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FDA Grants 510(k) Clearance to Market 2 Campylobacter Diagnostic Tests

The FDA grants 510(k) clearance to TECHLAB to market 2 noninvasive tests intended to aid in the diagnosis of campylobacteriosis.

Estimated to cause about 1.3 million illnesses on an annual basis in the United States, Campylobacter recently made headlines when an outbreak linked with contact with pet store puppies sprung up in 17 US states. Now, the US Food and Drug Administration (FDA) has granted 510(k) clearance to market 2 noninvasive tests intended to aid in the diagnosis of campylobacteriosis.

The CAMPYLOBACTER QUICK CHEK test is a diagnostic test capable of rapidly detecting Campylobacter jejuni and Campylobacter coli in under 30 minutes. The second test, the CAMPYLOBACTER CHEK test, “is a 96-well plate format for laboratories testing a large number of specimens, and can be used with or without automation,” according to the press release. Both tests have proven to be more accurate than culture and “have the highest positive predictive values” among Campylobacter immunoassays that are currently available.

Campylobacter infection is one of the most common causes of diarrheal illness in the United States, according to the Centers for Disease Control and Prevention (CDC). In fact, around 14 cases are diagnosed each year for every 100,000 people. However, the majority of cases go undiagnosed.

The most telltale symptoms to look out for when seeing patients is diarrhea (which is often bloody), fever, and abdominal cramps, according to the CDC. Sometimes, an infected individual will also experience nausea and vomiting due to infection. However, individuals are not always symptomatic. As such, many cases go undiagnosed, underreported, and are not recognized as outbreaks. When infections are suspected, culture or rapid diagnostic tests are used.

“Most Campylobacter testing is still performed by culture because the diagnostic immunoassays on the market have a PPV value of less than 50%. But culture requires up to 72 hours to give a result and is technically challenging due to the microaerophilic growth requirements of the bacteria,” vice president of Scientific Affairs at TECHLAB, Dr. Joel Herbein, is quoted to have said in the press release. “The Campylobacter products we have developed have a high PPV, can be performed on the benchtop in 30 minutes for the rapid to about an hour for the 96-well plate format, and offer clinicians more confidence in their testing results.”

Although most individuals infected with the bacteria tend to recover without specific treatment, physicians should instruct patients to drink extra fluids for as long as diarrhea lasts. The CDC reminds health care providers that antibiotics should only be used in patients “who are very ill or at high risk for severe disease.” Such people would include those with severely weakened immune systems, such as those with blood disorders thalassemia and hypogammaglobulinemia, AIDS, or those who are in the process of receiving chemotherapy.