Coronavirus tests – Review of at-home COVID-19 testing [JULY 2020]

Coronavirus Overview

This blog post is an introduction to coronavirus testing and a review of at-home coronavirus tests.

The first case of a newly discovered coronavirus was diagnosed in late 2019.  Now called COVID-19 (coronavirus disease 2019), the World Health Organization declared the outbreak a pandemic in March 2020 as it became a major public health emergency. Caused by the virus SARS-CoV-2, COVID-19 is a respiratory illness. It spreads through an infected person’s respiratory droplets when they cough, sneeze or talk in close proximity to a healthy person. Person to person contact occurs easily when individuals are within 6 feet (2 meters) of each other. Spread through contaminated surfaces is possible, but not considered the most likely cause of transmission. Careful and frequent hand washing and facial mask are strongly recommended to reduce infection risk.

Some people present only a few symptoms or no symptoms at all. Most cases of COVID-19 are mild or even asymptomatic while others can be severe. Symptoms typically appear 2-14 days after exposure (incubation period) to the virus and may include fever, cough, shortness of breath, and fatigue.

Patients with mild cases are encouraged to self-isolate at home and contact a medical provider. Severe cases most often require hospitalization. Older adults and persons with underlying health conditions may be at especially higher risk for more serious illnesses and complications and to require hospitalization. In fact, the spread of COVID-19 in nursing homes has been a critical challenge to the public health system that attempts to save lives and protect people.

As of June 2020, there is no vaccine or specific treatment for COVID-19. That means that the only way to prevent the spread is to protect yourself from exposure. The proper use of cloth face masks and social distancing are the basic means to achieve this goal. If you do get sick with COVID-19, the CDC (Center for Disease Control and Prevention; CDC website) asks that you stay home, keep yourself isolated from others in your household, and call ahead when needing to go out for medical treatment. 

To date there are over 3 million reported cases and over 100,000 deaths in the USA alone.

History of Testing

Symptoms of COVID-19 do not appear 2-14 days after exposure. Slowing the spread has been difficult partly because people without COVID-19 symptoms can spread the virus simply by talking and releasing respiratory droplets. 

The CDC provides guidance as to who should be tested for COVID-19 but final decisions are made by state or local health departments or healthcare providers. In general, testing for SARS CoV-2 is mostly recommended to high-risk patients who:

• Are 65 years or older
• Have severe symptoms
• Are immunocompromised
• Have underlying medical conditions
• Are healthcare workers

Testing is also recommended for those in close contact with a person who has tested positive for COVID-19, known as community testing.

The CDC recommends that patients consult with their health care provider to determine if they are eligible for COVID-19 testing. The provider will typically discuss symptoms and possible risks of exposure before making a referral for a COVID 19 test. 

Patients often ask where to find coronavirus testing near me. All COVID-19 testing was initially performed primarily at hospitals and clinics. Lately, drive-thru test sites have been popping up in an effort to reduce contact between possibly infected people and others. 

Most drive-thru sites still require pre-screening, an appointment, and a referral from a doctor. However, the options of where to get tested for coronavirus have expanded. Drive-thru sites can be found in a variety of locations including retail stores like Walmart and CVS and urgent care facilities. 

For people with insurance, COVID-19 testing at any testing site is free. The Families First Coronavirus Response Act requires private and federal insurance companies to pay for FDA-approved testing. The Coronavirus Aid, Relief, and Economic Security (CARES) Act extends this coverage to include testing not yet approved by the FDA.

Federal funding also allows the Department of Health and Human Services and states with Medicaid to provide free testing to those who are uninsured or have short-term health insurance.

At the start of the COVID-19 pandemic, not enough testing kits were available for the people who needed them. Hence, anyone with symptoms was considered to possibly have COVID-19. There are a number of reasons why such assumptions are insufficient and why COVID-19 testing is vitally important. Testing allows for identification of cases, treatment for the patient, and isolation to prevent further spread. Specifically, testing allows for:

• Treatment for people who are infected
• Characterization of the prevalence and spread of the virus
• Determination of who has had the virus and has recovered
• Contact tracing – determining who has been in contact with an infected individual   
• Possible determination of population immunity

Testing Types

As of June 2020, testing is becoming more accessible. Currently, there are two types of COVID-19 tests: tests for current infections (viral tests, also called RT-PCR tests) and tests that show for previous infections (antibody tests, also called serology tests).  

Viral Coronavirus Tests

There are two types of coronavirus tests (molecular and antigen diagnostic tests) that can diagnose patients as positive or negative for an active infection. Persons who think they currently have COVID-19 or have been in close contact with someone who tested positive should consult with a medical provider to see whether one of these tests is appropriate. 

A molecular test detects the virus’s genetic material while an antigen test detects proteins on the virus’s surface. Laboratories that conduct testing must be Clinical Laboratory Improvement Amendments (CLIA) approved labs or be point-of-care testing by facilities operating under a CLIA Certificate of Waiver. The CDC recommends individuals should only use molecular or antigen tests that have been approved by the FDA Emergency Use Authorization (EUA).

Molecular Coronavirus Tests

Molecular tests are the most accurate way to test for an active COVID-19 infection. An individual provides a nasal or throat swab for testing at an approved laboratory. Laboratory professionals extract genetic material from the sample, convert viral RNA to DNA, and use PCR to amplify the DNA into millions of copies. A chemical probe is mixed with the DNA and DNA binding to the probe indicates a positive test result for infection with the virus that causes COVID-19. 

Since the patient sample must be tested in a laboratory, it can take anywhere from a day to a week to process the results.  

Some tests now use saliva instead of a nasal or throat swab. 

Antigen Coronavirus Tests

Antigen tests are considered coronavirus rapid tests because they can be processed quicker than molecular tests. They are also less expensive. The test detects fragments of proteins found on or within the virus. 

An individual provides a nasal or throat swab. A laboratory professional submerges the sample in a liquid that releases the virus. They place the liquid on a test slide containing one set of COVID-19 specific antibodies and then cover the liquid with another mixture of antibodies. If COVID-19 proteins are present, they will be held in place by the first set of antibodies and able to be detected with the human eye with the second set. Results are usually available within an hour or less. 

Although antigen tests are quicker and less expensive than molecular tests, they have a higher chance of missing a positive infection. Because of this, health care professionals consider positive results as accurate but usually confirm negative results with a molecular test. 

Antibody Coronavirus Tests

A coronavirus antibody test can determine if a patient has been infected by COVID-19 in the past. They detect antibodies, proteins in the immune system that develop after an active infection. It can take 1-3 weeks after infection for enough antibodies to build up to be detected by a test. Therefore, antibody tests are only used to detect past infections — they cannot determine whether a person currently has COVID-19. Persons who think they were exposed to or recovered from COVID-19 should consult with a medical provider to see if an antibody test would be appropriate. 

An individual provides a finger stick or blood draw. Blood tests are used to detect antibodies that the body produces in response to a virus, such as IgM and IgG, and not the virus itself. Antibodies indicate if an individual had been infected in the past. These tests are not 100% accurate and false positives and false negatives do occur. Results are available the same day as testing in many locations and in 1-3 days in others. 

Rapid coronavirus tests for antibodies are available through medical providers and laboratories. There is not enough information to determine if an individual with COVID-19 antibodies is immune to future infections. 

At-home Coronavirus Tests

Most people can get a coronavirus test at their doctor’s office. However, there are also multiple companies that offer at-home COVID-19 testing kits that have been approved under the FDA’s Emergency Use Authorization (EUA):

• Pixel by LabCorp
• EverlyWell
• Veritas Genetics
• Vault Health
• Vitagene
• hims & hers

Scanwell Health is in the process of validating an antibody at-home blood test.

Here want to review these tests and answer frequently asked questions about at-home COVID-19 testing.

Pixel by LabCorp Coronavirus Test

Patients must fill out a screening survey before ordering the COVID-19 test. Tests requests are evaluated and authorized by an independent physician. If approved, a Pixel coronavirus test is delivered to the patient’s home. The patient collects the sample via a nasal swab and sends it to a  CAP-accredited and CLIA-certified LabCorp laboratory. A molecular viral test detects nucleic acid from the SARS-CoV-2 virus. Patients can access results online through their secure Pixel by Labcorp account 24-48 hours after the sample is received at the lab. Pixel by Labcorp provides an opportunity to talk with a licensed physician after the patient receives their results. 

The Pixel by LabCorp test costs $119 but the company does not require an upfront payment. They will either seek reimbursement from insurance or from the government for the uninsured.

EverlyWell Coronavirus Test

Patients must fill out a screening survey before ordering the COVID-19 test. If approved by an independent physician, an EverlyWell coronavirus test is delivered to the patient’s home. The patient collects the sample via nasal swab and sends it to Fulgent Therapeutics and Assurance Scientific Laboratories for testing. A molecular viral test detects nucleic acid from the SARS-CoV-2 virus. Patients will be sent their results online 24-48 hours after the sample is received by the lab. If the test is positive, EverlyWell provides a telehealth consult to assist patients in treatment and the next steps at no charge.

The Pixel by LabCorp test costs $109. HSA and FSA payments are accepted. EverlyWell cannot bill a patient’s insurance but they will provide an itemized receipt that patients can submit for reimbursement at the description of their health insurance provider.

Veritas Genetics Coronavirus Test

At this time, the Veritas Genetics at-home molecular viral test is only available to healthcare providers. It detects nucleic acid from the SARS-CoV-2 virus from a nasal swab sample.

Veritas Genetics offers a Veritas at-home coronavirus antibody test. Patients must complete a screening to determine their eligibility for the test, which will be ordered by a physician if approved. This test detects the presence of specific COVID-19 IgG antibodies in a patient’s blood sample. Patients collect a blood sample through depositing a few drops of blood on a paper and send it to a clinical laboratory for testing. Results are available through a secure online portal 48 hours after the lab receives the sample. If the test is positive, Veritas Genetics provides a telehealth consult to assist patients in treatment and the next steps at no charge.

Patients are reminded that antibody tests are not used to diagnose a current COVID-19 infection.

The Veritas Antibody Test costs $99.

Vault Health Coronavirus Test

Vault Health specializes in health plans to help men boost testosterone levels. Their coronavirus tests are designed for all patients, whether or not they identify as male. Patients must fill out an online questionnaire including symptoms, risk factors, and pertinent health history. A physician will order a Vault Health coronavirus test and ship it to the patient’s home. The patient collects a saliva sample with a Vault test supervisor over a Zoom call. The sample is sent to Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics, Rutgers University for testing. A molecular viral test detects nucleic acid from the SARS-CoV-2 virus. Results are available through a secure online portal 48-72 hours after the lab receives the sample. 

The Vault test costs $150. HSA and FSA payments are accepted. Vault cannot bill insurance companies. Upon request, they will provide an itemized receipt that patients can submit for reimbursement at the description of their health insurance provider.

Vitagene Coronavirus Test

Patients must fill out a screening survey before ordering the COVID-19 test. If approved by an independent physician, a Vitagene coronavirus test is delivered to the patient’s home. This test is also available to health care providers, local governments, and essential businesses. The patient collects a saliva sample in the provided tube and returns it in a prepaid mailer. The sample is tested at one of Vitagen’s partner laboratories operating under the Emergency Use Authorization guidelines of the FDA. A molecular viral test detects nucleic acid from the SARS-CoV-2 virus. Results are available through a secure online portal 72 hours after the lab receives the sample. Vitagene provides a telehealth consult to assist patients in treatment and the next steps at no charge.

The Vitagene test costs $129. HSA and FSA payments are accepted. Vitagene cannot bill insurance companies but they note that further insurance may cover the cost of the test if prescribed by a doctor.

hims & hers Coronavirus Test – NO LONGER AVAILABLE

Patients fill out an online questionnaire including health and symptoms and consult with a medical provider to determine if they are eligible to order the hims and hers coronavirus test. The patient collects a saliva sample, which is sent to Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics, Rutgers University. A molecular viral test detects nucleic acid from the SARS-CoV-2 virus. Results are available through a secure online portal 3-5 days after the lab receives the sample. Hims and hers provide consultation with a healthcare provider at no additional charge.

The hims and hers test costs $150. 

Scanwell Health Coronavirus Test

Scanwell Health is currently validating their coronavirus rapid test with laboratory partners and pursuing FDA EAU approval for their product. 

The Scanwell Health antibody test is an at-home blood test designed to detect COVID-19 specific antibodies in a patient’s blood. Patients fill out an online questionnaire with Lemonaid Health. If approved, a Lemonaid doctor or nurse practitioner orders the COVID-19 testing kit and delivers it to the patient’s home. Patient’s perform the blood test on the provided testing stick and share it with Lemonaid Health through a secure app. The test is interpreted by a Lemonaid Health medical professional who will respond usually within hours of receiving the test. Scanwell provides a telehealth consult to assist patients in treatment and the next steps at no charge.

Patients are reminded that antibody tests are not used to diagnose a current COVID-19 infection.

The Scanwell test will cost $70. 

Other Tests

The companies Carbon health and Nurx were producing nasal swab tests for COVID-19 in collaboration with third-party laboratories. Carbon Health offers testing at its physical locations but is not producing at-home tests at this time. According to its website, Nurx has stopped new testing and consultation tests.  

The quality and integrity of the at-home samples during shipping are not entirely known and concerning for some medical professionals. Many companies, including Everlywell, Vault, and Vitagene have made claims of testing sensitivity between 98 – 99.99%.

Another company that offers at-home coronavirus testing is LetsGetChecked.  

*Does not require an upfront payment. They will either seek reimbursement from insurance or from the government for the uninsured.

**Requires an upfront payment, but may be reimbursed by most insurance