NEW YORK – PerkinElmer said after the close of the market on Thursday that the US Food and Drug Administration has reissued an Emergency Use Authorization for the PerkinElmer New Coronavirus Nucleic Acid Detection Kit, allowing its use for pooled samples from patients suspected of having the SARS-CoV-2 virus.
The RT-PCR test initially received EUA in March. The reissued EUA is for the qualitative detection of nucleic acid from SARS-CoV-2 in human oropharyngeal swab, nasopharyngeal swab, and anterior nasal swab specimens collected from individuals suspected of having COVID-19 by their healthcare provider, a PerkinElmer spokesman said.
If the pooled test is negative, all individual samples are considered negative. If the pooled test is positive, each individual sample comprising the pool would need to be tested again separately.
Other companies whose tests have received authorization from the FDA for pooled sample testing include Hologic, Laboratory Corporation of America, and BayCare Laboratories. Quest Diagnostics received the first EUA from the FDA for pooled samples for COVID-19 testing.
"The ability to pool samples using a highly sensitive RT-PCR test offers diagnostic labs an efficient and accurate way to increase testing capacity," Masoud Toloue, general manager, diagnostics for Waltham, Massachusetts-based PerkinElmer, said in a statement.