What You Should Know:
– In-depth look list of FDA-approved COVID-19 test kits
The U.S. Food and Drug Administration (FDA) offers emergency use authorizations (EUAs) for unapproved products or new uses for approved items in urgent situations where no suitable alternatives exist. Dozens of companies have sought and received EUAs for their testing kits that screen for SARS-CoV-2 — more commonly referred to as COVID-19 or the novel coronavirus.
The FDA makes a distinction between approved”products and those that got EUAs. It cautions that EUA is not the same as an FDA-cleared or FDA product. However, many media sources — and some distributors and manufacturers of these tests — use the word “approval” or “approved” to discuss FDA testing products that received EUAs.
Here are the currently available commercial COVID-19 tests.
Type of Test: A real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test. Results are obtained in approximately four hours following nasal and nasopharyngeal swabs.
Availability: The FDA gave EUA designation on April 7. The product currently appears on the manufacturer’s website, but people must make inquires about purchasing.
Cost: Not listed
Type of Test: A real-time reverse transcription-polymerase chain reaction (RT-digital PCR) in vitro test.
Availability: The FDA granted an EUA on April 6. The FDA’s product documentation about this test lists a sales email and phone number, but does not provide further information about whether health care providers can order these tests now.
Cost: Not specified
Type of Test: A real-time in vitro RT-PCR test for upper and lower respiratory tract specimens or patient serum.
Availability: Only offered to labs certified to perform high-complexity tests. The company will also sell to laboratories located outside the U.S that have similar qualifications.
Cost: Provided to people who request quotes on the product’s website
Type of Test: A real-time quantitative reverse transcriptase-polymerase chain reaction (RT-qPCR) test to detect SARS-CoV-2 coronavirus in respiratory specimens or patient serum
Availability: Currently in stock for health care providers to order online
Cost: $250.00 plus shipping
Type of Test: This is a moderate-complexity, sample-to-answer rapid diagnostic test to detect SARS-CoV-2 in nasopharyngeal swabs. Lab personnel gets results in approximately two hours.
Availability: Available for qualified medical professionals to order now
Cost: Given after people submit quote requests on the company’s website
Type of Test: This option, which works on Luminex’s MAGPIX® system, allows running a standalone test to detect SARS-CoV-2, or also detect 20 other common respiratory pathogens. The SARS-CoV-2 test occurs using three viral genes (ORF1ab, E gene and N gene).
Availability: Offered now on the Luminex website
Cost: Not provided before users submit order quotes
Type of Test: A real-time RT-PCR test to qualitatively detect nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal patient swabs
Availability: Only provided to laboratories certified to perform moderate and high-complexity tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a.
Cost: Not specified
Type of Test: This is a real-time RT-PCR test for the qualitative detection of nucleic acid associated with SARS-CoV-2. Interested persons should refer to https://www.bd.com/ for further information on this test as it becomes available. The FDA approved this option through EUA on April 8, making it the most recent addition at the time of this writing.
Availability: Only provided to labs certified to perform moderate to high-complexity tests
Cost: Not provided
Type of Test: An in vitro test that detects COVID-19 in nasopharyngeal and oropharyngeal swabs. This is a high-capacity test that gives results in 24 hours. It also allows testing up to 5,000 specimens per day on a single instrument.
Availability: Only available to labs designated by Ipsum Diagnostics that are also certified to carry out high-complexity tests. The company is currently sharing its testing methodology with laboratories throughout the U.S.
Cost: Not specified
Type of Test: A lateral flow chromatographic immunoassay to detect the presence of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies. This is the first test of its kind that the FDA approved under its EUA designation. It confirms the presence of antibodies in blood samples taken from a patient within 15-20 minutes.
Availability: Only sold to laboratories certified for high or moderate-complexity tests
Cost: Not mentioned
Type of Test: A real-time PCR test to detect nucleic acid in nasopharyngeal swab samples. The panel detects and differentiates 21 viral and bacterial respiratory targets, including COVID-19. Comprehensive, qualitative results come back in about an hour, making this a rapid diagnostic test.
Availability: Only sold to facilities certified to carry out high and moderate-complexity tests
Cost: Given to customers who make inquiries
Type of Test: A rapid, automated in vitro real-time RT-PCR test that gives results in about 80 minutes
Availability: The FDA granted EUA status to this test on March 30. NeuMoDx Molecular™ will also provide access to research-use-only (RUO) tests in countries outside the U.S. where permission exists.
Cost: Available from the company upon request
Type of Test: This test relies on molecular testing that targets the RNA-dependent RNA polymerase (RdRp) gene associated with SARS-CoV-2. This option supports near-patient testing through direct throat, nasal, nasopharyngeal, oropharyngeal and viral transport media (VTM) swabs. Health care providers get results in under 15 minutes, making this an option for laboratories interested in using ultra-efficient FDA testing supplies.
Availability: Only sold to purchasers in the U.S.
Cost: Not specified until interested parties contact the company’s sales department
Type of Test: This is a TaqMan RT- PCR test targeting the ORF1ab gene. It is a highly sensitive option that provides results from throat swabs and bronchoalveolar lavage fluid within three hours.
Availability: Only offered to lab facilities that have high-complexity test certification
Cost: People can receive price quotes within 24 hours after contacting a BCI Genomics representative via the company’s website or other methods.
Type of Test: This is a real-time RT-PCR test suitable for nasopharyngeal and oropharyngeal swab specimens. The FDA testing documentation specifies that only labs certified for high-complexity tests can use this kit.
Availability: Although the FDA gave EUA status to Avellino on March 25, a search on the company’s website did not generate specific product results for this test. Interested parties should contact the business directly to inquire about availability and ordering stipulations.
Cost: Not listed
Type of Test: This real-time RT-PCR test qualitatively detects nucleic acid associated with COVID-19 in oropharyngeal and nasopharyngeal swab samples from humans.
Availability: PerkinElmer will only distribute this test to U.S. labs certified to do high-complexity tests, or laboratories elsewhere with similar qualifications. A banner on the site clarifies that the company increased its production capacity for this item and can ship millions of these tests to buyers.
Cost: Not provided until people contact the company to inquire
Type of Test: A rapid diagnostic test using polymerase chain reaction (PCR) technology. This product detects SARS-CoV-2 in throat and nasal swabs and provides results in only 30 minutes. The testing device fits in the palm. It is for point-of-care settings, such as doctor’s offices and nursing homes.
Availability: Parties in the U.S can purchase this test through Sekisui Diagnostics. They must email firstname.lastname@example.org. People located elsewhere should contact Mesa Biotech directly for ordering assistance.
Cost: Neither company provided cost specifics in their publicly accessible content
Type of Test: This is a fully automated, sample-to-result assay designed to detect nucleic acid associated with SARS-CoV-2. It is a nested, multiplexed real-time RT-PCR option. The product is another rapid diagnostic test that provides in-house results in about an hour.
Availability: Only personnel from moderate to high-complexity-certified labs can purchase this test. Moreover, the company’s website states: “…Commercial availability under EUA is anticipated in April of 2020. We plan to allocate this limited supply to areas where it is most needed. If we are able to offer the BioFire® COVID-19 Test to your institution, your account representative will contact you.”
Cost: Not specified
Type of Test: This is an automated molecular test for the qualitative detection of the virus that causes the novel coronavirus. Laboratories must have Cepheid’s GeneXpert Dx or GeneXpert Infinity system to use this testing option. It offers compatibility with nasopharyngeal swabs and nasal wash/aspirate specimens collected in patient care settings. Results are available in approximately 45 minutes.
Availability: Laboratories that have moderate to high-complexity certifications in the U.S. (or an international equivalent) can use this test. The company said it intended to begin shipping the product at the end of March, and it did not provide more recent information to confirm if that happened.
Cost: The product information does not include pricing. However, there are dedicated contact pages for international and U.S. customers.
Type of Test: This is another real-time PCR rapid diagnostic test that only detects the COVID-19 rather than other respiratory viruses. Thus, it’s a highly specific solution. This product bears the CE (Conformité Européene) mark, and it is in vitro diagnostic (IVD) certified.
Availability: Despite this product having received EUA designation from the FDA on March 20, the official website for the product still says it’s for the European market. However, searching for the product’s name in Google revealed some U.S. distributors.
Cost: The product’s website requests that all interested parties inquire for pricing details. However, U.S. Biological Life Sciences is one of the distributors serving United States customers. It provides a list price of $1,507.
Type of Test: This is an automated qualitative nucleic acid multiplex assay intended to assess nasopharyngeal swabs collected in VTM. The near-patient option provides results in under two hours, and laboratory workers can process up to 96 tests in eight hours.
Availability: The press release linked in the previous section states that the company sells this test in the U.S, and 30 international markets. The same source indicated that the company can currently produce approximately 100,000 of these tests per month and is in the process of ramping up production levels further.
Cost: Available upon request
Type of Test: This test targets several regions of the SARS-CoV-2 genome, including the ORF1ab and S gene. Health care providers can gather samples for this test through nasopharyngeal swab specimens. The product brochure for this test indicates that it gives results in just over an hour.
Availability: The product documentation does not list the certifications that facilities must have to use this test. However, it does specify that only “authorized laboratories” can use it.
Cost: DiaSorin Molecular lists product numbers for this test and the necessary accessories. However, it does not include prices and asks that interested parties get in touch for more information.
Type of Test: This test relies on RT-PCR technology to recognize SARS-CoV-2 via the qualitative detection of nucleic acids. It is a dual-target assay for RdRp and N genes. Health care providers can carry out nasal, nasopharyngeal and oropharyngeal swabs when using this test.
Availability: Only laboratories certified to do high-complexity tests may use this product.
Cost: Not provided to people who aren’t currently registered in the Abbot system. However, there is add-to-cart functionality for this test and its required accessories. That suggests a person could purchase them without issues after logging in as a recognized customer.
Type of Test: This FDA-approved option under EUA is a qualitative real-time RT-PCR test. It uses a multitarget molecular approach to screening for COVID-19. Although the preferred swab specimen type is nasopharyngeal, providers can also take an oropharyngeal swab. Other options are to carry out both those swabs and collect them simultaneously or get an anterior nares specimen from the patient.
Availability: This test is for doctor’s offices and hospitals that have an existing relationship with QuestDiagnostics. After collecting a specimen, a health care provider must send it to the nearest Quest Diagnostics accessioning laboratory for processing or have it picked up by a QuestDiagnostics representative. Test results are generally available three to four days after the receipt of a sample, although the timeframe can vary due to demand.
Cost: Not specified
Type of Test: This is a real-time RT-PCR assay. It provides the in vitro qualitative detection of SARS-CoV-2 from viral RNA via a nasopharyngeal or oropharyngeal swab from a suspected coronavirus patient. Results come in less than 75 minutes after collection, making this a speedy FDA testing choice.
Availability: The company currently has this test and its supporting accessories in its catalog. It asks interested customers to submit an order request through a form on the website or contact their local Quidel distributor.
Cost: Not provided
Type of Test: This is an RT-PCR test that allows health care providers to take nasopharyngeal or oropharyngeal swabs in VTM, nasopharyngeal or oropharyngeal washes/aspirates, bronchial washings or bronchoalveolar lavage for specimens. Results get sent back to the provider in two to four days, provided the patient tests positive. LabCorp does not contact health care providers when the results are negative or inconclusive.
Availability: Only health care providers in the United States may order this test. They should collect the specimens on-site and ship them to LabCorp rather than sending a patient to a LabCorp testing facility. LabCorp’s current testing capacity is approximately 40,000 samples processed per day.
Cost: Not given
Type of Test: This is another real-time RT-PCR in vitro diagnostic test where health care providers take nasopharyngeal and oropharyngeal swabs from patients with suspected coronavirus symptoms.
Availability: This test is intended for laboratories certified to perform high-complexity tests, plus have the Panther Fusion® system for processing the specimens. Individual patient results arrive back in about three hours. Moreover, the Panther Fusion® device can handle up to 1,150 tests per day. Hologic is currently shipping this test to U.S labs. It expects to produce up to 600,000 per month.
Cost: Not mentioned
Type of Test: This RT-PCR test is a single high-throughput kit that got FDA approved for EUA on March 13 and received authorization for use in Europe on March 21. The kit enables testing at clinical and public health laboratories, and it has a testing capacity of up to 94 patient swabs with results given for all in under two hours. Health care providers can collect nasopharyngeal swabs, nasopharyngeal aspirate and bronchoalveolar lavage when carrying out this test.
Availability: The company will only sell this product to clinical laboratories currently testing for COVID-19. It does not accept orders from individual medical professionals. This product is now available as a listed product on the enterprise’s website.
Cost: Provided after someone submits a quote request
Type of Test: This is a real-time PCR test that can analyze samples from nasopharyngeal swabs, oropharyngeal swabs and sputum. It detects Orf1ab, N and E genes, as well as different strains of the SARS-CoV-2 virus. Results typically come back in less than two hours.
Availability: The company will sell this test to authorized laboratories in the United States, as well as international companies recognizing the CE mark. People who are interested in this FDA testing kit should contact the company directly via telephone or email.
Cost: Not given
Type of Test: This option is a single-well, dual-target assay for an enclosed, automated testing system. It specifically detects SARS-CoV-2, plus offers pan-sarbecovirus detection for the sarbecovirus subgenus family containing SARS-CoV-2. It targets the ORF-1a and E-gene regions of the SARS-CoV-2 genome.
Availability: Roche created this test for use with the cobas® 6800 System or cobas® 8800 System. It is currently selling this product to U.S. and international laboratories that have either of those machines.
Cost: Not mentioned
Type of Test: This is an RT-PCR test requiring health care providers to collect nasopharyngeal and oropharyngeal swabs and sputum samples from patients.
Availability: According to an article published on March 2, only two New York labs had the authorization to conduct this test — The New York State Department of Public Health Wadsworth Center and the Public Health Laboratories of the New York City Department of Health and Mental Hygiene. This FDA testing arrangement came about after the FDA allowed high-complexity-certified commercial, academic and government labs to develop and use SARS-CoV-2 tests
Cost: Not mentioned
Type of Test: This is a real-time RT-PCR test that detects SARS-CoV-2 in both upper and lower respiratory specimens.
Availability: Only provided to laboratories authorized to conduct high-complexity tests
Cost: No pricing information provided
FDA Testing Kits for Home Testing Not Yet Available
The list above includes all the FDA-approved kits under the EUA designation as of the morning of April 9. However, they are all only offered to health care providers and authorized lab personnel. Thus, if a medical professional encounters a patient who insists they took a COVID-19 test at home and got results, they should inform that individual that no such tests are on the market and FDA approved yet.
The FDA published a statement warning people about fraudulent test kits marketed for home use. The government body is aware of the problem and aggressively seeking and deterring the manufacturers and distributors of such products.
A Quickly Changing Situation
More tests for SARS-CoV-2 that earned FDA approval under EUA are arriving on the market by the day. Thus, if a healthcare professional needs to choose which ones to use or buy, they should repeatedly check the FDA’s list — linked in the introduction of this article — for the most up-to-date information about commercially available COVID-19 tests.