BioSystems is introducing new models of semi-automated coagulometers aimed at small to medium-sized laboratories. The COAX family includes 1, 2 or 4 optical channel devices. Operation is very intuitive, with a high quality colour touchscreen, allowing easy patient data management. Including state-of-the-art optics, the instrument uses disposable cuvettes with automatic light level adjustment at each channel to avoid optical disturbances, and a high optical resolution that allows high accuracy. The absorbance of the reaction is monitored continuously so time control starts immediately after reagent addition (thus, not requiring special pipettes as triggers). Also, thanks to their neat design making them easy to clean, as well as their minimum maintenance requirements, the instruments meet the typical needs of small and medium-sized labs. For all devices in the COAX series, BioSystems offers a complete range of the most common tests: PT, APTT, FIB and TT, validated lot to lot to achieve maximum performance. Besides, COAX2 and COAX4 are able to read additional tests using either chromogenic or latex reagents, such as individual coagulation factors, Antithrombin III, Protein C or D-Dimer.

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PCSK9 protein (proprotein convertase subtilisin/kexin type 9) plays a major regulatory role in cholesterol homeostasis, mainly by reducing LDL-Receptor levels on the surface of hepatic cells. Reduced LDLR levels result in decreased metabolism of LDL-particles, which could lead to hypercholesterolemia. This activity made PCSK9 a novel target in cholesterol lowering therapy. The PCSK9 inhibitors (PSK9i) are a newer class of injectable drugs that have been shown to dramatically lower LDL cholesterol levels, by up to 60% when combined with a statin. PCSK9 inhibitors are monoclonal antibodies (MAbs), a type of biologic drug. PCSK9 has a key impact not only on circulating LDL-Cholesterol level but also on cardiovascular risk and atherosclerotic process. The determination of PCSK9 levels is obviously of great diagnostic as well as treatment monitoring importance. Applications include atherosclerosis, cardiovascular disease, lipid metabolism and diabetology.
BioVendor’s Human PCSK9 ELISA (RD191473200R) is a sandwich enzyme immunoassay for the quantitative measurement of PCSK9 in human serum and plasma samples (EDTA, citrate, heparin) using a 96-well assay format. The total assay time is less than 3.5 hours. Standard is recombinant protein and components of the kit are provided ready to use, concentrated or lyophilized. Limit of detection is 9 pg/ml.

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The rapid detection of antimicrobial resistance represents a major challenge for hospitals. Lateral flow immunochromatographic assays developed by Coris BioConcept are the ideal solution to save time, money and lives.

Enterobacteriaceae are Gram-negative bacteria mostly naturally living in our intestine. They are also largely described in serious infections such as sepsis, peritonitis, cystitis or pneumonia, often acquired in a healthcare environment such as the hospital. Antibiotics from the beta-lactam family are commonly used to treat those nosocomial infections. However, regarding their ability to adapt to any changing environment, bacteria have developed lots of mechanisms to counteract the action of beta-lactam molecules, such as the production of enzymes able to specifically hydrolyse them. These so-called beta-lactamases are typically found in Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli and many other bacteria. They confer a high level of resistance to a wide range of beta-lactam type of antibiotics. To face those resistant strains, carbapenems have been successfully used for years as the last resort medicine. However, carbapenemase-producing enterobacteriaceae (CPE) have now emerged, expressing new hydrolysis enzymes to deactivate carbapenem-like molecules. CPE outbreaks in healthcare facilities leave few alternative antimicrobial solutions and are therefore often associated with morbidity, mortality and tremendous care costs.

Fast identification of carbapenemases
Different types of carbapenemases have been described all over the world, the most worrying one being variants from the OXA-48, KPC, NDM and VIM families. Like described for other resistance, those bacterial enzymes are encoded by genes present on extra-chromosomal plasmids. This facilitates exchanges between Gram-negative bacteria and explains the successful worldwide transmission of those dangerous carbapenemases. Patients carrying and/or having clinical infections with CPE can be considered as reservoirs for transmission to other patients. Since warning campaigns from multiple global health organizations, almost every country in the world has now drawn up governmental guidelines for a proper control and management of CPE infections in hospitals.

As soon as identified, resistant strains should be quickly contained to avoid any spreading outside the facility, and the medication should be adapted for the recovery of the patient. A rapid detection of CPE at the clinical laboratory level is therefore essential to prevent infection spreading, isolate the facility and cure the patient. To this end, microbiological culture is largely used because of its simplicity and low cost. However, antimicrobial resistance profiles have been more and more variable and complicated to interpret, forcing laboratories to increase the amount of analyses and consequently the time to result. Confirmatory CPE phenotypic tests have emerged during the recent years, like colorimetric-based tests. But still they do not allow the precise identification of the carbapenemase type, are difficult to interpret, and require an additional day following the first culture. Mass spectrometry-based methods for routine CPE detection are not yet conventionally used since they require access to dedicated instruments. Decrypting antimicrobial resistance at the DNA level using molecular techniques is another solution, but unfortunately not available in every laboratory due to extra costs, time and staff required.

Rapid diagnostic solutions
Alternatively, the Belgian company Coris BioConcept has developed a range of lateral flow assays to help microbiological laboratories speed identifications of resistant strains. Those tests, named “RESIST” are available in the market since 2015. The novelty of the RESIST tests lies in the precise identification of carbapenemase proteins using specific monoclonal antibodies. Lateral flow assays are fast, providing results in less than 15 minutes directly after bacterial isolation on primary microbiological cultures. Moreover, results can be read with the naked eye, meaning that no specific equipment is required. This technology is also low cost and easy to handle.

Since RESIST tests have proven high performances (100% specificity and sensibility), they are nowadays highly recommended by Reference Laboratories for routine CPE analysis. Covering all variants from the 4 main OXA-48, KPC NDM and VIM carbapenemase families, RESIST tests have opened access to accurate, fast and cost-effective solutions for the identification of CPE’s. Today, the RESIST line includes up to 5 different single and multiplex CPE detection kits and is likely to expand in tests for the detection of other clinically important resistance mechanisms in Gram-Positive and Gram-Negative bacteria. Also complementary to primary microbiological cultures, Coris is progressing on using those rapid tests directly from patient samples in order to screen incoming patients and to shorten the time to CPE detection and consequently allow a faster and more efficient control and management of outbreaks in every healthcare facility around the world.

www.corisbio.com

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A new range of ELISAs provides differentiated analysis of antibodies against Coxiella burnetii, the causative agent of Q fever. According to Immunological Methods for the Detection of Infectious Diseases (MiQ. 2017), separate detection of antibodies against phase 1 and phase 2 antigens of C. burnetii is recommended to aid discrimination of acute and chronic infections. Acute primary infections are characterized by IgM and later IgG antibodies against phase 2 antigens, while antibodies against phase 1 antigens occur only in chronic infections. Three new ELISAs from EUROIMMUN provide sensitive detection of IgM or IgG antibodies against phase 2 antigens or IgG antibodies against phase 1 antigens and thus support the differentiation of acute and chronic C. burnetii infections. In evaluation studies with precharacterized sera the three ELISAs demonstrated high sensitivities and high specificities, underlining their suitability for use in screening analyses. The ELISAs are fully automatable.

Q fever occurs worldwide and is transmitted to humans by direct or indirect contact with infected animals, consumption of unpasteurized milk or bites from infected ticks. Acute infections manifest with mild flu-like symptoms, whereby complications such as atypical pneumonia or remittent fever can occur. Chronic courses are characterized by infection durations of more than six months and mostly lead to chronic endocarditis. Diagnosis of Q fever is based primarily on serological methods.

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