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Archive for category: Product News

Product News

C355 Certest

Influenza A real time PCR detection kit

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

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.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C355_Certest.jpg 442 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:16Influenza A real time PCR detection kit
C395 Fujirebio crop

Alzheimer markers assays

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

The Lumipulse G pTau 181 and β-Amyloid 1-40 assays are the latest additions to Fujirebio’s fully automated Neuro product line and complement the previously launched Lumipulse G Total Tau and β-Amyloid 1-42 assays. These assays are intended to measure β-Amyloid1-42, β-Amyloid1-40, total Tau and pTau181 in cerebrospinal fluid (CSF). Altogether, these four CSF markers support the diagnosis of Alzheimer’s disease, with the β-Amyloid1-42 / β-Amyloid1-40 ratio additionally being able to reduce the effect of inappropriate pre-analytics. These four assays are now available and can be run on the LUMIPULSE G600II and G1200 instruments. In comparison to the company’s INNOTEST predecessor assays, these newly CE-marked Lumipulse assays use the same well-established antibodies and show an improved performance. Low volume tests, like CSF biomarker analyses, generally benefit from the Lumipulse cartridge principle where one sample equals one test (per analyte), avoids wastage of reagents and the need for batch-testing.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C395_Fujirebio_crop.jpg 625 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:00Alzheimer markers assays

VACUETTE CAT Serum Fast Tube

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

Greiner Bio-One’s new VACUETTE CAT Serum Fast Tube is the optimal tube whenever results are needed fast. It enables serum to be analysed as quickly as plasma. The tube is coated with a mixture of Blood Clotting Activator (BCA) and thrombin. Thrombin, as an accelerator, speeds up the coagulation process: coagulation takes just five minutes, followed by centrifugation for five to ten minutes, giving the tube a major time-saving advantage over conventional serum tubes with a usual duration of about 40 minutes. Thanks to this short coagulation time, blood collection is also possible shortly before transport to the laboratory. Furthermore, the added gel forms a stable barrier between the serum and the cellular components of the whole blood after centrifugation. So, another advantage is the better preservation of the sample quality. The five-minute coagulation time rules out post clotting in the laboratory. As a result, preanalytical errors are reduced and accurate values can be used for diagnosis. www.gbo.com
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C351 Beckman

Automated plate streaking system

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

Beckman Coulter Diagnostics and NTE-SENER, the brand of the SENER group active in the field of healthcare technology, are partnering to enhance microbiology laboratory efficiency and effectiveness with the DxM 6100 Autoplak Advanced automated plate streaking system. The agreement between the two companies took effect June 16, 2017, making Beckman Coulter the sole distributor of the DxM 6100 Autoplak Advanced System for most European countries.
The DxM 6100 Autoplak Advanced System automates and integrates the core aspects of microbiology specimen processing, including plating and streaking, Gram stain slide preparation and enrichment broth inoculation. This streamlines routine tasks and helps laboratories manage increasing testing volumes by enabling them to reallocate technical resources as needed.
The DxM 6100 Autoplak Advanced System is compact for easy placement in tight workspaces. The open platform provides flexibility by allowing customers to use liquid transport tubes and consumables from various manufacturers and enabling them to customize protocols to accommodate current processes. Quality is enhanced through traceability, standardization and safe processes that reduce cross-contamination risk. The highly reliable DxM 6100 Autoplak Advanced System enables laboratories to maximize uptime for fewer workflow interruptions, and is supported by Beckman Coulter’s expert service and support professionals.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C351_Beckman.jpg 600 727 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:19Automated plate streaking system
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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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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