One of the most common endocrine disorders is primary hyperparathyroidism affecting more than 100,000 people in the United states alone. Excessive secretion of parathyroid hormone (PTH) often results in enlargement of the parathyroid gland. Measuring the PTH levels aids in effective disease management where surgical excision of the hyperfunctioning gland offers as a reliable treatment solution. Evaluating PTH levels during the surgery confirms successful resection of the hyperfunctioning gland. Existing laboratory-based assays are often time consuming and require large volume of blood sample. Most current assays take more than 20 minutes from the time of sample receipt. To overcome the current limitations, it is essential to come up with alternate solutions to provide better insight on the results with clarity while being able to get rapid results, with accuracy and minimal cross reactivity.
Point-of-care (POC) diagnostic devices have revolutionized effective solutions for existing limitation of laboratory techniques. According to a recent study, the current POC market crossed nearly $20 billion sale. POC testing has gained popularity as it provides rapid results within minutes, enables expedited decision making for clinicians near patient bed side while using it effortlessly without the need of expert laboratory personnel. Specific to PTH, POC device have not exhibited the clinical specificity required for real time decision making.
We have developed a rapid POC biosensor useful to monitor PTH concentration during parathyroidectomy to serve as a guide to surgeons. This affinity based electrochemical biosensor requires low volume (less than 40 uL) without altering the samples to test for real time PTH concentrations. One of the advantages offered by this developed biosensor is its ability to minimize the effects of cross-reactive signal interference due to its specific response to full length PTH. Sensitivity of the biosensor allows for limit of detection of 10 pg/mL enabling measurement in a wide dynamic range of up to 1000 pg/mL.
The use of POC testing device near patient eliminates the complications arising from sample deterioration, which currently must be sent to central laboratory exposing to different environmental conditions and temperatures. Portability aspect of POC require less space requirement as well. Many PTH assays in the past have been known for the variations in reporting PTH concentrations in the past as standardization of the assay hasn’t been effective. Encouraging the use of POC devices could eliminate the variations arising from using different detection methodologies. It further helps reduce costs and helps advance patient healthcare accessibility by providing technological solutions engineered to address current limitations.
Introducing rapid Point of care devices in the patient operating room to monitor real time PTH levels could prove to be a game changer in the field. The PTH specific device is precision engineered to provide accurate reliable results in no time, enabling effective decision-making, ultimately improving quality of patient care.