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Novel coronavirus (“COVID-19”) is an emerging infectious disease resulting in serious illness and death in the United States and worldwide.  A recognized vaccine or therapy to treat or prevent this disease has not yet been developed.  The SARS-CoV-2 virus has demonstrated the ability to spread rapidly and presents grave risk to public health and will have significant impact on the United States healthcare system. 

Test Kits are sold by Grayson solely for use by clinical laboratories or “Qualified Health Care Professionals” (defined below) for point-of-care testing in accordance with applicable state and federal laws and regulations and directives from governmental authorities.  The Test Kits are not intended for use and may not be used for at-home testing.  “Qualified Health Professionals” are health care practitioners who are properly licensed under applicable state laws with appropriate skills, training and knowledge. 

The Test Kits are intended for use solely to rapidly detect production of IgM and IgG antibodies to the SARS-CoV-2 virus (called “Serologic Tests” or “Antibody Tests”).  Serologic/Antibody Tests such as the Test Kits will identify patients who have been infected by the virus.  The Test Kits will not detect the presence or absence of the SARS-CoV-2 virus in a patient.

Tests for the presence of the SARS-CoV-2 virus are known as polymerase chain reaction (“PCR”) tests, or “Molecular Tests”.  PCR/Molecular Tests which detect the SARS-CoV-2 virus are highly complex, and are conducted in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).  

For more information about the differences between Serologic/Antibody Tests and PCR/Molecular Tests, see https://www.fiercebiotech.com/medtech/bd-to-offer-fingerstick-antibody-blood-test-for-covid-19 and https://www.sciencemediacentre.org/expert-comments-on-different-types-of-test-for-covid-19/

The correct interpretation of test results in conjunction with the clinical presentation of a patient is critical to informing patient management and minimizing transmission of the virus.  Accurate identification of a SARS-CoV-2 virus infection based on serology results, particularly those obtained from rapid tests used at the point of care, requires an understanding of the antibody response profile.  There is a window period between virus infection and the production of IgM and IgG antibodies, and the sensitivity and specificity of IgM/IgG antibody tests early in SARS-CoV-2 infection is not well characterized.  If testing is not performed by Qualified Health Professionals, misinterpretation of serology results may arise in the point-of-care setting, which may present grave risk to public health, and may result in serious illness and/or death of the patient and other persons with whom the patient comes into contact. 

Transmission-based safety precautions must also be used when collecting specimens from patients with a communicable disease.  Blood specimens collected for point-of-care testing should be regarded as potentially infectious not just for SARS-CoV-2, but also for other blood-borne infectious diseases.  Qualified Health Professionals must be trained in appropriate specimen collection and infection control procedures.  Inappropriate use of the Test Kit or misinterpretation of test results may result in risk of death or serious illness if the test is not performed by Qualified Health Professionals.