The US FDA has granted marketing clearance to Cepheid‘s Xpert Xpress Strep A test, according to the company.
The test provides rapid, accurate, and reliable molecular detection of Streptococcus pyogenes (Group A ?-hemolytic Streptococcus or Strep A) DNA from patient throat specimens in as little as 18 minutes for a positive result.
A recent report by the World Health Organization notes that the burden of Group A streptococcal infections globally continues unabated, even though the organisms remain susceptible to penicillin. Antibiotic treatment of acute pharyngitis, often caused by viruses and not bacteria, is often initiated inappropriately, in an effort to shorten the course of illness and prevent acute rheumatic fever, a complication of severe Group A Strep infection.
However, treatment of infections not informed by laboratory testing as to the causative pathogen can lead to organisms developing increased drug resistance. Delivering accurate on-demand test results helps healthcare providers improve antibiotic treatment strategies to limit antibiotic use to those patients who are likely to benefit from it.
“Untreated infections of the upper respiratory tract caused by Group A Streptococci can lead to serious health consequences,” said David H. Persing, MD, PhD, Cepheid’s Chief Medical and Technology Officer. “The speed and accuracy of the Xpert Xpress Strep A test allows patients and their healthcare providers to expect a definitive diagnosis at the point-of-care, and to avoid the need for lengthy and cumbersome confirmatory bacterial cultures.”
Xpert Xpress Strep A is the third test to join Cepheid’s new Xpert Xpress family for no-compromise speed, accuracy, and quality. Xpert Xpress Strep A utilizes automated real-time polymerase chain reaction (PCR) to detect Streptococcus pyogenes DNA. The built-in reagents deliver high performance specifications with no requirements for culture confirmation of negative results unless clinical symptoms persist or there is an outbreak of acute rheumatic fever (ARF).