COVID-19
Conditions
Brief summary
Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation
Detailed description
The Q-POC SARS-CoV-2 Assay is a real-time PCR test intended for use on the Q-POC instrument for the qualitative detection of nucleic acids from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in nasal mid-turbinate swabs (MTSW) obtained from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity or moderate complexity tests. The Q-POC SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Q-POC SARS-CoV-2 Assay in conjunction with the Q-POC instrument (Q29001).
Interventions
DIAGNOSTIC_TESTRT-PCR Test
High sensitivity RT-PCR COVID-19 Test. A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's Instructions For Use (IFU) in one nostril.
DIAGNOSTIC_TESTReal-time PCR Test
Mid-turbinate nasal swab samples will be taken from the opposite nostril that was not swabbed for the comparator sample using Copan FLOQ swabs and placed into MSwab buffer. In instances where opposite nostrils cannot be swabbed for both the comparator and the candidate tests, a 15-minute waiting period to allow for viral reloading will occur before collecting the candidate test sample.
Sponsors
New Day Diagnostics
PathAI
Bright Research Center
QuantuMDx Group Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a prospective clinical study enrolling adult patients with signs and symptoms that are consistent with SARS-CoV-2. Positive and negative specimens will be run on the Q-POC SARS-CoV-2 Assay in comparison with an FDA-approved reference standard to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be over the age of 18 years. * Participants must present with symptoms indicative of SARS-CoV-2 infection, within 0-5 days of symptom onset. * Participants must have capacity to give informed consent.
Exclusion criteria
* Participant is under the age of 18 years. * Participant does not have symptoms of SARS-CoV-2 infection. * Participant lacks capacity to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test | One hour | The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results |
| Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test | One hour | The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to 98% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects 18+ Years of Age A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril. | 877 |
| Total | 877 |
Baseline characteristics
| Characteristic | Subjects 18+ Years of Age |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 143 Participants |
| Age, Categorical Between 18 and 65 years | 727 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 358 Participants |
| Race/Ethnicity, Customized Do Not Wish To Disclose | 21 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 43 Participants |
| Race/Ethnicity, Customized Other/Multiple Selections | 386 Participants |
| Race/Ethnicity, Customized White | 62 Participants |
| Region of Enrollment United States | 877 Participants |
| Sex: Female, Male Female | 560 Participants |
| Sex: Female, Male Male | 317 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 877 |
| other Total, other adverse events | 0 / 877 |
| serious Total, serious adverse events | 0 / 877 |
Outcome results
Primary
Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to 98% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results.
Time frame: One hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects 18+ Years of Age | Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test | 736 Participants |
Primary
Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results
Time frame: One hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects 18+ Years of Age | Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test | 130 Participants |