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NephroCheck
NephroCheck is an assay to assess the risk of developing acute kidney injury.〔http://www.reuters.com/article/2015/01/22/biomerieux-brief-idUSFWN0V004020150122〕 The laboratory test was developed by Astute Medical, in San Diego, California, in collaboration with clinical investigators. It was notable for being the first test of its kind for determining whether certain critically ill hospitalized patients were at risk of developing moderate to severe acute kidney injury (AKI) in the next 12 hours. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death. == History ==
Nephrocheck took six years to be developed. The development included a discovery effort that tested over 300 possible biomarkers in clinical samples, an immunoassay cartridge and meter, clinical validation of the test in a series of extensive trials in the United States and Europe, CE mark in European countries and FDA-clearance to market it in the United States. It cost approximately $100,000,000 to develop and is intended for patients who are admitted to the hospital. The cost of the test is covered by a diagnostic related group (DRG) payment. The list price of the test to a hospital in the United States is $85. The price of the meter is approximately $5,000. Nephrocheck uses two urinary cell-cycle arrest biomarkers (e.g., TIMP-2 and IGFBP7) to determine if a person is at increased risk for developing moderate to severe acute kidney injury (AKI) in the next 12 hours.〔FDA PR, ibid〕 Knowing this earlier improves patient outcomes by allowing clinicians to focus on high risk patients and prevent further injury. Delays in diagnosis are common. AKI causes harm and is an increasingly common complication in hospitalized patients---affecting nearly 7-18%. Those with comorbidities and undergoing complex procedures are at high risk for developing AKI. It has been shown that up to 60% of critically ill patients will develop some form of AKI. Common functional markers, such as serum creatinine, have been used, yet they are late indicators of AKI.
抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「NephroCheck」の詳細全文を読む
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