Innovita (Tangshan) Biological Technology Co., Ltd. Innovita 2019-nCoV Ab Test (Colloidal Gold) MidaSpot COVID-19 Antibody Combo Detection KitĬOVID-19 Self-Collected Antibody Test SystemĦ1.1% (0-7 days), 92.9% (7-14 days), 100% (15+ days) Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test Included in the complete list are descriptions and phase of development. Tests that have been authorized for useĭownload the complete list of tests authorized for use (xlsx). This page was last updated on December 16, 2021.
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When available, the number of samples used for sensitivity/specificity definitions are listed in the product description in the extended versions of the tables. If a sensitivity or specificity is not listed, it was not listed/available at the time of posting. These measures are not independently validated by the Johns Hopkins Center for Health Security. A highly specific test should rule out all true negative results. A highly sensitive test should capture all true positive results. The manufacturer-reported sensitivity and specificity data is listed, where available. Noninclusion in this list should not be interpreted as judgment on validity or legitimacy of tests. This site is not intended to be used as a reference for funding or grant proposals. It only includes tests for which data and documentation is available and for which their stated intended use aligns with their regulatory status. This list is updated twice weekly, and only includes tests that have received a US Food and Drug Administration EUA. Active infection should be diagnosed using an antigen or molecular diagnostic test. Negative results do not rule out prior or current infection. These tests are not approved for diagnosis of acute, active SARS-CoV-2 infection, but may indicate previous exposure to the virus. This page provides up-to-date information on serology tests that have received emergency use authorization (EUA) available for use.
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The Johns Hopkins Center for Health released a report detailing considerations for a national strategy on serology testing, including actions for leaders and areas for continued research. These tests can give greater detail into the prevalence of a disease in a population by identifying individuals who have developed antibodies to the virus. Serology tests measure the levels of specific antibodies in the blood, revealing whether a person has been exposed to a particular pathogen by looking at their immune response. This type of testing is valuable because it can identify those who may have been asymptomatic and recovered. Serology testing for SARS-CoV-2 continues to be in high demand because it can help to better quantify the total number of cases of COVID-19 to date.
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Tests that have been approved for diagnostic useįact Sheet - Understanding the Accuracy of Diagnostic and Serology Tests: Sensitivity and Specificity (PDF) Serology tests for COVID-19