Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test — CAPTURE-2  

Covid19 Clinical Trial

Official title: A Multicenter Covid-19 Study Conducted to Evaluate the Agreement Between Fingerstick Whole Blood, Venous Whole Blood, Plasma & Serum as Determined on the LumiraDx POC SARS-CoV-2 Ab Test & to Evaluate the Ease of Use at Point of Care Sites

Status Active, not recruiting

Clinical Trial Summary

Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.

Clinical Trial Description

This is a prospective, multi-centre study. One (1) Reference Lab and approximately six (6) Healthcare or Research Facilities within geographic areas experiencing current Covid-19 outbreaks in the U.S. will participate in the study. Study sites may be Point of Care (POC) locations, such as physician office laboratories, urgent care and outpatient clinics, or dedicated research sites.

A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number.

Subjects will undergo two (2) fingerstick lancing's and 1 (one) venous blood draw. A total of eleven (11) tests (LumiraDx SARS-CoV-2 Ab and haematocrit) will then be performed using these samples. Specimens will be obtained from each subject enrolled using standard collection methods.

All operators at a site level performing the LumiraDx SARS-CoV-2 Ab POC Test in this study will be required to complete training detailing the running of the LumiraDx Test/Instrument. This will be completed as part of a familiarization period and all operators will be required to show proficiency in using the system for QC, fingerstick, whole blood, plasma and serum testing prior to testing subjects. This will be captured on relevant training forms as part of the site initiation visit. In addition, the operator's satisfaction and ease of use of the LumiraDx SARS-CoV-2 Ab Test will be evaluated by completing an Intended Use Operator Questionnaire.

The LumiraDx SARS-CoV-2 Ab POC Testing will be performed at the site on the same day as the date of collection. Samples will be shipped to a central laboratory for reference testing. Testing in the reference laboratory will be performed by trained laboratory personnel.

Approximately 200 subjects will be enrolled in this study. Approximately thirty (30) SARS-CoV-2 positive, and thirty (30) samples negative for SARS-CoV-2 will be enrolled at each site. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19

• NCT number: NCT04597047
• Study type: Interventional
• Source: LumiraDx UK Limited
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 9, 2020
• Completion date: September 30, 2023