New Point-of-Care Test Offers Fast, Accurate Pertussis Diagnosis

The FDA granted a 510(k) clearance to a novel point-of-care (POC) test for detection of Bordetella infections, such as pertussis. The test offers clinicians quicker, more accurate results in as little as 15 minutes.¹

“Faster and more accurate clinical decisions are critical for reducing the risk of severe complications and ultimately stopping the transmission of Bordetella infection,” Matt Sause, CEO of Roche Diagnostics, said in a news release. “This new test allows clinicians to quickly make a definitive and precise diagnosis to ensure patients get the right treatment earlier.”¹

Whooping Cough Cases Surge Worldwide

Pertussis, commonly known as whooping cough, is caused by Bordetella pertussis (B pertussis), a bacterium that infects only humans. The bacteria attach to the cilia—tiny, hair-like extensions lining parts of the upper respiratory system—and release toxins that damage the cilia and cause airway swelling. This process leads to the characteristic severe coughing fits that define the disease.²

Pertussis remains a major global public health threat, causing an estimated 24 million cases and 170,000 deaths each year. While the infection can affect people of all ages, infants under 6 months face the highest risk. Their underdeveloped lungs and narrow airways make it especially difficult to breathe during the repeated, forceful coughing spells, increasing the likelihood of complications and long-term health issues.^2,3

Often referred to as the “100-day cough,” whooping cough is highly contagious and can progress rapidly in young children. In recent years, cases have been rising worldwide. In 2025 alone, the US reported over 25,000 cases, marking the second consecutive year of above-average incidence, with several deaths recorded in Louisiana, Washington, and Kentucky.^2-4

Fast, Accurate Pertussis Detection

The POC assay for the cobas liat platform brings rapid, lab-quality PCR testing directly into the clinical encounter. The handheld system—already widely used for quick detection of respiratory pathogens such as SARS-CoV-2, influenza A/B, RSV, and Strep A—now includes an assay that targets 3 Bordetella species known to cause nearly indistinguishable cough symptoms¹:

1. B pertussis: causes classic whooping cough
2. B parapertussis: causes a milder pertussis-like illness
3. B holmesii: is an emerging pathogen increasingly associated with pertussis-like symptoms

By distinguishing among these pathogens, clinicians can identify the true cause of illness earlier and tailor care more appropriately.

One of the system’s defining advantages is speed. The cobas liat test can produce definitive PCR results in as little as 15 minutes, allowing providers to make informed decisions before the patient even leaves the exam room. This rapid turnaround supports timely treatment, helps curb transmission, and lessens dependence on central laboratory workflows.¹

For vulnerable populations—including young infants, older adults, and others at higher risk—earlier diagnosis can be critical. Fast, accurate identification of infection enables clinicians to intervene sooner, potentially preventing serious complications and improving overall outcomes.

Rising Cases Spark Innovation in Pertussis Prevention

The FDA’s clearance of the cobas liat POC test gives clinicians a powerful tool: lab-quality PCR results in minutes, not days, enabling faster isolation, earlier treatment, and more immediate protection for high-risk patients.

At the same time, researchers are advancing a first-of-its-kind intranasal vaccine designed to block transmission at its source. Early data show the nasal formulation may trigger stronger mucosal immunity in the upper airway—where Bordetella spreads—offering a potential path to reducing community outbreaks more effectively than current injectable vaccines.³

Together, these developments signal a shift in how pertussis may be identified and controlled. As diagnostics get faster and vaccines move closer to targeting transmission, public health officials say the tools needed to curb future surges may finally be within reach.

REFERENCES

1. Roche receives FDA clearance with CLIA waiver for its first molecular point-of-care test for the detection of Bordetella infections, including whooping cough (pertussis). Roche. December 2, 2025. Accessed December 3, 2025. https://diagnostics.roche.com/us/en/news-listing/2025/fda-clia-waiver-poc-test-whooping-cough.html

2. About whooping cough. CDC. April 2, 2024. Accessed December 3, 2025. https://www.cdc.gov/pertussis/about/index.html

3. Nasal vaccine could curb whooping cough transmission and boost local immunity. Pharmacy Times. November 12, 2025. Accessed December 3, 2025. https://www.pharmacytimes.com/view/nasal-vaccine-could-curb-whooping-cough-transmission-and-boost-local-immunity

4. Benadjaoud Y, Kekatos M. More than 25,000 whooping cough cases reported this year as Kentucky records 3rd infant death. ABC News. November 25, 2025. Accessed December 3, 2025. https://abcnews.go.com/Health/25000-cases-whooping-cough-recorded-year-higher-pre/story?id=127831021#:~:text=More%20than%2025000%20cases%20of%20whopping%20cough,far%20this%20year%2C%20updated%20federal%20data%20shows