There are 8 tests for the novel coronavirus that you can take at home. They work by collecting samples from the nose or mouth. Then, they're shipped to laboratories, where a process called "nucleic acid amplification" finds the virus' genetic material. The hope of at-home testing is to get tests in the hands of people who might otherwise struggle to find tests; rural areas and ZIP codes with more people of color tend to have less testing sites per capita. They cost anywhere from $0 to $150, and some of the companies accept funds from health savings accounts. Visit Business Insider's homepage for more stories.
Among the hundreds of tests out there for the novel coronavirus, just a handful have received emergency authorization from the US Food and Drug Administration to ship them to people's homes. With at-home tests, people self-collect their samples and ship them back to the testing company for analysis. Many of the companies have their own labs and tests, or partner with other groups to run the samples, according to the FDA and Business Insider's reporting. Over the past few months states have started reopening and testing supplies have increased. Even so, coronavirus tests may still be hard to find for many, according to the Centers for Disease Control and Prevention. There's fewer testing sites in areas that are at least 75% people of color, and nearly two-thirds of rural counties have none at all, according to reporting by Axios and analysis by the nonprofit Surgo Foundation. At-home testing could make getting checked for coronavirus more accessible for those groups. They're also useful for people who feel sick and don't want to infect others, or are similarly afraid of getting infected by visiting a testing site or clinic. People seem to be taking these companies up on their at-home options. Testing company Everlywell has shipped nearly 75,000 coronavirus tests since March, according to a spokesperson. Fulgent Genetics, another testing group, said it's processing thousands of the tests per day. LabCorp, the first healthcare company to get the at-home kits authorized, has run more than 4 million diagnostic tests since March, though that number includes those carried out at testing locations as well, a spokesperson told BI. The at-home tests are similar in their sensitivity, or ability to detect coronavirus-positive samples, and specificity, or their ability to detect coronavirus-negative samples. To get tested, customers usually fill out some kind of questionnaire, get the testing kit, and ship it back for results. The price of the tests can range, with some tests costing as much as $150. Under the CARES Act, insurers have to provide coronavirus testing at no cost to members, but many of them are not doing so, healthcare executives told BI. Here are the eight emergency authorized coronavirus tests you can get at home. How at-home coronavirus tests work
Unlike antibody tests, which measure for the body's immune response to the virus, these "diagnostic," "viral," or "molecular" tests detect the actual presence of the virus itself and, by extension, infection or very recent infection. They're how doctors tell patients who visit the hospital whether they have coronavirus or not. The tests work by a process called "nucleic acid amplification." That's when laboratory machines detect the genetic material of the virus by "amplifying" or copying it, according to Dr. Bobbi Pritt, a director in Mayo Clinic's Department of Laboratory Medicine and Pathology. Diagnostic tests work with a variety of samples from the upper respiratory tract. The best ones to use, according to Pritt, are nasopharyngeal swabs, which go way back in people's nasal passages until they reach the upper part of the throat behind the nose, called the nasopharynx. Viral loads tend to be heaviest there, Pritt said. Sometimes the tests used for at-home programs were studied in part with nasopharyngeal or other samples prior to getting the FDA's go-ahead, but the kits themselves use nasal and spit samples. While not ideal, it's easier for people to swab the insides of their mouths and noses than the back of their nasal passage; and they work about nine times out of 10, Pritt, who's developed diagnostic tests for other conditions, told BI. LabCorp
Official name: COVID-19 RT-PCR Test Who makes the test: LabCorp makes the collection kit, and the test was developed in-house using devices and equipment from Roche, Thermo Fisher, and Integrated DNA Technologies, depending on how it's run, according to the FDA and a LabCorp spokesperson. Tests are carried out at the company's facilities. How it works: After a survey, LabCorp can file the cost of the test to people's insurance, or possibly cover it with federal funds, depending on eligibility, a spokesperson told BI. Then, the company sends a collection kit that includes a swab that's inserted into their noses to get samples, known as a nasal swab. The collection kits are sent via FedEx, and results are posted online. Accuracy: The test correctly identified 100% of 40 positive samples and 50 negative samples in an analysis posted with the FDA. Those results used nasopharyngeal swabs, compared to the nasal swab used in the at-home kit. Price: $0 upfront, according to the company. You can get one here. Rutgers University
The device's official name: Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay Who makes the test: The test was developed by a wing of Rutgers' genetics institute in partnership with testing companies Spectrum Solutions and Accurate Diagnostics, according to Rutgers. It uses a collection device made by Spectrum, and samples go to the Rutgers Clinical Genomics Laboratory in Piscataway, New Jersey, according to the FDA. The test requires parts from healthcare giants PerkinElmer and Thermo Fisher Scientific. How it works: When purchased from testing startup Vault Health, the doctor-ordered kits are sent to people's homes. Over Zoom, healthcare professionals supervise customers, who give the kits samples of their saliva. Results are posted within days after samples arrive at the lab. Other distributors, including testing companies ixLayer and Vitagene, also sell the test, according to Rutgers. Accuracy: The Rutgers test identified 100% of 60 positive and negative coronavirus samples when using swabs of saliva, according to data provided to BI by Rutgers. Price: $150 via Vault and $129 via Vitagene, though both allow you to pay via a health savings account or a flexible savings account. You can get one from Vault Health here and from Vitagene here. Everlywell
Official name: Everlywell COVID-19 Test Home Collection Kit Who makes the test: Everlywell produces the kits that customers use to take samples, as well as the platform that, among other things, displays the results, a spokesperson told BI. The kits are analyzed by labs like Fulgent Genetics and Assurance Scientific, which use different diagnostic tests, according to the FDA. How it works: Depending on the shipping method, customers get their testing kits overnight or within 3 days. They go through a screening process, self-collect a nasal swab, and return the package to a drop-off location, according to Everlywell. The labs process them within 2 days. Accuracy: Both tests by Fulgent and Assurance correctly identified 100% of coronavirus samples as positive or negative in the clinical evaluations they shared with the FDA. Price: $109, which can usually be paid for using money in HSAs and FSAs, the spokesperson said. Everlywell also provides customers with the information they need to file claims with insurers. You can get one here. Fulgent Therapeutics
Official name: Fulgent COVID-19 by RT-PCR Test Who makes the test: Fulgent Genetics, the parent company of Fulgent Therapeutics, makes the test and collection kit. It's also permitted to use another kit made by Everlywell. All samples are analyzed at Fulgent's laboratory in Temple City, California. How it works: Once folks complete an online screening, Fulgent's Picture Genetics mails them a kit. They ship back their nasal swabs in a pre-labeled box. Customers can see their results online and discuss them, if desired, with a medical professional virtually. Accuracy: Fulgent's test found 100% of negative and positive coronavirus samples taken with a variety of swabs, according to a company study on 94 specimens. Price: $119, with the option to file for reimbursement with health plans You can get one here. P23 Labs
Official name: P23 Labs TaqPath SARS-CoV-2 Assay Who makes the test: P23's test uses parts from Thermo Fisher Scientific and works with collection kits made by testing companies Everlywell and OraSure Technologies, according to the FDA and a P23 spokesperson. Samples are tested in its lab in Little Rock, Arkansas. How it works: Once a clinician orders the test, it's shipped to people's homes. They take samples of their saliva with help from a healthcare worker online. The lab posts people's results to a website. It's sold by a handful of companies, including digital health companies Azova and ADx Healthcare, the spokesperson told BI. Accuracy: The tests are 98% sensitive and 99% specific, according to the company. Price: Between $109 and $129, depending on the kit and seller, the spokesperson said. You can get one here. PrivaPath Diagnostics
Official name: LetsGetChecked Coronavirus (COVID-19) Test Who makes the test: PrivaPath, doing business as LetsGetChecked, makes the collection kit, but uses the molecular test made by Hologic, according to an FDA document and a spokesperson for the company. They're performed in PrivaPath labs. How it works: People fill out an online questionnaire, and doctors approve their requests. Testing packages include return labels, bags, nasal swabs, and a transport tube, according to the FDA. Once the lab gets the test, the company says that results are posted online within 24 hours. Throughout, users can track their symptoms with a mobile app. Accuracy: Hologic's test found 69 out of 69 positive samples and 109 out of 109 negative samples, according to the company's analysis on nasopharyngeal swabs. Price: $119, though folks can file claims for reimbursement with their health plans, and LetsGetChecked is offering a 20% discount. You can get one here. Phosphorus Diagnostics
Official name: Phosphorus COVID-19 RT-qPCR Test Who makes the test: Phosphorus uses a kit made by OraSure Technologies to collect samples from customers, according to a spokesperson for the company; they're run in a Phosphorus lab in Secaucus, New Jersey, with tests made in-house. How it works: People can order the tests online after completing a questionnaire, which is reviewed by a doctor within 24 hours, the spokesperson said. Tests are shipped after approval and work via saliva samples. Physicians can chat about people's results with telemedicine. Accuracy: 97.1% sensitive and 98.2% specific, according to the company Price: $140, though people can seek reimbursement from their health plans You can get one here. Kaiser Permanente Mid-Atlantic States
Official name: KPMAS COVID-19 Test Who makes the test: KPMAS, a health plan that's part of California-based Kaiser Permanente, makes the collection kit and runs the tests in a laboratory in Rockville, Maryland. The tests themselves, however, are made by Roche. How it works: KPMAS can send the kit to eligible members of the health plan, or have them pick it up, according to the FDA. It's used with supervision from a healthcare worker over video. People insert swabs into their noses to get samples, then place them in a tube, and ship it with FedEx. Results are posted to kp.org. Accuracy: Roche's PCR test found 100% of the 50 positive samples and 100% of the 100 negative samples tested in the company's evaluation using nasopharyngeal swabs, an FDA filing shows. Price: Unspecified, though Kaiser notes that testing is available at no cost to members. How to order: KPMAS kits have to be arranged by a provider.
More like this (3)
Saliva tests that can screen for coronavirus infections are gaining traction, with tens of thousands of...Saliva tests that can screen for coronavirus infections are gaining traction, with tens of thousands of people across the country using such tests daily.
Fluidigm, a small-cap diagnostics company, surged as much as 42% on Wednesday after the FDA granted...Fluidigm, a small-cap diagnostics company, surged as much as 42% on Wednesday after the FDA granted its COVID-19 saliva test emergency authorization. Fluidigm's COVID-19 saliva test allows patients to avoid the more invasive nasal swab that has primarily been used to detect COVID-19 in a patient. According to Fluidigm, its saliva-based COVID-19 test "demonstrated 100 percent agreement" between the saliva results from the assay and the results from paired nasal swab samples tested with authorized assays. Andrew Left of Citron Research tweeted that Fluidigm will "change COVID-19 testing forever," adding that its stock is poised to surge 314% from its Tuesday close to $35. Visit the Business Insider homepage for more stories. Fluidigm might be the company to finally offer an alternative to the painful nasal swabs used to test patients for COVID-19. On Wednesday, the California-based small-cap diagnostics company received FDA emergency authorization for its COVID-19 saliva test. The company demonstrated that 100% of its saliva-based tests matched the results of nasal swabs in a clinical study, according to a press release. Fluidigm said the saliva test for COVID-19 will be available for immediate shipment, and each diagnostic system used to analyze samples will have a capacity of up to 6,000 tests per day. The arrival of a new COVID-19 test that is minimally invasive and produces rapid test results has the potential to change the dynamic of the testing landscape in the US, which has been bogged down by delayed test results and unwillingness of some to get tested due to the invasive nature of the nasal swab. Read more: David Baron's fund has returned 400% to investors in the last decade using 20 stocks or less. He shared with us the 3 stocks he snapped up in 2020 - and the 3 travel and entertainment bets he loves going forward. One hedge fund manager that sees potential in Fluidigm is Andrew Left of Citron Research. In a tweet on Wednesday, Left said he thinks Fluidigm could surge 314% from Tuesday's close to $35 due to the FDA's emergency authorization decision. "Company [Fluidigm] will change COVID-19 testing forever as their saliva-based test Demonstrated 100 Percent Agreement with Nasopharyngeal Assays," Left said, adding that Fluidigm has a "real product and management" team. Shares of Fluidigm surged as much as 42% to $12.45 in Wednesday trades. Join the conversation about this story » NOW WATCH: Why electric planes haven't taken off yet
The program allows people in the Seattle area to easily take a coronavirus test at home....The program allows people in the Seattle area to easily take a coronavirus test at home. Researchers say such testing is essential for future monitoring of the virus.