Carnitine/acylcarnitines screening is the most important part of the clinical laboratory diagnosis of amino acid, fatty acid or organic acid metabolism disorders. Carnitine / acylcarnitines screening allows the diagnosis of over 30 metabolic diseases from a drop of blood sample taken with a screening card. This screening test is performed by measurement of carnitine / acylcarnitines with isotope dilution tandem mass spectrometry. LC-MS/MS is a powerful tool that gives results for carnitine / acylcarnitines in 1.5 minutes. The screening can be performed by the Zivak Carnitine / Acylcarnitine LC- MS/MS Analysis Kit and Zivak NeoZin screening software. The main methods and procedures that have been selected are based on EN ISO 14971. The quantitative analysis of carnitine esters including free carnitine, C0, C2, C4, C6, C8, C10, C12, C14, C16, C16 OH, C18, C18 OH carnitine reveals disorders which are related to fatty acid oxidation. The quantitative analysis of carnitine esters including C3, C3DC, C4OH, C5, C5OH, C5DC carnitine reveals disorders which are related to organic acid metabolism.

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Ortho Clinical Diagnostics received CE Mark approval for its VITROS HIV Combo test. An important addition to the company’s infectious disease portfolio, the new test is available for purchase in Europe and other countries that accept CE Mark since June 2016. The VITROS HIV Combo, a fourth-generation assay, detects both HIV-1 and HIV-2 antibodies and the p24 antigen, enabling HIV-1 acute infection detection earlier than third-generation assays. According to estimates by the World Health Organization (WHO), 37 million people worldwide are living with HIV today. Starting antiretroviral treatment as soon as possible after diagnosis can help avert millions of AIDS-related deaths and new infections. According to the U.S. Centers for Disease Control and Prevention, identifying patients in the early stages of infection is crucial. With the launch of the VITROS HIV Combo, test laboratories can provide earlier detection of HIV for the benefit of their patients. An assessment of the clinical and technical performance of the VITROS HIV Combo on VITROS Systems during routine use at two external testing laboratories in Europe and at Ortho’s research and development laboratories confirmed it provides competitive sensitivity and specificity when compared with a leading commercially available fourth-generation test. In the comparison studies, assay sensitivity was evaluated on seroconversion panels — VITROS HIV Combo showed earlier detection of acute HIV infection in five of 34 seroconversion panels (agreement for 28 of 34 panels), indicating that the assay performance is very competitive in shortening the diagnostic window (the time between HIV infection and detection) – a valuable attribute in HIV testing. The assay’s class-leading p24 sensitivity and uncompromised specificity is enhanced by the proprietary technologies and benefits only available on VITROS Systems – Intellicheck Technology with its suite of quality checks (MicroSensor, SMART Metering) and VersaTip technology – a combination that provides laboratories the accuracy needed to have the utmost trust in their results.

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ELITechGroup Molecular Diagnostics announces the CE-IVD marking of the STI ELITe MGB Panel: a multiplex assay for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG), three major bacteria involved in sexually transmitted infections. STIs are a global burden with more than 1 million infections acquired every day worldwide.  Accurate and specific detection is important to reduce transmission and complications. In combination with the ELITe InGenius system, the STI ELITe MGB Panel makes it possible to simultaneously detect and differentiate in one single reaction Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium. Patient samples can be directly loaded into the system, which automatically performs all the steps of molecular diagnostics from extraction to result interpretation with minimal hands-on time. The clinical study has demonstrated excellent performance: respectively 96.4%, 100% and 100% diagnostic sensitivity and 100%, 98.4% and 98.4% specificity with C. trachomatis, N. gonorrhoeae and M. genitalium. STI ELITe MGB Panel is the 22nd CE-IVD assay of ELITe InGenius’ menu and the first one intended to diagnose sexually transmitted infections.  Recently identified, M. genitalium is highly prevalent in the general population, and share similar symptoms with C. trachomatis and N. gonorrhoeae, but their specific antibiotic treatments are not fully efficient to cure M. genitalium and generate antibiotics resistance strains. Co-detection of Mycoplasma genitalium, along with Chlamydia trachomatis, Neisseria gonorrhoeae improves the efficiency of STI diagnosis and patient management. ELITe InGenius offers a unique menu with quantitative and qualitative assays for transplant pathogen monitoring, healthcare associated infections, respiratory infections, meningitis, sexually transmitted infections, and the testing of coagulation factors.

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The Aquila 3-part differential hematology analyser (60 samples /hour throughput) can be used in many testing locations where high-quality complete blood count (CBC) results are desired. The instrument provides an optimal testing solution for both the experienced and inexperienced user, and practices which require a high-quality hematology analyser. Specifically designed for the decentralized laboratory and near-patient testing situations, this small analyser has low reagent consumption (<12ml), requires only a small sample size (20µl) and has a unique on-board reagent pack (sufficient for approximately 200 measurement cycles). With a small footprint, the analyser can be used in many locations, including small laboratories and in point-of-care applications. The low instrument reagent consumption coupled with its on-board reagent pack ensure that the shipping, storage and usage of reagents deliver enhanced ease of use as well as significant cost reductions. The newly available analyser, while requiring little bench space, features a large touch screen, an intuitive user interface, an optional back-up battery pack and extended connectivity options.
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The FastPack IP System is a fully automated quantitative immunoassay analyser designed for use in any size physician office laboratory. Utilizing sophisticated chemiluminescence technology, it provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button. The FastPack IP System is versatile and requires minimal space while offering a test menu that will make a clinical impact at the point-of-care. Assays include Vitamin D, Testosterone, TSH, Free T4, PSA and hCG. The system is simple to use with no specialized training required and “One Touch” operation providing an easy to use format. The innovative reagent pack contains all assay reagents for no chemical exposure with minimal hands-on time. No system maintenance is required. “On Demand” results increase office efficiencies by decreasing patient call-backs, while patient side answers allow for the adjustment of replacement therapy on the spot. The system requires minimal space, yet provides laboratory accuracy and precision at the simple push of a button. It utilizes monoclonal antibody technology coupled with a patented chemiluminescence substrate for true laboratory performance.

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