20 minute CoronaVirus Infectiousness Screening test - INNOVA RAPID ANTIGEN: 95% Sensitive and 99.68% Specific for currently infectious individuals with higher viral loads.
Who Provides the end to end service?
This screening service is provided by CHHP, a UK government approved UKAS applicant COVID-19 testing provider in the UK, and a CQC Registered diagnostics and screening provider since 2007. Certific is the remote test certification provider to CHHP. Service pending regulatory review.
Which test is used in the service?
The test CHHP is using in this service is the Innova Rapid Antigen Lateral Flow Test. This is one of the devices repurposed by public health authorities for the National Testing Programme, that has been authorised for home-use in schools, for healthcare workers and businesses. The test is CE-Marked as a Point of Care IVD and its performance in symptomatic patients has been independently verified by the UK Government Lab at Porton Down 11 Nov 2020: https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-patients-the-public-and-professional-users-a-guide-to-covid-19-tests-and-testing-kits . Service pending regulatory review.
How accurate is the test?
In ideal conditions with experienced professionals taking the sample and processing the test the test is expected to detect >97% of those who are currently highly infectious (usually those with symptoms) who are PCR Positive. The percentage of false positives (a positive test when you are not actually infected) is almost zero. We, CHHP, the UK Government, researchers and other independent groups are continually reviewing and validating the performance of tests. We do not rely on manufacturer's claims.
FULL PAPER: https://www.ox.ac.uk/sites/files/oxford/media_wysiwyg/UK%20evaluation_PHE%20Porton%20Down%20%20University%20of%20Oxford_final.pdf
IMPORTANT - When NOT to use this test: Rapid Antigen tests must never be used alone or relied upon to rule out COVID-19 infection if you suspect close contact with an infectious individual or if you are symptomatic yourself. Rapid Antigen tests are a valuable tool for finding people who would otherwise not be detected, thus helping reduce community spread together with good hygiene, distancing and mask wearing.
If you suspect contact or infection, this type of test is not appropriate, please do not take such a test yourself and assume you are clear if negative. Self-isolate and contact NHS111 immediately or an authorised private COVID-19 test provider who will order a Laboratory PCR Test or equivalent.
In simple terms, will this test tell me if I am totally clear?
No, not always. In the real-world, no test, not even the best laboratory PCR tests will reliably pick up infections in the first first 48-72 hours of incubation. Some people will incubate and remain undetectable for 10 or more days. Normally, incubation is 2-3 days. It is often not detectable then. While infection can be detected by PCR when viral load starts to rise sharply (normally at day 3, but up to two weeks), The best Rapid Antigen tests are currently only around half as sensitive at picking up infections at this stage. At this early stage someone who is rapid antigen negative, if tested properly, is much less likely to be infectious to others. At this early stage only about 5% of people will be infectious to others. It is very important to know that you can change from low infectivity to highly infectious in a matter of hours. Therefore a negative test one morning, for instance, may not be relied upon that evening or the next day. This is the reason why health care workers and school teachers are asked to test every 3-4 days. So, though not perfect by any means, the higher the frequency of testing the better.
How does Certific make testing any better?
There are lots of problem with frequently testing yourself or, for instance essential workers coming to your office or home
1. Cost: To have a medical professional ensure a proper test is conducted every time costs on average £50-£100 per test currently in the UK. Most people cannot possibly afford to do this privately as often as they would like. Certific enables health care providers to reduce their time and costs by doing most of the work that can be done by other trained professionals remotely using technology and telemedicine.
2. Convenience: It normally requires a visit to a healthcare professional or them visiting you which takes time, though it is much quicker than waiting for a Laboratory PCR result. There are rapid antigen services available as walk-in / drive-through centres in parts of the UK that is helping improve access and equality. Certific aims to bring the quality and assurance of regulated Point of Care testing (or swab-sampling for lab processing) into people's homes so they do have to take the time and risk to travel.
3. Accuracy: Test performance is worse if you are not with an experienced (and often expensive) professional in person. Providers try to help save money (for their patients too) by sending test kits to people's homes. Strictly, this is not the intended use of Point of Care professional use only test devices. Certific has been built to reduce to an absolute minimum the issues and errors of self-sampling and self-testing to make it as accurate and auditable as possible for continuous quality improvement.
4. Safety: Experienced medical professionals do not just do a test, they decide to use a test in combination with the 'clinical context' meaning the circumstances, contact history and symptoms reported by the patient. Certific asks the very same questions They then give an answer and guidance on what to do next. We also ensure that hazardous waste can be returned to us in a secure way for proper disposal free of charge. For those relying on the results of others screening at home, Certific professionally certifies the Identity of the person taking the test, the unique ID of every sampling / test kit used, the sampling technique, and the integrity of the testing process (or the sending of samples to Labs). Every one of the tests Certific certifies is reported to the relevant Public Health authority reporting systems as required by law.
- Sample type: Swab, CE-Certified for Nasal. IVD for Professional diagnostic and screening service use only.
- Sample support: In person, on site, or telemedicine support for trained individuals. This test and its interpretation is NOT intended for the general public without healthcare professional supervision.
- Test type: Point of Care Test; distributed as a home-test by UK Public Health
- Turnaround: 20 minutes
Report Includes: Certification
CHHP (a trading name of Dr Jack Kreindler Consulting Ltd) is UK Government approved for COVID-19 General and Test to Release Testing as a UKAS applicant for ISO:15189 and ISO:22870
CHHP is CQC Authorised and Regulated to provide Specialisms/Services for Diagnostic & Screening Procedures covering regulated coronavirus (COVID-19) testing https://www.cqc.org.uk/location/1-458564144
This COVID-19 RAPID ANTIGEN screening service uses the next generation of RAPID ANTIGEN viral infection tests as will be used by the UK Government 'Moonshot' testing programme. Our service using these new tests helps confirm if you are currently infectious and with professional interpretation help guide to the degree of your infectivity risk to others. A positive test followed by, we recommend, TWO clear tests 2 weeks clear of first symptoms is a strong indication of Recovery and being infection-free, but does not in any way confirm immunity to further infection or future transmission to others.
What will the COVID-19 RAPID Antigen Test result show me?
The result will be sent to one of our medical directors or senior clinicians. The test will either be POSITIVE or NEGATIVE.
What does a POSITIVE COVID-19 RAPID Antigen Test result mean?
It is extremely hard for such a test to give a false positive result. So, a positive result means that you are almost definitely infected with Coronavirus, and, as the test measures intact viral particles vs RNA (from dead or live virus as PCR measures), then the Rapid Antigen test can be better measure of how contagious or infectious your are than PCR.
If you are feeling sick & as our medical team will determine with you, then you may need to be closely monitored over a number of days. If you are not feeling unwell but have tested positive you are among the majority of people who are infected with Coronavirus and can transmit this to others through close contact or through touching shared surfaces.
What does a NEGATIVE COVID-19 RAPID Antigen Test result mean?
A NEGATIVE RAPID Antigen test is not a guaranteed result. No CE-Marked test today can measure the first stages of infection reliably in the first 3 days. But using the most sensitive swab technique, symptom reporting and our contact history algorithm we can advise on whether a negative is a true negative or not and how that impacts your isolation, contact, care and retesting strategy.
Getting a test for someone else
If you're applying for a test for someone else, and the person is aged 13 or over, check they're happy for you to get a test for them.