- Roughly 175 companies are making tests that can tell if people had the novel coronavirus.
- Called antibody or "serology" tests, they look for antibodies the body produces to fight off infection.
- We identified the top 20 tests from data filed with the US Food and Drug Administration.
- Visit Business Insider's homepage for more stories.
Roughly 175 companies are creating tests that aim to tell people if they've been exposed to the novel coronavirus.
Unlike tests that detect the virus itself, these kits are supposed to identify past exposure to it by looking for antibodies the body made during its immune response. Generally, antibodies stick around for weeks, months, or sometimes years after infections — and they often confer some level of immunity to the disease in question.
It's not yet understood how long and how well antibodies might protect a person from contracting COVID-19, the disease caused by the coronavirus, but they're best detected after two weeks since the onset of symptoms, according to filings with the US Food and Drug Administration reviewed by Business Insider.
Read more: A new tool in fighting the coronavirus pandemic just got one step closer to approval. Here's how 9 leading drugmakers are racing to develop antibody treatments.
The costs of antibody tests currently available to consumers ranges widely, from free (through some medical insurance policies or population surveys) to more than $150. Primary care physicians can order antibody tests for patients. You can also find them through local government programs or request them from Quest and LabCorp.
Read more: There are 8 coronavirus tests you can use from home. Here's how they work and where to order one.
The following list includes companies that have emergency authorization from the FDA, ranked by test sensitivity, or ability to detect true positives, though separate scores pertaining to specificity, or ability to detect true negatives, are also included. The scores are based on the companies' internal studies that were reported to the FDA.
This story was first published on April 28, 2020. It has been updated with new information about available tests.
University of Arizona Genetics Core for Clinical Services – 97.5%
The University of Arizona has a test for IgG antibodies that found 39 out of 40 positive samples for a "positive agreement" of 97.5%, and 317 out of 320 negative samples for a "negative agreement" of 99.06%, according to data filed with the FDA.
Those samples were tested more than two weeks after the donors' symptoms started.
DiaSorin – 97.56%
DiaSorin, a testing company based in Italy, got emergency approval on April 24.
Its test has 97.4% sensitivity after 15 days since symptom onset, according to a report released by the company. The specificity is 98.5%, as the test identified 985 out of 1,000 coronavirus-negative samples from blood donors.
In the FDA's data, however, the test's scores were slightly better, finding 40 out 41 coronavirus-positive samples (97.56%) and 1,082 out of 1,090 negative samples (99.3%).
In April, DiaSorin said it was scaling up production capacity to manufacture several million antibody tests over the next few months. It has a contract with federal health wings aimed at making the test available in the US.
Sensitivity and positive agreement are basically the same measurement, with a nuance in how researchers determine the real coronavirus cases among the samples. The same goes for specificity and negative agreement.
InBios International – 97.8%
Authorized for emergency use on June 10, InBio's kit, which detects IgG antibodies, is 97.8% sensitive and 98.9% specific, according to the company.
Healthcare providers can visit InBios' site to ask for tests.
Vibrant America Clinical Labs – 98.11%
Vibrant America's test works with dried blood spots or serum derived from fingerstick collection by a healthcare provider. It was temporarily approved on June 4.
The company's studies found the test correctly identified 98.11% of IgG and IgM coronavirus antibodies in both serum and blood spots. Among 501 negative serum samples, the test spotted 494, for a negative agreement of 98.6%. For blood spots, the negative score was similar.
Providers can order Vibrant America's test directly from its website for $119, but it can only be performed in laboratories that meet requirements for high-complexity diagnostics.
Beckman Coulter – 98.3%
Beckman Coulter, a subsidiary of healthcare giant Danaher, has a new test that just looks for the earlier IgM antibodies. In a study, it showed 98.3% positive agreement and 99.9% negative agreement between 15 and 30 days after the onset of symptoms, per FDA data.
A second test, authorized in the summer, looks for the later IgG antibodies. That one found 96.8% of positive cases and 99.6% of negative cases more than two weeks after symptoms in a company study.
Access Bio – 98.44%
Access Bio, a New Jersey-based test maker, got the FDA's clearance to sell its antibody kit on July 24. It requires blood draws and displays results on a small, plastic device after 10 minutes.
In a study conducted by the company, the test found 98.44% of positive samples and 98.9% of negative samples containing either IgM and IgG antibodies.
The test is being distributed by other names through companies like Truvian Sciences, a healthcare company in San Diego, and BTNX, a test maker in Canada, per the FDA.
BioCheck – 99.1%
Cleared on September 9, BioCheck's test spots IgM and IgG from serum samples. It found 99.1% of positive samples and 100% of negative samples in a study shared with the FDA.
The San Francisco-based test-maker is working with Accelerate Diagnostics to market and distribute the coronavirus kit, the companies said.
Xiamen Biotime Biotechnology Co. – 100%
A blood test, Biotime's kit uses cartridges, absorbent paper, and other materials to detect IgM and IgG antibodies. After 10 minutes, the company says it displays results with red lines indicating previous coronavirus infection.
The test has been studied several times now. One by the National Cancer Institute said it had combined scores of 100% sensitivity and 96.2% specificity for both kinds of antibodies. It got emergency approval from the FDA on July 24.
Diazyme Laboratories – 100%
Diazyme's test uses serum and plasma samples to look for IgG antibodies. In a total of 77 samples from 51 patients, it was 100% sensitive after 14 days since their symptoms started, per the FDA. It found 830 out of 852 negative samples for 97.4% specificity.
The California-based test- and device-maker got the FDA's temporary approval on July 8. Providers can find the distributor here, but the test is only available in labs with Diazyme's testing equipment.
Emory Medical Laboratories – 100%
Atlanta's Emory University test for IgG antibodies found 30 out of 30 coronavirus-positive samples after 14 days since their donors' symptom onsets, FDA data show; for negative samples, it missed just 9 out of 388 for a negative agreement score of 97.68%.
Emory said it's being used to help determine whether blood plasma from coronavirus survivors can provide immunity to others.
Testing is limited to Emory's laboratories, the FDA said in a filing.
Biocan Diagnostics – 100%
Biocan, a diagnostics company in Canada, has a speedy antibody kit resembling a pregnancy test. In healthcare settings, it gives people results in about 15 minutes.
The test is 100% sensitive and 99.4% specific, per FDA data.
Hangzhou Laihe Biotech – 100%
Laihe Biotech's test for IgM and IgG antibodies found 100% of positive samples and 99.43% of negative samples, according to a filing with the FDA.
The testing company is based in China and sells its antibody kits through distributors ChemVest and Hangzhou Didibaby Biotech, the company said in a recent announcement.
Roche Diagnostics – 100%
Roche, a biotech giant, launched its antibody test in April and got emergency authorization from the FDA on May 2.
In the company's study, the test was found to be 100% sensitive for 29 samples taken more than 13 days since donors were diagnosed with coronavirus. Among 5,272 negative samples, Roche's test only missed 10, according to the report.
Abbott Laboratories – 100%
Abbott says its test is 100% sensitive. In the company's study, it found 88 out of 88 coronavirus samples from people who developed symptoms more than 13 days prior to collection, according to the FDA. The test also scores high marks (99%) for specificity.
An independent study published on May 7 found Abbott's to be 100% sensitive after 16 days from the onset of symptoms and 99.9% specific.
Siemens Healthineers – 100%
Siemens Healthineers has an antibody test that looks for both IgM and IgG antibodies with 100% sensitivity and 99.8% specificity, according to the company.
The Germany-based healthcare giant's test is compatible with various systems, including the Antellica, Advia, Dimension Vista, and Dimension EXL.
On the Atellica, for example, it found 42 out of 42 positive coronavirus samples collected after 13 days since their donors developed symptoms, according to data filed with the FDA. For negative samples, the test identified 99.82% of more than 1,000.
Siemens' test performed similarly on the other test-processors, FDA data show.
Another test by Siemens just looks for the IgG antibodies, but can also quantify or count them to show researchers how immune responses change overtime. On one machine, it found 100% of the positives and 99.89% of the negatives in a study shared with the FDA.
NanoEntek America – 100%
NanoEntek's test is the size of a credit card and fits into a small container for analysis. Combining data from a few studies posted with the FDA, the test found 100% of the positive samples after 7 days since symptom onset, plus all of the negative samples.
Thermo Fisher Scientific
Thermo Fisher, a $184.44 billion device maker, has a test that found 100% of positive samples more than two weeks out from symptoms, as well as all the negatives. It was authorized by the FDA on October 9.
Babson Diagnostics – 100%
Babson's test found 29 out of 29 coronavirus-positive samples after 14 days since their donors' symptom onset, according to the FDA; its negative percent agreement was also 100%.
Babson, a startup based in Austin, Texas, specializes in diagnostic testing and works with healthcare giants Siemens Healthineers and Becton Dickinson. Its antibody testing is limited to Babson's lab in the city.
Companies near Austin can hire the company to test their employees for antibodies, though it offers free kits to grocery, healthcare, and social service workers, according to Babson's site.
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