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COVID-19 Testing

Testing is the biggest challenge in the US. New tests are being launched every day.

Here’s how to think about it.

RT-PCR (Reverse Transcription – Polymerase Chain Reaction)
  • Gold standard for accurately diagnosing COVID-19, per CDC and FDA
  • Detects presence or lack of virus RNA in a test sample
  • Tests run on large, expensive instruments in highly certified diagnostic labs
  • Samples can be collected using various devices across the anatomy

Examples:
+ Nasopharyngeal sample collected using a long flocked swab.
+ Short swabs of the front of the nostril and mid-nostril, per UnitedHealth Group study.
+ New Saliva sample collection addresses supply chain challenges.

POCT (Point of Care Tests) Molecular Diagnostic Tests
  • Tests use molecular diagnostics to detect presence of genetic material from virus
  • Tests are run on analyzers about the size of a toaster in the hospital or physician’s office
  • Samples are run one at a time and results can be obtained in five minutes to one hour

Examples:
+ Detect COVID-19 in as little as 5 minutes.
+ Combating the coronavirus pandemic – rapid test for COVID-19.

POCT (Point of Care Tests) Molecular Diagnostic Tests
  • Tests use molecular diagnostics to detect presence of genetic material from virus
  • Tests are run on analyzers about the size of a toaster in the hospital or physician’s office
  • Samples are run one-at-a-time and results can be obtained in five minutes to one hour

Examples:
+ Detect COVID-19 in as little as 5 minutes.
+ Combating the coronavirus pandemic – rapid test for COVID-19.

Semi-Quantitative Serology (IgM/IgG/IgA) Tests
  • Determines whether an Immunoglobulin (IgG/IgM/IgA) antibody is present
  • Test is conducted on standard ELISA laboratory analyzers
  • Requires blood samples collected via venipuncture or fingerstick
  • Tests are more accurate and more expensive than rapid test strips

Examples:
+ Description of serology assays.
+ Major lab offering.
+ BioIQ Offering.

Rapid IgG/IgM Tests
  • Determines whether an immunoglobulin (IgG/IgM) antibody is present
  • Immunoglobin protects against bacterial and viral infections
  • Tests provide results from a drop of blood in as little as five minutes
  • Tests are less accurate than RT-PCR tests and cannot be used to diagnose COVID-19.
  • Tests are less expensive than tests run on laboratory equipment (RT-PCR or POCT)

Examples:
+ UK coronavirus home testing to be made available to millions – The Guardian.
+ Test widely used in South Korea.

Rapid IgG/IgM Tests
  • Determines whether an immunoglobulin (IgG/IgM) antibody is present
  • Immunoglobin protects against bacterial and viral infections
  • Tests provide results from a drop of blood in as little as five minutes
  • Tests are less accurate than RT-PCR tests and cannot be used to diagnose COVID-19
  • Tests are less expensive than tests run on laboratory equipment (RT-PCR or POCT)

Examples:
+ US companies, labs rush to produce blood test for coronavirus immunity – The NY Times.
+ UK coronavirus home testing to be made available to millions – The Guardian.
+ Test widely used in South Korea.

Do I have the virus?

RT-PCR Testing

Lab or Point of Care Testing

Sample collection types include:

  • Nasopharyngeal flocked swab
  • Mid-nostril short swab (mid-turbinate)
  • Nostril swab (anterior nares)
  • Saliva specimen

Did I have the virus?

Antibody Testing (IgM/IgG)

Lab or Rapid Test Strip

Sample collection types include:

  • Venipuncture (whole blood or serum)
  • Fingerstick

Sensitivity of Key Biomarkers for COVID-19

Testing Models

These tests all have beneficial clinical uses and can be done in a variety of settings for a variety of purposes. They can even be combined depending upon what you would like to test for. Testing models and locations include:

Home Self-Collection

Saliva or nasal samples are collected with or without telehealth oversight and sent to the lab for RT-PCR testing.

Testing Tent

A sample is collected and sent to the lab for RT-PCR testing or a POCT test is completed.

Drive-Through

Can be a combination of rapid IgG/IgM and/or sample collection for RT-PCR testing.

Home Visit

A sample is collected by a clinician and sent to the lab for RT-PCR testing.

Worksite

Nurses or clinicians leverage worksite areas or occupational medicine clinics for sample collection for RT-PCR and/or antibody testing.

Test Comparison

 

Test Description Source Technician Uses Pros Cons Notes
RT-PCR
(Reverse Transcriptase – Polymerase Chain Reaction)
Extracts and amplifies the amount of RNA, then compares it to standard

Nasal/oral swab (flocked or newer synthetic)

Bronchia/alveolar lavage

Trained clinican

Acute illness screening and testing

Virus exposure, carriage

Gold standard

Lab high sensitivity

Clinical high sensitivity

Experience with test

Turnaround time

Equipment and skilled staff needed

Central lab needed

Expensive

Specificity unknown in current clinical situations – concern re: false negative rate

Working on alternative collection methods

Point of Care Molecular Testing (POCT) Extracts and amplifies the amount of RNA, then compares it to standard

Nasal/oral swab (flocked or newer synthetic)

Bronchia/alveolar lavage

Acute illness screening and testing

Virus exposure, carriage

 

Utilizes recommended molecular diagnostic testing principles

Results obtained in 15-45 minutes

Limited sensitivity/specificity

Serial testing limits capacity to 1-4 tests per hour

Leading devices have generated concerns regarding safety (to lab personnel) and accuracy
Rapid Point of Care Antibody Testing (POCT)

IgM/IgG qualitative antigen testing (various tests in development)

Use drop of blood (from a fingerstick) in as little as five minutes

Variable sources; blood at the moment is main source

Point-of-care admin and result

Acute illness screening and testing, indicates if you have been exposed

Quick

Rapid turnaround

Doctor’s office or locality based testing

Potentially scalable at clinician-office level

No experience at scale

Unknown clinical sensitivity and specificity

Not applicable for “immunity” testing

Can be used as a screening test to be followed with confirmatory test if needed
Semi-Quantitative Antibody Testing Blood/serum assay for IgM and/or IgG using serology or EUSA testing

Blood or serum

Technician/physician

Acute exposure and illness

Can test immune response and suggest acute reason for illness

May suggest immunity as research evolves and with serial testing over time

Actual concurrent viral load and infectability uncertain Immunity may not be long lasting

To learn more about the BioIQ COVID-19 Solution, click here or call 888-818-1594.