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After three years of hard work, Dr. Delfina C. Domínguez, professor of Clinical Laboratory Sciences and collaborator Dr. XiuJun Li, professor of Chemistry and Biochemistry, are ready to share the exciting news that their instrument-free point of care biochip device has been validated through clinical analysis to effectively detect Bordetella pertussis, the causative agent of whooping cough.

Despite high vaccination rates against pertussis in many countries, it remains endemic worldwide. The disease is commonly under diagnosed because most of the cases present mild infection and can be confused with many other conditions including RSV and rhinovirus. Additionally, protection against the bacteria is not permanent, leaving people vulnerable to infection later in life. Diagnosis is typically done in a clinical laboratory and the cost is expensive.

In an article published recently in a Lancet family journal, the professors outlined the methods they used to create an instrument free, low cost point of care device for fast and accurate diagnosis of pertussis.

This work was a collaborative effort, which included Dr. Li and a team of students (Dr. Maowei Dou et all), who led chip design and clinical validation of the biochip; Dr. Dominguez, who directed microbiological and molecular techniques; and Dr. Jennifer Dien Bard, director of Clinical Microbiology and Virology Laboratory at Children’s Hospital in Los Angeles, who provided the clinical samples and completed the pre-analysis by real time PCR. Once the analyses of clinical samples were completed at LA Children’s hospital (blinded) samples were sent to Â鶹¹ÙÍø to be analyzed by the biochip and compare the sensitivity and specificity of the biochip against reliable routine instrumentation used in the clinical laboratory.

Drs. Li and Dominguez shared their perspectives on how important the interdisciplinary nature of their work was to the overall success of the project.

“This is a highly interdisciplinary project supported by NIH, among biotechnology, microbiology and clinical studies. Without close collaboration and hard work from the three teams, the biochip would not have become possible,” said Li.

Dominguez agreed, adding “The nature of this project required having expertise across all areas and is really what made this a success.”

The chip’s simple design –plastic and paper – and tiny size (similar to a USB) hides a more complex microfluidic system within that integrates DNA amplification and makes diagnosis much easier for the operator. Due to its portability, ease of use and low cost – approximately $3 – the device will be particularly helpful in low-resource settings in developing nations, and may even be adapted to help diagnose other types of infectious diseases. Li and Dominguez anticipate that the device could also be used in other venues, including schools and community clinics, where operators can easily be trained on how to use it.

As for the future, the research team has already applied for a patent for the device, and is looking forward to clinical trials, the next stage in development of the project prior to it being released in the markets by a new start-up company founded by Li, microBioChip Diagnostics LLC.

The full Lancet article published by the team, “Rapid and Accurate Diagnosis of the Respiratory Disease Pertussis on a Point-of-Care Biochip,” can be accessed here: