Info for Laboratories about Coronavirus (COVID-19)


CDC has developed a laboratory take a look at to assist estimate how many individuals in america have already been contaminated with SARS-CoV-2, the virus that causes COVID-19. Clinicians and researchers seek advice from this as a serology take a look at, and plenty of industrial laboratories name it an antibody take a look at. CDC has additionally developed steering for using antibody assessments in medical and public well being settings.

An antibody take a look at seems for the presence of antibodies, that are particular proteins made in response to infections. Antibodies are usually detected within the blood of people who find themselves examined after an infection; they present an immune response to the an infection. Antibody take a look at outcomes are particularly vital for detecting earlier infections in individuals who had few or no signs.

CDC scientists are conducting research to find out how a lot safety (immunity) antibodies would possibly present towards getting contaminated once more. Based mostly on what we all know from related viruses, some reinfections are anticipated. Confirmed and suspected circumstances of reinfection of the virus that causes COVID-19 have been reported, however stay uncommon.

CDC’s serologic take a look at has been designed and validated for surveillance and analysis functions. It’s designed to estimate the share of the U.S. inhabitants beforehand contaminated with the virus – info wanted to information the response to the pandemic and defend the general public’s well being.

Industrial assessments can be found to supply take a look at outcomes to people.

CDC is evaluating the efficiency of economic antibody assessments

Commercially manufactured antibody assessments test for SARS-CoV-2 antibodies in people and can be found via healthcare suppliers and industrial laboratories. CDC is evaluating the efficiency of those assessmentsexterior icon in collaboration with the next federal organizations:

  • Biomedical Superior Analysis and Growth Authority
  • U.S. Meals and Drug Administration (FDA)
  • Nationwide Institutes of Well being
  • Outcomes from the federal analysis are included in FDA’s EUA Approved Serology Take a look at Efficiencyexterior icon and will likely be up to date as extra assessments are evaluated.

Learn CDC’s interim pointers for utilizing antibody assessments in medical and public well being settings.

About CDC’s serologic take a look at

CDC’s serologic take a look at is an enzyme-linked immunosorbent assay (ELISA)-based take a look atexterior icon to detect SARS-CoV-2 antibodies in serum or plasma elements of blood. The ELISA take a look at makes use of purified SARS-CoV-2 S protein (no stay virus) as antigen (designed by the Vaccine Analysis Middleexterior icon on the Nationwide Institutes of Well being). This take a look at is designed to reduce cross-reactivity to antibodies generated to different widespread coronaviruses that trigger much less extreme sicknesses, equivalent to colds. Nonetheless, potential cross-reactivity can’t be fully dominated out.

CDC’s serologic take a look at has a specificity of higher than 99% and a sensitivity of 96% primarily based on efficiency evaluations. It may be used to establish previous SARS-CoV-2 an infection in individuals who had been contaminated a minimum of 1 to three weeks beforehand.

CDC serology surveillance technique

CDC has a technique for utilizing serology testing as a part of surveillance efforts to higher perceive how a lot of the U.S. inhabitants has been contaminated with SARS-CoV-2 and the way the virus is spreading via the inhabitants over time.

Study extra about CDC’s COVID-19 serology surveillance technique.

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