Microengineered Lollipop for Patient-Centric Saliva Collection - PROJECT SUMMARY/ABSTRACT
Oral samples for respiratory disease diagnosis are essential as certain bacterial and viral infections can lead to
serious long-term conditions when left untreated. However, accessing these samples is challenging in some
cases, such as in young children and remote patients where telemedicine is essential. Currently, oral sample
collection relies on traditional naso- and pharyngeal swabs that are difficult, painful, and traumatic for young
children and potentially result in delayed access to diagnostic results, leading to negative outcomes. We
designed a novel, micro-engineered, lollipop-inspired platform (LolliTest) to improve on at-home oral sample
collection capabilities. The LolliTest was designed with two key features, (1) functionalized open microchannels
for pathogen capture and concentration and (2) time-controlled flavoring release to make the platform more
patient-centric. The use of open microfluidics (i.e., microfabricated channels without a ceiling) is advantageous
as it allows optimal saliva exchange and access to the capture areas while preventing mechanical abrasion by
the tongue or other surfaces of the mouth, which could dislodge captured bacteria. The time-controlled flavoring
release enables the user to intuitively know how long to use the LolliTest device, eliminating the need for complex
instructions in a home setting. To establish the platform, we propose two specific aims. Aim 1 will optimize the
LolliTest platform to capture known oral commensal microorganisms in healthy subjects. This enables safe
testing and development cycles with simple access to human subjects who have a range of bacterial
concentrations in their saliva. We will specifically adapt and optimize key features of the LolliTest, such as the
open-fluidic functionalized capture channels and the time-tailored flavor-release function, to enable the capture
of a selected microorganism in concentration commensurate with typical pathogens. This aim also allows
iteration to improve ease-of-use and subject experience based on user surveys. Aim 2 will demonstrate
functionality of the LolliTest platform to capture and detect Group A Streptococcus (GAS) in vitro and in a small-
scale clinical study to demonstrate the potential of the platform for acquisition of samples from children in the
clinic. We will compare results of the LolliTest sampling (followed by real time-polymerase chain reaction) with
conventional pharyngeal swabs and clinical analysis, validating the ability of the LolliTest to determine if a patient
is positive or negative for GAS. With deliberate design to maximize collection performance from saliva sampling,
our long-term vision is that our LolliTest platform will achieve better sensitivity and specificity than can be
obtained with current biospecimen collection techniques, while providing a platform that is preferred by patients
and usable in home settings. Ultimately, the LolliTest has the potential to make saliva sampling a new gold
standard for respiratory disease diagnostics.
