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.
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C337_Coris.jpg6758003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:17:222021-01-08 11:21:16Accurate, fast and low-cost CPE detection
Shimadzu’s Nexera MX ultra-fast multianalyte LC-MS system offers up to double the sample processing capability of the conventional approach. The Nexera MX features two analytical flow lines in a single LC-MS system. This setup maximizes operating efficiency by alternating between the two lines for injecting of samples. Capable of rapidly processing large numbers of samples, the Nexera MX will help to improve the workflow of customers. The Nexera MX system also includes the LabSolutions Insight software, providing assistance with quantitative analysis of large volumes of data. Read more
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/4010_Nexera_MX_CL-3-18.jpg3298003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:17:222021-01-08 11:21:16Nexera MX LC-MS system accelerates workflow and improves analytical efficiency
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.
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C340_Euroimmun.jpg6018003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:17:222021-01-08 11:21:16ELISAs for differentiation of acute and chronic Q fever
The Flu Typing I kit allows the identification and specific differentiation of Influenza A (H1N1) pdm09 and H3N2 subtypes in respiratory samples from patients with signs and symptoms of respiratory infection. Currently, Influenza A (H1N1) and Influenza A (H3N2) are the circulating seasonal Influenza A virus subtypes. This seasonal A (H1N1) virus is the same virus that caused the 2009 influenza pandemic. Influenza A (H3N2v) viruses were first detected in patients in 2011, with infections associated with prolonged exposure to pigs at agricultural fairs. Real-time PCR assays have been shown to be a sensitive and specific diagnostic tool for the detection of the two subtypes of Influenza A (H1N1 and H3N2) that are currently in general circulation among humans. VIASURE Flu Typing I Real Time PCR Detection Kit contains in each well all the components necessary for real time PCR assay in a stabilized format. RNA is extracted from specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for Influenza A (H1N1)pdm09 and H3N2 subtypes. In addition, thanks to the lyophilization process, it is possible to send the kit to any part of the world at room temperature without the need for a cold chain or special conditions, as it remains perfectly functional for two years.
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C355_Certest.jpg4428003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:17:222021-01-08 11:21:16Influenza A real time PCR detection kit
RIQAS is the largest international EQA/PT scheme with more than 45,000 participants in 133 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories. The RIQAS CO-Oximetry EQA Programme is a comprehensive programme suitable for monitoring the performance of 7 CO-Oximetry parameters. All samples are supplied in a liquid ready-to-use format ideal for both clinical and point-of-care testing (POCT). It’s convenient liquid ready-to-use format saves time and reduces the chance for user error while monthly reporting allows your lab to detect errors before they spiral out of control. Highly consolidated, covering 7 CO-Oximetry parameters, the RIQAS CO-Oximetry programme offers a streamlined approach to your EQA, allowing you to test your whole CO-Oximetry menu.
The new Nexera Mikros, a micro flowrate-compatible liquid chromatograph mass spectrometer, maintains the durability and operability of LC-MS systems while providing a significant increase in sensitivity. In pharmaceutical development, analysis occasionally has to be performed on trace amounts only of components in small blood samples. Examples include studies of the pharmacokinetics of new drug substances or their metabolism. In such cases, LC-MS systems compatible with nano flowrates have been utilized, in order to improve the efficiency of the intake of target components to the mass spectrometer. However, nano flowrate-compatible LC-MS systems often suffer from complications in terms of instrument operability and processing speed, such as a tendency for pipes to clog, difficulty in discovering liquid leaks, and the hours required for analysis of a single sample. The Nexera Mikros can accommodate a wide range of flowrates, from semi-micro flowrates (100 to 500 µL/min) which are often used for analysis in existing systems, to micro flowrates (1 to 10 µL/min). With this product, Shimadzu is contributing to improving productivity at pharmaceutical companies and clinical contract research organizations. Nexera Mikros achieves at least ten times the sensitivity for target compounds compared to standard LC-MS analysis. This is due to the LC-Mikros, a solvent delivery pump with a new control system to reduce pulsation and deliver a stable solvent flow even at low micro flowrates. In addition, positioning of the ionization interface has been optimized for more efficient sample introduction into the mass spectrometer. Another specific feature, UF-Link, achieves both high-sensitivity analysis and improved operability. Microscopic gaps (dead volume) in the piping connectors lead to a decrease in sensitivity by causing peak dispersion. UF-Link, a connection mechanism between Shimadzu’s newly developed analytical column and the mass spectrometer, ensures high sensitivity and, at the same time, enables one-touch connection between the analytical column and the ionization interface for the mass spectrometer. In addition, UF-Link is compatible with connections between commonly used analytical columns and the ionization interface, so column selection is flexible to suit the target sample.
The new valveless Waste Transfer Pump from Fluid Metering, Inc. (FMI) was designed for removal of waste fluid generated by medical diagnostic instrumentation during the process of analysing a variety of patient fluid samples. The waste fluid generally consists of, but is not limited to, a mixture of patient samples (blood components, urine samples etc..) combined with reagents, byproducts of reagent reactions and wash fluids. These fluids can have a broad range of physical characteristics, viscosity, suspended solids, human tissue, blood cells, just to name a few. The valveless, brushless DC Waste Transfer Pump utilizes FMI’s innovative CeramPump valveless piston fluid control technology. One moving part, a rotating and reciprocating ceramic piston accomplishes all fluid control functions within the pump, thereby eliminating the need for check valves present in other reciprocating pump designs (diaphragm, bellows, solenoid piston, syringe). The variety of suspended solids and particulates present in medical instrumentation waste often causes check valves to stick, clog, and eventually fail requiring the pumps to be removed from the system and serviced. The sapphire-hard, dimensionally stable ceramic internal components of the CeramPump also substantially outperforms peristaltic pumps relying on flexible tubing. Peristaltic pumps can have integrity issues as flexible tubing over time wears and needs to be routinely replaced, at best, and at worst, can rupture resulting in bio-contaminants leaking out of the system. FMI’s valveless, brushless DC motor Waste Transfer Pump integrates the long-life performance of a brushless motor, with a built-in driver, together with the advantages of FMI’s CeramPump valveless fluid transfer technology. The pump is easily integrated into any existing system design. All that is needed is a simple 24V DC input supply. Flow rates can be factory calibrated from 20 mL/min to 400 mL/min. The integral compact design with a small 6” x 2” x 2” (approx. 15 x 5 x 5 cm) footprint makes it ideal for medical and analytical instrumentation applications.
At the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2018), Fast Track Diagnostics, a Siemens Healthineers company, launched a new molecular thermocycler, the Fast Track cycler, and the complementary new FastFinder software. The Fast Track cycler is a compact platform that enables laboratories of all sizes to implement molecular testing with simplicity and speed while the FastFinder software improves workflows due to AI-powered automation. Weighing just two kilograms and measuring only 150 mm x 150 mm x 130 mm, the Fast Track cycler (FTC) is a compact thermocycler created to fit laboratories of all sizes. The platform is scalable: up to 10 thermocyclers can be connected to one computer, and laboratories can utilize a range of 1 to 480 wells. The Fast Track cycler uses magnetic induction technology for robust and reliable results. Because no calibration is required, the thermocycler does not drift or age and offers simple handling of the system. The FTC also comes equipped with Fast Track lyophilized technology, offering reagents for PCR experiments in a single sample tube, simplifying processes for users by eliminating the need to prepare the reaction mix before test implementation. With this technology, users simply add nucleic acid extracts to the prepared tubes before inserting into the cycler.
Co-oximetry is a methodology that measures the levels of the oxygen-carrying protein hemoglobin, which is the chief component of red blood cells. Co-oximetry is a useful tool in that it helps determine the levels of various forms of hemoglobin and can be used to diagnose a variety of conditions related to oxygen content in blood. Oxygen content is an important indicator of oxygen transport within the body. The oxygen transport of arterial blood is used to evaluate the ability of transporting oxygen from the lungs to the tissue. Randox Quality Control announce the launch of a new CO-Oximetry programme to complement their existing Blood Gas programme. Combining 7 parameters in a user-friendly, liquid ready-to-use format, the new RIQAS CO-Oximetry EQA programme has been designed with consolidation and convenience in mind – it’s even suitable for use in point-of-care testing. RIQAS is the world’s largest EQA scheme with 45,000 participants and 33 programmes ensuring peer groups are maximized. The added benefit of comprehensive yet user-friendly reports available within 72 hours of the submission date allowing corrective action to be taken in a timely manner saves time, money, and reputation by eliminating the need for expensive retesting, providing peace of mind. To complement the RIQAS CO-Oximetry EQA programme, the RIQAS Blood Gas EQA programme incorporates 10 parameters into a liquid ready-to-use format for ease of use. Read more
Roche has launched the first fully automated Zika IgG immunoassay, the Elecsys Zika IgG immunoassay for CE Mark countries, to help detect Zika virus infection. Accurate diagnosis of an infection with Zika virus is an urgent medical need, particularly for pregnant women, as an infection with Zika virus can cause impaired neurological development in babies whose mothers were infected during pregnancy. Diagnostic testing enables healthcare professionals to assess the immune status of patients, which can be of particular importance to expectant mothers, their partners and travellers, and detect evidence of a recent Zika virus infection. This new serological assay complements a significant advancement from Roche for Zika virus screening. On 5 October 2017, the U.S. Food and Drug Administration (FDA) granted IVD status to the cobas Zika test, for use with the cobas 6800/8800 systems, for the screening of blood and plasma donations in the United States. Zika virus serological testing could be used for accurate diagnosis of Zika virus infection when the virus’ RNA is no longer detectable in the patient’s blood sample. Due to the similarity of Zika virus to other viruses, such as Dengue virus, the Elecsys Zika IgG assay was developed as a highly specific assay to limit cross-reaction and reduce the occurrence of false positive results. This assay can also be used to later determine the seroprevalence of Zika virus in different populations and countries at risk to assess the level of immune status in a country. Zika virus belongs to the Flaviviridae family of viruses, including Dengue, Yellow Fever, Japanese encephalitis and West Nile viruses. Zika virus is mainly spread by infected mosquitoes, though transmission may also occur through mother-to-child, sexual intercourse and infected donor blood used for transfusions. There is now evidence that Zika virus is linked to birth defects in fetuses and newborns, and neurological complications in adults. Based on a systematic review of the scientific literature, in 2016 the World Health Organization (WHO) concluded that Zika virus infection during pregnancy may cause congenital brain abnormalities, including microcephaly; and that the virus is a trigger of Guillain-Barré syndrome and subsequently declared Zika virus as a public health emergency. Today, Zika virus infection remains a significant enduring public health challenge, requiring intense action, but is no longer classified as a public health emergency. Read more
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Accurate, fast and low-cost CPE detection
, /in Product News /by 3wmediaThe 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.comRead more
Nexera MX LC-MS system accelerates workflow and improves analytical efficiency
, /in Product News /by 3wmediaShimadzu’s Nexera MX ultra-fast multianalyte LC-MS system offers up to double the sample processing capability of the conventional approach. The Nexera MX features two analytical flow lines in a single LC-MS system. This setup maximizes operating efficiency by alternating between the two lines for injecting of samples. Capable of rapidly processing large numbers of samples, the Nexera MX will help to improve the workflow of customers. The Nexera MX system also includes the LabSolutions Insight software, providing assistance with quantitative analysis of large volumes of data.
Read more
ELISAs for differentiation of acute and chronic Q fever
, /in Product News /by 3wmediaA 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.
Read more
Influenza A real time PCR detection kit
, /in Product News /by 3wmediaThe Flu Typing I kit allows the identification and specific differentiation of Influenza A (H1N1) pdm09 and H3N2 subtypes in respiratory samples from patients with signs and symptoms of respiratory infection.
Currently, Influenza A (H1N1) and Influenza A (H3N2) are the circulating seasonal Influenza A virus subtypes. This seasonal A (H1N1) virus is the same virus that caused the 2009 influenza pandemic. Influenza A (H3N2v) viruses were first detected in patients in 2011, with infections associated with prolonged exposure to pigs at agricultural fairs.
Real-time PCR assays have been shown to be a sensitive and specific diagnostic tool for the detection of the two subtypes of Influenza A (H1N1 and H3N2) that are currently in general circulation among humans.
VIASURE Flu Typing I Real Time PCR Detection Kit contains in each well all the components necessary for real time PCR assay in a stabilized format. RNA is extracted from specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for Influenza A (H1N1)pdm09 and H3N2 subtypes.
In addition, thanks to the lyophilization process, it is possible to send the kit to any part of the world at room temperature without the need for a cold chain or special conditions, as it remains perfectly functional for two years.
Read more
Consolidate with Randox CO-Oximetry EQA/PT Programme
, /in Product News /by 3wmediaRIQAS is the largest international EQA/PT scheme with more than 45,000 participants in 133 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories.
The RIQAS CO-Oximetry EQA Programme is a comprehensive programme suitable for monitoring the performance of 7 CO-Oximetry parameters. All samples are supplied in a liquid ready-to-use format ideal for both clinical and point-of-care testing (POCT).
It’s convenient liquid ready-to-use format saves time and reduces the chance for user error while monthly reporting allows your lab to detect errors before they spiral out of control. Highly consolidated, covering 7 CO-Oximetry parameters, the RIQAS CO-Oximetry programme offers a streamlined approach to your EQA, allowing you to test your whole CO-Oximetry menu.
For more information, please click here
Read more
Micro flowrate compatible LC-MS
, /in Product News /by 3wmediaThe new Nexera Mikros, a micro flowrate-compatible liquid chromatograph mass spectrometer, maintains the durability and operability of LC-MS systems while providing a significant increase in sensitivity. In pharmaceutical development, analysis occasionally has to be performed on trace amounts only of components in small blood samples. Examples include studies of the pharmacokinetics of new drug substances or their metabolism. In such cases, LC-MS systems compatible with nano flowrates have been utilized, in order to improve the efficiency of the intake of target components to the mass spectrometer. However, nano flowrate-compatible LC-MS systems often suffer from complications in terms of instrument operability and processing speed, such as a tendency for pipes to clog, difficulty in discovering liquid leaks, and the hours required for analysis of a single sample. The Nexera Mikros can accommodate a wide range of flowrates, from semi-micro flowrates (100 to 500 µL/min) which are often used for analysis in existing systems, to micro flowrates (1 to 10 µL/min). With this product, Shimadzu is contributing to improving productivity at pharmaceutical companies and clinical contract research organizations. Nexera Mikros achieves at least ten times the sensitivity for target compounds compared to standard LC-MS analysis. This is due to the LC-Mikros, a solvent delivery pump with a new control system to reduce pulsation and deliver a stable solvent flow even at low micro flowrates. In addition, positioning of the ionization interface has been optimized for more efficient sample introduction into the mass spectrometer. Another specific feature, UF-Link, achieves both high-sensitivity analysis and improved operability. Microscopic gaps (dead volume) in the piping connectors lead to a decrease in sensitivity by causing peak dispersion. UF-Link, a connection mechanism between Shimadzu’s newly developed analytical column and the mass spectrometer, ensures high sensitivity and, at the same time, enables one-touch connection between the analytical column and the ionization interface for the mass spectrometer. In addition, UF-Link is compatible with connections between commonly used analytical columns and the ionization interface, so column selection is flexible to suit the target sample.
Read more
Valveless instrumentation waste transfer pump
, /in Product News /by 3wmediaThe new valveless Waste Transfer Pump from Fluid Metering, Inc. (FMI) was designed for removal of waste fluid generated by medical diagnostic instrumentation during the process of analysing a variety of patient fluid samples. The waste fluid generally consists of, but is not limited to, a mixture of patient samples (blood components, urine samples etc..) combined with reagents, byproducts of reagent reactions and wash fluids. These fluids can have a broad range of physical characteristics, viscosity, suspended solids, human tissue, blood cells, just to name a few. The valveless, brushless DC Waste Transfer Pump utilizes FMI’s innovative CeramPump valveless piston fluid control technology. One moving part, a rotating and reciprocating ceramic piston accomplishes all fluid control functions within the pump, thereby eliminating the need for check valves present in other reciprocating pump designs (diaphragm, bellows, solenoid piston, syringe). The variety of suspended solids and particulates present in medical instrumentation waste often causes check valves to stick, clog, and eventually fail requiring the pumps to be removed from the system and serviced. The sapphire-hard, dimensionally stable ceramic internal components of the CeramPump also substantially outperforms peristaltic pumps relying on flexible tubing. Peristaltic pumps can have integrity issues as flexible tubing over time wears and needs to be routinely replaced, at best, and at worst, can rupture resulting in bio-contaminants leaking out of the system. FMI’s valveless, brushless DC motor Waste Transfer Pump integrates the long-life performance of a brushless motor, with a built-in driver, together with the advantages of FMI’s CeramPump valveless fluid transfer technology. The pump is easily integrated into any existing system design. All that is needed is a simple 24V DC input supply. Flow rates can be factory calibrated from 20 mL/min to 400 mL/min. The integral compact design with a small 6” x 2” x 2” (approx. 15 x 5 x 5 cm) footprint makes it ideal for medical and analytical instrumentation applications.
Read more
Compact, 48-well thermocycler
, /in Product News /by 3wmediaAt the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2018), Fast Track Diagnostics, a Siemens Healthineers company, launched a new molecular thermocycler, the Fast Track cycler, and the complementary new FastFinder software. The Fast Track cycler is a compact platform that enables laboratories of all sizes to implement molecular testing with simplicity and speed while the FastFinder software improves workflows due to AI-powered automation.
Weighing just two kilograms and measuring only 150 mm x 150 mm x 130 mm, the Fast Track cycler (FTC) is a compact thermocycler created to fit laboratories of all sizes. The platform is scalable: up to 10 thermocyclers can be connected to one computer, and laboratories can utilize a range of 1 to 480 wells. The Fast Track cycler uses magnetic induction technology for robust and reliable results. Because no calibration is required, the thermocycler does not drift or age and offers simple handling of the system. The FTC also comes equipped with Fast Track lyophilized technology, offering reagents for PCR experiments in a single sample tube, simplifying processes for users by eliminating the need to prepare the reaction mix before test implementation. With this technology, users simply add nucleic acid extracts to the prepared tubes before inserting into the cycler.
Read more
CO-Oximetry EQA / PT programme
, /in Product News /by 3wmediaCo-oximetry is a methodology that measures the levels of the oxygen-carrying protein hemoglobin, which is the chief component of red blood cells. Co-oximetry is a useful tool in that it helps determine the levels of various forms of hemoglobin and can be used to diagnose a variety of conditions related to oxygen content in blood. Oxygen content is an important indicator of oxygen transport within the body. The oxygen transport of arterial blood is used to evaluate the ability of transporting oxygen from the lungs to the tissue.
Randox Quality Control announce the launch of a new CO-Oximetry programme to complement their existing Blood Gas programme. Combining 7 parameters in a user-friendly, liquid ready-to-use format, the new RIQAS CO-Oximetry EQA programme has been designed with consolidation and convenience in mind – it’s even suitable for use in point-of-care testing.
RIQAS is the world’s largest EQA scheme with 45,000 participants and 33 programmes ensuring peer groups are maximized. The added benefit of comprehensive yet user-friendly reports available within 72 hours of the submission date allowing corrective action to be taken in a timely manner saves time, money, and reputation by eliminating the need for expensive retesting, providing peace of mind.
To complement the RIQAS CO-Oximetry EQA programme, the RIQAS Blood Gas EQA programme incorporates 10 parameters into a liquid ready-to-use format for ease of use.
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Zika IgG assay
, /in Product News /by 3wmediaRoche has launched the first fully automated Zika IgG immunoassay, the Elecsys Zika IgG immunoassay for CE Mark countries, to help detect Zika virus infection. Accurate diagnosis of an infection with Zika virus is an urgent medical need, particularly for pregnant women, as an infection with Zika virus can cause impaired neurological development in babies whose mothers were infected during pregnancy. Diagnostic testing enables healthcare professionals to assess the immune status of patients, which can be of particular importance to expectant mothers, their partners and travellers, and detect evidence of a recent Zika virus infection.
This new serological assay complements a significant advancement from Roche for Zika virus screening. On 5 October 2017, the U.S. Food and Drug Administration (FDA) granted IVD status to the cobas Zika test, for use with the cobas 6800/8800 systems, for the screening of blood and plasma donations in the United States.
Zika virus serological testing could be used for accurate diagnosis of Zika virus infection when the virus’ RNA is no longer detectable in the patient’s blood sample. Due to the similarity of Zika virus to other viruses, such as Dengue virus, the Elecsys Zika IgG assay was developed as a highly specific assay to limit cross-reaction and reduce the occurrence of false positive results. This assay can also be used to later determine the seroprevalence of Zika virus in different populations and countries at risk to assess the level of immune status in a country.
Zika virus belongs to the Flaviviridae family of viruses, including Dengue, Yellow Fever, Japanese encephalitis and West Nile viruses. Zika virus is mainly spread by infected mosquitoes, though transmission may also occur through mother-to-child, sexual intercourse and infected donor blood used for transfusions. There is now evidence that Zika virus is linked to birth defects in fetuses and newborns, and neurological complications in adults. Based on a systematic review of the scientific literature, in 2016 the World Health Organization (WHO) concluded that Zika virus infection during pregnancy may cause congenital brain abnormalities, including microcephaly; and that the virus is a trigger of Guillain-Barré syndrome and subsequently declared Zika virus as a public health emergency. Today, Zika virus infection remains a significant enduring public health challenge, requiring intense action, but is no longer classified as a public health emergency.
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