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COVID vaccination efforts continue to gain momentum in the United States and around the world, but that doesn’t mean we’re out of the woods of the pandemic yet. Regular testing remains an important factor in helping to slow the spread of the disease, but has usually required a visit to your doctor or local clinic. Fortunately, this is no longer the case. Over the past few months, the FDA has what can be and return results in minutes rather than days.
If you have had an in-person COVID test in the past year, your nasal swab sample has likely been diagnosed using a (real-time RT-PCR), which is one of the lab methods. most accurate and widely used for detecting viral pathogens. such as Zika, Ebola and coronavirus.
The coronavirus contains only single-stranded RNA for genetic material which, unlike DNA, cannot be independently reproduced without the help of a host. As such, the virus must infect and reuse healthy cells in order to become more self-sufficient. RT – PCR mimics this process by first converting any coronavirus RNA present in a given sample into DNA – hence “” – then creating billions of copies of the genetic material and labeling them with a fluorescent dye for identification. .
The process is an offshoot of the more general PCR method, which is used to detect pathogens whose genetic material is in the form of DNA and therefore does not need amplification. This process is sensitive and very precise, although time consuming, but allows pathologists to detect coronavirus infection in its early stages, as only a tiny amount of initial RNA is required. While the RT-PCR technique presents a low risk of external contamination, its ability is limited in that it can only detect the coronavirus when it is currently present in a sample. This method cannot tell if someone has already been infected.
Some home tests use a similar process called isothermal amplification. Like PCR, isothermal amplification generates many copies of the genetic material of the coronavirus to facilitate detection. While AI is not as sensitive as the laboratory PCR method, it is more accurate than other home tests that look for antigens – pieces of coronavirus protein that elicit the body’s immune response.
For example, an antigen-based BinaxNOW test correctly detects the virus in symptomatic people. This figure drops to only 35% in the asymptomatic. Since antigen tests do not include a reverse transcription phase, they are faster and less expensive to perform than PCR and AI-based methods, but are less accurate and return higher levels of false negatives – especially in people who have only recently been exposed.
The antigen method provides more of a general estimate of your contagion, said Dr Gigi Gronvall of Johns Hopkins University at the . “If you get a positive result, you really have to isolate yourself,” she said.
So if you are asymptomatic, PCR or similar molecular test should be sufficient. If you suddenly find that you cannot smell or taste anything, take a PCR or the most sensitive antigen-based test you can find. If your test is positive, no matter what type of test you use, isolate yourself immediately and call a doctor.
So far, only a handful of home tests have obtained Emergency Use Clearance (EUA) from the FDA. EUAs are otherwise unapproved medical treatments, tests, or countermeasures that have been allowed to bypass the formal (and lengthy) FDA approval process in response to life-threatening health crises like the one we are facing. are currently facing.
This is the first home test available without a prescription. It is antigen based and takes 15 minutes to return a result. You will need to rub your nose and then drop the sample into a desktop analyzer with processing liquid. Once the device does its job, the results are transmitted via Bluetooth to your smartphone. This data is also shared via a secure, HIPAA-compliant cloud connection to health authorities to facilitate outbreak mapping. The test is expected to cost around $ 30, although the company has yet to announce where and when it might become available. The Ellume test showed an accuracy of 96% in people aged 2 years and older during its clinical trial in the United States.
a $ 231.8 million deal with the Australian company to purchase 8.5 million units of the test. Ellume “will deliver 100,000 tests per month from the Australian manufacturing plant to the construction of the US plant,” said a company representative. NPR. “At full capacity, the US plant will be able to produce up to 19 million tests per month. The 8.5 million tests for the US government are part of the overall manufacturing. “However, one of them went so far as to characterize the effort as” a spit in the ocean. “
The will also be available over the counter soon, but unlike the Ellume, it uses a nucleic acid amplification test (similar to PCR) for improved accuracy and generates results in 20 minutes. According to a recent, “In prospective studies to evaluate the use of the Cue OTC test, the results were 97.4% agreement for positive cases and 99.1% agreement for negative cases compared to results of ‘a highly sensitive EUA PCR lab test. ” The company has yet to announce pricing or availability.
is not just a mouthful, it’s quite a process. After answering a series of screening questions through the eMed Digital Health website, Abbot will deliver a test to your home. You will then be put in touch with a “telehealth professional” who will guide you through the sample collection process. Once you have dropped your sample into the analyzer, you should get your results in about 15 minutes via the Navica smartphone app. The Abbot test costs $ 25 and is only available with a prescription.
The cost is $ 50 and, like the Cue, uses molecular technology. As with BinaxNOW, it requires a prescription, so your doctor will need to order it on your behalf. The Lucira test is intended for people aged 14 and over, it returns results in 11 to 30 minutes.
If you don’t mind waiting a bit for your results, Amazon sells. Each costs $ 110 and you have to display it at the LA area lab for diagnosis. On the plus side, this test is saliva-based, so you won’t have to impale your nasal cavity with a Q-Tip to collect your sample. Results will be available within 24-72 hours on the company’s web portal.
Likewise, the CRL Rapid Response COVID-19 Saliva Test can cost $ 119 and returns results in 24 to 48 hours. If your test is positive, the company will ask a telemedicine representative to discuss the diagnosis and potential next steps.
Although all home tests have shown greater than 90% accuracy during their clinical trials, these numbers can fluctuate when regular people perform the tests themselves, so don’t consider a negative result a license to go out. and mingle. “When manufacturers prepare data to submit to the FDA, they conduct studies under very specific and highly controlled conditions that optimize test performance,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories. .
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