The growing concern about the proliferation of Zika infections in the Caribbean, Central and South America, has turned the fight against the virus in a global health emergency. The infection is mainly transmitted through the bite of the Aedes spp mosquitoes and presents symptoms like mild fever, arthralgia, myalgia, asthenia, headache and maculopapular rash clinical symptoms, plus additional symptoms like conjunctivitis, retroorbital pain, lymphadenopathy and diarrhea. There is widespread concern about the association of the Zika Virus with increasing cases of congenital microcephaly. Other research indicate that the virus can cause brain damage. CerTest Biotec has developed a new kit for the identification of Zika virus in patients presenting symptoms of the disease. This new "ready-for-use" product contains all the necessary components and reagents to perform a test that detects viral Zika RNA using the real time PCR technique. It is very important to complete the identification of the virus in the early stages of infection; therefore, it is recommended that samples of blood, serum and/or saliva are collected during the first 5 days after the onset of symptoms. The VIASURE Zika Virus real time PCR detection kit is designed for specific identification and quantification of Zika virus in clinical samples from patients with signs and symptoms of Zika virus infection. This test is intended for use as an aid in the diagnosis of the Zika virus in humans in combination with clinical and epidemiological risk factors. RNA is extracted from specimens, amplified using RT-amplification and detected using fluorescent reporter dye probes specific for Zika virus.
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New PTH Control for QC Portfolio
, /in Product News /by 3wmediaRandox Quality Control announces a further expansion to their comprehensive QC portfolio, the Acusera PTH Control. This new control has been designed with convenience in mind, providing the laboratory with a true third party solution for the measurement of PTH. The assayed liquid control has been developed with an extended open vial stability of 30 days and 2-year shelf life, reducing waste and ensuring consistency for this notoriously unstable assay.
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Zika Virus real time PCR detection kit
, /in Product News /by 3wmediaThe growing concern about the proliferation of Zika infections in the Caribbean, Central and South America, has turned the fight against the virus in a global health emergency. The infection is mainly transmitted through the bite of the Aedes spp mosquitoes and presents symptoms like mild fever, arthralgia, myalgia, asthenia, headache and maculopapular rash clinical symptoms, plus additional symptoms like conjunctivitis, retroorbital pain, lymphadenopathy and diarrhea. There is widespread concern about the association of the Zika Virus with increasing cases of congenital microcephaly. Other research indicate that the virus can cause brain damage. CerTest Biotec has developed a new kit for the identification of Zika virus in patients presenting symptoms of the disease. This new "ready-for-use" product contains all the necessary components and reagents to perform a test that detects viral Zika RNA using the real time PCR technique. It is very important to complete the identification of the virus in the early stages of infection; therefore, it is recommended that samples of blood, serum and/or saliva are collected during the first 5 days after the onset of symptoms. The VIASURE Zika Virus real time PCR detection kit is designed for specific identification and quantification of Zika virus in clinical samples from patients with signs and symptoms of Zika virus infection. This test is intended for use as an aid in the diagnosis of the Zika virus in humans in combination with clinical and epidemiological risk factors. RNA is extracted from specimens, amplified using RT-amplification and detected using fluorescent reporter dye probes specific for Zika virus.
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Prep automation in culture-independent pathogen PCR testing
, /in Product News /by 3wmediaMicro-Dx enables the culture-independent diagnosis of pathogens in various clinical samples. Micro-Dx is the first product combining walk-away automated human DNA removal and pathogen DNA extraction with broad-range rDNA Real-Time PCR and sequencing into a rapid diagnostic system for bacteria and fungi. Prominent advantages of molecular testing are the time gain compared to culturing and detection of pathogens that do not grow for reasons of fastidious nutrition requirements or growth inhibition due to antibiotic treatment of patients. Extraction of 1 to 12 samples is operated in the Select- NAplus instrument, which saves tedious manual handling and time. At the end of the procedure an exact differentiation of the species is obtained. Micro-Dx operates a wide range of specimens, including EDTA blood, CSF, BAL, aspirates from joints, swabs from wounds and abscesses and tissue biopsies from heart valves, liver and brain.
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Rapid test range for viral infections
, /in Product News /by 3wmediaMP Diagnostics’ newly launched MULTISURE Range consists of three separate devices for the diagnosis of diseases that are of major health concern: Dengue, HIV and HCV. The MULTISURE rapid tests are qualitative immunochromatographic assays intended for the screening of dengue, HIV and HCV infections and are equipped with MP Diagnostics’ patented reverse flow technology. The patented reverse flow technology enhances visual identification for easier interpretation of results. MP Diagnostics’ ASSURE Reader and ASSURE Palm Reader are developed for use with the MULTISURE range of rapid tests and are fully integrated instruments designed for the institution’s needs. The MP ASSURE readers complement the reading and documentation of results for both laboratory and point-of-care settings. With the latest upgrade in software, the MP ASSURE readers’ integration to management systems would be seamless for all users.
The new test range is for research use only in the United States.
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Immuno turbidimetric fecal CALPROTECTIN Assay
, /in Product News /by 3wmediaFecal calprotectin (fCAL) is the most important marker for in vitro diagnostic detection of gut inflammation. Immunological quantitation is well established and is used in the diagnostic process of inflammatory bowel diseases (IBD) and in the lifelong monitoring of these chronic conditions. fCAL testing today requires a significant level of lab resources including stool sample handling, extraction and the use of traditional immunological testing methods. The BÜHLMANN fCAL turbo assay is a big step towards full automation. It reduces the time to result as well as the total hands-on time significantly. It offers the possibility of random access and is independent of the clinical chemistry platform. Validated applications are available for the most common analysers. The combination with the proprietary extraction device CALEX Cap for pre-analytical sample preparation simplifies and accelerates stool diagnosis significantly. The BÜHLMANN fCAL turbo utilizes the well-established standardization of the BÜHLMANN fCAL ELISA to provide reliability and continuity of measurements.
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New reagent to measure dabigatran
, /in Product News /by 3wmediaStago completes its anticoagulant line with a new reagent, STA-ECA II, for the measurement of dabigatran plasma concentration in patients under treatment, in case of emergency (hemorrhage, urgent surgery or invasive procedure). STA-ECA II is an ecarin-based chromogenic assay which specifically measures the anticoagulant effect of direct thrombin inhibitors like dabigatran. The use of dedicated calibrators and controls is necessary. This assay is insensitive to lupus anticoagulant, heparin and variations in levels of coagulation factors and fibrinogen. Available on STA R Max, STA-R and STA Compact Max, STA-ECA II shows excellent analytical performances down to 15 ng/mL in the low range, with a high correlation to the reference technique for dabigatran measurement, LC-MS using “total dabigatran” protocol. With a long on-board stability (3 days) and at 2-8°C (28 days), this reagent is suitable for all types of laboratory activities.
In the USA and Canada this product is classified as “For Research Use Only”.
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Urine Oxalate assay
, /in Product News /by 3wmediaBioSystems launches a new reagent for the measurement of oxalate (oxalic acid) in urine. Oxalate is an end product of metabolism, predominantly derived from the breakdown of glyoxylate and glycine. It is eliminated entirely by urine and only about 15% of urinary oxalate is derived directly from dietary sources. Hyperoxaluria is a powerful promoter of calcium oxalate stone formation. An increased excretion of oxalate in urine may occur as a result of an excessive ingestion of oxalate-rich foods, because of malabsorption due to different gastrointestinal disorders (enteric hyperoxaluria) or because of an inborn error of metabolism (primary hyperoxaluria). Low oxalate values in urine are associated with hyperglycinemia or hyperglycinuria. BioSystems introduces this method (Oxalate Oxidase/Peroxidase – differential bireagent) in dedicated presentation for A15 and A25 analysers (code 12539: 1x25mL, 20 tests). It is calibrated using its own standard included in the kit. The kit also includes 20 pretreatment tubes which are also available separately in 100-unit packs (Oxalate Pretreatments Reagents: code 11839).
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HbA1c enzymatic assay
, /in Product News /by 3wmediaThe HbA1c value correlates with the average blood glucose level over the last 8-12 weeks and is used for monitoring and diagnosis of diabetes. DiaSys offers HbA1c net FS as a liquid-stable and ready-to-use 2-component assay. Due to the enzymatic test principle, excellent precision is ensured. Interference from a variety of hemoglobin variants like HbS, HbC, HbD, HbE, or HbF can be excluded. HbA1c net FS is characterized by a wide measuring range from 20 to 150 mmol/mol IFCC (4-6% DCCT/NGSP) and high on-board and calibration stability of up to 6 weeks. Moreover, this assay is standardized against the IFCC reference method and traceable according to the DCCT/NGSP network.
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Sekisui Diagnostics to distribute Qualigen Inc.’s POC immunoassay products
, /in Product News /by 3wmediaSekisui Diagnostics and Qualigen Inc. announce a new strategic partnership, encompassing both current business and future collaboration opportunities. Effective immediately Sekisui Diagnostics will assume commercial activities and distribution management for the FastPack IP System and associated products in the U.S. and international markets. The FastPack IP System is an established, point of care immunoassay system designed to enable physician office laboratories (POLs) to offer key quantitative test results where there is immediate clinical value. The test menu includes Vitamin D, Testosterone, TSH, Free T4, PSA, and hCG.
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QuikRead go CRP test cleared in the US
, /in Product News /by 3wmediaOrion Diagnostica’s QuikRead go CRP test received clearance from the US FDA to market the device for clinical laboratories. The QuikRead go test system measures C-reactive protein (CRP) in whole blood, plasma and serum in 2 minutes. The system consists of a small device and a ready-to-use reagent kit with all the materials for performing the test. This easy-to-use system is in wide use worldwide. The tests available for the system outside US includes CRP, CRP+Hb, Strep A and iFOBT. Measurement of CRP aids in the evaluation of injury to body tissues, and infection and inflammatory disorders. The advantages of measuring CRP lie in it being a sensitive, early, and reliable reflector of the acute-phase response. Quantitative measurement of CRP concentration has been reported to be a sensitive indicator of the efficacy of antimicrobial therapy and the course of bacterial infections. The rise in CRP level is non-specific.
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