An end-to-end COVID-19 test system

A highly scalable solution to detect active infections

Easy self-collection
using lower
nasal swabs

on-site sample

Authorized for use
in symptomatic

Next-day results
(from when the
order is placed)

Results sent
to ordering HCP
and patient

Intended Use: Helix SARS-CoV-2 Test

*two-sided 96% CI

The clinical performance of the Helix SARS-CoV-2 Test was evaluated using leftover anterior nasal swab specimens that were collected in 0.85% saline from individuals suspected of COVID-19 by a healthcare provider. A total of 45 positive and 62 negative samples that were previously tested with an FDA authorized RT-PCR assay were used in this study.

The Helix SARS-CoV-2 Test is an in vitro diagnostic real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected without supervision using the Helix COVID-19 Self-Collection Kit by individuals 18 years or older who are suspected of COVID-19 by a healthcare provider.

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