Bio Medical Devices/Services
Point of Care Raman Device for Detection of Gout
Gout affects millions of people in the US and the economic burden due to the disease is comparable to other chronic conditions such as Parkinson’s disease or migraine. Accurate identification of crystal identity is essential to pursue an appropriate form of treatment. Patients who have gout attacks seek care at hospitals, outpatient centers, urgent care or the ER with hot, swollen and painful joints; therefore, gout symptoms can be confused with other forms of arthritis. Therefore, conclusive diagnosis requires observation of synovial aspirates by polarized light microscopy (PLM) to confirm the presence of negatively or positively birefringent crystals. PLM analysis requires a microscope equipped with compensated polarization optics and a Clinical Laboratory Improvement Amendments (CLIA) certified pathologist or rheumatologist to conduct the analysis. Certified PLM is only feasible in major healthcare centers and central laboratories in selected rheumatology practices. Therefore, clinicians on the front line may be unable to diagnose gout during their clinical encounter or they depend on presumptive diagnosis based on clinical symptoms which lacks sensitivity and specificity. Therefore, a facile and automated point of care testing for gout and pseudogout is needed in primary care settings to inform the diagnosis and treatment of these diseases.
Point of care Raman device (POCR) is an existing prototype that is developed at Case Western Reserve University (CWRU) with past NIH R21 and R01 to identify MSU and CPPD crystals in synovial fluid. The method involves a simple and facile sample preparation to isolate crystals in a disposable cartridge which is then inserted in a compact, cost-efficient and automated device which identifies the crystal species based on fingerprint molecular spectroscopy. The method can be executed by the non-specialist by minimal training. POCR was evaluated using synovial fluid samples from symptomatic patients (N=174) and there was more than 90% agreement between the diagnoses of POCR and PLM conducted by a certified technician/pathologist. In the past, clinical synovial sample analyses were performed by researchers.
Spectral Energies, in collaboration with Case Western Reserve University (CWRU) and Cleveland Metro Clinic, is further developing the POCR in order to make it as commercially viable product as possible with support from National Institute of Health (NIH). The research team is anticipating that the end product would be cost-effective and can be handled by non-expert clinical staff. For further information, please contact us via email (firstname.lastname@example.org) or by phone (937-266-9570/937-902-6546).