COVID-19 tests come in many shapes and forms. The most well known is the nasopharyngeal swab assay, which had a few bumps in the road in the United States due to supply-chain issues with reagents, nasal swabs and other laboratory challenges. DiagnoseAtHome Inc. in partnership with CLIA labs will be offering a COVID-19 At-Home Blood Test provided in pin prick form to detect antibodies against COVID-19. This disposable point-of-care serology test can detect if a person has been recently infected with Covid-19, even in the absence of symptoms.

Coronavirus Disease 2019 (COVID-19) Testing

This article discusses the approach for the novel coronavirus disease 2019 (COVID-19, formerly known as 2019-nCoV) associated with an outbreak of respiratory illness that originated in Wuhan, Hubei Province, China in late 2019. The causative agent for COVID-19 disease is SARS-CoV-2 virus. 

Who to test for COVID-19 Coronavirus:

There are two ways of looking at this question. The first is, how to deal with the fact that we don’t have enough tests for everyone. If that is the case, we want to be selective with who receives the test, how many are tested and where we test. In an ideal world however, we have enough COVID-10 tests for entire countries, at which point experts suggest that we test everyone. In this fashion all of the strategies which can lead to effective “flattening of the curve” can take effect. The combination of social distancing, quarantining, case tracing and widespread testing could drastically impact our outcomes. We could screen both symptomatic patients, those with fever, cough, shortness of breath, body aches, myalgias and other viral symptoms, as well as asymptomatic patients, those without any symptoms at all. 

According to the CDC….who are we testing for COVID-19

Not everyone needs to be tested for COVID-19. Here is some information that might help in making decisions about seeking care or testing.

Most people have mild illness and are able to recover at home.
There is no treatment specifically approved for this virus.
Testing results may be helpful to inform decision-making about who you come in contact with.
CDC has guidance for who should be tested, but decisions about testing are at the discretion of state and local health departments and/or individual clinicians.

Clinicians should work with their state and local health departments to coordinate testing through public health laboratories, or work with clinical or commercial laboratories.

Reference: https://apps.who.int/iris/bitstream/handle/10665/331329/WHO-COVID-19-laboratory-2020.4-eng.pdf

The Evidence: A serological assay to detect SARS-CoV-2 seroconversion in humans

SARS-Cov-2 (severe acute respiratory disease coronavirus 2), which causes Coronavirus Disease 2019 (COVID19) was first detected in China in late 2019 and has since then caused a global pandemic. While molecular assays to directly detect the viral genetic material are available for the diagnosis of acute infection, we currently lack serological assays suitable to specifically detect SARS-CoV-2 antibodies. Methods: Here we describe serological enzyme-linked immunosorbent assays (ELISA) that we developed using recombinant antigens derived from the spike protein of SARS-CoV-2. These assays were developed with negative control samples representing pre-COVID 19 background immunity in the general population and samples from COVID19 patients. Results: The assays are sensitive and specific, allowing for screening and identification of COVID19 seroconverters using human plasma/serum as early as 3 days post symptom onset. Importantly, these assays do not require handling of infectious virus, can be adjusted to detect different antibody types and are amendable to scaling. Conclusion: Serological assays are of critical importance to determine seroprevalence in a given population, define previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic. Sensitive and specific identification of coronavirus SARS-Cov-2 antibody titers will also support screening of health care workers to identify those who are already immune and can be deployed to care for infected patients minimizing the risk of viral spread to colleagues and other patients.

Reference: https://www.medrxiv.org/content/10.1101/2020.03.17.20037713v1

But what if I test negative at the time of my COVID-19 Test?

If you test negative for COVID-19, you probably were not infected at the time your specimen was collected. However, that does not mean you will not get sick. It is possible that you were very early in your infection at the time of your specimen collection and that you could test positive later, or you could be exposed later and then develop illness. In other words, a negative test result does not rule out getting sick later.

What specimens are reliable to collect for COVID-19 Testing?

Standard testing to date has focused on respiratory material from the nasal pages. Respiratory material should be collected: - upper respiratory specimens: nasopharyngeal and oropharyngeal swab or wash in ambulatory patients - and/or lower respiratory specimens: sputum (if produced) and/or endotracheal aspirate or bronchoalveolar lavage in patients with more severe respiratory disease. ]

However, emerging data which has the potential to test millions more patients include clinical specimens of COVID-19 virus which has been detected in blood and stool. This has been seen previously with  coronaviruses responsible for SARS and MERS. The duration and frequency of shedding of COVID-19 virus in stool and potentially in urine is unknown. 

Blood Tests for COVID-19

Antibody tests (IgM/IgG serology), which are blood tests used in the detection of many infections, are important for a number of reasons. They can show what percentage of the population has ever been infected with the virus (even if the people aren't currently infected) — a key piece of information, given that many patients with COVID-19 may be asymptomatic and not diagnosed.  By knowing how many individuals have had the virus, researchers can calculate a more accurate fatality rate and have a better idea of the percentages of cases that are mild versus severe. This would immensely help at a population level.

Researchers could also use antibody tests to screen health care workers and identify those who are already immune to the virus, which would likely mean they could care for patients without the risk of being infected. We don’t know this forsure however, as there is no data that once infected a patient is “immune”. If COVID-19 behaves as other viruses, this immunity is hypothesized but the data currently does not exist for definitive proof.

An ELISA test, a common type of lab test in which researchers see a color change if a specific antibody is present in a sample has been shown to be effective in detecting COVID-19. This color change happens only when antibodies in a sample recognize and bind to specific proteins — in this case, proteins from SARS-CoV-2. To make the test, researchers created slightly altered versions of some of the proteins from SARS-CoV-2.

Using blood samples from three confirmed cases of COVID-19 and 59 people who did not have the infection, the researchers found that their test worked — it was positive only for those who had COVID-19.

Testing myself for COVID-19 at Home

Thanks to the FDA which has fast tracked approval of innovation in COVID-19 testing and treatment, DiagnoseAtHome Inc. will be offering at-home pin prick blood testing for COVID-19 antibodies. It is our hope that millions of North Americans will be proactive in testing themselves so we can amass the necessary data to strategize forward.

What can I do now to avoid COVID-19?

DIRECT FROM THE CDC

Know How it Spreads

cover your mouth when coughing and sneezing

  • There is currently no vaccine to prevent coronavirus disease 2019 (COVID-19).
  • The best way to prevent illness is to avoid being exposed to this virus.
  • The virus is thought to spread mainly from person-to-person.
  • Between people who are in close contact with one another (within about 6 feet).
  • Through respiratory droplets produced when an infected person coughs or sneezes.
  • These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.

Take steps to protect yourself

wash hands frequently

  • Clean your hands often
  • Wash your hands often with soap and water for at least 20 seconds especially after you have been in a public place, or after blowing your nose, coughing, or sneezing.
  • If soap and water are not readily available, use a hand sanitizer that contains at least 60% alcohol. Cover all surfaces of your hands and rub them together until they feel dry.
  • Avoid touching your eyes, nose, and mouth with unwashed hands.

Avoid close contact

avoid social contact

  • Avoid close contact with people who are sick
  • Put distance between yourself and other people if COVID-19 is spreading in your community. This is especially important for people who are at higher risk of getting very sick.

Take steps to protect others

Stay home if you’re sick

stay home if you're sick

  • Stay home if you are sick, except to get medical care. Learn what to do if you are sick.

Cover coughs and sneezes

Cover your face

  • Cover your mouth and nose with a tissue when you cough or sneeze or use the inside of your elbow.
  • Throw used tissues in the trash.
  • Immediately wash your hands with soap and water for at least 20 seconds. If soap and water are not readily available, clean your hands with a hand sanitizer that contains at least 60% alcohol.

Wear a facemask if you are sick

Wear a facemask

  • If you are sick: You should wear a facemask when you are around other people (e.g., sharing a room or vehicle) and before you enter a healthcare provider’s office. If you are not able to wear a facemask (for example, because it causes trouble breathing), then you should do your best to cover your coughs and sneezes, and people who are caring for you should wear a facemask if they enter your room. Learn what to do if you are sick.
  • If you are NOT sick: You do not need to wear a facemask unless you are caring for someone who is sick (and they are not able to wear a facemask). Facemasks may be in short supply and they should be saved for caregivers.

Clean and disinfect

clean and disinfect surfaces

  • Clean AND disinfect frequently touched surfaces daily. This includes tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
  • If surfaces are dirty, clean them: Use detergent or soap and water prior to disinfection.