The CovClear Rapid Antigen test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal swab specimens directly collected
Simple to use – Rapid Results in 3-20 Minutes
Highly Sensitive and Specific – Outperforming other antigen tests
Safety Advantage – Sealed Vial Protecting Collector Against Live Virus
No Reader Required – Reduced Cost
No Cassette Needed – Reduced Material Wastage
Early Detection – Reduced Exposure
Researched, developed & manufactured in the USA
Validated by Empowered Diagnostics, LLC. CovClear has been validated, but the FDA’s independent review of this validation is pending.
The CovClear™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly collected. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests, and at the Point of Care (POC), i.e., in patient care settings operating under a high complexity CLIA Certificate. Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The CovClear™ COVID-19 Antigen Test is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in Point of Care settings. The CovClear™ COVID-19 Antigen Test is only for use under the Food and Drug Administration’s Emergency Use Authorization (EUA).
For informational purposes only. Testing is limited to laboratories and patient care settings operating under a high complexity CLIA Certificate.
Remove a swab from the pouch.
Place the dry swab into one nostril until it reaches resistance.
Slowly rotate the swab 7 times over the surface inside the nostril.
Slowly remove the swab from the nostril while still rotating it. Repeat steps 2-4 on other nostril.
Pour entire buffer solution ampule into empty vial.
Insert dry swab into one nostril until you meet resistance. Swirl 7 times. Repeat with the same swab in other nostril.
Place swab into prepared vial with buffer solution. Slightly swirl the vial and swab for 30 seconds.
NOTE: DO NOT place the cap on the vial. DO NOT remove the swab.
Press tip against side of vial to squeeze liquid from swab for 10 seconds. Then place swab back into the buffer solution.
NOTE: DO NOT remove the swab.
Place new test strip, arrow pointing down, into vial with the swab.
NOTE: Touch test strip on the colored end only.
Place cap securely onto the vial with the test strip and swab inside.
NOTE: Cap will permanently lock in place. DO NOT tip vial over as this will invalidate the test.
READ RESULTS WITHIN 3-20 MINUTES
Interpretation of Results
A total of 292 subjects were tested in two investigational sites to evaluate the clinical performance of the CovClearTM COVID-19 Rapid Antigen Test strip. Subjects self-sampled and self-administered using the CovClearTM Test. The study was designed as an all comers study where subjects (both symptomatic and asymptomatic) over the age of 2 years, presenting to the site seeking COVID-19 testing for any reason, were eligible to enroll if they met all inclusion criteria and did not meet any of the exclusion criteria. All subjects also had a nasal swab sample collected by clinical study site staff for testing at a reference laboratory with an EUA high sensitivity molecular SARS-CoV-2 assay.
A total of 292 subjects were evaluated in this study. Fifty three (53) were symptomatic and two-hundred and thirty-nine (239) were asymptomatic at time of presentation. Symptomatic subjects were defined as those exhibiting at least one of the following signs and symptoms on day of presentation: Fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell, congestion or runny nose, diarrhea, nausea, or vomiting.
Asymptomatic subjects were defined as subjects not experiencing COVID-like illness symptoms on day of testing.
Age distribution of the 292 subjects is presented below.
The following table summarizes the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for the CovClear™ COVID-19 Rapid Antigen Test when compared with an FDA EUA high sensitivity molecular SARS-CoV-2 assay.
Analytical Sensitivity: Limit of Detection (LoD)
The LoD for direct swab was established using heat-inactivated SARS-CoV-2 isolate Hong Kong/VM20001061/2020). The strain was spiked into 0.5% saline solution prepared in accordance with BAM R66. The estimated LoD found from the initial two- fold serial dilution test was confirmed by testing 20 replicates. The confirmed LoD for direct swab was 7.12 x 103 TCID50/ml.
The specimen stability was established using heat-inactivated SARS-CoV-2 isolate Hong Kong/VM20001061/2020. Nasal swabs spiked with the heat-inactivated SARS-CoV-2 isolate Hong Kong/VM20001061/2020 at 3X LOD were Incubated at room temperature for 0, 2, 5, and 24 hours respectively prior to testing. All samples tested produced no qualitative impact on test line signal intensity as compared to the 0-hour condition, demonstrating that the CovClear™ COVID-19 Rapid Antigen Test performance was not affected by sample Instability for up to 24 hours at room temperature.
Analytical Specificity: Cross Reactivity and Microbial Interference
The potential cross-reactivity (exclusivity) of a panel of common organisms was evaluated with SARS-CoV-2 negative samples using the CovClear™ COVID-19 Rapid Antigen Test. Potential microbial interference was evaluated with samples containing heat-inactivated SARS-CoV-2 isolate isolate Hong Kong/VM20001061/2020 at approximately 3x LoD. 4.1. A total of twenty-five (25) potential cross-reactant samples were evaluated for cross-reactivity at predefined concentrations in accordance with the EUA guidelines Antigen Template for Test Developers (version October 26, 2020). No cross-reactivity was observed with the CovClear™ COVID-19 Rapid Antigen Test.
To estimate the likelihood of cross-reactivity with SARS-CoV-2 of organisms that were not available for wet testing, in silico analysis using the Basic Local Alignment Search Tool (BLAST) managed by the National Center for Biotechnology Information (NCBI) was used to assess the degree of protein sequence homology.
- The homology between SARS-CoV-2 nucleocapsid protein and human coronavirus HKU1 nucleocapsid protein is relatively low, at 36.7% across 86.4% of sequences, but cross-reactivity cannot be ruled out.
- The homology between SARS-CoV-2 nucleocapsid protein and Mycobacterium tuberculosis total protein (3,991 proteins) is relatively low, homology-based cross-reactivity can be ruled out.
- The homology between SARS-CoV-2 nucleocapsid protein and Pneumocystis jirovecii total protein (3,745 proteins) is relatively low, homology-based cross-reactivity can be ruled out.
Endogenous Interfering Substances Effect
To assess substances with the potential to interfere with the performance of the CovClear™ COVID-19 Rapid Antigen Test, positive and negative samples were tested with the addition of potentially interfering substances. The SARS-CoV-2 target concentration in the positive samples was approximately 3x LoD. All samples tested produced no qualitative impact to test line signal intensity, demonstrating that the CovClear™ COVID-19 Rapid Antigen Test performance was not affected by any of the 14 potentially interfering substances listed in the table below at the concentrations tested.
High-dose Hook Effect
The CovClear™ COVID-19 Rapid Antigen Test was tested up to 1.75x106 TCID50/ml of heat-inactivated SARS- CoV-2 strain and no high-dose hook effect was observed.
For questions, or to report a problem, please call Empowered Diagnostics at 954-354-2768.
Test system problems may also be reported to the FDA using the MedWatch reporting system (phone: 1-800-FDA-1088; fax: 1-800-FDA-1078: or http://www.fda.gov/medwatch).