion modes to meet varied analytical demands.

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Infections by carbapenemase-producing Enterobacteriaceae (CPE) are the cause of major public health concern worldwide and their detection is very challenging for diagnostic laboratories. Classical identifications need 48 to 72 hours with cultures and susceptibility testing followed by phenotypic and molecular methods. Development of new rapid diagnostic tests to track antimicrobial resistance patterns is considered as a priority core action. Non-molecular confirmatory testing of Class A (KPC) and B (VIM, IMP, NDM) carbapenemases already exists but not for detection of Class D carbapenemase (OXA-48-like). Phenotypic colorimetric assays are not able to confirm OXA-48 presence, while molecular tests need a dedicated environment, skilled staff and are expensive. Coris BioConcept has developed a new assay for identifying OXA-48 carbapenemase in collaboration with the CPE Belgian National Reference Centre of CHU Dinant-Godinne UCL. This test is performed directly from a single colony and represents the first non-molecular confirmatory assay for OXA-48 detection with results available in minutes.

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DiaSorin has further expanded its range of infectious disease assays for use on the DiaSorin Liaison Iam analyser with the launch of a new molecular assay for the rapid and reliable detection and quantification of cytomegalovirus (CMV).  CMV is the most prevalent infectious pathogen in solid organ and bone marrow transplant recipients, and can lead to allograft rejection and other serious complications. The DiaSorin Iam CMV assay is used to detect and quantify clinically relevant subtypes of CMV in human plasma, urine and cerebrospinal fluid (CSF), making it a valuable tool for the diagnosis and monitoring of CMV infection in transplant recipients and other immunocompromised individuals. Reactivation of latent CMV infection can occur in immunocompromised individuals. With increasing numbers of transplant recipients, as well as expanding indications for immune-modulating agents, the number of people at risk of CMV disease and related complications is increasing. The direct and indirect effects of CMV infection can have a significant impact on outcomes for transplant recipients. Furthermore, CMV is a major cause of morbidity in AIDS patients and in others with impaired immunity, for example due to sarcoidosis, lymphoma and corticosteroid therapy. Clinical manifestations amongst these patient groups include retinitis, pneumonitis, gastrointestinal disease and neurological disorders. Based on the innovative DiaSorin Q-LAMP technology, Iam CMV is the latest addition to an expanding portfolio of infectious disease assays for use on the DiaSorin Liaison Iam analyser. It is a molecular assay for the detection of CMV in human amniotic fluid and for the detection and quantification of the virus in human plasma, urine and cerebrospinal fluid (CSF). Iam CMV has been standardized against the WHO CMV International Standard (NIBSC, UK), as recommended in the updated International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation. With excellent intra-run precision (≤ 0.3 log cps/mL) and with diagnostic sensitivity (≥97%) and specificity (100%) comparable to conventional PCR, but with results in a fraction of the time required by PCR, Iam CMV provides a rapid and accurate method for the timely diagnosis and monitoring of CMV infection. The small footprint, ease of use and scalable design of the benchtop Liaison Iam Molecular Instrument makes it ideal for use in laboratory facilities of all sizes, including those that are located close to the patient. In addition to being used for the detection and monitoring of CMV infection in immunocompromised individuals, Iam CMV is also used in the diagnosis of maternal and fetal CMV infection in early pregnancy and for monitoring CMV infection in affected babies. The Iam CMV assay is CE marked and available for use outside of the USA and Canada.

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The FilmArray Gastrointestinal (GI) Panel is a 22-target panel, which includes bacteria, viruses and parasites that cause infectious diarrhea and is the most comprehensive gastrointestinal test to be cleared by the FDA. It contains several pathogens receiving FDA clearance for the first time. The FilmArray GI Panel is performed directly from stool in Cary Blair transport media, takes only two minutes to set up, and produces results in about an hour. The panel brings about a major improvement in the diagnosis of infectious diarrhea, delivering accurate and timely results. The breadth of pathogens on the GI Panel will aid clinicians with treatment decisions in cases of gastrointestinal infectious disease. The FilmArray GI Panel offers clinical laboratories a user-friendly alternative to the time-consuming, labour intensive and technically complex testing methods used today while improving accuracy, timeliness and diagnostic yield. Despite advances in food safety, sanitation and medical treatment, infectious gastroenteritis remains a significant problem in industrialized countries among all age groups. In the United States, between 200 and 375 million episodes of diarrheal illness are estimated to occur each year, resulting in 73 million physician visits, 1.8 million hospitalizations, 3,100 deaths and $6 billion in medical care and lost productivity. Early diagnosis facilitates timely and appropriate therapeutic interventions that can alleviate symptoms and prevent secondary infections.
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