The COVID-19 pandemic shines new light on the vital role that accessible healthcare testing plays in providing critical information when we need it most. While routine blood testing services have been common for decades, the pandemic has underscored the need to expand access to testing in real-time so all individuals can make informed decisions about their health and well-being. From rapid blood testing to COVID-19 antibody testing, the shift from laboratory testing to POC testing is becoming more important than ever.
Consumers can now access healthcare testing at their local drugstore or from the comfort of their cars. The broad range of COVID-19 testing options is a response to the urgent need to curb the spread of this virus at both individual and community levels. But this also signifies a crossroads for patient testing. Although the industry has traditionally relied on laboratory testing, point-of-care (POC) testing can provide a continuous stream of patient data, enabling new models of health promotion and maintenance to emerge and evolve over time.
What is POC testing? What is laboratory or lab-based testing? And how do POC and laboratory testing differ? Defining use cases for POC testing and lab-based testing is crucial especially in the current environment. The COVID-19 pandemic has accelerated the urgency to deliver improved health outcomes and experiences for consumers, as well as improved workflow efficiency and cost-effectiveness for healthcare providers and payers.
What is laboratory testing?
Let’s start with the traditional model: laboratory or lab-based testing. The clinician takes a sample from the patient and packages it up to ensure safe transport. This sample is shipped to a central lab to be processed by a technician. Depending on the complexity of the laboratory test, results can usually be generated within 1-2 days and a report is sent back to the clinician. The clinician then shares the test result with the patient – whether in person, by phone, email, or more commonly today, through a patient portal. Altogether, it can take up to a week from when the patient provides the sample until the results are delivered due to shipping, lab capacity, test processing, and data sharing.
What is point-of-care testing?
Point-of-care (POC) testing involves “…performing a diagnostic test outside of a laboratory that produces a rapid and reliable result, aiding in identifying or managing chronic diseases and acute infections.” This type of testing often happens on compact, automated instruments with consumable cartridges that are designed to test for a specific pathogen or measure a particular metabolic level. A POC test can also be much simpler, such as a lateral flow assay (like most over-the-counter pregnancy tests) or a protein-treated strip of paper inserted into a tube of saliva.
Patient test results from point-of-care diagnostics are usually delivered quickly, and they require only a minor amount of training, both to run the instrument and collect the sample. In some cases, patients can even collect the samples themselves. Most commonly, point-of-care testing is used in hospitals, clinics, and doctors’ offices when quick diagnosis is desirable or critical to the care plan. In the era of one-step checkouts and instant delivery services, POC testing devices are increasingly available at drug stores and pharmacies as a way to provide convenient and affordable services for consumers. With the growth of telehealth, other types of at-home POC tests will play an important role in complementing virtual visits, as well as longitudinal patient monitoring.
A point-of-care diagnostic test is fast. Rapid test results empower providers to integrate data into their treatment plan, with clear benefits across different care settings with varying levels of acuity. For example, providers in the emergency room can run point-of-care tests for influenza and COVID-19 to triage patients exhibiting signs of respiratory distress. During annual wellness visits, primary care providers can make the most of their time with patients by using POC tests to deliver results and develop the care plan – all in the same visit. This enables clinicians to provide a seamless, patient-centric experience.
Quick results are not the only convenience of point-of-care testing. POC testing achieves significant cost-efficiencies for patients and providers by streamlining workflows and improving resource allocation across the health journey, including transportation, trained technicians, and physician follow-up. Most point-of-care diagnostics are calibrated to work on smaller samples than are needed for lab tests, directly improving the patient experience. Furthermore, the growing number of settings for point-of-care testing provides patients with more options for where and when they test, which is important for patients with medical conditions that require regular testing.
Historically, POC testing has fallen short of the sensitivity and specificity associated with laboratory analyzers. In the past, the large volume associated with central laboratories has resulted in a lower cost-per-unit than POC testing due to economies of scale, but this must be considered within the broader context of clinical operations.
The near future: POC testing continues to narrow the gap
Improved extraction, microfluidics, miniaturization, and data processing techniques are bringing point-of-care test sensitivity and specificity in line with lab-based tests. At Truvian, we are committed to delivering upon the promise of routine blood testing with lab-accurate, quick, and cost-effective diagnostic information provided at the point of care. We believe that accuracy does not need to be sacrificed for convenience or speed. Our groundbreaking automated blood diagnostics platform will integrate all three crucial testing modalities – combining clinical chemistries, immunoassays, and hematology assays – to provide a laboratory-accurate comprehensive wellness panel using a small blood sample in 20 minutes.
At the onset of the pandemic, Truvian saw the opportunity to help close the COVID-19 antibody testing gap since questions arose regarding the accuracy of COVID-19 antibody tests. To expand access to reliable and affordable testing, we partnered on the development of the Easy Check COVID-19 IgM/IgG™ antibody test to exceed FDA standards with rigorous independent lab testing that ensures high sensitivity and specificity in a routine testing environment. Unlike other lateral flow COVID-19 antibody tests, Easy Check has demonstrated comparable performance to large lab-based serology analyzers. A landmark clinical study published in The American Journal of Clinical Pathology by Jerry Yeo, PhD, DABCC, FAACC, Professor of Pathology at the University of Chicago, found that Easy Check showed an overall concordance of 98.6% with Roche’s Elecsys® anti-SARS-CoV-2 antibody assay. During this independent analytical and clinical validation, Easy Check also achieved excellent clinical performance with a sensitivity of 96.6%, specificity of 98.2%, and overall accuracy of 98.1%. This is the new gold standard for SARS-CoV-2 antibody testing: lab-accurate patient test results within 10 minutes using plasma, serum, or whole blood samples.
The COVID-19 pandemic has transformed the healthcare industry, sparking an unprecedented pace of innovation. As we shift towards an increasingly patient-centered healthcare delivery system, POC diagnostics will make routine health testing more convenient, affordable, and actionable for connected consumers – ensuring that everyone who needs a test can receive one.
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- Truvian, Easy Check COVID-19 IgM/IgG Antibody Test, Accessed November 12, 2020.
- New Research Study Validates Performance and Accuracy of Truvian Sciences’ Easy Check COVID-19 IgM/IgG™ Test [news release]. San Diego, Calif.: Truvian Sciences, November 3, 2020.