In these times, with the coronavirus pandemic plaguing the entire world, everyone needs to be extra careful and vigilant. Staying alert and setting up precautionary measures to avoid the virus has become the new norm.
But despite the health crisis the world is facing, efforts of different pharmaceutical companies have led to the development of testing kits that can be used at home.
However, no matter how good the news this home testing kit brings, there are certain things every individual needs to know about it. Before buying a kit and getting yourself home tested, here are a few things that you need to know about all these testing kits, especially the ELISA kit.
First Things First: Is the FDA Involved?
FDA (Food and Drug Administration) approval is a very crucial authorization needed before consuming and using any type of food, medication, or health-related product. In days like these where there’s a health crisis happening, the FDA is cautious when it comes to giving approval and authorization to different home testing kits that are being manufactured.
It is important to take note that the FDA has given one emergency use approval, and only for an at-home collection kit, not an at-home diagnostic test. Rightfully, the FDA granted LabCorp America with emergency use approval, which is called Pixel.
LabCorp explains further that the authorization from the FDA does not mean approval. It is only authorized for the detection of nucleic acid from SARS-CoV-2. Other pathogens and viruses are not included.
What Does an “At-Home Collection Kit” Mean?
There’s quite a bit of confusion on this subject, and unfortunately, it is often misinterpreted by a lot of consumers. Some assume that these collection kits are diagnostic kits that will immediately show a result if you have been recently infected or have the virus in your system.
The real purpose of these home testing kits is for any individual to self-collect a sample from their body and have it sent back to a lab. These samples will be processed right away, so the results can come back as quickly as possible.
What is an ELISA Kit?
ELISA is an abbreviation that stands for enzyme-linked immunosorbent assay. It is an analytical procedure for qualitatively assessing or quantitatively measuring any amount, presence, or functional activity of a target entity. In simple terms, ELISA is a test to detect antibodies in one system. It also detects antibodies for a certain infection.
This is the reason why an ELISA kit tool is being used during this coronavirus pandemic. ELISA kits are a quick, convenient, and accurate research collection tool.
How Does the ELISA Kit Work? Is It an At-Home Collection Kit?
No, the ELISA kit is not an at-home collection kit. To give you a better visual of what an ELISA kit is, it works closely similar to a pregnancy test. The difference is that the kit comes with a needle, which will be used by the patient to prick their finger and collect a blood sample. After placing the sample on the plate, it takes at least 10-15 minutes for the results to appear.
How Accurate and Reliable are ELISA Kit Results?
The human COVID-19 IgM/IgG kit, popularly known as the ELISA kit, is technically a great test with accurate results. However, there are drawbacks regarding how specific and accurate the results these kits have. A survey done by Evaluate Vantage shows that few Elisa Kits created by different manufacturers, such as Abbott, show the best performance when it comes to sensitivity and specificity.
However, it is important to stress that the ELISA kit is a screening test. It can cast and pick up different proteins present in one’s system, which is why a negative result is not reliable to rule out whether an individual has been infected recently or not.
A positive result, as well, does not automatically mean that the person has the infection. Since the ELISA can pick up different proteins present in one’s system, there is a high possibility that there will be cases of false-positive and false-negative results.
Performing a much sensitive method to rule out a conclusion is deemed necessary. No one should highly rely on the results given by the ELISA kit, especially if they’ve performed a self-assessment and recognized there is something wrong with their current state.
The human COVID-19 IgM/IgG kit is used to perform at-home screening tests. However, it is imperative to stress that the results shown in the test kits cannot be used to rule out a conclusion. The ELISA Kit is a tool available to any individual who wants to get tested in the comfort of their own homes. No law is prohibiting anyone from purchasing these kits as these are already made available in the market. However, it still requires knowledge and research before you get yourself tested.