coronavirus tests and studies are underway using at-home collection kits

The increasing number of people testing positive for COVID-19 — the infection caused by the novel coronavirus -- demands easy-to-use sampling kits. Several organizations have been distributing different types of kits to facilitate both rapid testing of active COVID-19 infections and longer-term research studies of antibodies in blood that would help scientists understand immunity to the virus.

Kits that can be sent to remote patients from research organizations enable everyone to follow the much-needed social distancing rules recommended by the CDC and other organizations to avoid exposure to contagions.

Different Testing Approaches Are Pursued as the COVID-19 Crisis Evolves

At the onset of the coronavirus outbreak, the focus was on using saliva swabs to test people who were experiencing symptoms to find out if they were actively infected with COVID-19. Many countries restricted this type of lab testing to specialized World Health Organization (WHO) facilities.

Some U.S. states have since set up more facilities for rapid testing using saliva swabs, but they experience backlogs because there is an extremely large number of people that need testing. Delays make it difficult for labs to provide results within 24-48 hours. This negates efforts to curb community transmission of the disease.

More recently, there has been an intensified effort to conduct more COVID-19 molecular studies using blood samples and other specimens, but high demand has caused global shortages in reagents, leading to more delays. The WHO also cites significant limitations to testing in low- and middle-income areas.

WHO’s lab testing strategy recommendations for coronavirus require countries without adequate testing capacity to send specimens of suspected coronavirus-positive subjects to WHO labs. Several companies have developed home-based test kits to enable patients to collect their own samples at home and return their specimens to designated labs for testing.

Different Approaches to Specimen Collection for COVID-19 Studies

Researchers at the National Institutes of Health (NIH) and other organizations are leveraging remote blood collection tools like Neoteryx’s Mitra Cartridge device. The FDA-listed, class 1 Mitra microsampling device is considered the gold standard for collecting the precise volume of blood samples to be used by scientists in serological tests performed on the blood serum.

For serology studies, researchers analyze the blood samples for antibodies to the novel coronavirus. The presence of antibodies in a blood sample indicates that a person was previously infected with SARS-CoV-2 and recovered. In many cases, a person may not have realized they had the infection. This information is critical to understanding the spread of the disease and how many undetected cases have occurred. Blood sample studies also provide information about immunity. These blood tests are unlike cotton swab saliva tests, which only identify if a person is actively infected with the virus.

Companies Providing Devices and Technology for COVID-19 Testing

In addition to Neoteryx, which developed and FDA-listed its remote microsampling technology several years ago, other companies are now joining the battle to fight COVID-19 by leveraging remote specimen sampling technologies.

Some companies have developed new home specimen collection kits per recent FDA guidelines that were updated to address the coronavirus pandemic. One company says it uses specific criteria before sending out its Coronavirus Assessment Tool Kit. The patient must answer a series of questions while consulting with a provider. If a patient needs COVID-19 swab testing and is eligible for home-based collection, their healthcare professional makes an order and the kit is mailed to their homes.

With this COVID test, a sample of saliva is taken from inside the cheek or roof of the mouth instead of the back of the throat or the nose. The patient ships the sample back to the company's lab for analysis. 

Benefits of At-Home Specimen Collection & Remote Testing

With home-based specimen collection as an option, people stay at home for self-managed sample collection, which reduces their risk of cross-contamination. In some cases, blood sampling kits are mailed to study participants by research organizations that are conducting long-term serology studies. In other cases, saliva sampling kits are mailed to patients from a lab and the patients ship their saliva specimens back to the lab for testing.

An advantage of saliva testing that uses a cheek swab is that they aren’t prone to supply chain constraints as are nasal and throat swabs. This allows companies to reach more patients.

Efficacy of At-Home Specimen Collection for COVID-19 Tests & Studies

Different types of scientific tests and studies are being conducted for COVID-19. Two types are NAAT and serological studies. NAAT (nucleic acid amplification test) detects the presence of the SARS-CoV-2 virus that causes COVID-19. Evidence shows it has a high accuracy rate.

PCR (polymerase chain reaction) helps isolate infected patients and prevent transmission, so early testing is critical. The specimen testing process takes 3-4 hours, and results are available within several days. Evidence shows PCR testing alone has a 66.7% chance of detecting coronavirus within the first week. This discovery affirms the efficacy of recently developed home-based testing kits. RT-PCT tests from a few companies indicate comparable performance between throat swab tests and home saliva collection.

Serology (blood serum) studies detect antibodies in the body. The body produces IgM and IgG antibodies to fight foreign bodies called “antigens.” Once infected with COVID-19, the body produces antibodies to fight the infection. Serology studies help identify people who have developed antibodies to the SARS-CoV-2 virus, allowing them to serve as donors to infected patients. Serology studies can also help researchers develop scientific models of the virus for further investigations, including drug studies and vaccine development.

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