Allplex™
2019-nCoV Assay (USA Only)
Allplex™
2019-nCoV Assay:
U.S. FDA -
Emergency Use Authorization
Simultaneous detection and identification of 3 target genes specific for COVID-19
Allplex™ 2019-nCoV Assay is a multiplex Real-time PCR assay for simultaneous detection of 3 target genes of SARS-CoV-2 in a single tube. The assay is designed to detect RdRP and N genes specific for SARS-CoV-2, and E gene for all of Sarbecovirus including SARS-CoV-2.
Instructions for Use
Fact Sheet for Health Care Providers
Fact Sheet for Patients
Features
RESULT
The highlighted result represents positive results for E gene of Sarbecovirus in FAM channel, RdRP gene and N gene of COVID-19 in Cal Red 610 and Quasar 670 respectively.
ANALYTES
Allplex™
2019-nCoV Assay (USA Only)
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COVID-19 (N gene)
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COVID-19 (RdRP gene)
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Sarbecovirus (E gene)
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Internal Control (IC)
SPECIMENS
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Sputum
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Nasopharyngeal swab
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Oropharyngeal swab
ORDERING INFORMATION
Product:
Allplex™2019-nCoV
Assay (USA Only)
Cat No. / Size:
RP10250X / 100 rxns
NOTE
Allplex™ 2019-nCoV Assay has not been FDA cleared or approved. This test has been authorized by FDA under an emergency use authorization for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.