PerkinElmer’s COVID-19 test kit has received a reissued Emergency Use Authorization (EUA) from the FDA enabling its use through sample pooling.
The EUA will enable laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to increase the number of people who can be tested through the PerkinElmer® New Coronavirus Nucleic Acid Detection Kit. Labs using the real-time RT-PCR in vitro diagnostic assay for COVID-19 can pool multiple samples together using resources needed for a single test.
If a pooled test is negative, all the individual samples are considered negative. If the pooled test is positive, each of the individual samples in that pool should be tested again separately to determine which of the samples are positive.
The EUA validates batch testing by leveraging the ability of the test to detect low amounts of viral genetic material, PerkinElmer said.
“The FDA has recognized that there is great interest in sample pooling to test for COVID-19,” said Masoud Toloue, PhD, vice president and general manager, diagnostics, PerkinElmer. “The ability to pool samples using a highly sensitive RT-PCR test offers diagnostic labs an efficient and accurate way to increase testing capacity.”
The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is a real-time RT-PCR test designed to qualitatively detect nucleic acid from SARS-CoV-2 in human oropharyngeal, nasopharyngeal, and anterior nasal swab samples.
The FDA issued its initial EUA for the RT-PCR test as a COVID-19 diagnostic in March. PerkinElmer’s RT-PCR test is marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is available in over 30 countries worldwide.
Several sample pooling EUAs
The FDA has granted EUAs allowing pooled sample testing through several companies’ tests—starting on July 18 when the agency reissued an EUA to Quest Diagnostics that authorized use of its Quest SARS-CoV-2 rRT-PCR test with pooled samples containing up to four individual swab specimens collected under observation. The Quest test became the first COVID-19 diagnostic test to be authorized for use with pooled samples.
A week later, Laboratory Corporation of America received a reissued EUA for pooled and broad population testing via its COVID-19 RT-PCR Test. In September, the FDA updated the EUAs of Hologic for its Panther Fusion SARS-CoV-2 assay. Other companies receiving EUAs for pooled sample tests have included BayCare Laboratories for its BayCare SARS-CoV-2 RT PCR Assay; and Hologic for its Panther Fusion SARS-CoV-2 assay, granted in September.
PerkinElmer cited comparative data posted by the FDA on its website showing that the company’s New Coronavirus Nucleic Acid Detection Kit had the lowest Limit of Detection (LoD) among authorized COVID-19 molecular diagnostic tests reported, making it the most sensitive assay that can detect three-fold less viral material in samples compared to the assay in second place, and over 90-fold times less viral material in samples compared to the industry average.
The test kit has a limit of detection 20 copies/mL for the SARS-CoV-2 ORF1ab and N genes. It does not show cross reactivity with common respiratory tract pathogens and blood stream pathogens including: Human coronavirus (229E, OC43), SARS coronavirus (plasmid), MERS coronavirus (plasmid), Adenovirus (3, 2, 31, 37, 51 types), Enterovirus (A, D), and Rhinovirus (A, B).
PerkinElmer says its New Coronavirus Nucleic Acid Detection Kit is designed to prevent the reporting of incorrect results through positive, negative, and internal controls.
The test kit is the latest addition to PerkinElmer’s portfolio of SARS-CoV-2 offerings, which include tests that apply high-throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence, and lateral flow based serology testing.