It hasn’t been too long ago when the feared COVID-19 disease spread throughout the world— putting the entire population in turmoil. As each country tackles the current pandemic with its own strategies, medical professionals, scientists, and pharmaceutical companies have developed testing kits non-stop to counter the virus.
Since the call for testing kits requires immediate action, the U.S. Food and Drug Administration (FDA) has listed approved commercialized Coronavirus (COVID-19) Kits for the use of the public.
However, the FDA also has other initiatives, like the EUAs testing kits, that differ from the FDA approved products. Read on to learn more about these testing kits.
EUAs Vs. FDA Approved Products
Since many use the word "approval" when discussing test kit products, you should learn the difference between the EUAs from the FDA approved kits.
First off, the emergency use authorizations (EUAs) is the authority given to the FDA for products that are unapproved or are new. In this case, items that are considered as EUAs have the go signal for release and use if a situation calls for it.
On the other hand, FDA approved products are those that were cleared by the FDA thoroughly through the proper process. Thus the term "FDA approved"
Abbot ID NOW COVID-19 Assay
ID NOW COVID-19 Assay is a test heavily relying on molecular testing that targets the genes of the coronavirus, which is the RNA-dependent RNA polymerase. This kind of kit is a near-patient diagnostic test, wherein samples are taken from the throat, nasopharynx, and oropharynx. The results from this testing kit can be provided under 15 minutes, making it a rapid test.
Logix Smart Coronavirus 2019 (COVID-19) Kit
The testing kit from CO-DIAGNOSTICS INC. is a real-time in vitro RT-PCR test that uses the patented CoPrimer technology. This diagnostic kit is used for the qualitative detection of coronavirus RNA strands in the body.
In this case, the test comes from the patients that meet the clinical criteria. Those that show symptoms of the disease are asked for samples from one's lower respiratory tract and upper respiratory tract fluids.
Luminex ARIES SARS-CoV-2 Assay
The ARIES SARS-CoV-2 Assay testing kit from Luminex is a rapid diagnostic test kit to detect coronavirus. This moderate-complex, sample-to-answer kit is used as a nasopharynx swab specimen for testing, where lab personnel can extract results in just two hours.
Luminex NxTAG CoV Extended Panel
Another testing kit option from Luminex is their NxTAG CoV Extended Panel, which works on their MAGPIX system, allowing a standalone test to detect the virus. Not only that, but this kit can also detect 20 other common respiratory pathogens, which significantly helps with determining a patient's health status.
Smart Detect SARS-CoV-2 rRT-PCR Kit
The Smart Detect SARS-CoV-2 rRT-PCR Kit from InBios is another type of a real-time RT-PCR test wherein results are obtained immediately. These results are released approximately within four hours and are eventually followed up with swab testing.
BD BioGX SARS-CoV-2 Reagents for the BD MAX System
B.D. Bioscience's testing kit, SARS-CoV-2 Reagents for BD MAX System, is another real-time RT-PCR test kit meant for the nucleic acid’s qualitative detection. The said test kit performs moderate to high complexity tests and uses samples taken from nasopharynx and oropharynx swab tests of patients showing symptoms.
Ipsum Diagnostics COV-19 IDx Assay
A test kit coming from the Ipsum Diagnostics, the COV-19 IDx Assay, is a vitro test that detects the virus from the nasopharyngeal and oropharyngeal sample swabs of patients suspected of coronavirus. The kit also runs a high-capacity test that allows up to 5,000 specimens and provides results approximately within 24 hours.
Cellex qSARS-CoV-2 lgG/lgM Rapid Test
The Cellex qSARS-CoV-2 lgG/lgM Rapid Test is a type of kit categorized as a lateral flow immunoassay for the qualitative detection and differentiation of antibodies, IgM and IgG, to catching strains of coronavirus.
The samples used for testing are in the serum, plasma, or venipuncture of whole blood specimens from suspected patients. For those unfamiliar with sample serums, it is the liquid portion of the blood clot containing the antibodies. Additionally, test results of the antibodies can be provided within 15-20 minutes.
QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel
The QIAGEN QIAstat-Dx SARS-CoV-2 Panel is another real-time PCR test to detect the nucleic acid from samples of suspected patients through nasopharyngeal swab specimens.
This panel amazingly detects and differentiates 21 bacterial and viral respiratory concerns, including the coronavirus. The test kit's results can be provided within an hour.
NeuMoDx Molecular SARS-CoV-2 Assay
The testing kit from NeuMoDx is an automated rapid test kit, another type of RT-PCR diagnostic test method. Samples for this type of test kit are taken from the nasopharyngeal, oropharyngeal, and nasal area. Its multiplexed assay detects two of the coronavirus' Nsp2 and N genes.
Since the NeuMoDx Molecular SARS-CoV-2 Assay is a rapid test kit, the results from the examined specimen can be obtained in about 80 minutes.
The world fell into turmoil due to an enemy that can’t be seen with the naked eye. To address the lack of equipment for a new pandemic, the FDA granted EUAs to different test kit manufacturers. Thus, the progress in creating and distributing these testing kits has become the pillar that supports the health workers in fighting the deadly virus.