CovClear COVID-19
Rapid Antigen Test

RAPID COVID-19 DIAGNOSTIC TEST.
RAPID RESULTS WITHIN 3MINUTES!

High
Accuracy
researched and developed in the USA
Short
Nasal
Rapid
Results

CovClear Is the 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.

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).

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COVID-19 Antigen Rapid Test

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98.5%

Sensitivity

100%

Specificity

Sample Collection

1

Remove a swab from the pouch.

2

Place the dry swab into one of the patient’s nostrils until it reaches resistance.

3

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

4

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

Test Instructions

1

Pour entire buffer solution ampule into empty vial.

2

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

3

Place swab into prepared vial with buffer solution. Slightly swirl the vial and swab for 30 seconds.

4

Press tip against side of vial to squeeze liquid from swab for 10 seconds. Then place swab back into the buffer solution.

5

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

6

Place cap securely onto the vial with the test strip and swab inside.

NOTE: Read results after 3 minutes. Do not read results past 20 minutes.

Interpretation of Results

Important Documentation

CovClear™ Rapid Antigen Test Product Insert

A total of 76 blinded dry nasal swab samples were tested in one investigational site to evaluate the clinical performance of the CovClear™ SARS-Cov-2 Rapid Antigen Test strip. Nasal swab specimens were collected from patients with COVID-19 like symptoms during the 2020 COVID-19 season. All the Nasal swabs were added to the CovClear™ vial (either dry or in buffer). All the Nasal swab specimens were confirmed as positive or negative and validated with Ct value by the FDA EUA RT-PCR as a comparator method. The samples were randomized, blinded and tested using the instructions provided by the Instruction for Use.

All the study samples were random and assigned a study ID prior to testing. The expected results of the sample were completely blinded to the operators. 11% of the positive samples had Ct values over 30.

SARS-coronavirus was not tested as part of this study. Additional testing may be required to determine if this pathogen will generate cross-reactivity at the CovClear test line. 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.
  • The homology between SARS-CoV-2 nucleocapsid protein and human coronavirus 229E nucleocapsid protein is relatively low, but cross- reactivity cannot be ruled out. However, a result of the cross-reactivity wet study showed that CovClear™ COVID-19 Antigen had no cross-reactivity against human coronavirus 229E.
  • No homologous protein was detected as a result of in silico assay with the proteins of Mycoplasma pneumoniae and the nucleocapsid protein (NP) of SARS-CoV-2. So, cross-reactivity of CovClear™ COVID-19 Antigen against Mycoplasma pneumoniae can be ruled out.

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7GM is NOT accredited by WHO or CDC to perform checks. 7GM doesn’t administer Medical Services This information is not intended as s substitute for medical care. Contact your physician with any COVID-19 concerns. Copyright © 2020 – All Rights Reserved.

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7GM is NOT accredited by WHO or CDC to perform checks. 7GM doesn’t administer Medical Services This information is not intended as s substitute for medical care. Contact your physician with any COVID-19 concerns.