The point-of-care diagnostics market is projected to grow rapidly within the next decade, despite high profile failures of early players in the industry such as the multibillion-dollar startup Theranos.
What is a point-of-care testing device?
Point-of-care testing devices are handheld or operated on a bench top and designed to provide rapid, accurate test results outside of a laboratory setting. Small quantities of patient samples such as saliva, blood, or urine are processed via serologic testing (immunoassays) or nucleic acid amplification, among other methods, to generate test results within minutes of sample collection.
What are the advantages of point-of-care testing?
The quick turnaround time between sample collection and result afforded by point-of-care testing devices makes them very useful in healthcare settings, especially in emergency situations where delays in medical intervention may be costly. Equipped with the necessary medical information in real time, healthcare providers can diagnose illnesses and make treatment-related decisions more rapidly, thereby reducing wait times, limiting patient suffering and, ultimately, improving health outcomes. The removal of the immediate need for laboratory testing adds to the appeal of point-of-care testing devices, especially in resource-limited settings.
Advances in technology have supported the rapid growth of the point-of-care diagnostics industry. In the face of the COVID-19 pandemic and the urgent need for the diagnosis of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) carriers, more funding has been directed toward point-of-care diagnostic technology that could support the detection of microorganisms other than SARS-CoV-2 post-pandemic.
Innovations in point-of-care diagnostics for SARS-CoV-2:
Here, we highlight a few SARS-CoV-2 point-of-care diagnostic devices, including those from recipients of the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) Phase 2 funding for the scale-up and manufacturing of point-of-care technology (Ellume, Ubiquitome, Luminostics, Visby Medical).
LumiraDx: LumiraDx Platform SARS-CoV-2 antigen and antibody tests
LumiraDx’s LumiraDx Platform is a small, portable device designed for operation in a clinical environment. It operates on test strip technology and supports testing for SARS-CoV-2 antigens and testing for antibodies against SARS-CoV-2 using microfluidic immunofluorescence assays. The antibody test requires a small blood sample obtained by finger prick, while patient samples for the antigen test are obtained via nasal/nasopharyngeal swab and eluted with fluid. Samples are applied to a test strip within the platform for analysis in under 15 minutes.
Ellume: Digital fluorescent immunoassay antigen test
Ellume’s fluorescent immunoassay testing device is designed for point-of-care testing in clinical settings and for at-home use. The COVID-19 Home Test kit includes a single-use Bluetooth-capable testing device (analyzer), a nasal swab for patient sample collection, and processing fluid. SARS-CoV-2 viral proteins are detected via Ellume’s patented method of fluorescence immunochromatography and test results are sent via Bluetooth to the user’s smartphone within 15 minutes.
Ubiquitome: Liberty16 real-time polymerase chain reaction test
Ubiquitome’s Liberty16 is a battery-operated portable real-time polymerase chain reaction (RT-PCR) device designed for point-of-care use. Liberty16 amplifies and detects nucleic acid from patient samples collected via nasal swab within 40 minutes of processing. Ubiquitome has partnered with a Yale University research team to adapt this technology for use with saliva samples.
Luminostics: Clip COVID Rapid Antigen Test
Luminostics’s handheld Clip COVID Rapid Antigen Test uses a lateral flow immunoluminescence assay to detect SARS-CoV-2 antigens from samples eluted from nasal swabs. Test results are sent to the user’s smartphone within 30 minutes. The Clip COVID Rapid Antigen Test is designed for use in clinical settings and may soon be available for at-home use.
Visby Medical: COVID-19 Test
Visby Medical’s COVID-19 Test is a compact, palm-size RT-PCR device designed for use in clinical settings and in other locations with Clinical Laboratory Improvement Amendments certificates of waiver. Samples obtained via nasal swabs are eluted and loaded onto the device for nucleic acid amplification and analysis within 30 minutes.
Point-of-care diagnostics industry outlook:
Point-of-care testing devices are poised to change the pace of healthcare service delivery by reducing the wait times between testing and diagnosis and removing unnecessary delays in clinical decision-making. The COVID-19 pandemic has also demonstrated the need for point-of-care devices in non-clinical settings, such as airports and homes.
With many of these devices in development for SARS-CoV-2 detection in clinical and non-clinical settings, the outlook for the point-of-care industry is bright. Miniaturized serology and DNA amplification technology have allowed for the advances seen in the market today, with more advances on the way. This paves the way for technology that can accomplish what Theranos promised but failed to deliver: the diagnosis of multiple conditions on a single platform using small quantities of patient samples.
Companies with platforms that support the use of single-use inserts and are capable of running multiple diagnostic programs lead the way in this pursuit. As more of these devices make their way into non-traditional spaces, however, future challenges for the point-of-care diagnostics industry will include the management of the waste generated by single-use hardware and the provision of robust security for the personal data processed by these devices.
