The Helix Laboratory

The Helix Laboratory is a high-complexity, CLIA-certified, CAP-accredited facility. Helix’s extraction platform uses reprogrammable Hamilton STAR liquid handling robotics and has full redundancy. Helix is also exploring extraction-free workflows which will enable higher throughput.

Intended Use

The SARS-CoV-2 assay is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory nasopharyngeal (NP), anterior nares (AN) and oropharyngeal (OP) swab specimens from individuals suspected of COVID-19 by their healthcare provider.

Contact us to learn more about our COVID-19 resources

Please note: we are not accepting orders from individuals at this time

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The Helix COVID-19 test

Helix is helping communities and health systems safely navigate through this pandemic by leveraging our state-of-the-art CLIA / CAP lab to provide an end-to-end, highly scalable solution to detect active COVID-19 infections.

Ordering and return of results

Helix is equipped to take orders from healthcare professionals, provide clinical return of results to the ordering professional, and manage reporting to public health agencies. Results available by end of the next day after the sample is received in the lab.

Sample collection

Helix's test is easy to use (with healthcare provider supervision) and comes with lower nasal swabs, ambient temperature and transport stable media, and a barcoded tube.

High sensitivity and specificity assay

Clinical performance studies show the Helix COVID-19 test, a real-time RT-PCR assay, has a limit of detection (LoD) of 1000 Viral copies / mL and high sensitivity and specificity.

Highly automated clinical laboratory

The Helix Laboratory, a CLIA/CAP facility with a demonstrated track record of powering high volume genomic projects, has a high-throughput, automated accessioning process and is capable of scaling rapidly to meet demand.

An end-to-end COVID-19 test system

Bringing our extensive experience in high volume genomic testing to expand access to sensitive and scalable testing

Fully kitted, including
room temperature and
transport stable media

Easy, self-collected
lower nasal swab with
healthcare professional
(HCP) oversight

Results available
next day after
sample receipt
at Helix's laboratory

Results directly to
patient and ordering
HCP; summary report
available

Helix COVID-19 test Limitations

  • Testing is limited to the Helix Clinical Laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests;
  • This test has not been FDA cleared or approved;
  • This test has been validated in accordance with the FDA's Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency). FDA independent review of this validation and issuance of an Emergency Use Authorization (EUA) is pending.

COVID-19 Research

As the COVID-19 pandemic continues to unfold, Helix researchers are shifting focus and resources to helping to advance our collective knowledge, including evaluating alternative sample collection approaches and exploring the genetics of COVID-19 pathophysiology.

Modeling the impact of
COVID-19 surveillance testing

In addition to social distancing measures, suppression of SARS-CoV-2 depends on surveillance testing and quarantine of infected individuals to break chains of transmission within a population. Here, we model what impact surveillance testing could have under various conditions.

Saliva testing less sensitive than
NPS in the community

Given Helix’s experience with automated, high throughput processing of saliva samples, Helix investigated the feasibility of saliva as a collection type. Unfortunately, in a prospective study conducted with Renown Health and UCSD, saliva lacked sufficient sensitivity in community populations and Helix is therefore focused on nasal swabs. Helix’s data is consistent with other studies in the community setting, where saliva has lower sensitivity than nasal swabs using RT-PCR.

Genetics of COVID-19 pathophysiology

In an analysis of phenotypic data related to COVID-19 (collected via a recent survey), Helix researchers have found preliminary evidence for a new COVID-19 symptom: Sensitive skin. Respondents who had previously tested positive for COVID-19 reported experiencing sensitive skin much more frequently than people who tested negative (40% vs 7%). This represents an approximately 6-fold enrichment, making it similarly as predictive of COVID-19 as the loss of sense of taste or smell symptom.

GWAS of severe COVID-19 symptoms

Data from the Exome+ assay as well as an ongoing phenotypic survey of research consented participants is being contributing to studies done through the Host Genetics Initiative. One recent study leveraged this data to support the finding of an association between a specific gene cluster and COVID-19 severity.