The U.S. Food and Drug Administration (FDA) has allowed the marketing of the NephroCheck test, which can be used to help determine if patients are at risk of developing moderate to severe kidney injury in the 12 hours following the administration of the test. This would help guide doctors as they care for the patient and try prevent kidney failure and possible death.

This would be extremely helpful in patients with symptoms of E. coli to help predict risk of Hemolytic Uremic Syndrome (HUS), a severe complication of E. coli food poisoning. What happens is Shiga toxins produced by certain E. coli bacteria (O157 the most common) invade the kidneys, causing little blood clots that destroy blood cells. The kidneys are damages and often fail to function. It is mostly children who develop STEC-HUS (STEC for Shiga toxin Escherichia Coli).

Why are Kidneys Important?

There are 2 kidneys, bean-shaped and about the size of a fist. They filter blood to produce urine, which is a combination of wastes and extra water.  This is the only organ in the body that can do that, so when the kidneys fail, the waste and extra water build up in the body and cause severe illness. In some cases, there is multiple organ failure (heart, liver, pancreas) and severe brain damage.

HUS patients can have a stroke or heart attack, even if the patient is just a little child. All HUS patients get really high blood pressure, called hypertension. This is not your ordinary high blood pressure, but life threateningly high blood pressure. Historically, about %15 of patients died, but that number is dropping.

The kidneys filter waste and extra water out of the blood.  and are important in controlling blood pressure and other essential body functions. When kidneys are not functioning properly, waste builds up in the body and can cause serious health problems.

Why is This Test Needed?

In some cases, E. coli patients quickly develop HUS. If the NephroCheck test is administered to E. coli patients, this may help determine which ones will develop HUS. If a patient already has symptoms of HUS, it may help determine if the HUS is going to cause kidney failure. This early detection could save lives.

What makes the NephroCheck test different is that it is the only test approved by the FDA that predicts kidney injury. Current laboratory tests can only determine whether the patient already has acute kidney injury (“acute” because it is sudden onset).

According to the FDA:

NephroCheck detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine, which are associated with acute kidney injury. Within 20 minutes, the test provides a score based on the amount of the proteins present that correlates to the patient’s risk of developing AKI within 12 hours of the test being performed.

The FDA approved the test after it reviewed 2 clinical studies evaluating the test’s safety and effectiveness. The studies looked at more than 500 patients at 23 hospitals. According to the FDA, “NephroCheck accurately detected 92 percent of AKI patients in one study and 76 percent in the other.”

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