Point of care (POC) diagnostic devices produce results outside of laboratory settings by collecting and analyzing specimens at the time of the patient’s visit to the doctor’s office or outpatient treatment location. Patients can sometimes use point-of-care diagnostic devices at home, as with pregnancy or blood glucose tests. Technology advancements have expanded the applications of point-of-care diagnostic devices to provide a broader range of tests.

Point-of-care testing devices can be as simple as a thermometer or the basic pulse/oximeter that so many people purchased when news came out that extreme but “silent” low blood oxygen levels could indicate COVID-19. Other POC devices gather blood, saliva, urine, stool, and skin cells. They then expose the sample to a medium intended to detect the presence of certain types of cells or chemical markers. The medium is like a strip infused with a substance or chemical that will react with the sample and show a visible result (like the colors that emerge in a home pregnancy test kit) that indicates the presence or absence of the disease or condition the test is performed to detect.

Some typical applications of point-of-care diagnostic devices include:

• Cholesterol testing
• Blood glucose level testing
• Alcohol or drug tests
• Analysis of electrolytes and enzymes present or absent in the sample
• Tests for signs of infection
• Fecal matter tests for markers of colon cancer
• Blood markers for certain cardiac conditions
• Levels of blood gases that might cause medical concern

Some of the newest point-of-care (POC) diagnostic devices come in the form of wearables that use electrochemical sensors to detect the presence of, for example, blood alcohol levels.

Benefits of Point of Care Devices

Testing with POC devices is convenient. The devices are small and portable. They provide fast results. POC devices protect the integrity of samples, and some even deliver results via internet connectivity integrated into the device. In the development phase, many in vitro diagnostics companies for a new product team up with a diagnostics and life sciences device design company to ensure that new devices will work as intended.

Factors That Affect Design

The main concern of POC diagnostic device design is that the device will provide an accurate result while ensuring the integrity of the specimen sample. Depending on the application of the point-of-care diagnostic device and the type of specimen tested, the materials the device is made of, and the kind of plastic or metals used in the device, may be critical to its testing accuracy. Simplicity, convenience, and comfort are important factors as well, as these affect the user experience and, thus, the willingness to undergo testing or use the test at home according to instructions or as prescribed.

Considerations for designing diagnostic device mechanisms may include packaging, how users can safely dispose of the device, and how the device communicates results to avoid ambiguity. Follow-up care depends on accurate results, so the quality of the design process and reputation for accuracy should be a significant consideration when selecting a point-of-care diagnostic device.