Home >> Tag Archives: EKF Diagnostics

Tag Archives: EKF Diagnostics

EKF handheld hemoglobin analyzer with POC connectivity

January 2023—EKF Diagnostics’ DiaSpect handheld hemoglobin analyzer now connects securely to EKF Link, the company’s point-of-care middleware. DiaSpect is also now equipped with Bluetooth and internal storage for 4,000 tests and QC results, as well as the capability to provide a calculated hematocrit value alongside the hemoglobin result. Test results are stored and accessed securely on a centralized platform.

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EKF to distribute FDA-cleared Lucica glycated albumin test

July 2022—EKF Diagnostics announced the availability of the FDA-cleared Lucica Glycated Albumin-L test kit, manufactured by Asahi Kasei Pharma Corp. and sold exclusively in the United States by EKF. Lucica Glycated Albumin-L is a specific, quantitative test for glycated albumin for the intermediate-term monitoring of glycemic control in patients with diabetes.

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EKF launches β-ketone, glucose POC analyzer

May 2020—EKF Diagnostics has launched in the United States its Stat-Site WB dual-use whole blood β-ketone and glucose meter for professional use in the management of diabetes. The CLIA-waived handheld analyzer quantitatively measures β-ketone (beta-hydroxybutyrate) from fresh capillary and venous whole blood in 10 seconds and delivers quantitative measurements in five seconds for glucose in fresh capillary, venous, and neonatal whole blood. The system has a measurement range of 0.1–8.0 mmol/L for β-ketone and 0.5–33.3 mmol/L for blood glucose. Its hematocrit range is 10–70 percent for β-ketone and 20–70 percent for blood glucose.

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EKF, McKesson distribution agreement

April 2019—EKF Diagnostics has signed a private label distribution agreement with McKesson Medical-Surgical for the company’s hand-held, reagent-free hemoglobin analyzer, the DiaSpect. The DiaSpect will be sold by McKesson under its own branded line as the McKesson Consult Hb analyzer.

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Ortho, EKF collaborate on BHB assay, 2/18

February 2018—Ortho Clinical Diagnostics and EKF Diagnostics announced an agreement that allows Ortho customers to access EKF’s Beta-Hydroxybutyrate LiquiColor Assay, a CLIA moderate-complexity test for use on Ortho’s Vitros 4600 Chemistry System and Vitros 5600 Integrated System.

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PCT assay for Beckman AU analyzers, 1/18

January 2018—EKF Diagnostics announced that its Stanbio Chemistry Procalcitonin LiquiColor assay has been FDA cleared and validated for use on Beckman Coulter AU480, 680, and 5800 clinical chemistry analyzers. EKF confirms the immediate availability of a user defined application for running this 10-minute test for bacterial infection and sepsis on these ­analyzers.

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POC connectivity solution for HbA1c analyzers, 3/17

March 2017—EKF Diagnostics previewed a point-of-care connectivity solution for its range of HbA1c analyzers at Medica 2016 in November in Düsseldorf, Germany. Its connectivity package for Quo-Test and Quo-Lab HbA1c analyzers enable secure, bi-directional communication between the POC analyzers and a multitude of central data management systems.

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Benchtop clinical chemistry analyzer, 9/15

EKF Diagnostics launched its Altair 240 clinical chemistry analyzerEKF Diagnostics launched its Altair 240 clinical chemistry analyzer, a benchtop platform that is EKF’s first fully integrated chemistry system for the global market. The fully automated system has LIS bidirectional connectivity, and double arm functionality yields up to 480 tests per hour.

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Diabetic biomarker test, 5/15

May 2015—EKF Diagnostics has introduced the Stanbio Chemistry Glycated Serum Protein LiquiColor test, a diabetic biomarker test that provides a two- to three-week indicator of average blood glucose, closing the information gap between daily blood glucose testing and the two- to three-month HbA1c reading. GSP serves as an accurate intermediate marker of glycemia in instances where HbA1c may be of limited value, such as pregnancy, reduced RBC lifespan, and hemodialysis.

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Hemoglobin analyzer, plasma centrifuge, 9/14

September 2014—EKF Diagnostics highlighted its expanding product portfolio at its subsidiary’s booth, Stanbio Laboratory. DiaSpect Tm, which previewed at the meeting, is a palm-sized hemoglobin measurement system that gives laboratory-quality performance for anemia screening. Delivering results in one to two seconds, this analyzer is CE marked and currently undergoing FDA approval.

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EKF, Joslin Diabetes Center collaboration, 2/15

February 2014—EKF Diagnostics has entered a multiyear collaborative relationship with Joslin Diabetes Center in support of the ongoing clinical and commercial translation of tumor necrosis factor receptor 1 and 2 biomarkers. EKF will access certain clinical and research expertise at Joslin under the center’s corporate liaison program to further develop its TNFR biomarker test.

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EKF Molecular, MGH announce collaboration, 12/14

December 2014—EKF Diagnostics announced it has entered a two-year research collaboration with Massachusetts General Hospital to develop PointMan assays that can detect treatable cancer mutations in blood samples. MGH will use PointMan DNA for the detection of genetic variation in circulating tumor cells isolated from a patient’s blood using MGH’s CTC-Chip instrument.

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DNA enrichment kits, 2/14

February 2014—EKF Molecular Diagnostics launched four PointMan DNA enrichment kits for the research-use-only market, with planned diagnostic registration in Europe in 2014. As a real-time PCR technology, PointMan provides reliable and extremely sensitive detection of cancer mutations by amplifying the target sequence of interest in a background of wild-type genes. Using this technology, the enrichment kits are an ideal research tool for understanding biomarker and drug response.

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End-stage renal disease test, 9/13

EKF Diagnostics offers a novel test to accurately identify diabetic patients at high risk of progression to end-stage renal disease (ESRD) up to 10 years before currently available tests can. EKF’s sTNFr1 test is an ELISA assay that has the potential to significantly improve diabetic patient management and outcomes. The test accurately detects circulating levels of soluble tumor necrosis factor ...

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Rapid strip-based hemoglobin test, 9/13

EKF Diagnostics offers its Stat-Site M Hgb strip-based test for quick and easy hemoglobin analysis for rapid anemia determination. Stat-Site M Hgb is a portable handheld analyzer. The pocket-sized device delivers accurate hemoglobin analysis results within 30 seconds from 15 µL of fingerstick whole blood. This hemoglobin photometer is maintenance-free and includes intuitive, step-by-step on-screen instructions to minimize operator training. ...

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β-hydroxybutyrate strip test, 9/13

EKF Diagnostics’ Stat-Site M β-HB is a strip-based test for β-hydroxybutyrate that provides a quick and easy assessment of diabetic ketoacidosis (DKA), delivering results in less than 80 seconds. The presence and degree of ketosis can be assessed rapidly at the point of care by accurately measuring blood levels of β-HB, which accounts for 78 percent of the three ketone ...

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DNA enrichment kits, 9/13

EKF Diagnostics offers its EKF Molecular Diagnostics’ PointMan DNA enrichment kits. The three kits are for enriching mutations in BRAF, KRAS, and EGFR T790M genes associated with skin melanoma and colorectal and lung cancers. PointMan kits provide highly specific and ultrasensitive enrichment of mutant genes in a background of wild-type (normal) genes. PointMan real-time PCR technology provides reliable and extremely ...

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