The CLEAR winner in Covid-19 Antigen testing

 

 

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

  • CovClear iconSimple to use – Rapid Results in 3-20 Minutes

  • CovClear iconHighly Sensitive and Specific – Outperforming other antigen tests

  • CovClear iconSafety Advantage – Sealed Vial Protecting Collector Against Live Virus

  • CovClear iconNo Reader Required – Reduced Cost

  • CovClear iconNo Cassette Needed – Reduced Material Wastage

  • CovClear iconEarly Detection – Reduced Exposure

  • CovClear iconResearched, developed & manufactured in the USA

 

CovClear has received CE marking for sale in the European Union.

PERFORMANCE

98.5% Sensitivity
98.5%

Sensitive

100% Specificity
100%

Specific

Validated by Empowered Diagnostics, LLC. CovClear has been validated, but the FDA’s independent review of this validation is pending.

Intended Use


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).

CovClear Antigen Test

For informational purposes only. Testing is limited to laboratories and patient care settings operating under a high complexity CLIA Certificate.

Sample Collection

CovClear - Step 11

Remove a swab from the pouch.

CovClear - Step 22

Place the dry swab into one nostril until it reaches resistance.

CovClear - Step 3 3

Slowly rotate the swab 7 times over the surface inside the nostril.

CovClear - Step 4 4

Slowly remove the swab from the nostril while still rotating it. Repeat steps 2-4 on other nostril.

Test Instructions

CovClear Instructions: Step 11

Pour entire buffer solution ampule into empty vial.

CovClear Instructions: Step 22

Insert dry swab into one nostril until you meet resistance. Swirl 7 times. Repeat with the same swab in other nostril.

CovClear Instructions: Step 33

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.

CovClear Instructions: Step 44

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.

CovClear Instructions: Step 55

Place new test strip, arrow pointing down, into vial with the swab.

NOTE: Touch test strip on the colored end only.

CovClear Instructions: Step 66

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

CovClear Results