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PSA Determinations with Microfluidics: A Novel Point-of-Care Analysis
Stephen M. Zappala, MD1, John A. Libertino, MD2, Alan Wein, MD3, E. Darracott Vaughan, MD4, Peter Scardino, MD5.
1Andover Urology, Andover, MA, USA, 2Lahey Clinic, Burlington, MA, USA, 3University of Pennsylvania, Philadelphia, PA, USA, 4Cornell University, New York, NY, USA, 5Memorial Sloan Kettering Center: Columbia University, New York, NY, USA.
BACKGROUND:
PSA measurement with the OPKO Analyzer is introduced as a point-of-care device. The microfluidic system is differentiated by the ablity to attain accurate, quantitative immunoassay results with a finger stick droplet of whole, unprocessed blood. All of the bio-reagents are contained within a 50 micron channel, inside a credit card size cassette. The cassette is inserted into a desk top analyzer with results available within ten minutes.
METHODS:
The study was performed in a clinical setting with non-laboratory personnel. 72 male volunteers were enrolled in one site with IRB Approval: (age range 50 to 82, median 61.5). PSA values were compared between the OPKO Analyzer and an ADVIA Centaur ELISA from a reference lab. A finger-stick droplet (10 microliters) from OPKO was compared to an immediate upper extremity venipuncture (Control). All results are represented as ng/mL.
RESULTS:
PSA values ranged from 0.1 to 8.3 ng/mL. No visible outliers were identified. Data analyzed by linear regression yielded a slope of 1.05 and an R squared value of 0.94. Specifically, low range data between 0.10 and 1.0, reveal excellent correlation.
CONCLUSIONS:
The OPKO PSA Analyzer is a novel testing platform based upon a sliver amplification immunoassay. The OPKO results reveal excellent correlation and are comparable to a conventional ELISA. The device streamlines efficiency and conserves time, space, and energy. The OPKO Analyzer is anticipated to be CLIA waived and can multiplex, determine up to four biomarkers on the same droplet of blood. This represents the original, pilot study on microfluidics and PSA: larger studies are ongoing in both Europe and USA.
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