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.
1. InBios Smart Detect SARS-CoV-2 rRT-PCR Kit
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.
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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
2. Gnomegen COVID-19 RT-Digital PCR Detection Kit
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
3. CO-DIAGNOSTICS INC. Logix Smart Coronavirus 2019 (COVID-19) Kit
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
4. ScienCell SARS-CoV-2 Coronavirus Detection Kit
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
5. Luminex ARIES SARS-CoV-2 Assay
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
6. Luminex NxTAG® CoV Extended Panel
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
7. BD BioGX SARS-CoV-2 Reagents for the BD MAX™ System
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
8. BD SARS-CoV-2 Reagents for the BD MAX™ System
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
9. Ipsum Diagnostics COV-19 IDx Assay
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
10. Cellex qSARS-CoV-2 IgG/IgM Rapid Test
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
11. QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel
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
Source: HIT Consultant