The CoaguChek XS Plus has FDA clearance for nonwaived services, and CLIA waiver approval is pending. The CoaguChek XS Plus system from ROCHE DIAGNOSTICS DIVISION, Indianapolis, was introduced in 2007 as the company’s fifth-generation POC anticoagulation monitor, becoming part of the most frequently used family of prothrombin time (PT)/international normalized ratio (INR) POC testing devices in the United States. Daily maintenance, the company says, uses a built-in quality-control (QC) package and requires less than 5 minutes of staff time. Levels are monitored automatically for reagent bottles in tilted racks, and a dilution range of up to 1:1,200 is possible. The system’s specialty menu can be custom defined by the user to include profiles for disseminated intravascular coagulation and for the risk of thrombosis or bleeding, in addition to reflex testing. The system’s special features for handling high test volumes include the ability to manage both normal and pathological specimens using walk-away and random-access methods. For the detection of von Willebrand disease, there is an automated ristocetin cofactor activity test. In addition to employing state-of-the-art immunological, chromogenic, agglutination, and clotting methodologies on a single platform at three wavelengths, the system offers (for research use) advanced coagulation testing in the form of the automated endogenous thrombin potential test. The system can use customer protocols to customize software that will enhance efficiency. For example, specialty and routine testing can be conducted simultaneously. Customer input, gathered during a series of interviews of many users of the other 1,500 installed systems in the BCS line, was used to add features that enhance workflow and improve productivity. This coagulation analyzer, introduced in 2006, is intended for high-volume work environments and has been optimized to improve turnaround time for results. SIEMENS HEALTHCARE DIAGNOSTICS, Deerfield, Ill, makes the BCS® XP system. Manufacturers have adopted several strategies to help laboratories meet these goals, both in the clinical laboratory and at the point of care (POC). As is so often the case, the laboratory is being expected to increase test volumes while decreasing turnaround times and costs. In addition to mounting volumes, there is increasing pressure to return results to clinicians rapidly so that anticoagulant therapy can be fine-tuned, since outcomes appear to be tied to the successful use of anticoagulant therapy at a stable, effective level. Patients awaiting surgery, those with suspected disseminated intravascular coagulation, and those being screened for congenital clotting disorders also add to the list of candidates for coagulation tests. More patients are using anticoagulants for long periods (or permanently), particularly following implantation of mechanical heart valves or after episodes of atrial fibrillation.Īn additional, more recently expanded group is using antithrombotic agents after, or to prevent, deep venous thrombosis, arterial or pulmonary embolism, stroke, angina pectoris, and myocardial infarction. The number of patients needing coagulation testing is growing, not only as part of the general trend toward higher test volumes, but because new applications for coagulation testing are being found.
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