Determine Your Patient’s Antibody Response with This COVID-19 Blood Test
Precision Point Diagnostics’ COVID-19 serum test measures IgM and IgG antibodies to the nucleocapsid protein found in SARS-CoV-2, the virus that causes COVID-19. The novel coronavirus, first reported in Wuhan, China in 2019, has unfolded into a historic global pandemic complete with testing shortages, leaving nations grasping for answers and solutions.
Help Your Patients Get Answers About Their Coronavirus Status
With this COVID-19 blood test, you can determine early and late immune response to the SARS-CoV-2 virus. Blood antibodies to the virus increase in the first weeks after symptoms and can be used in conjunction with diagnostic polymerase chain reaction (PCR) testing. IgM antibodies elevate as part of the early immune response to the virus, usually within a week of symptoms. IgG antibodies increase 2-3 weeks after symptom onset as part of the late, or chronic, response to the virus. Taken together, these results can help clinicians determine if their patients were exposed, infected, or if they have long-term antibody production to coronavirus. This test is ideal for travelers, people who had COVID-19 symptoms, people who have had exposures to known positive cases, or people who had a potentially false-negative PCR test.
- Fever or chills
- Shortness of breath or difficulty breathing
- Muscle or body aches
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
Disclaimer: This test is for in vitro diagnostic use and has been authorized by the FDA under an EUA (Emergency Use Authorization) for use by authorized laboratories.
Our test has not been FDA cleared or approved. Our test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
Our test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.