Public health agencies such as the U.S. Food and Drug Administration (FDA) have alerted clinical laboratories and the healthcare community about SARS-CoV-2 viral mutations
PerkinElmer, Inc. (NYSE:PKI) today announced the launch of two Research Use Only (RUO) solutions, PKamp™ VariantDetect™ SARS-CoV-2 RT-PCR Assay and Next Generation Sequencing-based NEXTFLEX® Variant-Seq™ SARS-CoV-2 Kit. Using nucleic acid extracted from samples that previously tested positive, laboratories can use these assays to identify genomic mutations reported in relation to SARS-CoV-2 variants.
Public health agencies such as the U.S. Food and Drug Administration (FDA) have alerted clinical laboratories and the healthcare community about SARS-CoV-2 viral mutations. Upon detecting a positive case using a first-tier diagnostic assay, second-tier assays such as the PerkinElmer PKamp VariantDetect and NEXTFLEX Variant-Seq kits provide further information about mutations in the sample.
The PKamp VariantDetect SARS-CoV-2 RT-PCR assay can detect mutations associated with B.1.1.7, B.1.351 and P.1 variants, which are the predominant variant strains known today. The NEXTFLEX Variant-Seq SARS-CoV-2 WGS workflow can detect all SARS-CoV-2 genetic changes relative to the strain originally identified in Wuhan, China.
“While continuing to rely on gold-standard RT-PCR tests for COVID-19 diagnosis, we must understand emerging variants to effectively limit the spread of the virus,” said Masoud Toloue, Ph.D., senior vice president, diagnostics, PerkinElmer. “The second-tier assays made available today are the outcome of a product development engine primed to continue producing assays that will help labs outpace the virus.”
PerkinElmer continues to work on the frontlines of improving COVID-19 testing. The PerkinElmer® New Coronavirus Nucleic Acid Detection Kit is the most sensitive molecular test for COVID-19 on the market, according to comparative data released by a FDA Reference Panel, and can be used to test symptomatic or asymptomatic individuals, individually or in pools of up to five samples. The Company’s comprehensive SARS-CoV-2 offerings also include high throughput RNA extraction, RT-PCR, antigen testing, workflow automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
Source: Company Press Release