CNET:

Coronavirus Home Test Kits: These are the Tests Available Now

Mercey Livingston & Amanda Capritto
October 14, 2020

During the first few months of the coronavirus pandemic, COVID-19 tests were in extremely short supply. You needed a doctor’s order to get tested and to get those orders, you had to meet specific criteria, such as having a fever and showing other COVID-19 symptoms.

The US isn’t struggling as much now with a shortage of coronavirus test kits and related supplies, thanks partly to the advent of at-home testing. These tests — of which there are now eight authorized for use — eliminate the need for someone who is feeling sick to go to a testing site or clinic, which in turn means that fewer people are exposed to the virus.

More than half a year into the pandemic, testing remains a crucial element of slowing the spread, because it identifies people who are carrying the virus, both those who are ill and those who aren’t exhibiting any symptoms. Once people are aware that they are infected, they can take the proper measures to avoid others to prevent exposure.

Medical testing companies started developing coronavirus home test kits back in March, but the Food and Drug Administration was initially slow to authorize them, warning consumers of potentially fraudulent tests. As the pandemic wore on, the FDA began issuing emergency use authorizations, or EUAs, to help increase the total number of available tests. As of October, just about anyone can order an at-home coronavirus test with just a few clicks.

Here’s what to know about at-home test kits, the FDA’s stance, and how to get tested if you have symptoms of COVID-19 or think you’ve been exposed. There are currently two types of tests available for home use: swab tests and saliva tests.

A man wearing a protective face mask reacts as a doctor takes a swab from his nose to test for the coronavirus.

Doctor takes a swab from his nose to test for the coronavirus | PHOTO: ANUSHREE FADNAVIS/REUTERS

CNET:

Coronavirus Home Test Kits: These are the Tests Available Now

Mercey Livingston & Amanda Capritto
October 14, 2020

During the first few months of the coronavirus pandemic, COVID-19 tests were in extremely short supply. You needed a doctor’s order to get tested and to get those orders, you had to meet specific criteria, such as having a fever and showing other COVID-19 symptoms.

The US isn’t struggling as much now with a shortage of coronavirus test kits and related supplies, thanks partly to the advent of at-home testing. These tests — of which there are now eight authorized for use — eliminate the need for someone who is feeling sick to go to a testing site or clinic, which in turn means that fewer people are exposed to the virus.

More than half a year into the pandemic, testing remains a crucial element of slowing the spread, because it identifies people who are carrying the virus, both those who are ill and those who aren’t exhibiting any symptoms. Once people are aware that they are infected, they can take the proper measures to avoid others to prevent exposure.

Medical testing companies started developing coronavirus home test kits back in March, but the Food and Drug Administration was initially slow to authorize them, warning consumers of potentially fraudulent tests. As the pandemic wore on, the FDA began issuing emergency use authorizations, or EUAs, to help increase the total number of available tests. As of October, just about anyone can order an at-home coronavirus test with just a few clicks.

Here’s what to know about at-home test kits, the FDA’s stance, and how to get tested if you have symptoms of COVID-19 or think you’ve been exposed. There are currently two types of tests available for home use: swab tests and saliva tests.

A man wearing a protective face mask reacts as a doctor takes a swab from his nose to test for the coronavirus.

Doctor takes a swab from his nose to test for the coronavirus | PHOTO: ANUSHREE FADNAVIS/REUTERS

Types of At-Home COVID-19 Tests Available

Saliva Tests

spectrum-solutions-covid-19-saliva-collection-kit-06

The Spectrum Solutions saliva collection device used for at-home saliva tests. © Spectrum Solutions

Much like taking a DNA test, saliva tests have you spit into a tube, seal it and send to a lab. These tests aren’t invasive and can easily be done at home, which helps protect health care professionals from being exposed to the coronavirus at testing sites, and reduces the demand for personal protective equipment.

On April 13, the FDA granted Rutgers University’s RUCDR Infinite Biologics biorepository emergency authorization for a new method it developed to test saliva samples for the coronavirus. It wasn’t until May 8 that the FDA authorized Rutgers Clinical Genomics Laboratory to actually start testing samples of saliva collected at home for the coronavirus, using collection kits from Spectrum Solutions. This was the first at-home diagnostic test using saliva samples, and it originally could only be obtained with a prescription from a doctor. Now, all you have to do is take an assessment that asks about your symptoms.

Following that authorization from the FDA, two companies, Vault Health and 1Health.io (the parent company of Vitagene), announced plans to sell the saliva tests for at-home use under supervision from a doctor through telemedicine. Both tests are now available without telemedical approval and use the Spectrum Solutions Saliva Collection Kits.

Saliva tests are much less invasive, less uncomfortable, and pose less risk for health care providers — so why did it take so long to approve them? The FDA needed to make sure the samples could provide the same level of accuracy as nasal swabs. When it comes to concerns over how the saliva tests perform compared to nasal swabs, the research is promising.

Yale Public Health researchers published preliminary research in April that showed saliva tests were just as accurate — and sometimes even more accurate — than nasal swab tests. Since then, more studies have repeated and confirmed those findings.

Types of At-Home COVID-19 Tests Available

Saliva Tests

spectrum-solutions-covid-19-saliva-collection-kit-06

The Spectrum Solutions saliva collection device used for at-home saliva tests. © Spectrum Solutions

Much like taking a DNA test, saliva tests have you spit into a tube, seal it and send to a lab. These tests aren’t invasive and can easily be done at home, which helps protect health care professionals from being exposed to the coronavirus at testing sites, and reduces the demand for personal protective equipment.

On April 13, the FDA granted Rutgers University’s RUCDR Infinite Biologics biorepository emergency authorization for a new method it developed to test saliva samples for the coronavirus. It wasn’t until May 8 that the FDA authorized Rutgers Clinical Genomics Laboratory to actually start testing samples of saliva collected at home for the coronavirus, using collection kits from Spectrum Solutions. This was the first at-home diagnostic test using saliva samples, and it originally could only be obtained with a prescription from a doctor. Now, all you have to do is take an assessment that asks about your symptoms.

Following that authorization from the FDA, two companies, Vault Health and 1Health.io (the parent company of Vitagene), announced plans to sell the saliva tests for at-home use under supervision from a doctor through telemedicine. Both tests are now available without telemedical approval and use the Spectrum Solutions Saliva Collection Kits.

Saliva tests are much less invasive, less uncomfortable, and pose less risk for health care providers — so why did it take so long to approve them? The FDA needed to make sure the samples could provide the same level of accuracy as nasal swabs. When it comes to concerns over how the saliva tests perform compared to nasal swabs, the research is promising.

Yale Public Health researchers published preliminary research in April that showed saliva tests were just as accurate — and sometimes even more accurate — than nasal swab tests. Since then, more studies have repeated and confirmed those findings.

Swab tests

Swab tests require you to swab the inside of your nose or cheek to collect a sample that can be tested for the coronavirus. While many swab tests at testing sites collect a sample from deep in your nasal passage, at-home versions are less invasive.

The FDA authorized the first at-home test kit, Pixel by LabCorp, on April 21. The FDA worked with LabCorp to develop the test and said it’s as accurate as a sample taken by a doctor. The test is performed with a special swab enclosed in the kit that the patient uses to take a sample from the nasal passage, and then you mail your sample back to LabCorp.

Initially, this test required a doctor’s orders to purchase, but it has since become available to everyone who takes a short assessment.

Spectrum Solutions Manufactures Only FDA Authorized Saliva Collection Device for COVID-19 Testing Integration

Spectrum Solutions Manufactures First FDA Authorized Saliva Collection Device for COVID-19 Testing Integration

AT-HOME COVID TEST KITS YOU CAN BUY NOW

Test Name Testing Service or Lab  Type of Test Price
Pixel by Labcorp LabCorp Lower nasal swab Bills insurance
LetsGetChecked PrivaPath Diagnostics Lower nasal swab $119
Everlywell Everlywell Lower nasal swab $109
Vault Vault Health, Spectrum Solutions, RUCDR Infinite Biologics Saliva sample $150
Vitagene Vitagene Saliva sample $129
Picture Fulgent Genetics Lower nasal swab $119
Hims and Hers Rutgers RUCDR Infinite Biologics Saliva sample $150
Phosphorus Phosphorus Diagnostics Saliva sample $140

Swab tests

Swab tests require you to swab the inside of your nose or cheek to collect a sample that can be tested for the coronavirus. While many swab tests at testing sites collect a sample from deep in your nasal passage, at-home versions are less invasive.

The FDA authorized the first at-home test kit, Pixel by LabCorp, on April 21. The FDA worked with LabCorp to develop the test and said it’s as accurate as a sample taken by a doctor. The test is performed with a special swab enclosed in the kit that the patient uses to take a sample from the nasal passage, and then you mail your sample back to LabCorp.

Initially, this test required a doctor’s orders to purchase, but it has since become available to everyone who takes a short assessment.

AT-HOME COVID TEST KITS YOU CAN BUY NOW

Test Name Testing Service or Lab  Type of Test Price
Pixel by Labcorp LabCorp Lower nasal swab Bills insurance
LetsGetChecked PrivaPath Diagnostics Lower nasal swab $119
Everlywell Everlywell Lower nasal swab $109
Vault Vault Health, Spectrum Solutions, RUCDR Infinite Biologics Saliva sample $150
Vitagene Vitagene Saliva sample $129
Picture Fulgent Genetics Lower nasal swab $119
Hims and Hers Rutgers RUCDR Infinite Biologics Saliva sample $150
Phosphorus Phosphorus Diagnostics Saliva sample $140
Spectrum Solutions Manufactures Only FDA Authorized Saliva Collection Device for COVID-19 Testing Integration

Spectrum Solutions Manufactures First FDA Authorized Saliva Collection Device for COVID-19 Testing Integration

CNET-Coronavirus Home Test Kits-Spectrum Solutions

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Who is Spectrum Solutions?

Headquartered in Salt Lake City, Utah, Spectrum Solutions is a life science and medical device manufacturing company that focuses its fully-integrated industry expertise on creating forward-looking and scalable end-to-end solutions for clinical diagnostic projects and commercialized product plans. Spectrum is a single-source provider of innovative medical device engineering & product manufacturing, molding, chemical formulation, packaging design, customized kitting, & direct-to-user fulfillment. Its bio-sample collection devices, patented technologies, and dedicated services deliver measurable process optimization, unprecedented efficiency, and unmatched global scalability.

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Leslie Titus Bryant Spectrum Solutions SpokesmanSpectrum Corporate Spokesman
Leslie Titus Bryant
Director of Marketing & Brand
admin@spectrumsolution.com

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Tim Rush, Springboard5
801-208-1100
tim.rush@springboard5.com

Get to Know Our #PartoftheSolution

Who is Spectrum Solutions?

Headquartered in Salt Lake City, Utah, Spectrum Solutions is a life science and medical device manufacturing company that focuses its fully-integrated industry expertise on creating forward-looking and scalable end-to-end solutions for clinical diagnostic projects and commercialized product plans. Spectrum is a single-source provider of innovative medical device engineering & product manufacturing, molding, chemical formulation, packaging design, customized kitting, & direct-to-user fulfillment. Its bio-sample collection devices, patented technologies, and dedicated services deliver measurable process optimization, unprecedented efficiency, and unmatched global scalability.

#partoftheSolution

Leslie Titus Bryant Spectrum Solutions SpokesmanSpectrum Corporate Spokesman
Leslie Titus Bryant
Director of Marketing & Brand
admin@spectrumsolution.com

Tim Rush Public Relations, Springboard 5Media Contact
Tim Rush, Springboard5
801-208-1100
tim.rush@springboard5.com

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Health is a dynamic state of wellbeing. Healthcare providers and researchers have long believed that changes in our saliva record our ongoing state-of-health story. This encrypted source of individual truth, and how to best use it, delivers us all a quicker path to informed decisions and treatments free of adverse reactions.

Interestingly, saliva acts as a wide resource of genomic information useful for identifying and monitoring in real-time a disease as well as its state of progression. Additionally, saliva analysis looks at the cellular level, the biologically active compounds, making saliva a true representative of what is clinically relevant.

Spectrum’s technically-superior saliva collection systems have not only been engineered to lead the saliva collection industry in molecular diagnostics and clinical research applications but deliver the safest, most robust biomaterial for the earliest detection and diagnosis of disease and infection.

  • Saliva provides the earliest path to critical detection and diagnosis
  • First EUA authorized saliva collection device for COVID-19 testing & authorized device for direct-to-patient at-home sample self-collection
  • Used in supervised & unsupervised sample collection LDT workflows of symptomatic & asymptomatic users
  • Pain-free, non-invasive, & safe – ideal for those needing frequent & repeat testing
  • In-device live virus inactivation at ambient temps (COVID-19 EUA validated data)
  • Eliminates any need for hood containment offering immediate sample processing upon arrival
  • Removes the need for any temperature-controlled storage or transport of samples 
  • Single device for DNA & viral RNA applications 
  • Safest collection approach & most robust biomaterial for detecting COVID-19
  • Delivers 99.998% highest levels of testing accuracy & sensitivity
  • Formulation identifies infections at its earliest stage from as few as 200 copies/ml (lateral flow rapid tests need 10,000-20,000 copies/ml)
  • A single preserved saliva sample provides opportunity for multiple tests
  • Over 10 days of post-collection stability with no degradation in sample efficacy
  • System maintains critical bio-sample consistency 
  • Mass-testing scalability & easy device integration using validated and supported processes
  • Mitigates any risk of infection throughout the testing process 
  • Pinpoint life-cycle stage of active viral infection
  • Eliminate UN3373 biohazard shipping designation with clearance from USPS, FedEx, & UPS
  • Delivers the highest levels of testing accuracy using qualified extraction chemistries
  • Chemistry enables easy extraction & purification for a maximum sensitivity boost
  • Proteins present in blood are also present in saliva from fluid leakage at the gum line
  • Saliva contains the entire library of proteins, hormones, antibodies, and other molecular compounds measured in routine blood tests
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