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FDA grants CLIA waiver for Strep A molecular test


FDA has granted CLIA waiver for the Alere i Strep A test. The test, which was cleared for marketing by FDA in April 2015, is the first molecular platform that detects Group A Streptococcus (GAS) bacteria in 8 minutes or less.

FDA has granted CLIA waiver for the Alere i Strep A test. The test, which was cleared for marketing by FDA in April 2015, is the first molecular platform that detects Group A Streptococcus (GAS) bacteria in 8 minutes or less .

Related: FDA grants first-ever CLIA waiver of rapid syphillis test

Alere i Strep A detects GAS bacteria in throat swab specimens using the company’s proprietary Molecular In Minutes (MIM) isothermal nucleic acid amplification technology (iNAT).

With CLIA waiver, the Alere i Strep A test will be available in a broad range of healthcare settings, including physician offices, hospital emergency rooms, and retail and walk-in clinics in the United States.

Related:Strep A rapid molecular test gets FDA clearance

"CLIA waiver expands the access of this test to more patients, which can help drive positive outcomes throughout the integrated delivery network/managed care organization," said Ryan Schmidt, vice president of infectious disease marketing at Alere.

The Strep A test is the second assay on the Alere i molecular platform, which initially received 510(k) clearance for the detection and differentiation of influenza A and B virus in 2014. In January 2015, Alere i Influenza A & B became the first-ever molecular test to receive CLIA waiver.

GAS pharyngitis causes a considerable cost to society, according to Schmidt. In the United States, it is estimated that GAS pharyngitis in children alone costs between $224 million and $539 million per year. In addition to the acute symptoms of sore throat, GAS can lead to suppurative sequelae, including peri-tonsillar abscess, and nonsuppurative sequelae, including rheumatic fever.


NEXT: Five ways formulary managers can become more vigilant of GAS


Schmidt offers 5 ways formulary managers can become more vigilant of GAS:

#1. Measure/monitor the percentage of sore throat infections that are given antibiotics.

“If it is significantly over one-third, we can guess that physicians are just giving antibiotics to anyone that walks in the door regardless if they are getting results back from the lab-GAS has a general prevalence of 30%,” he said.

#2. Measure turn around time it takes to get Strep A results from the laboratory if they don’t have point of care.

“If that is more than a half hour, more than likely, the lab may be producing great results, but if there is no impact on treatment, who cares?,” Schmidt says.

#3. Measure how many throat swabs are taken versus how many scripts for pharyngitis.

“This would indicate how many doctors are just treating on symptoms-which we know is not accurate-rather than truly knowing by taking swabs and testing,” he says.

#4. Measure length of stay in the ED for pharyngitis.

“For many hospitals, they are looking at patient satisfaction,” Schmidt says. “There are billboards for wait times in emergency department [ED]. Satisfaction for children visits is directly related to how long they are there.”

#5. Measure how many times culture is positive.

“Most diagnostic algorithms ask for the negative results to be confirmed via culture,” he says. “Fewer culture-positive results would indicate that we got it right while the patient was still with the [provider] which will indicate that the right treatment protocol was achieved.”

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