The purpose of a self-test is to detect active infection. SARS-CoV-2 diagnostic self-tests require individuals to collect a specimen from their nose/throat (can be a nose swab, throat swab, saliva, or a combination of all), conduct the test, and interpret the results according to the instructions provided. Where required, individuals would also be responsible for reporting the results by instructions from public health authorities. These tests are rapid antigen detection tests (RADTs) that can be done at home, without the involvement of any health professionals or laboratory staff.
Instructions for the sampling and test procedures provided by the manufacturer and/or public health authorities should be well-designed, easy to read, locally adapted, and user-friendly. Instructions should clearly describe the environmental conditions, incubation times, the time between sampling and reading, and correct interpretation of positive and negative results, in an illustrated way so that they can be easily followed by a layperson. Clear detailed instructions can significantly reduce errors in the performance of a rapid self-test, as described from the existing experience of self-testing kits for other pathogens. ECDC TECHNICAL REPORT Considerations on the use of self-tests for COVID-19 in the EU/EEA 3 Self-tests allow individuals to obtain the result very quickly (within approximately 30 minutes), which may facilitate more timely isolation and may alleviate the bottlenecks for laboratory response identified in the recent ECDC rapid assessment of laboratory practices and needs related to COVID-19. For the test result to be registered with the public health authorities, the individual would need to actively report the result.
This is done using a single-use self-test kit that can be used at home (or in another setting) and without any specialized laboratory equipment or training.
Self-swabbing (or self-sampling) refers to an individual collecting their own swab, or specimen, for a SARS-CoV-2 test. This test could be performed using a self-test or could be performed in a laboratory (or other healthcare settings) by a trained person.
Rapid antigen diagnostic tests (RADTs) have been developed as both laboratory-based tests (requiring specialized analysis equipment) as well as for ‘near-patient or ‘point-of-care use, for which the analysis is performed on a handheld cartridge with a visual readout. RADT results are usually generated 10 to 30 minutes after the start of the analysis.
Sensitivity is the probability of a true positive. A true positive is when an infectious individual is correctly identified as a case (infectious) when tested using the particular test.
Specificity is the probability of a true negative. A true negative is when a person without the infection is correctly identified as a non-case (non-infectious) when tested using the particular test.
A false positive is when a non-infectious individual (a non-case) is incorrectly identified as a case (infectious) when tested using the particular test. A false negative is when an infectious individual (a case) is incorrectly identified as a non-case (non-infectious) when tested using the particular test.
The instructions to use the test kits may vary slightly depending on their designs. It is best to refer to the instruction sheets provided by each manufacturer. However, they usually come with similar components such as a swab, a test strip, and a buffer solution in a tube.
Here is an explanation of using Biosynex COVID-19 Antigen Self-Test kit, one of our highest selling brands:
Note the timeframe for results as some brands show results in 10 minutes and have to be read in no more than five minutes as the results may become inaccurate after that.
COVID-19 is detected if two lines show: Both the Control (C) line and the Test (T) line. The C and T are indicated on Biosynex and some other brand kits. Also, few other brands may show up as blue and pink lines respectively. The T line is the critical indicator. It shows that the test kit had managed to pick up coronavirus proteins. Instructions for the Abbott kits suggest that users “look closely”, pointing out that the presence of any T line, no matter how faint, is a positive result.
Biosynex also states that the C line, which appears when the test was performed correctly, may appear within a few minutes, quicker than the T line would. So, it is important to wait before the given time is up before getting an answer on how many lines are showing.
If no C line appears, the test did not work and is considered invalid.
Why COVID-19 Rapid Antigen Test is recommended? COVID-19 rapid antigen tests (RADTs) that can be used as self-tests to detect SARS-CoV-2 are becoming available in the European Union/European Economic Area (EU/EEA). These tests require individuals to collect a specimen, conduct a test and interpret the results by themselves.
Earlier there were only a few RADTs available for self-testing for COVID-19, and there was no CE-marked RADT for self-testing placed on the EU market in compliance with Directive 98/79/EC.
From a public health perspective, self-tests can offer advantages when used to complement professionally administered RADTs or RT-PCR tests. They can improve the accessibility to testing. They allow individuals to obtain the result very quickly, which could support the early detection of infectious cases and reduce further community transmission.
Self-testing could therefore enhance disease control with prompt identification and isolation of cases. However, shifting the responsibility of reporting test results from health professionals and laboratories to individuals could lead to underreporting, and make response measures such as contact tracing and quarantine of contacts even more challenging. Current indicators for monitoring the intensity and spread of the COVID-19 pandemic (testing rates, test positivity rates, and case notification rates) could be affected, and it could be difficult to monitor disease trends over time. An additional challenge is that samples from self-testing would not be available for sequencing and monitoring variants of concern.
In addition to the above, public health authorities looking to implement self-tests should take into account the population they are targeting, as well as the disease prevalence in that population. The use of a COVID-19 Antigen Rapid Test allows us to detect the presence of SARS-CoV-2 antigens in our body and to take initial precautionary isolation measures to reduce the spread of the virus.
Due to the constant high incidence of COVID-19 cases worldwide, there is a high need for accurate and reliable diagnostic devices that are easy to use and have a prompt response, to enable frequent testing operations. Constant high incidence of COVID-19 cases worldwide, there is a high need for accurate and reliable diagnostic devices that are easy to use and have a rapid response, have been developed, to facilitate the diagnosis and traceability of newly infected people: the antigen tests.
Since the transmission of the SARS-CoV-2 virus seems to occur days after exposure, when the viral load reaches its peak, the frequency of testing is increasingly important to slow down the spread of the pandemic.
Taking a self-test is very easy. You can do the test very quickly and when and wherever you want. The most important thing is that you read the information leaflet carefully and follow the instructions. In short, taking a self-test means that you take a sample of your throat or nose mucus and put it in a liquid. Using this liquid and a pipette, you can then simply drip the mixture of your mucus and the liquid onto the test device. Just wait as long as indicated on the instruction leaflet and then you have your result!
Testing has been a vital tool in the fight against coronavirus disease 2019 (COVID-19), as clinicians decide how to advise patients and governments to implement strategies to “flatten the curve.” Testing should also play a critical role in speeding our path to economic recovery. Fast, convenient, cheap, accurate, and widely-used tests can help identify both infected individuals who should self-isolate and those who have recovered, pose low contagion risks, and can help others fight the virus. We need rapid development and broad dissemination of home tests and issuance of an immunization passport for those with presumed immunity.
COVID-19 self-test kit, mailed to your home, which would quickly reveal coronavirus immunity. A positive result indicates you may have recovered from an asymptomatic, mild, or not-so-mild case. Such a result would allow you to take more moderate precautions and return to work alongside others like you—and even comfortably interact with infected patients.
Also, imagine a COVID-19 self-test kit would provide your infection status within few minutes. If the result is positive, you will self-isolate and contact a telemedicine physician. If the result is negative, you will continue to follow CDC protocols, including practicing social distancing, wearing fabric masks, and work from home if possible.
Health leaders looked for ways to test for the virus without exposing people who were sick or healthcare workers. From online screening tools to virtual tracking, curbside testing to mail-in swabs, COVID-19 testing in the United States took many forms throughout the pandemic.
To reduce regulatory bottlenecks, the FDA granted special authorizations to speed up the approval process for many COVID-related medical devices, including test kits. The FDA issued an emergency use authorization for their use.2
Due to the hasty nature of the approval of many COVID-19 tests, as well as a lack of good data on test results, it's difficult to say how accurate home testing is. The FDA found that some fully at-home COVID tests can be as accurate as 96% for negative test results and 100% for positive test results. For now, the standard PCR test is considered the gold standard in COVID-19 testing.
Some studies have found that antigen tests were effective early in the infection process, but that the sensitivity of these tests decreased as virus shedding slows later in the disease course. Antigen tests are also believed to have higher false-negative rates than molecular tests. Testing accuracy may also be affected by how someone collects the testing sample and how it is processed.
Testing is crucial to controlling the spread of COVID-19. Early testing efforts encountered many problems, but new tools like COVID home tests have been approved for use and make it easier than ever to find out whether you have been infected and avoid spreading the virus. If you have a positive test, be sure to take the appropriate precautions to avoid spreading the disease and seek help from your healthcare provider as soon as possible. Even if you get a negative result from a home test but have COVID-19 symptoms see your doctor right away for testing and diagnosis.
When using home test kits, you are self-testing, not self-diagnosing. Remember, as with all home screening, monitoring, or family planning products, you should follow up in case you are not sure whether you have used the kit properly or not.
No matter which at-home test kit you use, certain guidelines should be followed:
Rapid self-tests can be administered individually and independently. These SARS-CoV-2 antigen tests can be carried out anywhere and do not require any equipment. Results are available 15 to 30 minutes after taking the test. Some tests require an oral or nasal swab. Other, more recent test kits, work with saliva or stool samples.
The advantages of antigen self-tests are that the tests are fast, reliable, and easy to take. You can do the test where and when you want, you don't need an appointment for the test and you will have the result after thirty - and sometimes even ten! - minutes. If the result is positive, the test is extremely reliable, so you know for sure that it is better to stay at home to avoid infecting your surroundings.
The Robert Koch Institute (RKI), Germany's public health authority, says test strips containing antibodies bind antigens, which activates an enzyme. A positive result will produce a visible coloration. The RKI says antigen self-tests are particularly suited for detecting high viral loads that are especially contagious.
Approved rapid self-test kits must guarantee a sensitivity of over 80%, meaning they must detect four out of five infections. Approved tests kits must also ensure specificity of over 97%, meaning they may only produce three false positives when carried out on 100 individuals.
A more recent study in the US suggests self-swabbing is relatively effective. Researchers asked about 500 clinic patients with flu-like symptoms to self-swab their nostrils and their tongues. The results were compared with swabs taken by healthcare professionals from where the back of the nose meets the throat.
The professionals detected more positive results, but the self-swabbers were within 10 percent of the professional positives. Other types of testing may be a better option. A study that asked participants to drip saliva into collection tubes found that this was a better source of viral material than samples from where the nose meets the throat. The false-negative rate appears to be lower too – only 12 percent, compared with 24 percent for traditional swabbing, says Anne Wyllie at the Yale School of Public Health, who led the study.
Lateral flow antigen tests are tests that can process COVID-19 samples quickly without the need for laboratory equipment. They differ from polymerase chain reaction (PCR) tests, which look for genetic material from the virus and are generally more sensitive. The benefit of lateral flow tests is that most tests generate easy-to-understand results in under half an hour and can be used at the point of care rather than sent to a lab to process.
In December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) issued an exceptional use authorization (EUA) to the Department of Health and Social Care to allow the use of the Innova lateral flow self-test to detect infection in asymptomatic individuals who otherwise would not be tested.
A EUA is when a manufacturer applies to supply a medical device that does not comply with the law to protect a patient’s health if there is no legitimate alternative available. The EUA means that the Innova lateral flow test can be used by a member of the public, with no previous experience of testing, in their own home or another community setting such as a place of work.
Lateral flow is an established technology, adapted to detect the presence of a particular protein target, and is routinely used in healthcare settings because it is affordable, easy to use, delivers fast results, and has a high level of accuracy. The best-known example of a lateral flow test is the home pregnancy test kit.
In the case of COVID-19, the target of the lateral flow test is proteins, or antigens, found in the COVID-19 virus. The COVID-19 test kit is a hand-held device with an absorbent pad at one end and a reading window at the other. Inside the device is a strip of test paper that changes color in the presence of COVID-19 antigens. Using one swab, a sample is taken first from the tonsils and then from the nostril. Alternatively, a saliva sample may be used.
A Cochrane review, published on 24 March 2021, investigated whether commercially available, rapid point‐of‐care antigen (lateral flow) and molecular tests were accurate enough to diagnose COVID‐19 infection reliably, and to find out if accuracy differed in people with and without symptoms. The reviewers included 64 studies published up to September 2020, which investigated 16 different antigen tests and five different molecular tests.
They found that in people with confirmed COVID‐19, antigen tests correctly identified COVID‐19 infection in an average of 72% (ranging from 34% to 88%) of people with symptoms, compared with 58% of people without symptoms. In addition, they found that the tests were most accurate when used in the first week after symptoms developed.
In people who did not have COVID‐19, antigen tests correctly ruled out infection in 99.5% of people with COVID-19-like symptoms and 98.9% of people without symptoms. Although the overall results for diagnosing and ruling out COVID-19 were good, the reviewers pointed out that 69% of studies used the test in laboratories instead of at the point of care.
They concluded that some lateral flow antigen tests may be most useful to identify outbreaks, or to select people with symptoms for further testing with PCR, allowing self‐isolation or contact tracing, and reducing the burden on laboratory services. But they added that more evidence was needed on rapid testing in people without symptoms.
Analysis of community testing data, released by the Department of Health and Social Care (DHSC) in March 2021, suggested that lateral flow tests had a specificity of “at least 99.9%”. Specificity is a measure of how good the test is at detecting true negative cases; in this case, a 99.9% specificity means that there is fewer than one false positive in every 1,000 lateral flow tests carried out.
However, the analysis used data from locations using the supervised testing model. Regular, rapid testing has been in place for some time for NHS and cares home staff. The government now recommends twice-weekly testing using lateral flow tests for free to all adults in households with primary- and secondary school, and college-aged children and young people, including childcare and support bubbles. This is in addition to the two tests that all secondary-school and college students and staff are asked to carry out each week at home.
You can use the antigen self-test for a lot of different situations. First of all, you can use the self-test to quickly and easily test whether you have corona if you experience mild symptoms. If you test positive, you will know right away that you have to stay inside, cancel your appointments and stop being in contact with your surroundings.
As an employer, you can also use the self-tests for meetings, events, or in the office to protect your employees from the virus as much as possible. The chance that one of your employees has corona and infects his or her colleagues reduces considerably by using the self-tests. So if for whatever reason, it is important to gather several people at the office, you can make sure that your employees can do their job without worrying about the virus.
Finally, you can use antigen tests as a check-up for several reasons, for example before going on a holiday, when visiting your grandparents, if you have been in contact with someone who has corona, when coming back from a high-risk country, and so on!
With cases rising rapidly in all corners of the world, not only are more people being tested but more people are seeking out tests or wondering if they should get tested because of potential exposure. Effective testing is essential in helping slow the spread of the virus by identifying those who have the virus and enabling treatment or isolation. Testing is also crucial to learn more about how the virus spreads and how prevalent it remains in a given community.
But for those reasons, too, health officials have to be careful that they’re being efficient with their tests. In other words, with ongoing shortages still an issue, the importance of making sure those most in need get tested means not everyone should be getting tested.
As we’ve learned more about how the virus spreads, so, too, has the CDC tweaked its recommendations. Besides testing for people who have symptoms of COVID-19 or upon reference by your healthcare provider or state health department, the CDC now suggests testing for asymptomatic patients who have been exposed to someone with a confirmed case. According to updated guidance, the CDC says, “Due to the significance of asymptomatic and pre-symptomatic transmission, this guidance further reinforces the need to test asymptomatic persons, including close contacts of a person with documented SARS-CoV-2 infection.”
As with so many other aspects of COVID-19, there’s no direct answer. In many cases, a person with the virus would test positive around three to five days after contracting it; the CDC itself says the virus has a median incubation time of four to five days. That’s about the same average amount of time it takes for symptoms to develop, though the CDC notes the incubation period could be anywhere from two to 14 days.
In other words, getting tested the day after a potential exposure means you’ll have a very high chance of a negative test result even if you have been infected. As for how long you’d have to wait to actually get tested, it really depends on where you live because wait times vary not just from city-to-city and state-to-state but system-to-system. In the same city, you could get a wide variety of wait times.
While some people may face little delay, others may encounter hours-long lines or a wait of several weeks for an appointment to receive a test. Being exposed to the virus can put you at certain risk for catching the virus. Guidelines say that close contacts or that co-living with the infected person have a 50% or more risk of contracting COVID-19.
Hence, it’s essential that you watch out for symptoms, step into a quarantine yourself, and most importantly, get tested. Getting tested is a necessity because it can happen that a person could asymptomatically spread the virus onto others, i.e. posit no typical COVID-19 symptoms, yet be a carrier and expose many more to additional risks.
Contact tracing is one of the first and preventive steps to stop the infection from surging. Therefore, any or almost all close contacts of a COVID-19 infected individual are asked to follow precautions and take care of their health. According to WHO protocols, close contact of a person is defined as anyone who is exposed to a particular COVID-19 case, 2-10 days after illness onset.
That being said, anyone who has spent considerable time around an individual before the diagnosis, or is an immediate family member, is said to have a high exposure risk, since they could have caught viral load from the patient. The first step to take post-contact tracing would be to step into self-imposed quarantine, i.e, limit your exposure to the outside world for a given period of time. This would ensure that you don’t put others at risk, and safeguard your world too.
It’s also important that you protect the ones living with you. Wear a protective face covering or mask, distance yourself and wash hands frequently. Remember, proper hand hygiene and mask use can cut down transmission risk by up to 70% in many cases. Avoid people from coming in outside, or inviting people home.
Apart from the quarantine measures, it's also crucial you start taking steps to protect your health and boost immunity. Some of the steps can be doing saltwater gargles, steam inhalation, and ensuring that you eat good quality fruits and vegetables which benefit your immunity.
Yoga and meditation apart from certain breathing exercises will also help alleviate stress levels and keep the body fresh. Preventive testing will provide assurance and guide you to take the next steps. Truth be told, there is no set best time to take a COVID-19 test. It can depend on a whole lot of factors, including the progression of symptoms.
In most cases, with COVID-19, the incubation period for the virus is 5-14 days. Most people, who get exposed to the virus and catch the infection tend to develop symptoms in a week. Hence, the first week is crucial and often, the best time to take a COVID-19 test would be 4-5 days after exposure.
However, many cases of COVID can be asymptomatic as well, i.e., people may have the virus, but show no symptoms. Even in these cases, a test should be taken at the end of the first week. Till then, proper quarantine measures should be followed. When a person is exposed to the scary virus, he or she is also a risk to others around him, or could potentially be more contagious. In case of an infection, symptoms start to come up anywhere between 5-10 days. However, a person with COVID-19 could be contagious 48-72 hours before starting to experience symptoms. Many researchers also say that this is the peak time for transmission to happen, and good quarantine, isolation measures could reduce the risk of infection spread. Now it’s perfect to go for the COVID-19 self-test and check whether you have caught the disease or not.
Besides some of the most prevalent symptoms of COVID-19, patients also experience health problems that do not appear in every person infected with the virus. Ranging from mild to severe COVID, the following are the symptoms that may vary from person to person.
In other cases, patients with COVID-19 have spoken of other unusual and lesser-known signs such as abdominal pain, eye infection, and brain fog.
Patients with COVID-19 have complained of abdominal pain before developing other symptoms prevalent to the disease. These include diarrhea, nausea, and constipation. According to reports published by the American Journal of Gastroenterology, 204 patients in China, 48.5 percent suffered from stomach issues.
Similarly, cases of eye infections in many COVID patients have increased with time. Conjunctivitis as it is popularly known, which describes the reddening and swelling of white tissues in the eye, has been identified as a rare but prevalent symptom in coronavirus patients.
COVID-19 has also lead to a state of mental confusion in people. While fatigue and the feeling of tiredness have been recognized as common symptoms in COVID-19 patients, some individuals have also reported complaints of mental fatigue, also known as brain fog. According to a recent study conducted by researchers at Zhongnan Hospital of Wuhan University, a similar pattern of symptom development was identified in 140 patients who had tested positive for the virus. The research claimed that around 99% of the patients developed a high temperature initially, while more than half experienced fatigue and a dry cough. About a third also experienced muscle pain and difficulty breathing. People suffering from mild symptoms of COVID can self-isolate and rest at home without any hospitalization. However, once the symptoms escalate and you have trouble breathing or experience heavy chest pain or enter a state of confusion, you must act fast and seem medical attention, at the earliest. Call your service operators and take all the precautionary measures to avoid the spread of the virus.
If someone had symptoms of a lower respiratory tract infection, including a significant cough, shortness of breath, and fever, that would definitely be a trigger to go in and see your local provider right away, and then they will make the decision. Do you fall into that category of someone that should be tested or do we have other explanations for those symptoms? Because, again, right now there are so many other pathogens in the community that can cause the same kind of symptoms as this particular virus.
So there's a really specific criterion that the CDC has released to us to work up what we consider a suspect, and the first is that someone needs to have symptoms. So they need to have a fever and lower respiratory tract symptoms like a cough or shortness of breath. But beyond the symptoms, they also need to have a significant exposure risk. So that exposure right now is travel and exposure to people where there are high communities spread like China, like South Korea, Japan, Iran, and Italy.
The second important person to consider who should need testing would be someone that has symptoms and has contact with a confirmed case of coronavirus. Now, there's a third category of patients that the CDC has recommended testing, and that is a patient that has a severe acute respiratory syndrome. This is a hospitalized patient that has pneumonia and we have ruled out other causes of that pneumonia.
At Nobraa we sell COVID-19 self-test kits for use at home. The self-test kits can be used to test yourself and/or your employees if somebody has symptoms if somebody has been in contact with a person who is infected by the virus, or for preventive reasons. With the antigen test, you can check whether your body contains antigens of the coronavirus.
These antigens are pieces of proteins from the virus that trigger an immune response in your body. If you have these antigens of the COVID-19 virus in your body, you are carrying the virus at that moment. This means you could be contagious and can spread the virus to your surroundings.
If you want to buy large numbers of self-tests, for whatever situation, then Nobraa is the right place for you. Nobraa is a wholesaler of medical products and therefore sells many products by the dozen, hundreds, and sometimes even thousands. The self-tests, both saliva tests, and nasal swab tests are also available in large quantities.