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FAQ’s
Inspire COVID-19 Testing Solution Questions
For an additional fee, Inspire Diagnostics will staff large testing groups as needed. e.g. Back to School scenarios.
No. The rapid tests we offer are intended for use in point-of-care settings. Therefore, testing processes and specimen collection are very straight-forward and can easily be administered by customer in-house medical personnel such as School Nurses or Company on-site Medical Resources.
Depending on your specific needs, we can deliver a tailored COVID-19 testing solution which includes any or all of the following components: Rapid COVID-19 test kits and if required, analyzer devices, PCR testing service for confirmatory testing, cloud-based test management platform to facilitate large scale deployments, mobile app for self-service test report access and test scheduling, turnkey mobile on-site testing service, available application integration with client’s enterprise management systems.
Our system is completely HIPAA-compliant to ensure the privacy of your employees’ test results.
Test results will be reported to the customer’s designated healthcare professional via our Inspire Community Health cloud-based application. Test results can also be delivered directly to each individual test subject via this same platform through a HIPAA-compliant mobile app. Test results can be “pushed” electronically to other platforms as needed.
As a point-of-care test, we expect that the FDA’s Emergency Use Authorization will allow the test to only be administered by organizations that are either certified or waived under the CLIA (Clinical Laboratory Improvement Amendments) regulations which are enforced by the federal government, specifically the Centers for Medicare and Medicaid Services (CMS). The Inspire Community Health Testing Program will be administered by technicians with the required state and federal certifications.
Yes, for convenience and comfort, Inspire Diagnostics has test kits which are saliva-based only requiring test subjects provide sputum in a collection tube. The process is easy to explain, apply and can be adaptively supported by parents, teachers and administrators.
We have established a strategic partnership with the manufacturers of our point-of-care test kits in order to ensure availability of test kits to meet our clients’ needs. We do not currently anticipate any shortages.
The cost of the program may vary based on the testing strategy and frequency. However, the program can be tailored considering your financial objectives.
There is not a one-size-fits-all approach to testing. Testing strategies and frequency will vary based on the characteristics of the various segments of your workforce/community as well as by industry/sector. Based on input from Inspire’s expert medical advisory team, we will work with you to devise the optimal testing approach that considers your specific requirements and constraints as well as the best practices recommended by our experts.
Our rapid antigen test has a sensitivity (true positive rate) of 88.3% and a specificity (true negative rate) of 100%. Our point-of-care antibody test can identify positive and negative results with an accuracy of 96-97%.
All of our available tests are either currently approved under the FDA’s Emergency Use Authorization (EUA) or are pending FDA EUA approval. Tests that are pending EUA have been submitted to the FDA by the manufacturer and are in review by the FDA. In accordance with FDA regulations, tests that are pending EUA approval can be distributed and used in the U.S. under the supervision of a high complexity CLIA licensed laboratory. Inspire Diagnostics has partnered with a number of CLIA laboratories to administer any tests that require such oversight.
Our Access Bio CareStart COVID-19 Rapid Antigen Test is currently FDA EUA Approved for use in point-of-care settings under a CLIA certificate of waiver. Our Boditech COVID-19 Rapid Antibody Test is currently pending FDA EUA approval.
General COVID-19 Testing Questions
Unless otherwise required by state or federal law, for health protection reasons, no Test Kit cancellations can be accepted after such Test Kit has shipped.
If your Test Kit has not shipped, then you may cancel your Order by contacting us at shipping@inspirediagnostics.com. In such case, we will reimburse you all payments received as soon as practicable, but not later than fourteen (14) days from the cancellation date using the same means of payment as you used for the initial payment.
Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens including influenza viruses. Rapid antigen tests perform best when the person is tested in the early stages of infection with SARS-CoV-2 when viral load is generally highest. The FDA cites rapid antigen tests can be used for screening testing in settings in which repeat testing could quickly identify persons with SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission. Further, in such setting, immediate results with antigen tests can be more valuable even though they may have lower sensitivity than PCR tests, especially when rapid turnaround time is required.
The table below highlights some key points of differentiation between PCR and antigen tests.
Summary of Some Differences between RT-PCR Tests and Antigen Tests
| RT-PCR Tests | Antigen Tests | |
|---|---|---|
| Intended Use | Detect Current Infection | Detect Current Infection |
| Analyte Detected | Viral RNA | Viral Antigens |
| Specimen Type(s) | Nasal Swab, Sputum, Saliva | Nasal Swab |
| Sensitivity | High | Moderate |
| Specificity | High | High |
| Test Complexity | Varies | Relatively Easy to Use |
| Authorized for Use at the Point-of-Care | Most devices are not, some devices are | Yes |
| Turnaround Time | Ranges from 15 minutes to > 2 days | Approximately 15 Minutes |
| Cost/Test | Moderate | Low |
Source: Interim Guidance for Rapid Antigen Testing for SARS-CoV2, September 4, 2020
| Rapid, Point-of–Care | At-Home Collection | Saliva Tests |
|---|---|---|
| Rapid, point-of-care tests use a mucus sample from the nose or throat, but can be analyzed at the doctor’s office or clinic where the sample is collected and results may be available in minutes. These may be molecular or antigen tests. | At-home collection tests, available only by prescription from a doctor, allow the patient to collect the sample at home and send it directly to the lab for analysis. | Saliva tests allow a patient to spit into a tube rather than get their nose or throat swabbed. Saliva tests may be more comfortable for some people and may be safer for health care workers who can be farther away during the sample collection. |
Source: Coronavirus Testing Basics, CDC, July 2020
There are three different types of tests – molecular, antigen and antibody tests. The most common molecular test is the polymerase chain reaction (PCR) test. Molecular and antigen tests are both considered to be diagnostic tests.
A PCR or antigen test is used to identify an active coronavirus infection. PCR tests detect the COVID-19 virus’ genetic material. The antigen test detects proteins on the surface of the virus.
The antibody tests looks for antibodies that are made by a person’s immune system in response to a COVID-19 infection. According to the FDA, antibodies most commonly become detectable 1–3 weeks after symptom onset, at which time evidence suggests that infectiousness likely is greatly decreased and that some degree of immunity from future infection has developed. Antibody tests are commonly used to determine if the test subject has previously had a COVID-19 infection.
The table below summarizes the primary types of COVID-19 tests.
Coronavirus Tests
| Molecular Test | Antigen Test | Antibody Test | |
|---|---|---|---|
| Also known as: | Diagnostic test, viral test, molecular test, nucleic acid amplification test (NAAT), RT-PCR test, LAMP test | Rapid diagnostic test (some molecular tests are also rapid tests) | Serological test, serology, blood test, serology test |
| How the sample is taken: | Nasal or throat swab (most tests)
Saliva (a few tests) |
Nasal or throat swab
Saliva (from Inspire Health |
Finger stick or blood draw |
| How long it takes to get results: | Same day (some locations) or up to a week | One hour or less
Approximately 15 minutes |
Sam day (many locations) or 1-3 days
Approximately 15 minutes |
| Is another test needed: | This test is typically highly accurate and usually does not need to be repeated. | Positive results are usually highly accurate, but negative results may need to be confirmed with a molecular test. | Sometimes a second antibody test is needed for accurate results. |
| What it shows: | Diagnoses active coronavirus infection | Diagnoses active coronavirus infection | Shows if you’ve been infected by coronavirus in the past |
| What it can do: | Show if you ever had COVID-19 or were infection with the coronavirus in the past. | Definitely rule out active coronavirus infection. Antigen tests are more likely to miss an active coronavirus infection compared to a molecular tests. Your health care provider may order a molecular test if your antigen test shows a negative result but you have symptoms of COVID-19 | Diagnose active coronavirus invection at the time of the test or show that you do not have COVID-19 |
Source: Coronavirus Testing Basics, CDC, July 2020
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