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Archive for category: Product News

Product News

C256 Axis Shield

Anti-CCP clinical chemistry test

, 26 August 2020/in Product News /by 3wmedia

Anti-CCP is the marker of choice among rheumatologists for aid in the serological diagnosis of rheumatoid arthritis (RA). For over 15 years Axis-Shield has been a major pioneer developing this marker on a number of different technologies and is now making available the first anti-CCP test designed for use on open clinical chemistry systems. With excellent clinical specificity and sensitivity for patients with RA, results can be received in 10 minutes. This latex-enhanced immunoturbidimetric test is suitable for use with either serum or plasma. This methodology will allow laboratories to consolidate their testing along with other acute phase reactants and serological markers associated with rheumatic diseases. Each reagent pack supplied has 100 tests. Controls and calibrators are available separately.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C256_Axis-Shield.jpg 494 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:27:16Anti-CCP clinical chemistry test
C416 Euroimmun

Automated evaluation of IFA for infection diagnosis

, 26 August 2020/in Product News /by 3wmedia

The EUROPattern system has been extended to include computer-aided evaluation of indirect immunofluorescence assays (IFA) for infectious disease diagnosis. Parameters encompass Chlamydia spp., Bartonella spp., Mycoplasma spp., HHV-6, CHIKV, coxsackievirus, EBV, DENV, hantaviruses, sandfly fever viruses, YFV and ZIKV. The assays utilize infected cells, antigen-expressing cells or bacterial smears to detect the corresponding antibodies in patient samples. IFA BIOCHIP Mosaics provide combinations of different substrates for efficient multiplex analyses. The EUROPattern microscope provides automated acquisition of the immunofluorescence images for convenient evaluation at the PC screen. It allows fast automated focusing and image recording for up to 500 fields in less than two hours. Slides are identified by means of matrix codes, eliminating the risk of mix-ups. Results can be checked retrospectively at the microscope if necessary. For selected parameters, e.g. EBV, sophisticated classification software provides positive/negative classification of the fluorescence signals, including titre designations with confidence values for positive samples. Negative results can be verified in batch for increased efficiency. The controlled LED in the microscope provides over 50,000 hours of constant light intensity, ensuring highly reproducible results. Results are consolidated into one report per patient and compared with previous findings. Different software user levels provide a hierarchical review of results, thus increasing security. All fluorescence images and reports are digitally archived. The software can be fully integrated into existing laboratory software (LIS) for a streamlined laboratory routine. The infection parameters complement established EUROPattern applications, such as the fully automated evaluation of ANA, ANCA, Crithidia luciliae, recombinant-cell and antigen-dot IFA.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C416_Euroimmun.jpg 800 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:20:55Automated evaluation of IFA for infection diagnosis
C389 Coris crop

Carbapenemase variants detection test

, 26 August 2020/in Product News /by 3wmedia

Surveillance and control of resistance to beta-lactam among gram-negative bacteria remains nowadays a big concern for microbiologists worldwide. Descriptions of OXA-48 associated infections are still revealing huge impact on antimicrobial treatment and patient morbidity. For clinical laboratories, OXA-48 and its variants represent the most challenging resistance mechanism to detect and are often under-detected by routine diagnostic methods. Multiple allelic variants of OXA-48 have been described, with diverse hydrolytic profiles. As an example, the single amino acid substitution and four amino acid deletion described in OXA-163 confer an increased hydrolytic activity against cephalosporins, coupled to a loss of resistance to carbapenems. This particular hydrolytic profile makes detection confusing. Treatment failures can impede patient recovery and favour the selection of new resistant strains. Until recently, efficient identification of OXA-163-expressing strains relied on gene sequencing, which is not practical for a clinical laboratory daily routine. The recently available immunochromatographic lateral flow assay developed by Coris BioConcept to specifically differentiate OXA-163 from OXA-48 proteins, replaces costly and lengthy genotypic methods. This phenotypic test is an easy-to-use and instrument-free test that provides a fast (15 minutes) and accurate (100%) identification of variants. Precise detection of other carbapenemases will be included in the test to reach a 5-parameters assay. This up-coming “RESIST-5” test commercialized by the same company is the ideal tool to precisely identify the most prevalent carbapenemase-mediated resistance mechanisms on a single phenotypical assay. Its use on a daily routine in healthcare facilities will enable a broader surveillance of worldwide-disseminating new carbapenemase variants and help clinicians in the daily patient care.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C389_Coris_crop.jpg 470 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:03Carbapenemase variants detection test
C365 Qiagen new

Multiplex molecular diagnostic platform

, 26 August 2020/in Product News /by 3wmedia

Qiagen has announced the launch of QIAstat-Dx in Europe, providing a one-step, fully integrated molecular analysis of common syndromes as tested for in infections, oncology and other diseases. The launch follows the closing of the acquisition of Stat-Dx announced in January 2018 and the successful completion of defined development activities by Stat-Dx.
QIAstat-Dx (formerly Stat-Dx DiagCORE) represents the next-generation in multiplex molecular diagnostic systems that enables fast, cost-effective and flexible syndromic testing with novel Sample-to-Insight solutions powered by Qiagen chemistries. The system, based on the proprietary DiagCORE technology, received CE-IVD marking in January 2018 and already has a significant installed base among early adopters. QIAstat-Dx is now being launched with an upgraded CE-IVD-marked respiratory panel that detects 21 pathogens. The panel is the first test in a deep and broad pipeline of planned assays for QIAstat-Dx which spans infectious diseases, oncology, companion diagnostics and other disease areas. Using Qiagen sample and assay technologies, the system can deliver true Sample-to-Insight processing of even the most challenging samples, opening up opportunities in a broad range of application areas not possible with currently available systems. Samples include tissue samples in pathology, liquid or difficult-to-handle sputum samples in infectious disease, with direct onboard swab processing. The system is the only multiplex syndromic testing system based on real-time PCR (polymerase chain reaction) technology that can process up to 48 targets and is designed with the additional capability to process immunoassays. These features create superior target and application versatility, as well as disease management options. This system enables customers to precisely quantify biological targets, which is specifically important in oncology or transplantation patients and leads to improved treatment decisions. The use of real-time PCR also allows a vast portfolio of current real-time PCR tests to be portable onto the system. The proprietary workflow design with an attractive cost of ownership has the potential to enable laboratories to take a tailored approach to the selective analysis and reporting of tested molecular targets. The flexible approach will represent a significant improvement over currently available systems that offer rigid panel designs, and therefore require co-processing of molecular targets found to be irrelevant in the patient sample, which may complicate reimbursement.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C365_Qiagen_new.jpg 761 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:13Multiplex molecular diagnostic platform
C404 Greiner

Versatile tube holder with male luer lock

, 26 August 2020/in Product News /by 3wmedia

The new VACUETTE SAFELINK tube holder facilitates quick and easy blood collection. The tube can be used in combination with all medical products that have a standard female luer lock connection, such as winged cannulae. Above all, it is characterized by its simple handling.
The luer lock feature sets the VACUETTE SAFELINK apart from the conventional Greiner Bio-One tube holders and makes it particularly suitable for blood collection from venous access devices according to guideline recommendations. Furthermore, tests show that the secure connection withstands pressures of up to 185mmHg. This, along with the functional design and practical handling could make a significant contribution to efficiency in everyday healthcare situations.
The simple screw connection ensures safe and successful blood collection. With a controlled threading movement, the single-use product connects safely and smoothly to the respective medical device. The VACUETTE SAFELINK is manufactured from unbreakable plastic and does not contain natural rubber latex.
Greiner Bio-One uses targeted market monitoring as the basis for implementing ongoing enhancements, so its product portfolio is regularly optimized and expanded. The range of accessories already includes various tube holders, from the standard holder through to the safety version. The VACUETTE SAFELINK holder is a perfect addition to the product line with its screw system for a secure connection.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C404_Greiner.jpg 533 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:20:58Versatile tube holder with male luer lock
C377 Euroimmun

Combined detection of anti-Zika virus IgAM in acute infections

, 26 August 2020/in Product News /by 3wmedia

A new ELISA provides parallel detection of anti-Zika virus antibodies of classes IgA and IgM against the highly specific viral non-structural protein (NS-1). Anti-Zika virus NS-1 antibodies of class IgA are a novel alternative indicator of acute infection, and their detection is particularly useful in cases where IgM is not detectable. This can occur, for example, in patients who have had previous contact with a flavivirus through infection or vaccination (e.g. dengue, yellow fever, tick-borne encephalitis, Japanese encephalitis or West Nile viruses). When these individuals become infected with another virus of the genus Flavivirus, in this case Zika virus, the specific IgM response may be absent (secondary immune response). In these cases, determination of specific IgA can facilitate diagnosis of the acute Zika virus infection.
Studies have shown that although not all patients with an acute Zika virus infection exhibit specific IgM and specific IgA antibodies, all tested samples were reactive for at least one of the two parameters. Therefore, combined testing for IgM and IgA is beneficial for reliable diagnosis of acute infections.
In the study, serum samples of 31 patients with confirmed acute Zika virus infections from the Dominican Republic, where Zika and dengue viruses are endemic, and 40 patients from Vietnam with acute dengue virus infection were tested with the new ELISA. The Anti-Zika Virus IgAM yielded a sensitivity of 100% (31/31) and a specificity of 95% (38/40). In comparison, the Anti-Zika Virus IgM demonstrated a sensitivity of 29% (9/31) and a specificity of 100% (40/40). Thus, combined detection of both antibody classes instead of just IgM leads to a threefold increase in the sensitivity for acute Zika virus infections without a significant loss of specificity.
Early diagnosis of acute infections with Zika viruses is particularly important for pregnant women since the virus may interfere with the neurological development of the fetus and can cause microcephaly. However, also in adults the viral infection may have long-term neurological consequences. Therefore, timely recognition of this infectious disease is required.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C377_Euroimmun.jpg 426 567 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:06Combined detection of anti-Zika virus IgAM in acute infections
C340 Euroimmun

ELISAs for differentiation of acute and chronic Q fever

, 26 August 2020/in Product News /by 3wmedia

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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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C340_Euroimmun.jpg 601 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:16ELISAs for differentiation of acute and chronic Q fever
C394 SSI image2

S. pneumoniae and L. pneumophila rapid test

, 26 August 2020/in Product News /by 3wmedia

Streptococcus pneumoniae is the leading cause of community-acquired pneumonia and Legionella pneumophila causes costly hospital and ICU admissions. It is difficult to clinically distinguish between the two bacteria and due to different treatment of the diseases, guidelines recommend double testing.
The ImmuView Antigen test makes it now possible to readily distinguish between both microorganisms in patients with presumed infection, allowing clinicians to initiate the correct antibiotic treatment. It is the only rapid test that identifies both Streptococcus pneumoniae and Legionella pneumophila in one single test for urine and CSF samples. ImmuView is very simple to use, does not require any special equipment, and provides a result in just 15 minutes. In fact, in only 3 simple steps, it determines whether the patient has a double infection, a S. pneumoniae infection, a Legionella infection, or none of these.  

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C394_SSI_image2.jpg 300 400 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:00S. pneumoniae and L. pneumophila rapid test
C374 Coris 01

Identification of OXA-23 carbapenem-resistant Acinetobacter spp.

, 26 August 2020/in Product News /by 3wmedia

The global spread of carbapenemresistant Acinetobacter spp., and particularly A. baumannii, in healthcare settings causes a major threat to patient survival. Worldwide, drug-resistant Acinetobacter spp. are responsible for serious nosocomial outbreaks, mostly in intensive care units. Even though different resistance mechanisms have been described, production of Amber Class D oxacillinases OXA-23-like hydrolysis enzymes is the most frequently acquired mechanism. Fast and accurate detection of OXA-23-producing strains remains challenging at the laboratory level. Specific identification of oxacillinase-expressing Acinetobacter requires genotypic molecular assays that remain expensive and not commercially available. However immunochromatography lateral flow tests are cost-effective and convenient to detect drug-hydrolysing enzymes. Today, a large panel of lateral flow tests to detect carbapenemase-expressing Enterobacteriacea, named “RESIST”, is commercialized by the Belgian company Coris BioConcept. In order to fulfill the unmet need for fast and reliable detection of drugresistant Acinetobacter, Coris BioConcept developed a new lateral flow assay, “OXA- 23 K-SeT”, for the specific identification of OXA-23-mediated carbapenem-resistant in Acinetobacter spp. from a single colony. With results available in less than 15 minutes, this easy-to-use and instrument-free rapid test represents the first phenotypic, specific and non-molecular confirmatory assay for OXA-23 detection. It will expand the RESIST range of products already adopted nowadays by routine and reference laboratories worldwide, offering an additional tool to ensure the successful treatment of patients and to prevent the spread of carbapenemase-producing bacteria in healthcare settings.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C374_Coris_01.jpg 627 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:11Identification of OXA-23 carbapenem-resistant Acinetobacter spp.
C341 Elitech crop

Respiratory bacterial panel

, 26 August 2020/in Product News /by 3wmedia

ELITechGroup Molecular Diagnostics has recently launched a high-performance multiplex assay, the Respiratory Bacterial ELITe MGB Panel, for the diagnosis of bacterial respiratory infections, validated with ELITe InGenius, the company’s fully automated sample-to-result system.
Respiratory infections are common causes of morbidity and mortality worldwide. Regardless of the pathogen involved, similar symptoms can be observed making the diagnosis difficult to establish from only considering a symptom-based approach. Using a molecular diagnostic method is crucial to effectively determine the pathogens involved, prevent the misuse of antibiotics, and ensure an optimal patient management.
In combination with ELITe InGenius, the Respiratory Bacterial ELITEe MGB Panel is the first panel specifically designed to detect main relevant respiratory bacteria, CE-IVD validated with a sample-to-result system.  Respiratory Bacterial ELITe MGB Panel detects and differentiates in one single reaction M. pneumoniae, C. pneumoniae, and L. pneumophila.  The clinical study has demonstrated excellent performance: 100% diagnostic sensitivity and 100% diagnostic specificity were obtained with all targets.
The validation with ELITe InGenius offers many advantages to laboratories in comparison to other solutions available in the market: fully automated workflow from extraction to result interpretation, hand-on time reduced to a few minutes, and accurate results.
The CE-IVD ELITe InGenius respiratory menu will be further broadened in the coming months with a new Real-Time PCR assay for the detection of Mycobacterium tuberculosis and associated multidrug-resistant (rifampicin and isoniazid) forms.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C341_Elitech_crop.jpg 460 612 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:19Respiratory bacterial panel
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