Over the years, the increasing introduction of transportable, portable, and handheld medical instruments has resulted in the migration of point-of-care (POC) testing from the hospital environment to a range of medical and non-medical environments including the workplace, home, disaster care and most recently, convenience clinics. In the face of the ongoing global COVID-19 pandemic, the reliance upon and need for testing without the direct involvement of healthcare professionals has become arguably more important now than ever before, according to Kalorama Information in the new report At-Home Testing: COVID-19 Trends and Future Potential.

Rapid tests to detect the presence of the coronavirus at the point of care, which are faster and cheaper, are a vital addition to the testing arsenal needed to contain and fight COVID-19, even with vaccines readily available.  There are now FDA-authorized COVID-19 tests sold online and in stores that can be used completely at home.  At-home tests allow individuals to collect their own sample and test it with a system that gives results in minutes at home.

It’s been more than one year since the world was thrown into the chaos of the COVID-19 pandemic.  One thing that has become apparent is that early diagnosis is crucial to prevent the spread of such infectious diseases throughout a community.  Rapid diagnosis, such as what is offered through at-home testing, is also key to containing outbreaks by allowing for efficient contact tracing in communities.

In many situations, POC and self-testing at home are tools to overcome roadblocks in testing due to sampling issues and testing delays.  Self-collected samples and home tests are provided by a growing number of hospital and independent laboratories to expand the network of testing options in all major markets in North America and Europe.

Home self-testing is not new: pregnancy tests, urine screening dipsticks, and glucose monitoring products are readily available in pharmacies and retail outlets in various major markets worldwide.  Consumers also make online purchases of kits marketed for STIs, HIV, allergies, vitamin D, food sensitivity, ancestry, and DNA testing.  These kits generally involve the collection of cheek swabs and saliva specimens that are then sent to a laboratory for processing.

From a public health perspective, at-home self-tests can offer advantages when used to complement professionally administered rapid tests or lab-based tests.  They can improve the accessibility to testing.  They allow individuals to obtain the result very quickly, which could support the early detection of infectious cases and reduce further community transmission.

Despite the apparent positives, the home-based rapid tests for infectious diseases are a work in progress and have their share of critics. Naysayers contend that preanalytical problems often surface with self-collection methods and home tests that can put patients at risk.  While home sample collection kits are designed to be simple, problems commonly occur with self-collection that can affect the quality of the sample and, therefore, the subsequent test result.

Nevertheless, from a public health perspective, self-tests can offer advantages when used to complement professionally administered rapid tests or lab-based tests.  They can improve the accessibility to testing.  They allow individuals to obtain the result very quickly, which could support the early detection of infectious cases and reduce further community transmission.

Self-testing with over counter (OTC) and direct to the consumer (DTC) kits could therefore enhance disease control with efficient identification and isolation of cases. However, there again are potential disadvantages, as shifting the responsibility of reporting test results from health professionals and laboratories to individuals could lead to underreporting, and make response measures such as contact tracing and quarantine of contacts challenging because the test results do not enter a government database.  Current indicators for monitoring the intensity and spread of the COVID-19 pandemic such as testing rates, test positivity rates, and case notification rates, could be affected, and could make it difficult to monitor disease trends over time.  An additional challenge is that samples from self-testing would not be available for viral sequencing and monitoring variants.

For more information on these and other topics related to this market, purchase At-Home Testing: COVID-19 Trends and Future Potential by Kalorama Information at: https://kaloramainformation.com/product/at-home-testing-covid-19-trends-and-future-potential/.

At-Home Testing: COVID-19 Trends and Future Potential

Rapid tests to detect the presence of the virus at the point of care, which are faster and cheaper, are a vital addition to the testing arsenal needed to contain and fight COVID-19.

Kalorama Information reported a mixed result with point of care testing, defined by tests that can deliver a result meaningful during a patient visit with a provider or on their own.  In 2020, sales of POC testing reached $29,316 million, according to Kalorama Information, a sister publication to Lab Pulse.  That’s up double digits from 2019, which would normally be pretty intense growth according to the Arlington, VA-based producer of IVD market research reports, but the growth in sales belies the reduction of business for the average point-of-care test product.  New COVID-19 tests fueled growth while the pandemic ravaged business in other test categories.  This according to Kalorama’s Information The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 8th Edition.

“Everywhere but infectious disease, this is a story of a declining market,” said Bruce Carlson, Publisher of Kalorama Information, a Science and Medicine Group brand.  “But since infectious disease has long been seen as the growth pathway for POC, that counters the long-term damage.  Many companies who make other products just pivoted their brands towards it, and when you combine uber-success in this category with recovery in 2021 in other categories, there’s no permanent damage to overall POCT from the pandemic.

But as Kalorama’s report indicates, for product managers in some routine POC segments, it’s a different story.  Sales were down as COVID-19 caused a contraction of the segment due to lockdown, closures, limited physician visits and a reduction in elective and outpatient surgery.

“It’s point of care-there so has to be a care event for POC to be used,” Carlson said. “And there was a disturbing trend in 2020, less care events; less visits to healthcare practitioners for preventive visits, less ER visits even, and this affected the majority of test products.”

Specifically, Kalorama’s report notes two bread-and-butter categories of testing that were hurt by the pandemic:

  • The POC blood and electrolytes testing market was negatively affected by COVID-19. This was mainly due to lockdowns, limited physician/patient visits and a reluctance of patients to seek medical attention. Routine blood workups were limited along with other non-life-threatening assessments. The market contracted in high single digits for 2019-2020.
  • The POC coagulation testing market was negatively affected by COVID-19. This was mainly due to lockdowns and limited physician/patient visits. The self-testing portion contracted due to patient lockdowns and limited availability to purchase coagulation testing materials. The professional segment also declined significantly due to the aforementioned issues.  The market contracted about more than 20%.

Meanwhile, Kalorama said, the POC infectious disease market grew at over 300%, which made up for the entire market loss in other areas.  That’s COVID-19 mostly, but not solely as a lot of healthcare infection and respiratory condition tests were utilized last year as well.

More information and scores of categories of testing with sizing and forecasts, can be found at https://kaloramainformation.com/product/the-worldwide-market-for-point-of-care-poc-diagnostic-tests-8th-edition/

The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 8th Edition

Globally, millions of dollars are spent annually on POC diagnostic testing, both professional testing and self-testing.