Awareness Technology, Inc. has announced FDA clearance and release of ChemWell RPR for reliable and cost-effective syphilis screening. ChemWell RPR replaces the manual labour-intensive and subjective visual rapid plasma reagin (RPR) reading with a fully automatic, 190 results-per-hour process that objectively interprets and stores photographic images. This allows laboratories to use the US CDC recommended traditional nontreponemal screening algorithm instead of the higher-cost and complicated reverse algorithm while reducing hands-on time by 92%, compared to a manual RPR test. RPR yields fewer false positives and is therapeutically useful unlike treponemal testing, The innovative system was developed in cooperation with Arlington Scientific Inc. (Salt Lake City, Utah USA) who is selling in North America and Europe under the brand name Evolution. Awareness Technology will supply the rest of the world through its distribution and technical service channels.

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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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Beckman Coulter recently announced the release of the DxH 900 hematology analyser, giving mid- to high-volume clinical laboratories the ability to perform complete blood count (CBC) and white blood cell differential tests with minimal repeats. The DxH 900 is now available for sale in Europe, the United States, Canada, Australia and New Zealand. The DxH 900 analyser offers advanced technologies to support patient care, by delivering the right results the first time. Foundational to the system are its core technologies, including the enhanced Coulter Principle, VCS 360 and DataFusion. These features offer high-resolution analysis of cells in their near-native states, providing a precise cellular assessment for excellent red blood cell, platelet and white blood cell test results on the first pass. The suite of technologies is intended to help laboratories deliver quality results for fast, accurate clinical decision-making. At the same time, the system includes automated solutions that streamline the number of procedural steps needed to produce those results, offering predictable performance and greater laboratory efficiency. The DxH 900 analyser demonstrates 93% first-pass throughput, providing accurate flagging and reducing the number of slide reviews. This helps to generate reportable results as quickly as possible, reducing the time, supplies and costs that may be required for systems with higher repeat rates. Adding to this is the analyser’s lean reagent portfolio, which includes four reagents compared to eleven reagents required by other analysers. Further, the DxH 900 features one of the smallest footprints in its class, making it highly efficient in utilization of laboratory space. Many of the parameters available with the DxH 900 analyser are designed to directly impact patient care by addressing critical conditions, such as thrombocytopenia, anemia and leukopenia. Beckman Coulter is evaluating a hematology sepsis parameter that is part of a routinely ordered test in the emergency department, where earlier recognition and treatment of sepsis can begin. This test can be performed on the DxH 900 analyser (see below). The DxH 900 hematology analyser complements the recently announced DxH 520 system, and further expands Beckman Coulter’s hematology portfolio.
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In 2016, 91 countries reported a total of 216 million cases of malaria, an increase of 5 million cases over the previous year. The global tally of malaria deaths reached 445,000 deaths, about the same number reported in 2015. Although malaria case incidence has fallen globally since 2010, the rate of decline has stalled and even reversed in some regions since 2014. Mortality rates have followed a similar pattern. Early and accurate diagnosis of malaria is essential for both rapid and effective disease management and surveillance. High-quality malaria diagnosis is important in all settings as misdiagnosis can result in significant morbidity and mortality. The proportion of febrile children presenting for treatment is mainly taking place in Public Health facilities (from 2013-2015, 35-50 % febrile children presented in sub-Saharan Africa countries). With a clinical sensitivity and specificity reaching 80% of data results performed on P. vivax and P. falciparum, the Malaria flag of HORIBA Medical delivers a Suspicion Malaria Infection screening provided in routine use on hematology analysers. It is combined with the hematology whole blood count and not a separate test with additional costs. This Suspicion Malaria flag is generated by a complex algorithm using the “data mining” technique based on the analysis of many analytical variables of the complete hemogram and not only variables of the automated formula. The Malaria flag is used as a screening test and invites the biologist to implement the usual laboratory techniques for the diagnosis of malaria. The Suspicion Malaria Flag option is available on the ABX Pentra XL 80 and Pentra XLR range and, hence, offers a cost effective and fast malaria screening. Since complete blood count (CBC) and leukocyte differential count (DIF) are the basic, most common tests in clinical laboratories, hematology analysers that can screen for the presence of malaria parasites offer a significant advantage for both potentially malaria-infected patients and busy diagnostic labs. HORIBA hematology systems combine micro sampling, efficiency, robust technology, intuitive software as well as high throughput (rapid one-minute whole blood testing) at costs lower than other methods, such as microscopic examination.

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