A newly cleared point-of-care test will enable rapid identification of whooping cough, according to a press release from manufacturer Roche.

The molecular test uses the cobas liat system and earned an FDA clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for the detection of Bordetella infections, including pertussis.

The CLIA waiver means that the test is approved for use in settings outside of a traditional lab, including a doctor’s office or pharmacy, and is considered sufficiently simple that it can be performed by healthcare personnel without extensive medical training.

The test is currently available and provides polymerase chain reaction (PCR) results after approximately 15 minutes at the point of care, according to the company. Early symptoms of pertussis are similar to other respiratory illnesses, and a quick-turn test can confirm a diagnosis and facilitate timely treatment to prevent further spread of illness and protect patients from severe complications.

The new test is designed to differentiate among three types of Bordetella infection that can cause similar symptoms, including cough, according to the company. In addition to Bordetella pertussis, the cause of classic whooping cough, the test identifies the B parapertussis strain associated with milder illness, and an emerging variant known as B holmesii that is associated with pertussis-like symptoms that could complicate diagnoses.

Timing Is Everything

“Early identification of pertussis allows for faster initiation of antibiotic therapy which reduces the risk of developing severe symptoms and complications; and also helps to reduce the risk of transmission to others,” said Shirin Mazumder, MD, infectious diseases specialist and associate professor at The University of Tennessee Health Science Center, Memphis, Tennessee, in an interview. Early identification also allows for more timely initiation of antibiotic prophylaxis to close high-risk contacts, said Mazumder.

The new test can help address the challenges of pertussis diagnosis, as the clinical presentation varies according to age and vaccination status, Mazumder told Medscape Medical News. “Atypical presentations can occur among young infants where apnea rather than classic cough may be present,” she said.

Current testing modalities include culture, which has limited sensitivity, narrow timing requirements, and can take nearly a week for results to return, Mazumder noted. PCR testing has improved sensitivity, but must be collected within the first 2 weeks of illness for best results, she said.

Advantages of the new point-of-care test include not only a quick turnaround to facilitate rapid diagnosis and implementation of treatment but also identification of the specific Bordella strain behind the infection, said Mazumder. “Testing for additional respiratory viruses can be done using the same machine,” she added. However, financial barriers associated with the machine, including reagents and other operational costs, may limit access and implementation, especially for clinics or healthcare facilities in resource-limited areas, she said.

The use of a rapid test to diagnose pertussis cases early in the clinical course can also decrease the duration and severity of symptoms and reduce the transmission to others, which can reduce the likelihood of outbreaks, said Mazumder, “Rapid testing also helps to identify cases more easily in an outbreak situation,” she said.

Research related to the test was supported by Roche. Mazumder disclosed having no financial conflicts of interest.