The introduction of urine dipstick technology, with its speed and simplicity, led to an explosion of point-of-care testing (POCT). Urine pregnancy is one of the most commonly performed POCTs, with millions of patients tested annually in emergency rooms, outpatient clinics, and other non-laboratory settings. Testing is performed to aid in the early detection of pregnancy, depending on the clinical situation.
Despite this enormous utility and testing volume, there has been relatively little advancement in testing technology. Most tests require manual timing and visual interpretation. Visually read tests are subject to individual observer capabilities and make record keeping, billing, and QA/QC monitoring a challenge, particularly when run in busy patient care settings. We are now seeing the emergence of new instrumented, connected technologies that will aid both patients and health professionals.
Defining next generation POC urine pregnancy testing
The following criteria can be used by laboratories to define next-generation technology and screen the many testing possibilities:
- Excellent sensitivity and specificity
- Time. The total time from sample collection to reporting the test result must be as short as possible and within the time frame of a typical patient visit.
- Objective results that eliminate operator interpretation
- Ease of use
- Size. Instrumentation must be small enough for all settings
- Onboard data storage, LIMS, EMR, WIFI, and/or cellular wireless capabilities must be available to properly document and store testing for medical, legal, test utilization monitoring, accounting, and/or billing purposes.
To meet the above criteria, some diagnostic companies are moving to fluorescence-based chemistries combined with small, easy-to-use, and yet sophisticated analyzers. The use of innovative fluorophores coupled with monoclonal antibodies yields substantial improvements in sensitivity. Fluorophores with sufficiently large Stokes shifts prevent interference from naturally fluorescent compounds found in biological samples. The placement of a large number of fluorescent molecules inside individual microbeads yields a highly amplified signal in the assay. Further, some manufacturers have made strides by working with fluorophores that are resistant to bleaching under ambient light, obviating the need to protect from ambient light.
From the point of view of instrumentation, highly experienced device manufacturers are developing analyzers with sophisticated assay analysis software that further improves assay performance by controlling for a multitude of sample and user-related issues. These newer analyzers also ensure both ease of use for the end user and accurate results for the patient and the clinician.
Benefits of next-generation assays and systems
When new and emerging POC analyzers are coupled with the latest science in assay chemistry, the following benefits can be expected:
- Improved patient care and physician satisfaction
- Reduced operator-to-operator variability
- Reduction of procedural variation and operator errors through automation, barcoding, and other instrument control features
- The ability to automatically capture, store, and transmit patient results.
Choosing the right POCT device
Given the challenges that laboratories are facing today, including financial constraints, increasing demands, and personnel shortages, many labs can greatly benefit from adopting next-generation POC immunoassay analyzers. The greatly improved performance, objectivity, connectivity options, and ease of use means the laboratory can complement its existing instruments and platforms with a faster, easy-to-use, and cost-effective solution. The incumbent technologies still have a place, but they can be better allocated when coupled with a next-generation POC analyzer.
Next-generation POC assay systems are now available that give medical professionals, including laboratory managers, options that did not exist even two or three years ago. These options include objective and automated results, customizable settings, and the ability to directly transmit the results to office, hospital and/or laboratory information systems.
Timothy T. Stenzel, MD, PhD, joined Quidel Corporation in 2009 as Chief Scientific Officer. He has also held senior positions at the molecular diagnostics company Asuragen, Abbott Laboratories, and Duke University. Rhys de Callier, MBA, is Director of the Sofia Business Unit for Quidel. He has served in various roles in marketing, business development, and strategic planning.
