Circular 1 Health COVID-19 Test FAQ's
Confirm what type of test you offer e.g. that it is a nucleic acid test utilising LAMP technology?
We run a test that detects the viral RNA genome, initially via high sensitivity rapid LAMP with confirmation of all positives detected by CE marked PCR. We do not use or sell lateral flow rapid antigen tests in our testing service. According to the Public Health England evaluation report published in November 2020, the best available (the Innova test) is only 73% sensitive in the hands of a trained medical staff (such as a nurse) and, even worse, only 57% sensitive when used by non-specialists.
What accreditations, if any, does the test have e.g. CE mark, MRHA approval etc?
For the nasal and nasal/throat swab we use CE marked collection devices. The first step of the laboratory test (RNA extraction) uses a CE marked kit, then we use our in-house validated LAMP test followed by CE marked PCR. The test process is operated to ISO 15189 standard and the UKAS accreditation process is underway.
Any additional international approvals e.g. FDA?
The test is not operated in the US currently so FDA EUA approval is not required
What sample is used e.g. saliva, OP swab or NP swab?
Depending on the customer’s preferred protocol we use nasal (not nasopharyngeal) or nasal/throat sampling using a CE marked sterile swab (synthetic flock material), used dry (no viral transport medium is employed). Saliva sampling is in development using a proprietary leak-proof and safe container. Breath testing is also under development.
Who collects the sample?
Any additional equipment needed to perform assay?
Assay is not intended for customer use; samples are transported to the C1H testing laboratory.
We understood that other LAMP tests have been developed as a saliva test. You are describing it as a swab test. Can you explain further the procedure and how this swab is to be taken by the individual themselves?
The LAMP test was originally developed by our supplier in late March 2020 as a nasal swab test in collaboration with King’s College London and Guy’s and St Thomas’ Hospital. They used a deep nasal swabbing method and kept the swab dry after sampling to simplify the collection and subsequent transport process. The procedure has now been further refined by C1H to avoid the need for deep nasal swabbing and is far less invasive than before. Instructional videos are available from C1H showing both options of nasal swabbing and the nasal/throat technique. Saliva and breath is currently being investigated as an alternative sample type in combination with LAMP testing.
Do you have more information about the sensitivity of the test claiming to be as accurate as the PCR test.
Our LAMP test supplier has published work with King’s College in a high prevalence population (London Care Home, 21 residents tested, March 2020) where the LAMP test, using a single nasal swab, achieved 80% sensitivity and 100% specificity i.e. no false positives vs. a double swab PCR reference. Subsequently, the LAMP test performance has been upgraded in C1H’s routine testing service and in an in-house study using 566 nasal swab samples collected in a low prevalence population (UK workforce, July/August) 100% sensitivity and 99.1% specificity was achieved using a single nasal swab LAMP test vs. the reference PCR. In the proprietary testing algorithm employed by C1H we re-test all LAMP positives using the reference PCR and this use of two different testing methods in series upgrades the overall specificity performance of the testing service to 99.995%. As a further QC check on the performance of the service we also use a subsampling process where up to 20% of the initial LAMP negatives are retested using PCR; in a further sensitivity study using 9500 nasal swabs there was full concordance between the LAMP and PCR detection methods. In summary C1H’s testing service uses two complimentary viral genome testing methods in series to ensure the highest sensitivity and specificity performance.
Do you also have information about the False Positive percentage?
If someone is tested positive does the testing facility report this as well to the authorities to start the formal follow up?
The LAMP negative and PCR positive results are reported to Public Health England and Public Health Scotland (depending on the location of the testing laboratory), who receive full details of the individuals concerned.
What is the shelf life of the swab kits if you purchase them in advance and are there specific conditions to store them?
The shelf life of the swab kits is indefinite as they are a synthetic flock material with a plastic stem, sealed in a plastic sleeve and supplied sterile by the manufacturer. Saliva and breath kits for home collection, when they become available, will also have an indefinite shelf life as they are simple plastic mouldings.