Illumina COVIDSeq Test

This test has been authorized by FDA under an emergency use authorization (EUA) for use as an in vitro diagnostic test for detection and/or diagnosis of COVID-19.

No, this test only detects SARS-CoV-2, the virus causing COVID-19.

This test utilizes an amplicon approach for target resequencing of SARS-CoV-2. Refer to the Instructions for Use document for workflow instructions and other details.

Emergency Use Authorization authorizes the FDA to facilitate the availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency. When the state of emergency ends, the test is no longer authorized for clinical use and defaults to standard regulatory requirements.

This test is available to a limited number of early access customers who are experienced sequencing high sample volumes and meet workflow requirements, including being fully equipped with NovaSeq 6000 Systems, DRAGEN, and PCR equipment. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

More testing is necessary to control the global pandemic and return to work, school, and normal activities. However, there is a major shortage in COVID-19 testing-related products, and many clinical labs are facing capacity and resource constraints. COVIDSeq, leveraging highly scalable and accurate sequencing technology, is enabling labs to ramp up and diversify testing, contributing to improving testing capacity for COVID-19.

This product is available for Performance Evaluation Only (PEO) in European countries regulated by CE-IVD, or as Research Use Only (RUO) in other non-U.S. countries. Depending on the region and country, additional data may be required to enable COVIDSeq to be used as a diagnostic test.

This assay is only authorized for use with the NovaSeq 6000 S4 Reagent Kit with the Xp workflow. Use of other NovaSeq 6000 Reagent Kits or other Illumina sequencing systems would require independent validation and a separate Emergency Use Authorization submission.

This test is authorized for use with nasopharyngeal (NP), oropharyngeal (OP), and mid-turbinate (MT) nasal swabs.

Up to 384 samples can be loaded per lane on a NovaSeq S4 flow cell for a total of 1536 samples per flow cell. 2 flow cells can be run simultaneously for a total of 3072 samples per run.

Up to 384 UD indexes (IDT for Illumina Nextera DNA Unique Dual Indexes Sets A-D) are available through Illumina.

This test uses the Illumina DRAGEN COVIDSeq Test Pipeline.

A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management should follow current CDC guidelines.

A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19.