This is a prospective multicenter study conducted to evaluate the performance of theLumiraDx SARS-CoV-2 & Flu A/B tests at point of care sites. Subjects presenting withsymptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time ofthe study visit will be enrolled and asked to donate swab sample(s) for testing on thedevice under evaluation.
This will be a prospective study at point of care sites in the United States for the
clinical validation of the LumiraDx SARS-CoV-2 & Flu A/B test for the differential
detection of the SARS-CoV-2, and influenza A & B using anterior nasal samples. Up to
1,500 or more symptomatic subjects who are currently experiencing symptoms associated
with COVID-19 and Influenza A & B may be enrolled.
The samples are obtained from each subject using standard collection methods and are
processed and tested by untrained operators without laboratory training and with no prior
experience using the candidate test.
The primary objective of this study is to evaluate the performance (positive percent
agreement, negative percent agreement and 95% confidence intervals for upper and lower
bounds) of the LumiraDx SARS-CoV-2 & Flu A/B test for the qualitative and differential
detection of SARS-CoV-2, Influenza A & B virus antigen using anterior nares samples
collected by a healthcare professional, compared to a 510(k) cleared or Emergency Use
Authorized (EUA) high-sensitivity reverse transcription-polymerase chain reaction
(RT-PCR) test for COVID-19 and a 510(k) cleared Influenza A/B test.
The secondary objective is to assess the usability and user accuracy/performance around
limit of detection (LoD) of the investigational test using a questionnaire and accuracy
study.
Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B
The LumiraDx SARS-CoV-2 & Flu A/B test is an automated rapid microfluidic
immunofluorescence assay for use with the LumiraDx Platform, for near-patient testing,
intended for the qualitative and differential detection of nucleocapsid viral antigens
from SARS-CoV-2, influenza A, and influenza B in an anterior nares sample (from both
nostrils) collected by a healthcare professional for individuals aged 2 years and older.
The test is authorized for individuals with symptoms of COVID-19, influenza A and B
within the first 6 days of symptom onset.
Inclusion Criteria:
1. Written informed consent obtained prior to study enrollment.
2. Male or female aged 2 years of age or older
3. Subject is currently exhibiting fever, or one or more symptoms associated with
COVID-19 or influenza (such as, but not limited to, chills, cough, shortness of
breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat,
congestion or runny nose, nausea or vomiting or diarrhea) and must present within 6
days of symptom onset. Subject must still be exhibiting symptoms on the day of
sample collection.
Exclusion Criteria:
1. Subject does not understand or is not able and willing to sign the study informed
consent or be verbally assented.
2. Subject has had the seasonal influenza and/or the SARS-CoV-2 vaccine within the past
5 days.
3. Subject is not able to tolerate sample collection.
4. Subject is currently undergoing antiviral treatment such as baloxavir marboxil
(trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir
(Rapivab®).
5. Subjects undergoing treatment currently and/or within the past thirty (30) days with
prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may
include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or
receiving convalescent plasma therapy for SARS-CoV-2.
6. Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days.
7. Subjects who have had a nasal wash or aspirate as part of their standard of care
treatment on day of study visit prior to study sample collection.
8. Subjects who have had recent craniofacial injury or surgery, including to correct
deviation of the nasal septum, within the previous six (6) months.
Cullman Clinical Trials
Cullman, Alabama, United States
Investigator: Randal Quinn, MD
quinnmd@cullmanclinicaltrials.com
Investigator: Randal Quinn, MD
Philip Estes
858-355-7143
Philip.Estes@lumiradx.com
Randall Quinn, MD, Principal Investigator
Cullman Clinical Trials