Clinical trial NCT04597047: Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: POC
SARS-CoV-2
Antibody
Lead sponsor: LumiraDx UK Limited
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 153
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are asked to provide Capillary and Venous Blood Samples.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects aged ≥ 2 years.
2. The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days. (subjects must be 14+ days post symptom onset at the time of recruitment).
3. Written informed consent must be obtained prior to study enrollment.

   1. A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
   2. The Legal Guardian or Legal Authorized Representative of a subject who is under the age of 18 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the IRB).

Exclusion Criteria:

1. Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
2. The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
3. The subject has previously participated in this research study.

Primary outcomes:
measure: Performance Evaluation
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Northglenn
country: United States
facility: Centura Health Physician Group, Northglenn Office
state: Colorado
city: Wichita
country: United States
facility: Professional Research Network of Kansas
state: Kansas
city: Jackson
country: United States
facility: Physicians Quality Care of Jackson
state: Tennessee
Study officials:
affiliation: Eclipse Clinical Research
name: Vicki Kalen
role: PRINCIPAL_INVESTIGATOR
affiliation: Professional Research Network of Kansas
name: William Simon
role: PRINCIPAL_INVESTIGATOR
affiliation: Centura Health Physician Group
name: Matthew Morgan
role: PRINCIPAL_INVESTIGATOR
affiliation: Physicians Quality Care of Jackson
name: Melanie Hoppers
role: PRINCIPAL_INVESTIGATOR
References: