COVID-19 Point-of-care Diagnostics: Barriers and Opportunities

COVID LIMS

October 27, 2021

Since the onset of the COVID-19 pandemic in December 2019, clinicians and researchers around the world have been working day and night to get ahead of the virus. At the beginning of 2021, COVID-19 became the leading cause of death in the U.S. and many other countries, highlighting the need for urgent measures to arrest the spread and reduce deaths from the pandemic. To achieve this objective, early diagnosis is essential, with conducting millions of tests globally per day.

Given the limited testing resources, such a massive scale of testing has been hard to achieve. Point-of-care testing (POCT) can help accelerate mass testing for COVID-19. POCT refers to a system of testing conducted at or near the place where a specimen is collected instead of transporting it to an offsite laboratory. This reduces delays that may happen due to transportation, and consequently, results can be made available within minutes as opposed to hours. POCT can be used in settings such as the following:

  • Physician offices
  • School health clinics
  • Homes for the elderly
  • Long-term care facilities
  • Pharmacies
  • Emergency rooms

COVID-19, caused by SARS-CoV-2, has high transmissibility. While some infected people may display symptoms, others remain asymptomatic. Presently, the standard method for COVID-19 testing is the reverse transcription-polymerase chain reaction (RT-PCR) which tests the sputum, nasopharyngeal swabs, and lower respiratory tract secretions. Current testing methods mostly employ high-throughput automated equipment, and tests are performed in centralized laboratories.

Benefits of POCT

Point-of-care testing (POCT) could help reduce the COVID-19 testing load because it facilitates timely detection, has ease of use, and offers greater approachability to users. This could go a long way in promoting early detection and treatment.

Other benefits of POCT include the following:

  • Offers flexibility of testing
  • Leverages cost-effective and portable instrumentation
  • Enhances patient engagement in their self-care
  • Eliminates the need for transporting samples, minimizing errors
  • Reduces processing errors and turnaround time
  • Helps in quickly identifying individuals requiring hospitalization or advanced clinical care

POCT methods with a high degree of sensitivity and specificity will enable the speedy acquisition of information regarding the presence of the virus and the possible host responses.

Drawbacks of POCT

POCT has a few disadvantages compared to traditional laboratory tests. The accuracy of POCT results may diminish based on the analytical sensitivity of the assays being used. Another challenge with POCT is that tests are often conducted by members of the clinical team who may not be laboratory trained. These individuals may lack the understanding of the quality control measures, which may compromise the accuracy of the test results.

Current and Future Challenges of POCT for COVID-19

COVID-19 is likely to become an endemic disease over time. Therefore, it will be necessary to have multiplexed POCT devices to differentiate between different strains of the coronavirus and other respiratory illnesses. The performance of these devices will need to be tested and validated following FDA recommendations.

Clinical testing is now moving to nasal swabs and saliva from the anterior nostrils. This facilitates self-administration of COVID-19 tests and will improve the scaling of diagnostics.

New molecular and antigen devices that have been authorized for POCT will pose challenges in collecting adequate samples, devising proper collection techniques, and maintaining a competitive price to make the tests accessible.

While the presence of viral RNA or antigens usually signifies the presence of an active infection, this might not always be the case. A nasal swab may collect inactivated viruses that implies a person who has tested positive for the virus may not be infectious. This calls for the high specificity of tests to prove the actual presence of the coronavirus.

Lastly, it is difficult to predict how long an individual will be immune to the infection after receiving the vaccine. Therefore, it is imperative to have tests to ascertain immunity after vaccination.

What is the Role of a LIMS in Point-of-Care Diagnostics?

A Laboratory Information Management System (LIMS) can help streamline and automate operations in point-of-care testing facilities such as physician offices, schools & universities. This will enable them to offer rapid and accurate POC testing services. A COVID LIMS carries out the following key roles:

  • Manage patient data such as demographics, informed consent, and medical history
  • Manage the collection and storage of COVID-19 specimens
  • Manage COVID-19 tests, test results and flag positive results automatically based on preconfigured formulas
  • Report COVID-19 test results following FDA and CDC reporting guidelines
  • Deliver test results securely and digitally
  • Manage COVID-19 diagnostic kits and POCT devices
  • Manage workflows, SOPs, staff training, and inventory

Conclusion

Point-of-care testing is a crucial strategy to get us ahead of the pandemic; minimize morbidities, mortalities, and negative economic impact. POCT will guide individuals to know if they are COVID-19 positive or negative. It will also guide their decision to seek medical care, quarantine, or practice social distancing if they have tested COVID-19 positive. Furthermore, it provides COVID-19 test results quickly, enabling physicians to make clinical decisions and initiate timely treatment of their patients.

A cloud-based COVID LIMS helps POCT facilities automate and streamline their workflows, which will reduce turnaround time and amplify their productivity. Acceleration of mass testing will go a long way in curbing the spread of the COVID-19 virus.

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