Serology-based tests for COVID-19
Serology testing for SARS-CoV-2 is at increased demand in order to better quantify the number of cases of COVID-19, including those that may be asymptomatic or have recovered. Serology tests are blood-based tests that can be used to identify whether people have been exposed to a particular pathogen by looking at their immune response. In contrast, the RT-PCR tests currently being used globally to diagnose cases of COVID-19 can only indicate the presence of viral material during infection and will not indicate if a person was infected and subsequently recovered. 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.
The Johns Hopkins Center for Health recently released a report detailing considerations for a national strategy on serology testing, including actions for leaders and areas for continued research. You can find this report here.
This page serves to provide up to date information on serology tests that are in development or available for use. Importantly, many of these tests have been approved for research use only, which indicates that they are not yet approved for use as a public health diagnostic tool or for at-home diagnosis. Some of these tests may move forward to approval for diagnostic use, while others may be appropriate for research only.
Disclaimer
This website is updated twice weekly, and only includes tests for which data and documentation is available and for which their stated intended use aligns with their FDA (or relevant national regulatory body) status. This site does not include tests that are in subsection IV.D of the FDA Policy for Diagnostic Tests for Coronavirus Disease-2019, as these have not been approved by the FDA and may not have indicated to the FDA that they are pursuing EUA approval. This site is not intended to be used as a reference for funding or grant proposals. Non-inclusion in this list should not be interpreted as judgment on validity or legitimacy of tests. If you do not see your test on this list, but would like it to be considered, please fill out the following form. Submission does not guarantee inclusion on this site.
Note on sensitivity and specificity data
Here we list the manufacturer-reported sensitivity and specificity data, where available. A highly sensitive test should capture all true positive results. A highly specific test should rule out all true negative results. These measures are not independently validated by the Johns Hopkins Center for Health Security. If a sensitivity or specificity is not listed, it was not listed/available at the time of posting. When available, the number of samples used for sensitivity/specificity definitions are listed in the product description.
It should also be noted that the terms “sensitivity” and “specificity” may not appear in the manufacturers’ information sheets, but rather these values are often reported as “positive percent agreement” and “negative percent agreement.” The FDA recommends that manufacturers use these terms to indicate that a non-reference standard was used when evaluating the test.
This page was last updated on May 6, 2020.
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Description of types of serology assays
Rapid diagnostic test (RDT): This is typically a qualitative (positive or negative) lateral flow assay that is small, portable, and can be used at point of care (POC). These tests may use blood samples from a finger prick, saliva samples, or nasal swab fluids. RDTs are often similar to pregnancy tests, in that the test shows the user colored lines to indicate positive or negative results. In the context of COVID-19, these tests most frequently test for patient antibodies (IgG and IgM), or viral antigen. In some cases, it can be beneficial to measure baseline (before infection) of IgG and IgM titers.
Enzyme-linked immunosorbent assay (ELISA): This test can be qualitative or quantitative and is generally a lab-based test. These tests usually use whole blood, plasma, or serum samples from patients. The test relies on a plate that is coated with a viral protein of interest, such as Spike protein. Patient samples are then incubated with the protein, and if the patient has antibodies to the viral protein they bind together. The bound antibody-protein complex can then be detected with another wash of antibodies that produce a color or fluorescent-based readout. In the context of COVID-19, these tests most frequently test for patient antibodies (IgG and IgM).
Neutralization assay: This test relies on patient antibodies to prevent viral infection of cells in a lab setting. Neutralization assays can tell researchers if a patient has antibodies that are active and effective against the virus, even if they have already cleared the infection. These tests require whole blood, serum, or plasma samples from the patient. Neutralization assays depend on cell culture, a lab-based method of culturing cells that allow SARS-CoV-2 growth (like VeroE6 cells). When virus and cells are grown with decreasing concentrations of patient antibodies, researchers can visualize and quantify how many antibodies in the patient serum are able to block virus replication. This blocking action can happen through the antibody binding to an important cell entry protein on the virus, for example.
Chemiluminescent immunoassay: This test is typically quantitative, lab-based, and uses whole blood, plasma, or serum samples from patients. A variation of this test can use magnetic, protein-coated microparticles, known as a chemiluminescent microparticle immunoassay. The test relies on mixing patient samples with a known viral protein, buffer reagents, and specific enzyme-labeled antibodies that allow a light-based, luminescent read-out. Any antibodies in the patient sample that react to the viral protein will form a complex. Then, (secondary) enzyme-labeled antibodies are added that bind to these complexes. This binding induces a chemical reaction that produces light. The amount of light (radiance) emitted from each sample is then be used to calculate the number of antibodies present in a patient sample. This test can look for multiple types of antibodies, including IgG, IgM, and IgA.
|
Type of test |
Time to results |
What it tells us |
What it cannot tell us |
Figure |
|
Rapid diagnostic test (RDT) |
10-30 minutes |
The presence or absence (qualitative) of antibodies against the virus present in patient serum. |
The amount of antibodies in the patient serum, or if these antibodies are able to inhibit virus growth |
|
|
Enzyme linked immunosorbent assay (ELISA) |
2-5 hours |
The presence or absence (quantitative) of antibodies against the virus present in patient serum. |
If the antibodies are able to inhibit virus growth. |
|
|
Neutralization assay |
3-5 days |
The presence of active antibodies in patient serum that are able to inhibit virus growth ex vivo, in a cell culture system. |
It may miss antibodies to viral proteins that are not involved in replication. |
|
|
Chemiluminescent immunoassay |
1-2 hours |
The presence or absence (quantitative) of antibodies against the virus present in the patient serum. |
If the antibodies are able to inhibit virus growth. |
Tests that have been approved for diagnostic use in the United States
|
Country of development |
US/China |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
RDT, lateral flow assay, which detects IgM and IgG to the nucelocapside protein of SARS-CoV-2. The sensitivity is 93.8% and specificity is 95.6%, when tested at 2 Chinese hospitals in a total of 128 COVID19 positive patients, and 250 COVID19 negative patients (as detected by RT-qPCR). |
|
Sensitivity |
93.8% |
|
Specificity |
95.6% |
|
Phase of development |
Approved by FDA for EUA on diagnostics, has CE approval |
|
Proposed release |
available for purchase by research labs/healthcare providers (product number 5513) |
|
Date |
April 1, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
This test detects IgM and IgG antibodies to the nucleocapsid (N) protein of SARS-CoV-2. Sensitivity and specificity values were not released. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Approved for EUA by the FDA |
|
Proposed release |
April 14, 2020 |
|
Date |
April 15, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
This test detects IgG and is designed to be used with VITROS Immunodiagnostic Products and the VITROS ECi/ECiQ/3600 Immunodiagnostic System and the VITROS 5600/XT 7600 Integrated Systems. Sensitivity was approximately 87.5% and specificity is approximately 100%. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Approved for EUA by the FDA |
|
Proposed release |
Current |
|
Date |
April 24, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
This test detects, qualitatively, IgG present in the serum of patients. The ELISA based method uses a 1:50 dilution of human serum that is flowed over a plate coated with the spike protein receptor binding domain (RBD). Sensitivity and specificity are not yet available. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Approved for EUA by the FDA |
|
Proposed release |
April 15, 2020 |
|
Date |
April 16, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
This test detects IgM and IgG via lateral flow assay. IgM test line sensitivity was approximately 95.7%. IgG test line sensitivity was approximately 99%. Specificity for both IgM and IgM were reported around 99%. |
|
Sensitivity |
95.7% (IgM) and 99% (IgG) |
|
Specificity |
99% (both IgM and IgG) |
|
Phase of development |
Approved for EUA by the FDA |
|
Proposed release |
Current |
|
Date |
April 24, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
This test is designed to run on the LIAISON XL analyzer and detects IgG specific to recombinant spike protein subunits 1 and 2 (S1 and S2). Specificity was approximately 98%. Sensitivity was approximately 90% on samples obtained 5-15 days post-symptom onset. For samples taken greater than 15 days post-symptom onset, the sensitivity was approximately 97%. |
|
Sensitivity |
90-97% |
|
Specificity |
98% |
|
Phase of development |
Approved for EUA by the FDA |
|
Proposed release |
Current |
|
Date |
April 24, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
Modified ELISA |
|
Authors/Company |
|
|
Description |
The Platelia SARS-CoV-2 Total Ab assay measures IgM, IgG, and IgA antibodies to SARS-CoV-2. The target antigen is recombinant nucleocapsid protein, coupled with peroxidase that provides the read-out. Human serum or plasma samples are required.The sensitivity and specificity are not yet known, though it appears the readout of the assay may be quantiative or qualitative. |
|
Sensitivity |
98% |
|
Specificity |
99% |
|
Phase of development |
Received EUA |
|
Proposed release |
Current |
|
Date |
April 29, 2020 |
|
Country of development |
US/Switzerland |
|
Type of Serological Test |
electro-chemiluminescence immunoassay (ECLIA) |
|
Authors/Company |
|
|
Description |
The test couples chemiluminescence immunoassay technology with an electric pulse that allows for rapid quantifiation of captured antigen-antibody complexes from patient serum samples. The target antigen is the viral N protein.The test assays for IgM and IgG, and takes about 18 minutes. The test should be run on the Elecsys Anti-SARS-CoV-2 on the cobas e 411, cobas e 601, cobas e 602, or cobas e 801 analyzers. Sensitivity was determined from 204 samples, and specificity from 5,272 negative samples. |
|
Sensitivity |
From 0-6 days, 65.5%; from 7-13 days, 88.1%; from 14 days onward, 100% |
|
Specificity |
99.81% |
|
Phase of development |
Received EUA, available for purchase by healthcare professionals and researchers. |
|
Proposed release |
Current |
|
Date |
May 2, 2020 |
|
Country of development |
Germany |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
The Euroimmun AG IgG ELISA assay uses the viral S1 region of the spike protein to quantify IgG antibodies present in serum samples. Sensitivity and specificity were determined compared to onset of symptoms in PCR positive and negative samples. Sample sizes varied over time. |
|
Sensitivity |
From 0-10 days, 13.9%; from 11-20 days, 61.1%; from 21 days onward, 100%. 90% by NCI validation |
|
Specificity |
100% by NCI validation |
|
Phase of development |
Received EUA, available for purchase by healthcare professionals and researchers. |
|
Proposed release |
Current |
|
Date |
May 4, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
Microsphere immunoassay |
|
Authors/Company |
|
|
Description |
This test assays for total antibodies (IgG, IgM, and IgA) in human serum samples. The test uses full-length recombinant nucleocapsid protein from SARS-CoV-1 (it is stated that the sequence is similar enough to use the other virus' N protein-90% homologous). The test should be run with a Luminex FlexMap dual laser cytometer. |
|
Sensitivity |
Not stated |
|
Specificity |
93-100% |
|
Phase of development |
Received EUA, available for purchase by healthcare professionals and researchers. |
|
Proposed release |
Current |
|
Date |
April 30, 2020 |
Tests that have been approved for diagnostic use in other countries
|
Country of development |
US/China |
|
Type of Serological Test |
RDT, solid phase immunochromatographic assay |
|
Authors/Company |
|
|
Description |
The (COVID-19) IgG/IgM Rapid Test will assay patient antibodies to SARS-CoV-2 from blood or plasma samples. |
|
Sensitivity |
87.9% (IgG) and 97.2% (IgM) |
|
Specificity |
100% for IgG and IgM |
|
Phase of development |
CE approved, used in China in clinical settings, awaiting FDA approval |
|
Proposed release |
Shipments should be ready by early April |
|
Date |
March 10, 2020 |
|
Country of development |
US/China |
|
Type of Serological Test |
Proprietary |
|
Authors/Company |
|
|
Description |
This kit is for detection of IgG and IgM for SARS-CoV-2 in the blood, taking only 15 minutes, and is an at-home test. |
|
Sensitivity |
87.3% |
|
Specificity |
100% |
|
Phase of development |
Cleared by China's National Medical Products Administration (NMPA), and pending approval by US FDA |
|
Proposed release |
6-8 weeks (May 1 to May 15), depending on FDA approval date |
|
Date |
March 20, 2020 |
|
Country of development |
Singapore |
|
Type of Serological Test |
Not explicity stated, though their "gold standard" is a neutralization assay |
|
Authors/Company |
|
|
Description |
The Wang lab developed two tests. One, which has about 90% sensitivity, is rapid and uses recombinant viral proteins to detect reactive antibodies. The second is their "gold standard" and utilizes a viral neutralization assay but takes 3-5 days. |
|
Sensitivity |
90% |
|
Specificity |
|
|
Phase of development |
Deployed in Singapore |
|
Proposed release |
Not stated |
|
Date |
March 1, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
Lateral flow assay (RDT) |
|
Authors/Company |
|
|
Description |
Wondfo SARS-CoV-2 Antibody Test, which is a lateral flow assay that assays patient IgG and IgM. The article did not specify target antigens, sensitivity, or specificity |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
CE/IVD, approved by NMPA in China for point of care testing |
|
Proposed release |
CE/IVD in the EU |
|
Date |
Feb. 22, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
RDT (colloidal gold lateral flow assay) |
|
Authors/Company |
|
|
Description |
Tests for IgM against SARS-CoV-2. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Cleared by China's National Medical Products Administration (NMPA) |
|
Proposed release |
Approved for use in China |
|
Date |
Feb. 22, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
The test, DNK-1419-1, assays for patient IgG and IgM with 92% accuracy. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
The NMPA has approved it in the 7th edition of Diagnostic and treatment protocol of COVID-19 |
|
Proposed release |
Used in China, no other approvals to date |
|
Date |
Date not given |
|
Country of development |
The Republic of Korea |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
This company currently offers 3 tests. 1) The Standard Q COVID-19 IgM/IgG Duo which tests for both IgG and IgM patient antibodies to SARS-CoV-2. Sensitivity was 82% and specificity was 97% (based on data from 30 healthy donors and 33 COVID-19 positive individuals. 2) Standard Q COVID-19 Ag, which detects virus antigen from nasopharyngeal swabs, and 3) Standard F COVID-19 Ag FIA, which detects viral N protein present in nasopharyngeal swabs in a fluorescence based assay. |
|
Sensitivity |
82% |
|
Specificity |
97% |
|
Phase of development |
Approved for diagnostic us outside the US, Research use only in US |
|
Proposed release |
2-3 weeks |
|
Date |
March 26, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
MayoClinic is developing an ELISA to test for antibodies to SARS-CoV-2. The types of antibodies are not stated, nor is sensitivity or specificity. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Clinical |
|
Proposed release |
April 6, 2020 |
|
Date |
April 1, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
RapCov Rapid COVID-19 Test is an in vitro diagnostic test for IgM and IgG antibodies. In a study with 18 healthy and 18 COVID-19 positive patients, the sensitivity was 89% and specificity was 100%. It should be noted that "specificity" was only performed on healthy patient samples, not patient samples from related viruses. Further testing is necessary to validate the test. It is currently being used to study community prevalence in Chester County, PA. https://advaite.com/press-release/advaite-deploys-covid-19-rapid-antibody-test-kits-to-chester-county-and-collaborates-with-pennsylvania-companies-to-scale-up-manufacturing/ |
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Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Research use only (IVD), not approved for diagnostic use. This company was not found on any FDA categorization of tests |
|
Proposed release |
April 2020 |
|
Date |
April 6, 2020 |
Tests that have been approved for research or surveillance purposes only
|
Country of development |
US |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
KT-1032 tests for IgG to SARS-CoV-2, while KT-1033 tests for IgM to SARS-CoV-2. The kits do not state the antigens of interest. These were tested on 54 COVID-19 negative patients for specificity, and 30 COVID-19 positive patients for sensitivity. |
|
Sensitivity |
100% |
|
Specificity |
100% |
|
Phase of development |
Approved by FDA, for clinical use only and for research use. Not for at home testing. The test itself has not been evaluated by the FDA |
|
Proposed release |
Ongoing |
|
Date |
March 3, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
The test, COVID-19 IgG/IgM Rapid Test, tests for patient IgG and IgM in a lateral flow assay. |
|
Sensitivity |
96.9% |
|
Specificity |
99.4% |
|
Phase of development |
Not approved for use in the US, but available for purchase by research labs/healthcare providers |
|
Proposed release |
available for purchase by research labs/healthcare providers and export out of the US |
|
Date |
March 12, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
RDT (colloidal gold lateral flow assay) |
|
Authors/Company |
|
|
Description |
This assay detects patient antibodies, IgG and IgM, on a lateral flow assay. It uses a recombinant viral antigen, though it does not state the specific antigen. The test is a 3 line read-out, one line for a control, one line to detect IgM, and one to detect IgG. Three lines indicates the patient has both IgG and IgM. Sensitivity was measured from 397 positive patients, and specificity from 128 negative patients. |
|
Sensitivity |
88.6% |
|
Specificity |
90.63% |
|
Phase of development |
CE/IVD, approved by FDA but only for research use |
|
Proposed release |
CE/IVD, available for purchase by research labs/healthcare providers in the US, but only for research use |
|
Date |
March 16, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
This test, the Coronavirus (COVID-19) IgM/IgG Rapid Test Kit, detects patient IgM and IgG to SARS-CoV-2 in patient blood samples. It detects antibodies against the viral N protein. |
|
Sensitivity |
84.1% |
|
Specificity |
92.3% |
|
Phase of development |
CE/IVD, approved for research use only in the US. Approved for research use under FDA EUA. |
|
Proposed release |
available for purchase by research labs/healthcare providers, CE/IVD approved |
|
Date |
March 19, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
Kit DEIASL019 detects patient IgG for SARS-CoV-2, and uses the whole virus lysate as the antibody binding target. The reported sensitivity and specificity are 100% (from 16 and 30 samples, respectively). The DEIA2020 kit only tests for patient IgG that reacts to N protein. |
|
Sensitivity |
100% |
|
Specificity |
100% |
|
Phase of development |
Not approved for diagnostic use; for research use only |
|
Proposed release |
available for purchase by research labs/healthcare providers, but not for diagnostic use |
|
Date |
March 20, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
This company has two kits, one (KTR-1032) which targets patient IgG, and one (KTR-1033) that targets IgM. The target antigen is an "HRP-labeled-COVID-19 antigen." Sensitivity was determined from 30 positive patients, and specificity was determined from 54 negative patients. |
|
Sensitivity |
100% |
|
Specificity |
100% |
|
Phase of development |
Research use only, CE/IVD outside the US |
|
Proposed release |
available for purchase by research labs/healthcare providers, but not for diagnostic use |
|
Date |
Date not given |
|
Country of development |
China/US |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
The Coronavirus Rapid Test assays for IgG and IgM antibody in blood or plasma samples, with 92-96% accuracy. |
|
Sensitivity |
82% (IgM) and 92% (IgG) |
|
Specificity |
94% (IgM) and 97% (IgG) |
|
Phase of development |
CE approved |
|
Proposed release |
available for purchase by research labs/healthcare providers, CE approved |
|
Date |
Feb. 2020 |
|
Country of development |
China/US |
|
Type of Serological Test |
RDT, immunofluorescence, colloidal gold |
|
Authors/Company |
|
|
Description |
There are three tests: 1) the 2019 nCoV Ag test, which assays sputum or nasal swabs for SARS-CoV-2 antigens and gives a fluorometric read out, 2) the 2019-nCoV Ag GICA test, which uses colloidal gold, and 3) the 2019 nCoV IgG/IgM GICA rapid test which assays for patient antibodies to the virus from blood samples |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
CE/IVD approved |
|
Proposed release |
available for purchase by research labs/healthcare providers, CE/IVD approved |
|
Date |
Date not given |
|
Country of development |
The Republic of Korea |
|
Type of Serological Test |
RDT (colloidal gold lateral flow assay) |
|
Authors/Company |
|
|
Description |
This test is a colloidal gold lateral flow assay that can be read in 10 minutes, and measures presence of patient IgG and IgM. Sensitivity was determined from 100 samples, and specificity was determined from 150 samples. |
|
Sensitivity |
91% |
|
Specificity |
96.7% |
|
Phase of development |
CE/IVD approved |
|
Proposed release |
available for purchase by research labs/healthcare providers, CE/IVD approved |
|
Date |
Date not given |
|
Country of development |
The Republic of Korea |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
US supplier Henry Schein will distribute the test for IVD use only |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Korea EUA approved |
|
Proposed release |
available for purchase by research labs/healthcare providers, but not for diagnostic use |
|
Date |
Date not given |
|
Country of development |
Singapore |
|
Type of Serological Test |
RDT, prescreen step |
|
Authors/Company |
|
|
Description |
This is a pre-screening, at home test (though not authorized for at-home use yet). It tests for IgG and IgM antibodies, and is reported to be 92% accurate. The sensitivity was determined from 300 samples, and specificity from 1000 samples. |
|
Sensitivity |
82% |
|
Specificity |
96% |
|
Phase of development |
CE certified awaiting FDA EUA. |
|
Proposed release |
available for purchase by research labs/healthcare providers, CE/IVD approved |
|
Date |
Date not given |
|
Country of development |
Germany |
|
Type of Serological Test |
ELISAs |
|
Authors/Company |
|
|
Description |
This company has two tests, including EI 2606-9601 A, which tests for patient IgA, and EI 2606-9601 G, which tests for patient IgG. The target antigens were not stated, nor were specificity or sensitivity of tests. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Research use only, CE/IVD in EU |
|
Proposed release |
CE/IVD in the EU |
|
Date |
March 12, 2020 |
|
Country of development |
Germany |
|
Type of Serological Test |
RDT, lateral flow assay |
|
Authors/Company |
|
|
Description |
This RDT tests for IgM and IgG of patients, with 92-98% sensitivity in later stages of the infection (day 11-24) with 100% sensitivity. |
|
Sensitivity |
92-98% |
|
Specificity |
100% |
|
Phase of development |
Research use only |
|
Proposed release |
Appears available for purchase by research labs/healthcare providers, but no clear approvals |
|
Date |
Date not given |
|
Country of development |
China |
|
Type of Serological Test |
RDT (colloidal gold lateral flow assay) |
|
Authors/Company |
|
|
Description |
COVID-19 IgG/IgM Combo Rapid Test Device is an RDT that tests for patient IgG and IgM antibodies. The sensitivity and specificity for total antibodies were 93.1 and 100%, respectively. For IgG, sensitivity is 82% and specificity is 100%. For IgM, the sensitivity is 62% and specificity is 100%. |
|
Sensitivity |
93.1% |
|
Specificity |
100% |
|
Phase of development |
CE/IVD |
|
Proposed release |
CE/IVD |
|
Date |
Feb. 2020 |
|
Country of development |
China |
|
Type of Serological Test |
Not listed |
|
Authors/Company |
|
|
Description |
The company provides two tests the 2019-nCoV IgG , and 2019-nCoV IgM tests. The test is a chemiluminescent immunoassay (CLIA). It has been clinically tested in China, though the exact specificity and sensitivity was not stated. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
CE/IVD approved |
|
Proposed release |
available for purchase by research labs/healthcare providers, CE/IVD approved |
|
Date |
Feb. 19, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
They offer, 1. Wantai SARS-CoV-2 Ab Rapid Test Kit, 2. Wantai SARS-CoV-2 IgM ELISA kit, and 3. Wantai SARS-CoV-2 Ab ELISA kit. The kits do not state which antigens are used as targets. 93.1% sensitivity and 100% specificity. |
|
Sensitivity |
93.1% |
|
Specificity |
100% |
|
Phase of development |
Approved for Research use only, unclear if available in the US |
|
Proposed release |
Released in China |
|
Date |
Feb. 25, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
This company provides 2 tests, the iFlash-SARS-CoV-2-IgG and the iFlash-SARS-CoV-2-IgM, which test for patient antibodies to the virus. The target antigen is not specified. The sensitivity of the IgG assay is over 90%, and specificity is over 95%. For the IgM test, the sensitivity and specificity are both over 95%, based on assaying over 1200 Chinese patient samples. |
|
Sensitivity |
90% (IgG) and 95% (IgM) |
|
Specificity |
95% (IgG) and 95% (IgM) |
|
Phase of development |
CE/IVD approved |
|
Proposed release |
available for purchase by research labs/healthcare providers, CE/IVD approved |
|
Date |
Feb. 27, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
RDT (colloidal gold lateral flow assay) |
|
Authors/Company |
|
|
Description |
The SARS-Cov-2 Antibody Test strip tests for patient IgG and IgM. The press release did not disclose sensitivity or specificity of the test. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
CE/IVD approved |
|
Proposed release |
available for purchase by research labs/healthcare providers, CE/IVD approved |
|
Date |
March 12, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
RDT (colloidal gold lateral flow assay) |
|
Authors/Company |
|
|
Description |
The SARS-CoV-2 IgG/IgM kit tests for patient antibodies to the virus from blood or plasma samples. There is no reported sensitivity or specificity. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Only approved for in vitro diagnostic use |
|
Proposed release |
available for purchase by research labs/healthcare providers |
|
Date |
Date not given |
|
Country of development |
The Republic of Korea |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
GenBody FIA COVID-19 IgM/IgG (COVI025) |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Research use only, CE/IVD in EU |
|
Proposed release |
CE/IVD in the EU |
|
Date |
March 2, 2020 |
|
Country of development |
United Kingdom |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
Seems to be an RDT (probably to IgM and IgG). No description was given, other than they received 1 million pounds investment from the UK government. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
They are validating now with Liverpool Trop Med and St. Georges, London |
|
Proposed release |
Date not given |
|
Date |
March 29, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
RDT, lateral flow assay, which detects IgM and IgG to the nucelocapside protein of SARS-CoV-2. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Research use only, CE/IVD approved |
|
Proposed release |
available for purchase by research labs/healthcare providers |
|
Date |
Date not given |
|
Country of development |
USA |
|
Type of Serological Test |
Not stated, seems to be ELISA |
|
Authors/Company |
|
|
Description |
Emory University has developed a serological test for COVID-19. Details of the test, such as method, target antigen, and antibody type are not listed. The Clinical Immunology section of Emory Medical Laboratories (EML) plans to begin testing 300 people per day, scaling up to 5000 tests per day by June. They state that it will take one vial of blood. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Research use only, approved under FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 Section IV.A |
|
Proposed release |
April 2020 |
|
Date |
April 13, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
This RDT detects IgM and IgG, though the target antigen is unclear. Sensitivity appears to be 93.8%, and sensitivity is 99.1%, in 704 samples tested. The location of the trial was not disclosed. |
|
Sensitivity |
93.1% |
|
Specificity |
99.1% |
|
Phase of development |
Research use only, not approved by the FDA |
|
Proposed release |
Available for purchase by research labs/healthcare providers |
|
Date |
April 15, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
Chemiluminescent microparticle immunoassay (CMIA) |
|
Authors/Company |
|
|
Description |
This test detects IgG by measuring antibody-antigen binding in terms of relative light units (RLU). It is intended to be used with the ARCHITECT i1000SR and i2000SR systems. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Received EUA by the FDA |
|
Proposed release |
Current |
|
Date |
April 26, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
ELISA (not stated) |
|
Authors/Company |
|
|
Description |
This tests detects antibodies, including IgG, to SARS-CoV-2 using the cobas e analysers. The sensitivity and specificity have not yet been disclosed. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Not approved by the FDA, applying for EUA |
|
Proposed release |
Mid-May in countries accepting the CE mark |
|
Date |
April 17, 2020 |
|
Country of development |
UK |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
The authors developed an in-house ELISA, with recombinant SARS-CoV-2 trimeric spike protein. They were testing for IgM and IgG, against RT-qPCR. They found, in 31 samples, there was 100% sensitivity for IgG after 10 days post symptom onset. |
|
Sensitivity |
100% |
|
Specificity |
|
|
Phase of development |
Research use only |
|
Proposed release |
Not stated |
|
Date |
April 20 2020 |
|
Country of development |
US |
|
Type of Serological Test |
Capture chemiluminescence immunoassay. |
|
Authors/Company |
|
|
Description |
The Diazyme DZ-Lite SARS-CoV-2 IgG and SARS-CoV-2 IgM CLIA test kits test for IgG and IgM, respectively. The assay has a chemiluminescence readout, and must be read on Diazyme DZ-Lite 3000 Plus chemiluminescence analyzers. When IgG and IgM results are used together, the sensitivity is 90-95.6% and specificity is 96.5%. |
|
Sensitivity |
91.2% (IgG) and 78.7% (IgM) |
|
Specificity |
97.3% (IgG) and 97.5% (IgM) |
|
Phase of development |
Available for purchase by healthcare/research professionals. Not approved by the FDA. Under section IV.D |
|
Proposed release |
Current |
|
Date |
April 21, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
The Abcam Novel Coronavirus IgM Antibody Detection Kit detects IgM specific to the SARS-CoV-2 nucleocapsid protein. Their Novel Coronavirus IgG Antibody detects IgG specific to the nucleocapsid protein as well. Specificity and sensitivity are not stated. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Available for purchase by healthcare/research professionals. Not approved by the FDA. Under section IV.D |
|
Proposed release |
Current |
|
Date |
April 21, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
Not stated |
|
Authors/Company |
|
|
Description |
This test can test for IgG or IgM to SARS-CoV-2, and was developed in-house. The assay specificity and sensitivity were not stated. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Research use only. Not yet authorized by the FDA, but in th EUA application process |
|
Proposed release |
Current |
|
Date |
April 24, 2020 |
|
Country of development |
Canada |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
This test is an RDT that detects IgG and IgM to SARS-2-CoV. The target antigen is not stated. The sensitivity is 93.4% and the specificity is 97.7%, in testing over 180 positive samples and over 500 negative samples. The kit was also recently used in a study (https://www.medrxiv.org/content/10.1101/2020.04.22.20075564v1.full.pdf) on IgM and IgG antibodies in COVID-19 patients. After 2 weeks, IgM was detected 95.8% in positive cases, and IgG was detected in 62.5% of cases. |
|
Sensitivity |
93.4% |
|
Specificity |
97.7% |
|
Phase of development |
Not FDA authorized (subsection IV.D). For research use only |
|
Proposed release |
Current |
|
Date |
April 27, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
Chemiluminescent immunoassay |
|
Authors/Company |
|
|
Description |
The BioCheck MS-FAST system and SARS-CoV-2 chemiluminescence-based tests can process blood, serum, or plasma samples in 30 minutes to detect IgM and IgG antibodies. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Applying for FDA EUA |
|
Proposed release |
Available for purchase by research labs/healthcare providers, but not for diagnostic use |
|
Date |
April 15, 2020 |
|
Country of development |
Germany |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
The Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect both early and late marker IgG/IgM antibodies in human finger-prick blood samples. |
|
Sensitivity |
99.9% IgM and 91.8% IgM |
|
Specificity |
99.5% IgG and 99.2% IgM |
|
Phase of development |
CE approved |
|
Proposed release |
Available for purchase by research labs/healthcare providers, CE approved |
|
Date |
|
|
Country of development |
US |
|
Type of Serological Test |
Chemiluminescent immunoassay |
|
Authors/Company |
|
|
Description |
The primary chemiluminescent assay is to detect IgG against SARS-CoV-2. The company has reported that 440 samples can run per hour, per analyzer, using the Atellica platform. |
|
Sensitivity |
93.2% |
|
Specificity |
100% |
|
Phase of development |
Not FDA approved, in development |
|
Proposed release |
In development, though the company has stated that they plan to provide tests to the Austin, TX area healthcare workers and retailers, as well as researchers, first. |
|
Date |
April 30, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
Protein microarray |
|
Authors/Company |
|
|
Description |
This group worked to improve upon ELISA based methods with a protein microarray that allows for multiplexing (pooling) of samples. Dried blood spots were found to be usable for this type of test. For the study, they had 158 positive samples and 1418 negative. Overall sensitivity was varied, and sensitivity/specificity reported here is reflective of when all antigens and all antibodies were combined. There was no cross-reactivity to antibodies to other coronaviruses. |
|
Sensitivity |
98.1% |
|
Specificity |
98.6% |
|
Phase of development |
Research use only |
|
Proposed release |
Not stated |
|
Date |
May 5, 2020 |
Tests that are still in development
|
Country of development |
US |
|
Type of Serological Test |
CRISPR-based lateral flow assay |
|
Authors/Company |
|
|
Description |
Using a CRISPR-Cas12 based method, they can specifically detect virus RNA for the E and N genes. This is called the DETECTR assay, and does not assay for patient antibodies, but the presence of viral RNA. The CRISPR-Cas12 RNA targeting is followed by isothermal amplification of the target, resulting in a visual readout with a fluorophore.This was 90% sensitive and 100% specific. |
|
Sensitivity |
90% |
|
Specificity |
100% |
|
Phase of development |
Pre-clinical |
|
Proposed release |
In development |
|
Date |
March 10, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
Not stated |
|
Authors/Company |
|
|
Description |
They are now beginning testing in specific populations, 1) people who have not been diagnosed but live in a COVID-19 hotspot, 2) a later national survey, and 3) populations like healthcare workers. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Clinical |
|
Proposed release |
Not given |
|
Date |
April 4, 2020 |
|
Country of developmentU |
US |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
An ELISA based method using recombinant receptor binding domain (RBD) regions of the spike protein or the full length spike protein. COVID-19 patient sera was most reactive to the full length spike protein, while non-COVID-19 patient sera did not react to either protein above background |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Pre-clinical |
|
Proposed release |
Not stated |
|
Date |
March 18, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
Proprietary |
|
Authors/Company |
|
|
Description |
This kit is being tested in a small community in Colorado, in partnership with the Public Health Department of San Miguel County, to test all residents for a SARS-Cov-2 antibody. The assay is testing for antibodies to recombinant fragments of the S, N, and M proteins. So far, the test has 100% sensitivity and specificity after day 10 of symptoms, according to their website. This has not been approved by the FDA. They also state that "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" |
|
Sensitivity |
100% |
|
Specificity |
100% |
|
Phase of development |
In testing in San Miguel, CO |
|
Proposed release |
Ongoing trials in Colorado, no stated release date |
|
Date |
March 19, 2020 |
|
Country of development |
Netherlands |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
Modifying existing beta version ELISA kits (EUROIMMUN Medizinische Labordiagnostika AG) for IgG or IgA, and an in-house ELISA kit, they coated plates with recombinant S1 domain of the spike protein. The commercially available kits are not yet approved for use. They found that the kits were sensitive and specific for the S1 region of SARS-CoV-2, looking at 45 samples overall. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Pre-clinical |
|
Proposed release |
Not stated |
|
Date |
March 20, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
RDT |
|
Authors/Company |
Jiangsu bioPerfectus technologies |
|
Description |
This company has two tests, the PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit and the PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit. The IgM/IgG test assays for patient antibodies to the virus from a blood sample, while the Ag Rapid test assays for SARS-CoV-2 antigen from nasal swab samples. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Developed, awaiting approval |
|
Proposed release |
Appears available for purchase by research labs/healthcare providers in China, but no clear approvals |
|
Date |
March 3, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
RDT |
|
Authors/Company |
|
|
Description |
The SARS-CoV-2 IgM/IgG Antibody test kit uses blood or plasma samples to detect patient antibodies. There is no listed sensitivity or specificity |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
No clear approvals |
|
Proposed release |
available for purchase by research labs/healthcare providers, but no clear CE or FDA approvals |
|
Date |
Date not given |
|
Country of development |
Belgium |
|
Type of Serological Test |
Dipstick (lateral flow assay) |
|
Authors/Company |
|
|
Description |
This lateral flow assay detects SARS-CoV-2 antigen in nasal mucus samples. The sensitivity was approximately 60% when tested in two different hospitals. |
|
Sensitivity |
60% |
|
Specificity |
99% |
|
Phase of development |
Clinically testing |
|
Proposed release |
available for purchase by research labs/healthcare providers, does not appear to have any approvals |
|
Date |
March 24, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
It appears that Vitalant (a blood donation company) and UCSF have teamed up to make an in-house antibody test for SARS-CoV-2. It is an ELISA based assay, though they have not disclosed which antibodies are detected. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
In development |
|
Proposed release |
Date not given |
|
Date |
March 31, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
Klein lab, JHSPH |
|
Description |
They have adapted an ELISA, based on Amanat et al 2020, that tests for IgG and IgM to the full length Spike protien and to the receptor binding domain (RBD). They are now working to get a mucosal IgA ELISA working. So far, they are using the kit to test samples from Johns Hopkins Hospital. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Pre-clinical |
|
Proposed release |
Not given, but being used for research use |
|
Date |
April 6, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
This group developed an in-house ELISA testing for patient antibodies (IgM and IgG) to the SARSr-CoV Rp3 nucleocapside (N) protein. They found that on day 5, 81% of patients were positive for IgM and 100% were positive for IgG (of 16 COVID-19 positive patients). |
|
Sensitivity |
81% (IgM) and 100% (IgG) |
|
Specificity |
|
|
Phase of development |
Pre-clinical |
|
Proposed release |
Not given |
|
Date |
February 17, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
Chemiluminescence immunoassay |
|
Authors/Company |
|
|
Description |
Using a fully automated chemiluminescent assay on a YHLO Biotech analyzer, Qian and colleagues processed the serum of patients with or without COVID-19 at 10 hospitals. They tested for IgM and IgG to the nucleocapsid and spike proteins (both recombinant). Clinical sensitivity (in over 500 samples) of IgM was 85.88% and to IgG 96.62%, relative to rRT-qPCR. They used over 900 samples from patients with diseases other than COVID-19, as well as over 500 non-hospitalized (healthy) patient samples to determine specificity. They found the test to be 97.33% for hospitalized patients. |
|
Sensitivity |
85.6% (IgM) and 96.62% (IgG) |
|
Specificity |
99.49% (IgM) and 99.1% (IgG) |
|
Phase of development |
Pre-clinical development |
|
Proposed release |
Not stated |
|
Date |
April 21, 2020 |
|
Country of development |
China |
|
Type of Serological Test |
Chemiluminescent immunoassay |
|
Authors/Company |
|
|
Description |
This lab based chemiluminescent assay detects IgM, IgG, and IgA (all serum) against the SARS-CoV-2 nucleocapsid and spike receptor binding domains. Using samples from 87 positive patients, they found that sensitivity was improved when using the RBD rather than the N protein. RBD based test results were used for sensitivity and specificity. |
|
Sensitivity |
98.6% (IgA), 96.8% (IgM), and 96·8% (IgG) |
|
Specificity |
98.1% (IgA), 92.3% (IgM), and 99·8% (IgG). |
|
Phase of development |
Pre-clinical |
|
Proposed release |
Not stated |
|
Date |
April 22, 2020 |
|
Country of development |
USA |
|
Type of Serological Test |
Microfluidic ELISA |
|
Authors/Company |
|
|
Description |
This startup, based out of the University of Michigan, has a microfluidic chip that allows rapid ELISA assays. The chip can utilize a variety of reagents, so companies that have developed target viral antigens and anti-IgM or IgG antibodies could adapt their assay for use on this chip. The test only takes 15 minutes, and requires a few drops of blood. Sensitivity and specificity were not listed, but will likely depend on the reagents used. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Pre-clinical |
|
Proposed release |
Not stated |
|
Date |
April 26, 2020 |
|
Country of development |
Hong Kong/US |
|
Type of Serological Test |
ELISA, micro-neutralisation (MN) and plaque reduction neutralisation tests (PRNT) |
|
Authors/Company |
|
|
Description |
Perera and colleagues sought to create a sensitive ELISA, matched with a novel microneutralization assay. They also performed plaque reduction neutralization assays. The MN assay has the advantage of higher throughput, though results take 4 days. The MN and PRNT assays had significant agreement, validating the MN assay. This shows not only antibody titers, but the neutralizing capability. Several sensitivities were recorded at different time points during the assay. The sensitivities listed here are from 11-18 days post symptom onset, from 14 samples. |
|
Sensitivity |
92.8% (IgM) and 71.4% (IgG) measured by ELISA; 64% were positive in the MN assay; 92.8% were positive in the PRNT assay |
|
Specificity |
100% in MN assay |
|
Phase of development |
Pre-clinical |
|
Proposed release |
Not listed |
|
Date |
April 23, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
ELISA |
|
Authors/Company |
|
|
Description |
This group sought to improve ELISA based methods by using dried blood spots, rather than serum samples from venipuncture, for detection of antibodies to SARS-CoV-2. The receptor binding domain of the spike protein was used as a target. They found that both blood spiked with viral antigen, as well as with 9 PCR-positive patient samples, there was a significant signal difference relative to negative samples. |
|
Sensitivity |
|
|
Specificity |
|
|
Phase of development |
Preclinical |
|
Proposed release |
Not stated |
|
Date |
May 5, 2020 |
|
Country of development |
US |
|
Type of Serological Test |
Single molecule array (Simoa) |
|
Authors/Company |
|
|
Description |
This group used single molecule array assay to measure total antibodies to SARS-CoV-2. The Simoa protocol has shown, in other cases, 1000-fold improvement in sensitivity over standard ELISA, and it allows analysis of multiple types of antibodies and antigens at once. The target antigens are Spike Protein, S1 subunit, Receptor Binding Domain (RBD), and Nucleocapsid protein. |
|
Sensitivity |
First week of infection, 86%; second week of infection and onward, 100% |
|
Specificity |
100% |
|
Phase of development |
Preclinical |
|
Proposed release |
Not stated |
|
Date |
May 5, 2020 |
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