The Multisure HCV antibody test is intended to fill the gap that exists in the current Hepatitis C diagnosis and may provide additional information about the infection profile. MP Diagnostics Multisure HCV is a qualitative multiparameter immunochromatographic assay, intended for the detection and differentiation of Hepatitis C antibodies that may be present in patients with acute or chronic Hepatitis C infection. This innovative test is developed based on the patented reverse-flow technology, giving greater sensitivity and stronger visual signals. The multiparameter platform test uses human whole blood, plasma or serum. The test has a short test-time and can detect & differentiate HCV antibodies against both structural and non-structural proteins across all six genotypes. Multisure HCV Antibody Assay is instrument-free, easy to use and is suitable for use as Point-of-care or with automation and does not require highly trained personnel to perform the test. The test has excellent correlation with PCR, EIA & immunoblot. It allows medical professionals to get additional information about the infection profile as well as stage; patients may be able to receive earlier diagnosis, timely treatment and thereby a better disease management.

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Human African Trypanosomiasis (HAT) or sleeping sickness is a life threatening neglected tropical infection affecting rural population in sub-Saharan Africa. The disease causes severe neurological disorders often leading to death if not treated. Since years, HAT control has been facilitated by the Card Agglutination Test for Trypanosomiasis (CATT/T.b.gambiense), which is particularly suited for large scale screening. But now, with the steadily decreasing prevalence of HAT, specificity becomes a critical parameter. Furthermore, the target population lives in precarious conditions (without electricity) and this test must be robust enough to be carried out in very difficult conditions. A new diagnostic test stable at ambient temperature, cheap and that can be performed with minimal training is the best solution.  To fulfil all these requirements, Coris BioConcept has developed the “HAT Sero K-SeT”, which has been successfully validated in the DR of Congo (specificity of 98,6 % ; sensitivity of 98,5 % ; n=493).

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Mainly intended for use in blood banks or laboratories, the Enzygnost HIV Integral 4 is an HIV combination test (or HIV Combo test), a type of assay that detects both the HIV p24 antigen and HIV antibodies, and is increasingly becoming the standard screening technique used by healthcare authorities in many countries within the European Union. The assay delivers both excellent specificity and sensitivity. In a study of 14,169 donor samples tested at three different blood banks, initial specificity was demonstrated at 99.94 percent. Data also show that the HIV Integral 4 assay has higher sensitivity and provides superior seroconversion performance (quicker prevalence of the antibody) compared to other currently available assays, detecting HIV infection up to 14 days earlier. The new assay is available on the Quadriga BeFree and BEP Siemens laboratory systems.
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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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A new series of reagent kits is specifically designed for in vitro diagnostic use in conjunction with mass spectrometry instrumentation for clinical analysis. The first kit is focused on vitamin D analysis and is CE marked to meet European regulatory requirements. Highly selective and sensitive, MS provides routine diagnostic testing laboratories in Europe with the ability to quantitate multiple trace level compounds in a single analysis with high confidence in the results. The first kit in the new SCIEX IVD-MS portfolio to harness this advanced technology for routine clinical applications is the SCIEX IVD-MS Kit for 25-OH Vitamin D Analysis.  This kit is designed to help clinicians make diagnoses of vitamin D deficiencies, with the ability to quantitate both 25-OH-Vitamin D2 and 25-OH-Vitamin D3 in a single run. Adequate levels of vitamin D have been known for decades to be essential for strong bones.  Recent research has linked vitamin D to be important in the prevention of multiple common and serious diseases, such as type 1 diabetes, cancer and heart disease. The new SCIEX IVD-MS kits work with the AB SCIEX 3200MD CE-IVD series of MS systems – including the API 3200MD and 3200MD QTRAP LC/MS/MS systems – which the company launched recently in Europe.
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