Point of Care Testing (POCT) is defined as medical diagnostic testing performed outside the clinical laboratory in close proximity to where the patient is receiving care. POCT is typically performed by non-laboratory personnel and the results are used for clinical decision making.
What is an Immunoassay?
Immunoassays are chemical tests used to detect or quantify a specific substance, the analyte, in a blood or body fluid sample, using an immunological reaction. Immunoassays are highly sensitive and specific. Their high specificity results from the use of antibodies and purified antigens as reagents. An antibody is a protein (immunoglobulin) produced by B-lymphocytes (immune cells) in response to stimulation by an antigen. Immunoassays measure the formation of antibody-antigen complexes and detect them via an indicator reaction. High sensitivity is achieved by using an indicator system (e.g., enzyme label) that results in amplification of the measured product. Immunoassays may be qualitative (positive or negative) or quantitative (amount measured).
The purpose of an immunoassay is to measure (or, in a qualitative assay, to detect) an analyte. Immunoassay is the method of choice for measuring analytes normally present at very low concentrations that cannot be determined accurately by other less expensive tests.
The world market for POC tests has shown consistent growth of approximately 9.8% annually, a trend that is expected to continue until 2021. Point-of-care testing is estimated to reach $36.96 Billion by 2021.
The Target System will meet the POCT market criteria as follows:
- Rapid turnaround time
- Low volume preferably whole-blood sample
- Direct application of a non-critical volume or placement of sample directly into instrument
- Disposable device or minimal maintenance required
- Minimal technical expertise required
- Positive identification and specimen tracking strategy that eliminates specimen identification errors
- Simple "goof proof" strategy for recording collection time and result reporting
- Simple strategy for calibration and QC
- Transferability of data to the LIS or HIS
- Compares to "Gold Standard"
- Affordable cost
The two factors that are significant to the rapid growth of POC testing are technology advancements and health care economics. The development of new and improved technologies has resulted in the ability to make evidence-based medical decisions that improve patient outcomes and reduce patient acuity, criticality, morbidity and mortality. Quicker diagnosis of infectious agents can also permit the earlier prescription of appropriate medications, thereby potentially shortening the duration of illness.
The commercial success of the current generation of small, simple to use diagnostic devices which provide rapid results in POC applications has been limited by their inability to provide precise, highly sensitive, quantitative measurement. Parallax's Target System technology addresses these limitations by applying sophisticated immunochemical and optical methods to detect and quantify virtually any analyte present in a liquid. Development data indicates that sensitivity will be comparable to expensive and complicated laboratory-based analyzers.
Additionally, the economic climate is driving significant changes in the manner in which patients will be tested and how results are delivered. Recent revisions to government regulations, together with growing patient and insurer pressures on hospitals and physicians have increased incentives to reduce overall patient healthcare costs while providing a higher level of care to a greater number of patients. One cost-cutting measure is to reduce the high cost of diagnostic testing carried out in central laboratory sites by increasing POC testing.
The Target System provides the platform for the development of a series of quantitative tests for important diagnostic applications that can provide results at a patient's bedside, in a doctor's office, in the emergency room, in a clinic, in an ambulance, on the battlefield, on site agri-business locations, rural and economically disadvantaged areas.
Why POC Tests?
Patients get immediate result and do not have to wait days or more for important information.
Patients do not have to come back to the doctor’s office.
POC Tests, on the average, cost 30%-50% less than outside labs for equivalent tests.
Insurance companies save money.
Patients save money on co-pays.
With outside labs doctors do not generate revenue.
With POC tests “in house” at doctor’s offices, the doctor generates revenue for their practice.
The Patient wins
Saves money through reduced co-pay
The Insurer wins
The Doctor wins
Happier and more satisfied patients
Increase in revenue generation for their practice.