Spartan COVID-19 System: Evaluation of Clinical Sample Collection

Evaluation of Clinical Sample Collection Project: Spartan COVID-19

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04473248

Enrollment

Registered

2020-07-16

Start date

2020-06-28

Completion date

2020-08-30

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.

Detailed description

Once the subject is recruited,two nasopharyngeal swabs using the standard method will be taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19 System. The lab-based predicate test will be taken at the same time, with results reported back to Spartan to be compared with results obtained from the Spartan COVID-19 System.

Interventions

DEVICESpartan COVID-19 System

PCR analysis of patient samples using the Spartan COVID-19 System

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Masking description

The results of the Spartan COVID-19 System tests will not be shared with the participant or the lab, but the lab results will be shared with Spartan once analysis of the Spartan System samples is complete.

Intervention model description

Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* must have tested positive for COVID-19 via the existing nucleic acid testing method.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Asses the % agreement between predicate results and Spartan COVID-19 results.	Through study completion; anticipated to be less than 6 months.	The purpose of this study is to evaluate which method has the best % agreement between the lab-based predicate results and Spartan COVID-19 System results.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026