General Manager Global Business/Head of Sales
DiaSys Diagnostic Systems GmbH
Procalcitonin FS - When time matters in sepsis management
Serum procalcitonin (PCT) levels represent a sensitive marker for severe and systemic bacterial infections. PCT is primarily produced in thyroid C cells as a precursor of calcitonin but expressed in nearly all tissues by stimulation of interleukins and bacterial endotoxins. In healthy individuals, PCT concentrations are usually below 0.05 ng/mL, and a significant increase of PCT up to a thousand-fold appears within a few hours in patients with severe and systemic bacterial infections.
DiaSys Procalcitonin FS is a fluid-stable, particle enhanced immunoturbidimetric assay with outstanding onboard and calibration stability, providing a convenient workflow on clinical chemistry analyzers. Procalcitonin FS determination in serum and plasma within the measuring range of 0.2 ng/mL to 50 ng/mL can be performed with high precision at clinical cut-off levels for sepsis. The performance is complemented by high tolerance to endogenous interferents and various therapeutics used in sepsis management. Procalcitonin FS shows good correlation to established methods. Results from ring trials and a publication demonstrate the strengths of the assay.
C-reactive protein (CRP) is the best known among the acute-phase proteins whose concentration increases in blood as a response to inflammatory disorders. CRP supports the body’s immune defense against pathogens e.g., it activates macrophages, which engulf and digest bacteria. CRP enables early detection of inflammatory processes as it rises earlier than fever and white blood cell (WBC) counts (leucocytes).
DiaSys CRP FS is a liquid-stable immunoturbidimetric test with dedicated ready-to-use calibrators and controls. The quantitative test results allow true differentiation of borderline cases. The test is standardized to the international reference material, has a wide measuring range, high prozone security and excellent correlation to competitor tests. The test is easily applicable to clinical chemistry analyzers with a variety of instrument applications available.
Cystatin C FS
The most common form of kidney disease is chronic kidney disease (CKD), which is slowly progessive. If not treated at a early stage, it leads to irreversible nephron loss, end-stage renal disease and/or premature death. The majority of patients suffering from CKD remain asymptomatic and, therefore, undiagnosed until their kidney function is severely impaired.
Creatinine, the most widely used test to diagnose kidney disease, fails when it comes to early detection due to insensitivity regarding decreasing glomerular filtration rate (GFR), the best-known measure of kidney function. In comparison, cystatin C levels increase in parallel with decreasing GFR, making it a superior marker, particularly to identify mild to moderate renal dysfunction. In contrast to creatinine, cystatin C blood levels are independent from factors such as sex, muscle mass, diet, or most inflammatory ageing processes.
With regard to the many advantages of cystatin C, DiaSys provides an immunturbidemetric assay, which may be applied on a broad range of clinical chemistry analyzers. DiaSys Cystatin C FS is characterized by an outstanding analytical sensitivity in addition to superior correlation with nephelometry. The assay offers excellent onboard and calibration stabilities up to 12 weeks and a high prozone security. The standardized test is essential for reliable kidney diagnosis in clinical chemistry laboratories.
Cardiovascular risk assessment with HDL-c direct FS and LDL-c direct FS
Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels. It is the world’s leading cause of death, according to a report published in the Journal of the American College of Cardiology in December 2022.
CVD may be prevented by targeting modifiable factors that contribute most significantly to the global burden of CVDs.
High levels of LDL-Cholesterol (LDL-C) are major risk factors contributing to the formation of atherosclerotic plaques and are thereby strongly associate with coronary artery disease (CAD) and related mortality. In contrast, high-density lipoprotein containing cholesterol (HDL-C) is a lipoprotein class characterized by a protective effect impeding plaque formation. Thus, HDL-C shows an inverse relationship to CAD prevalence. Indeed, low HDL-C values constitute an independent risk factor, whereas LDL-C is the primary marker for targeting lipid-lowering therapy.
DiaSys has recently extended its cardiovascular risk assessment portfolio by two innovative new reagents, HDL-c direct FS and LDL-c direct FS. Both are homogenous assays for direct determination. The high quality reagents manufactured in Germany offer long calibration and onboard stability of up to 4 months. Combined with wide measuring ranges and good precision at clinical cut-off points, DiaSys assays HDL-c direct FS and LDL-c direct FS are of high value for clinical-chemistry laboratories.
Product details HDL-c direct FS
Download Flyer HDL-c direct FS
Product details LDL-c direct FS
Download Flyer LDL-c direct FS
β-Hydroxybutyrate 21 FS
Diabetic ketoacidosis is an acute, life-threatening complication which should be detected and treated immediately. Urine test strips that are commonly used for detection of ketoacidosis, are associated with several limitations. Since β-hydroxybutyrate levels increase more rapidly than levels of acetoacetate and acetone, serum/plasma β-hydroxybutyrate determination is a superior biomarker for ketoacidosis and recommended by the American Diabetes Association. Benefits are a minimized risk for false negative results, earlier identification and treatment through quantitative results and measurements that are less susceptible to drug interference.
With β-Hydroxybutyrate 21 FS, DiaSys offers a liquid-stable, ready-to-use reagent applicable to common clinical chemistry analyzers. The assay is suitable for serum and plasma samples, has a wide measuring range, excellent precision and superior calibration and onboard stability of up to 12 weeks. The test includes the DiaSys Lipid Clearing System, assuring correct results unaffected by lipid interference.
Total bile acids 21 FS
Determination of total bile acids in serum is essential for early detection of liver damage and to diagnose and follow-up intrahepatic cholestasis of pregnancy (ICP). Methods used in the past to determine total bile acids in stool samples, such as the 7-day 75-selenotaurohomocholic acid retention assay (75SeHCAT) or alternative methods, such as LC-MS or GC-MS, are technically complex and very time-consuming.
Nowadays, determination of total bile acids is frequently performed in stool samples to diagnose irritable bowel syndrome with diarrhea (IBS-D), bile acid diarrhea (BAD) and Crohn's disease. In September 2022, DiaSys expanded the application range for their Total bile acids 21 FS reagent and now offers the assay for use in serum and stool samples. DiaSys Total bile acids 21 FS for serum and stool samples may be conveniently applied on automated analyzers commonly available in any clinical laboratory and are highly timesaving.
The liquid-stable, ready-to-use reagent shows a wide measuring range for the recommended sample material (up to 200 µmol/L in serum and 130 µmol/L in stool samples), good precision and long onboard and calibration stability. Furthermore, DiaSys Total bile acids 21 FS shows minimized interferences by a large number of possible interfering substances in serum and stool samples as well as a good reproducibility. The special calibrator offered for optimal performance and the multi-parameter controls for convenient workflow can be used for both sample materials specified.
Total bile acids 21 FS Brochure
New DiaSys Enzymatic Method for Determination of Total Bile Acids in Serum on BioMajesty ® JCA-BM6010/C Clinical Chemistry Analyzer
respons®940 – Clinical Chemistry Analyzer
respons®940 is a fully automatic random access analyzer (RAM) with a sample throughput of 400 (640 incl. ISE) tests/hour. Due to durable quartz cuvettes, low reaction volume, maintenance free photometer and intuitively operated software, respons®940 offers the economic use and reliability required in small to medium sized labs. Along with with DiaSys' high quality reagents perfectly matching to respons®940, highest result security and, therefore, a minimized number of reruns can be assured.
Diagnostic Reagents and System Solutions of Outstanding Quality!
DiaSys Diagnostic Systems is a leading specialist in development and manufacturing of diagnostic system solutions. Our goal is to combine high quality with ease of use and to reduce the environmental burden. Focusing on clinical chemistry and immunoturbidimetric tests, DiaSys has introduced more than 100 reagents in user-friendly kits for manual or automated use. DiaSys reagents ensure reliable results in routine and special diagnostics as e.g. diabetes, metabolic syndrome, lipid disorders, iron metabolism, pancreatic, kidney or liver diseases.
The instrumentation portfolio comprises automated clinical chemistry analyzers for small to medium sized laboratories (respons®910, respons®920, respons®940 and BioMajesty®JCA-BM 6010/C), semi-automated analyzers (StarDust MC15) and POCT instruments (InnovaStar® and SensoStar). Additionally, DiaSys offers a broad range of calibrators (TruCal) and quality control material (TruLab).
DiaSys continuously expands its reagent and system portfolio.
At the beginning of 2020, DiaSys launched a new sensitive marker for severe and systemic bacterial infections – Procalcitonin FS. DiaSys Procalcitonin FS is a fluid-stable, particle enhanced immunoturbidimetric assay with good precision at clinical cut-offs for sepsis. The assay has an outstanding onboard and calibration stability. The performance of Procalcitonin FS is comparable to established methods, presenting a reliable alternative for clinical chemistry analyzers.
DiaSys is an ISO certified company since 1996 (ISO 13485). To date, customers and partners in more than 100 countries rely on DiaSys’ quality.
Area of business
• Laboratory equipment