Point Of Care Testing for Pharmaceutical Development: Accelerating Drug Discovery
Until the recent development of point of care (POC) testing, most diagnostic tests were performed by collecting a sample directly from the site or source and sending the sample to a laboratory, where it would take days or weeks to obtain results.
Diagnostic testing in the medical industry has traditionally been conducted using a “centralized” approach for decades. This centralized approach implements the consolidation of diagnostics from numerous access points, involving the collection of samples that are sent to laboratories capable of performing complex, high-throughput sample processing and testing. Results are obtained and sent to the medical profession, and the process takes at least a few days on average.
The Development of POC Medical Devices
The need to obtain faster test results continues to grow. The medical industry, in particular, has developed portable POC medical testing devices that are relatively easy to use in various environments. The ever-changing landscape of sample testing continues to drive the evolution of faster methods to produce results and maintain testing accuracy and cost-effectiveness. Point-of-care devices are sought in the medical field, as well as in the agricultural, food and beverage, and numerous other industries.
What Is Point Of Care Testing?
In the past two decades, there has been a significant increase in the in vitro diagnostics (IVD) market, most notably in the point of care (POC) testing category. POC tests are diagnostic tests performed directly at the site or source. POC testing is best defined by where the testing is done, i.e., at a location outside the centralized laboratory, rather than by the kinds of testing that are performed.
There are many point-of-care testing methods used in the medical field, and they may be referred to by many different names, such as near-patient testing, remote testing, satellite testing, and rapid diagnostic testing. Contrary to the centralized diagnostic testing approach, point-of-care solutions provide a “decentralized” approach that enables decentralized access points, does not require an off-location laboratory to perform testing and provides much faster results that allow for immediate healthcare interaction.
What Are The Advantages Of Point-Of-Care Testing Equipment?
Generally, POC testing encompasses any tests conducted at or near the site or source where a sample is taken. In medical applications, a sample is taken from or near a patient and at the site where care or treatment is provided. POC lab test results are typically available relatively quickly (within minutes or a few hours), so any necessary action can be taken without delay, significantly reducing the time needed for medical decision-making. POC tests are largely molecular and/or antibody-based tests that utilize the specific detection of DNA markers or specific antigen and antibody interactions, which produce a result that is visible to the eye or detected by a small electronic instrument.
The devices used to obtain the results of a POC test come in an array of forms. One of the most common is basic dipsticks that operate using lateral flow technology. POC testing using lateral flow dipsticks may be able to detect proteins, antibodies and, in some instances, amplified DNA products. Lateral flow-based POC tests usually reveal results within a few minutes, and the results are determined “colorimetrically,” meaning that a color change is viewed visually. Lateral flow dipsticks have been incorporated into many over-the-counter medical-based POC tests, such as urinalysis tests and tests to detect the bacteria that cause strep throat.
Point-Of-Care Testing Examples Outside of Medical Applications
Although the early development of POC testing was largely based on meeting needs in the medical industry, there are many different point-of-care testing examples in other industries. Examples of these are the agricultural and food and beverage industries. The agricultural industry, in particular, needs diagnostic tests that can be performed in the field. Several plant diseases caused by bacteria and fungi require rapid, accurate detection and identification to prevent the spread of infection. Besides saving a significant amount of time by not having to send the sample to a laboratory and having to wait for results, an additional benefit of using point of care laboratory tests is that they can be done by farmers or growers themselves rather than investing additional time and money in having trained biological analytical professionals complete the tests.
Several molecular-based POC diagnostics tests may require small, usually inexpensive instruments to produce and visualize the test results. Molecular-based POC tests are often designed to detect the presence of a viral, bacterial, fungal or protozoan microorganism in a sample like a blood or saliva sample. These molecular based POC tests usually rely on the amplification of a target DNA marker that if detected, indicates the presence of an infectious microorganism and a positive result.
The technological methods that form the basis of POC testing continue to advance. More recently, the innovation of alternative nucleic acid (i.e. DNA and RNA) amplification techniques has provided a platform for the development of POC tests that can produce results very quickly without compromising the specificity and sensitivity of the assay, and deliver results with accuracy akin to that of the Polymerase Chain Reaction (PCR). In addition to obtaining accurate test results, another important criterion of a POC test is the speed at which it produces the results. These so-called “rapid” POC test kits are more available in the lateral flow assay dipstick form where they can be used successfully as more of a preliminary diagnosis. For more definite results, nucleic acid amplification has the ability to provide test results with a higher level of accuracy.
Isothermal nucleic acid amplification is a more recently developed technique for amplifying DNA and RNA without using expensive laboratory instruments and equipment. A number of isothermal nucleic acid amplification techniques have been successfully developed. One notable isothermal nucleic acid amplification technique is called “loop-mediated isothermal amplification” or LAMP. The advantage of designing a POC test using isothermal amplification technology is that it maximizes the important criteria of POC testing: convenience, speed, accuracy and cost-effectiveness. Many isothermal assays produce results within 30 to 40 minutes, and the results may be produced colorimetrically using a lateral flow assay, i.e., dipstick method, or by producing a change in color in the reaction tube to indicate a positive versus negative result.
Why Trust POC Testing Kits From Helix Biological Laboratories?
Helix Biological Laboratory has recently developed nucleic acid detection and identification assays using isothermal amplification technology to confirm the presence of specific microorganisms in various sample types, including food products, environmental water, agricultural samples and probiotic products. The goal of the development of these isothermal-based nucleic acid detection and identification assays is to incorporate them into diagnostic POC diagnostics kits that can be used on-site so that rapid, accurate results data can be obtained.
With the continued increasing demand for POC testing across a number of industries, Helix Biological Laboratory has the vision of being a laboratory that will be a leader in the POC diagnostic testing industry. With continued innovation of point-of-care devices, Helix Biological Laboratory is determined to bring forth new methods, products, services and solutions that have a significant positive impact and value. Through the transformation of creative concepts into tangible results, we believe that we will advance the efficiency and effectiveness of POC testing.
