by Greg Lathan
President
During 2020, the most effective method of screening employees who were potential carriers of SARS-CoV2 was the administration of a CDC recommended questionnaire, coupled with a temperature scan from a non-contact thermometer. The COVID questionnaire was utilized to identify those workers who were experiencing COVID symptoms or those employees who had potential contact with individuals who were COVID carriers. Temperature scans were used to determine if employees exhibited elevated body temperature. It is well documented that the incubation period for COVID-19 is anywhere from 2-14 days. Couple that with the high percentage of asymptomatic carriers or those with only mild symptoms and the inherent shortcomings of screening employees solely with temperature scans and a questionnaire become glaringly apparent. A highly sensitive, rapid screening methodology to identify coronavirus carriers is vital to limit workplace exposure.
In our prior COVID blog in January, The EI Group summarized the three basic types of COVID screening tests – PCR, antigen and antibody. Many pharmaceutical manufacturers are racing to secure FDA approval via an Emergency Use Authorization (EUA) to bring their Rapid Antigen Tests (RATs) to market. Screening for the novel coronavirus antigen (or surface proteins) is less costly and significantly faster (15-30 minutes) than PCR tests, allowing for rapid “point of contact” (POC) testing. The FDA EUA requires RATs to show a minimum of 80% sensitivity in identification of COVID carriers. Although RATs are normally less sensitive that PCR tests, they are also more likely to identify those COVID carriers who are the most infectious, with the highest probability of transmitting coronavirus to others. Ideally, an individual who tests positive for SARS-CoV2 antigen, should subsequently take a PCR test for confirmation.
RapidTests.org, founded by Chris Said, PhD and directed by Michael Mina, MD, PhD, Professor of Epidemiology, Harvard School of Public Health, have compiled a list of 74 manufacturers who intend to develop rapid POC COVID antigen tests. Of these 74 manufacturers, only nine have received EUA by the FDA. The EI Group reached out to the eight manufacturers with EUA approval whose RAT employs a nasal swab for sample collection (with the remaining manufacturer using saliva, commonly known as a spit test). At the time this blog was drafted, only three of these manufacturers with EUA had responded. The remaining entities either informed us that their product, although EUA approved, would not be ready for the general market for several months or we received an automated email response indicating they would be in touch in the near future. Based on the feedback we received from the RAT manufacturers in the table below, the only shallow nasal swab tests ready for purchase are the BD Veritor system and the Quidel Sophia 2. Both rapid antigen tests use portable analyzers. The analyzers and the media, which are used for analysis, require the purchaser to have a CLIA waiver. Obviously, as more EUA approved manufacturers bring their RAT system to market, coupled with the over 60 manufacturers currently seeking EUA approval, there will be several more systems available.
The most promising RATs who have a supply of screening test kits available now include:
Although ONLY a screening tool, POC rapid antigen screening of the workforce for the SARS-CoV-2 surface protein will definitely be a “game changer.”
During COVID screening of over 200,000 employees at 12 industrial facilities for elevated body temperature and administration of a COVID questionnaire, four employees in 10,000 (or 1 employee in 2,500 workers) were found by EI to be coronavirus carriers. In contrast, after adding rapid POC COVID antigen testing only once a week, EI was able to identify five COVID carriers in every 350 employees (or 1 worker for every 70 workers!). It is becoming increasingly apparent that rapid antigen screening will play a key role in preventing the spread of COVID-19 in the workplace!
How Can We Help?
If your facility needs assistance in establishing an occupational COVID-19 Rapid Antigen Testing process, The EI Group can help! Our cumulative “boots on the ground” knowledge, amassed over the past year, has revealed that proper planning and communication is key to effective/efficient screening of potential workers who may be coronavirus carriers before they enter the workplace.
Please do not hesitate to contact us at (800) 717-3472 or ei@ei1.com.