Widespread COVID-19 screening programs are the only way many businesses, schools and other organizations can keep running. Using PCR tests, however, often creates unmanageable turnaround times as clients must send samples to labs; wait for them to be received, prepped, batched, tested; and their results reported. Rapid antigen tests, while not quite as accurate, are speedy and good enough for workplace screening programs. Although, instead of taking business away from labs, rapid tests can create opportunities for labs to expand services.
Rapid Antigen Testing Upsides and Downsides
Dozens of rapid antigen tests have received FDA Emergency Use Authorizations to help combat the COVID-19 pandemic. Abbott’s BinaxNOW COVID-19 Ag Card, for example, can be used at the point of care and returns results within fifteen minutes. These tests are produced in high volumes and are cheap enough to make weekly or bi-weekly workplace testing realistic. In general, rapid antigen tests have specificities as high as laboratory-based NAATs such as real-time PCR. Although false positives may occur, they are rare enough to be easily handled by follow-up rtPCR testing.
The current demand for molecular testing has already pushed many labs to their limits. Had screening programs continued to rely solely on molecular testing, the millions of swabs and aliquots flooding into testing laboratories would have paralyzed resources. Thanks to antigen testing, screening programs only add samples from patients with positive antigen tests to laboratory workloads.
But screening programs also present challenges to most businesses and educational institutions. Typically, they do not have workers who are qualified to administer the tests, nor do they have the resources to properly store and handle the tests. The data these tests generate is also an issue. Unless they are in the healthcare industry, most organizations do not understand how HIPAA and other regulations apply to patient information.
Labs Offer Screening Solutions with COVIDLIMS
Workplace screening programs present testing laboratories the opportunity to expand their services to combat the pandemic. Testing labs handle patient data every day and have the processes for staying in compliance with healthcare privacy regulations. They can train and deploy qualified employees to perform antigen tests at client worksites (or outsource). Also, when an antigen test returns a positive result, these employees can immediately collect samples for rtPCR testing at the lab.
However, laboratories need the right laboratory information management system (LIMS) to handle the volume of test results that screening programs generate. LabLynx created COVIDLIMS to take on the data management burdens COVID-19 testing places on labs. Pre-populated with coronavirus assays and workflows, this HIPAA-compliant data management system automates the high volume of data COVID-19 testing produces.
This automation can start at the point of care with LabLynx’s C-SIC Kit (COVID Sample Information Collection Kit). The kit includes a barcode scanner, a barcode label printer as well as a wireless tablet that securely interfaces with COVIDLIMS’ cloud database. Forms on the tablet auto-populate with patient and test information. If an antigen test generates a positive result, the C-SIC Kit will print barcode labels to track the specimens collected for rtPCR testing.
Labs can use COVIDLIMS to track samples through the testing process. The system can automatically report results to patients or physicians — as well as to public health agencies at the local, state and federal level.
- “COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card” – US Food & Drug Administration
- “Interim Guidance for Antigen Testing for SARS-CoV-2” – US Centers for Disease Control and Prevention
- “How Labs Can Get Involved in COVID Screening Programs” – LabLynx