COVID-19 Detection Kits Fact Sheet

U-TOP™ COVID-19 Test Kits

Fact Sheet & Resources

Product Description

The U-TOP COVID-19 Detection Kit is a one-step real-time RT-PCR test. The AQ-TOP COVID-19 Rapid Detection Kit is a Real-Time Loop Mediated Isothermal Amplification (RT-LAMP) test. 

 

Both tests are intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens and sputum from individuals who are 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, to perform high complexity tests.

 

The kit composed of 2X Reaction buffer, Enzyme Mix, Reaction Mix, Positive control and Negative Control.

 

 

Can the U-TOP and AQ-TOP COVID-19 Detection Kits be used in the United States?

U-TOP and AQ-TOP COVID-19 Detection Kits have been authorized by the FDA under the Emergency Use Authorization. For more information see the Emergency Use Authorization FDA website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

 

Who is Seasun Biomaterials?

Seasun Biomaterials is an in vitro diagnostic company that develops molecular diagnostic platforms of infection diseases, cancer and genetic and epigenetic disorders. 

 

Seasun develops and commercializes innovative real-time PCR-based diagnostic platforms through the development of proprietary technologies to provide more advanced molecular diagnostic services. 

 

Seasun Biomaterials reliable products are used in hundreds of hospitals and laboratories throughout the world.

http://www.seasunbio.com/english/etc.html

What are the symptoms of COVID-19?

Many patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of clinical illness associated with COVID-19. Based on what is known about the virus that causes COVID-19, signs and symptoms may appear any time from 2 to 14 days after exposure to the virus. Based on preliminary data, the median incubation period is approximately 5 days, but may range 2-14 days.

Public health officials have identified cases of COVID-19 infection throughout the world, including the United States, which may pose risks for public health. Please check the CDC web page for the most up to date information.

 

What do I need to know about COVID-19 testing?

Current information on COVID-19 for healthcare providers is available at CDC’s web page, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information” section).

  • The COVID-19 Detection Kit can be used to test in oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens and sputum.
     

  • The COVID-19 Detection Kit should be ordered for the detection of COVID-19 in individuals who are suspected of COVID-19 by their healthcare provider.
     

  • The COVID-19 Detection Kit is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

 

Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available at the CDC’s website (see links provided in “Where can I go for updates and more information” section).

Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of having COVID-19 as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information” section).

 

What does it mean if the specimen tests positive for the virus that causes COVID-19?

A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management should follow current CDC guidelines.

The COVID-19 Detection Kit has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.

All laboratories using this test must follow the standard testing and reporting guidelines according to their appropriate public health authorities.

 

What does it mean if the specimen tests negative for the virus that causes COVID-19?

A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19.

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing should be considered by healthcare providers in consultation with public health authorities.

Risks to a patient of a false negative include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.

What is an EUA?

The United States (U.S.) FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.

An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19.

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).

 

Where can I go for updates and more information?

CDC webpages:

General: https://www.cdc.gov/COVID19

Healthcare Professionals:  https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html

Information for Laboratories: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-laboratories.html

Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html

Isolation Precautions in Healthcare Settings:  

https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html

Specimen Collection: https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html

Infection Control: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/index.html

 

FDA webpages:

General: www.fda.gov/novelcoronavirus

Testing Basics: www.fda.gov/media/140161/download

EUAs:  (includes links to patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

COVID-19 Test Kits