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.

COVIDSeq can be used to perform strain typing for monitoring virus evolution and epidemiology. It can be used to report virus sequence in a clinical sample for Public Health and research applications.

The Illumina COVIDSeq test does not provide information on the role of specific mutations detected and its risk to reduced vaccine efficacy, impact on transmissibility, or impact on patient.

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

This test uses an amplicon approach for target resequencing of SARS-CoV-2. Consensus sequence is reported when +90 amplicons are detected. This information enables virus genome analysis for research use and provides insight into the SARS-CoV-2 strain present in the sample to help researchers track virus strains.

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.

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 intended for detection of SARS-CoV-2 virus RNA in authorized countries (Canada, Japan, Philippines, Singapore, and U.S.) under each country’s respective authorizing agency.* Depending on the region and country, additional data may be required to enable COVIDSeq to be used as a diagnostic test. A Research Use Only (RUO) version of this product is available for virus genome analysis for research use.

This assay is only authorized for use with NovaSeq 6000 v1.0 S4 and SP reagent kits, with NextSeq 2000, and with NextSeq 500, 550, 550Dx (in RUO mode) v2.5 HO reagent kit. Use of other systems and/or reagent kits 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 and SP flow cell for a total of 1536 samples per S4 flow cell and 768 per SP flow cell. Two flow cells can be run simultaneously for a total of 3072 or 1536 samples per run respectively.

Up to 384 samples per run on the NextSeq 2000.

Up to 384 samples can be loaded per HO flow cell.

Up to 384 unique dual indexes (IDT for Illumina PCR Indexes Sets 1-4) are available through Illumina.

Analysis is performed by the DRAGEN COVIDSeq Test Pipeline installed on the local DRAGEN server or by the DRAGEN COVIDSeq Test App on BaseSpace Sequence Hub.

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.