FDA-Approved At-Home COVID-19 NAAT

Introduction:

The virus that causes COVID-19, SARS-CoV-2, can be diagnosed with a nucleic acid amplification test, or NAAT. NAATs are e-used to detect genetic material. The RNA (ribonucleic acid) sequences that make up the virus's genetic material are precisely identified by NAATs for SARS-CoV-2.

NAATs for upper or lower respiratory tract test specimens for SARS-CoV-2. Depending on the test being run and the manufacturer's recommendations, a specific type of specimen must be gathered when testing for SARS-CoV-2.

What Is Over-The-Counter FDA-Approved At-Home COVID-19 NAAT?

Rapid testing, also known as at-home over-the-counter (OTC) COVID-19 antigen testing, is used to identify proteins from the virus that causes COVID-19, SARS-CoV-2, known as antigens. Molecular techniques, such as polymerase chain reaction (PCR) testing and other nucleic acid amplification tests (NAATs), which identify genetic material called RNA from the virus, are more likely to detect the SARS-CoV-2 virus than at-home COVID-19 antigen tests. This is particularly true in those who are not exhibiting COVID-19 symptoms or in the early stages of an illness. Presently, all FDA-approved COVID-19 antigen tests that may be performed at home are permitted for serial testing, often known as repeat testing.

What Are Nucleic Acid Amplification Tests (NAATs)?

The virus that causes COVID-19, SARS-CoV-2, can be diagnosed with a nucleic acid amplification test, or NAAT. Genetic material (nucleic acids) is detected using NAATs. The RNA (ribonucleic acid) sequences that make up the virus's genetic material are precisely identified by NAATs for SARS-CoV-2.

NAATs for upper or lower airway test specimens for SARS-CoV-2. Depending on the test being run and the manufacturer's recommendations, a specific type of specimen must be gathered when testing for SARS-CoV-2. The first step in the NAAT process is to amp up or create numerous copies of whatever genetic material may be present in the specimen of the virus. By amplifying certain nucleic acids, NAATs can identify extremely minute levels of SARS-CoV-2 RNA in a sample, which increases the test's sensitivity in COVID-19 diagnosis. Stated differently, NAATs are unlikely to yield a false-negative result for SARS-CoV-2 and can identify trace levels of the virus with high reliability.

When Should One Test for COVID-19?

Take a test as soon as one feels any of the symptoms, and if the results are negative, repeat the procedure as directed.

A minimum of five whole days should pass after an individual has been exposed to COVID-19 before undergoing testing if one is symptom-free. Patients can have a wrong outcome if they test too soon.

Tests may be required as part of a screening test program if one is in certain high-risk situations.

In particular, if an individual is in an area with a moderate or high COVID-19 Hospital Admission Level, think about getting tested before interacting with anyone who is at high risk for severe COVID-19, such as elderly individuals, immunocompromised individuals, or persons with other medical disorders.

How Do NAATs Work?

To enhance nucleic acids and identify the virus, NAATs can employ a variety of techniques, such as but not restricted to:

1. Polymerase chain reaction with reverse transcription (RT-PCR).

2. Amplification that is isothermal, such as

• Nicking endonuclease amplification reaction (NEAR).

• TMA stands for transcription-mediated amplification.

• LAMP stands for loop-mediated isothermal amplification.

• HDA stands for helicase-dependent amplification.

• Short palindromic repeats that are regularly spread out in clusters (CRISPR).

• SDA stands for strand displacement amplification.

What Are the Things Involved in At-Home COVID-19 NAAT?

• The COVID-19 test cartridge.

• The sample wand nasal swab.

• The cartridge reader (which is used by the Health Monitoring System).

• The health mobile application, which can be downloaded onto compatible mobile smart devices like smartphones, is all part of the approved test.

What Is the Importance of Expiration Dates for At-Home COVID-19 NAAT?

The test's expected working life, or shelf-life, is determined by measuring it from the date of production. The test is supposed to function as correctly as it did when it was made through the expiration date, which is specified at the end of the shelf life. There are situations where a test's expiration date can be prolonged.

If the maker provides data indicating that the shelf-life is longer than what was previously known when the test was first authorized, it is indicated by an extended expiration date. Find the row in the table below corresponding to the manufacturer and test name listed on the box label of the test to see whether the expiration date of the at-home OTC COVID-19 test has been extended. The Expiration Date field will read "Extended Expiration Date" and link to a PDF that contains the lot numbers, original expiration dates, and the extended expiration dates if the expiration date has been extended. Do not use the test after the original expiration date on the test if the lot number, original expiration date, or phrase (expiration date can be seen from the box label) appears in the expiration date column.

What Does the Results of the At-Home OTC COVID-19 Test Indicate?

In-home OTC COVID-19 testing that has FDA approval is primarily antigen tests. Even if they are not ideal, they offer a quick and easy approach to testing for COVID-19, so an individual can find out whether one is infected and should avoid contact with others to stop the virus from spreading.

• Positive Result: Patients are most likely to have COVID-19 if an at-home COVID-19 antigen test yields a positive result. In addition to calling their healthcare physician, anyone who tests positive for COVID-19 or who is probably infected with the virus should adhere to the CDC's recommendations for staying at home and avoiding contact with others.

• Negative Result: A negative result from an at-home COVID-19 antigen test indicates that the test did not detect the virus causing COVID-19; however, this is not enough to rule out COVID-19 because certain tests may miss the virus at an early stage of infection. While using an antigen test, always do another test, if not sooner than 48 hours after a negative result. Use the following information to evaluate a negative test result and decide what to do next.

What Are the Drawbacks of At-Home COVID-19 NAAT?

• If one happens to become infected with COVID-19 as soon as they are exposed to it, it can take up to five days, or even longer, for a COVID-19 antigen test to identify the virus. The time it takes for a test to identify the virus can differ depending on the test and COVID-19 variant.

• The degree of contagiousness or the ability to infect others with the virus. No test exists that can determine that. Even before receiving a positive test result, one could infect people with COVID-19.

• Unless the test is expressly approved for the identification of these viruses, if an individual has another kind of respiratory infection, such as the flu or respiratory syncytial virus (RSV).

Conclusion:

One can determine whether they have a current COVID-19 infection by using over-the-counter (OTC) COVID-19 diagnostic tests at home. Without a prescription, one can self-test these over-the-counter COVID-19 diagnostic tests at home (or anywhere) with FDA approval. It is not necessary to send a sample to a laboratory to take the test; an individual can get the test online or at their neighborhood pharmacy, collect the sample, run the test, and view the results themselves. To lower the chance of receiving a false negative test result, an individual should repeat testing with the majority of at-home OTC COVID-19 tests to determine if one has symptoms or not after a negative result.