Rockville, Maryland, December 18, 2020 – AOAC INTERNATIONAL announced today that it has issued Certificates of Validation for three proprietary test kits that detect SARS-CoV-2, the causative agent of COVID-19 illness, on environmental surfaces.
The three tests are the first to pass the rigorous independent evaluation required by the globally recognized AOAC Research Institute’s Performance Tested MethodsSM Program, which implemented an Emergency Response Validation process to accelerate the review process.
“Food manufacturers and contract labs have stringent protocols to ensure their facilities are free of harmful pathogens and more recently, viruses,” said Erin Crowley, president of AOAC INTERNATIONAL. “Now, they also have independently validated tests they can use to ensure their sanitation protocols are effective and they continue to provide a culture of safety for their essential employees.”
In this initial phase of the validation process, test kits were evaluated for detection of the virus on stainless steel surfaces only. AOAC will expand validation to a broader range of environmental surfaces and food matrices in a follow-up project.
While SARS-CoV-2 is known to be susceptible to standard disinfection methods,1 recent studies have shown that it can also be highly persistent on non-porous surfaces2 such as stainless steel.
Certifications were issued for the VERIPRO® SARS-CoV-2 Environmental Assay by bioMérieux; EnviroX-Rv by PathogenDx, and COVID-19 Indoor TestTM by Phylagen.
To perform the reviews, the AOAC Research Institute technical consultants (Patrick Bird, Sharon Brunelle Ph.D., Maria Nelson and Zerlinde Johnson) assembled a team of analytical science experts.
This validation project broke new ground by employing in silico (“in silicon”) analytical techniques that harness modern computational power to compare results against large databases of genetic information. This has a significant advantage over traditional “wet-lab” testing in that genetic sequences from tens of thousands of strains of SARS-CoV-2 and near neighbors could be analyzed for inclusivity and exclusivity. Moreover, obtaining and shipping large numbers of SARS-CoV-2 strains and variants necessary for comparison could be difficult and potentially dangerous.
AOAC received validation applications for nine test kits in this initial phase of the program. In addition to the three that have received certification, four are in the final stages of certification and two are being revised for re-submission.
“The extraordinary depth and precision of in silico analysis in this Emergency Response Validation Program are remarkable,” said Scott Coates, AOAC Research Institute Director. “Some kits are demonstrating over 97 percent perfect matches for more than 15,000 SARS-CoV-2 genomes, when traditionally we can only test against 100 species, strains or variants. This is world-class research conducted in double-time tempo.”
For information, please email Scott Coates at email@example.com or call at 301-924-7077 Ext. 137.
1. “Stability of SARS-CoV-2 in different environmental conditions”, The Lancet Vol. 1 Issue 1, May 1, 2020, https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30003-3/fulltext (accessed December 10, 2020)
2. “The effect of temperature on persistence of SARS-CoV-2 on common surfaces”, Virology Journal, 7 October 2020 https://virologyj.biomedcentral.com/articles/10.1186/s12985-020-01418-7 (accessed December 10, 2020)