We may in practice all need to get used to a new normal. However, the oncoming availability of reasonably accurate cheap lateral flow Antigen rapidtest kits for the SARS-CoV-2 virus and their use for triaging patients will revolutionise national health management. This is because the immediate results provided by these Rapid tests will enable Public Health officials to isolate positive cases on a precautionary basis sooner in their infectious period whilst they await the result of an confirmatory PCR test several days later.
19th November 2020: We have published the first edition of our new Employer's COVID-19 Testing Protocol, providing a simplified version of Government UK's official guidance as of 6th October 2020, full details are here...
23rd October 2020: The Department of Health & Social Care has spent £160,730,000 on Rapid-test Antigen Kits from Abbott Rapid Diagnostics Limited see web and Innova Medical Group Inc see web as GOV.UK gears up for Rapid Testing to Triage citizens before requesting the slow but accurate 'Gold standard' RT-PCR Tests from the existing Pillar 2 Lab system.
The public debate in the UK about how we should best respond to the challenges of COVID-19 has been handicapped by limited information about and understanding of the various methods of testing and how the available and upcoming technology can be put to best effect. The need to test and trace contacts and likely sources of infection is generally accepted but there are different types of test with different strengths and weakness concerning speed, accuracy, cost, availability and the ease or difficulty of obtaining good representative samples from the person in question.
Hence we believe that a public debate informed by the current and upcoming availability of COVID-19 testing is overdue and we wish to help to develop that debate. Whilst we should clearly be guided by experts those experts have a responsibility to clearly articulate their views and advice in an accessible form, avoiding jargon and avoiding talking down to citizens. British citizens are ready, willing and able to make up their own minds about how these challenges should be tackled and to take responsibility for their own part in what is required.
On June 15, 2020 the United Kingdom’s Medical Health Regulatory Authority (MHRA) published a formal Target Product Profile (TPP) describing what was required for “Point of Care SARS-Cov-2 Detection Testing”. This was an invitation to manufacturers to submit for formal approval products meeting this TPP and illustrates the likely future for mass testing in the UK. MHRA states
The TPP points the way towards a more efficient testing strategy where patients are quickly triaged using fast simple point of care tests before being put, when testing positive for SARS-CoV-2, into precautionary isolation whilst the more accurate but much slower RT-PCR test is undertaken in a remote laboratory in order to confirm or cancel the diagnosis.
The triaging concept, tiered testing to reduce the load on the national NHS, PHE and Lighthouse testing labs, will greatly improve testing efficiency but is dependent on adequate supplies of in-vitrio medical devices that meet the TPP followed by the redesign of the current national testing system to accommodate a different mode of operation.
“Implementation of the testing strategy will be enhanced by parallel testing capability offered through the availability of point of care tests (POCT) that can quickly detect the SARs-CoV-2 virus in a near patient setting, allowing health and care professionals to efficiently triage patients depending on their likelihood of being infected.”
“Such tests require taking a small sample of bodily fluid and looking for the presence of viral nucleic acids or antigens specific to SARS-CoV-2, the causative agent of COVID-19. When available these tests could be used across the broad spectrum of health and care settings and eventually in non-healthcare contexts, such as schools, airports and prisons. They should thus be safe, simple, robust and have a rapid time to test result.”
This TPP is designed exclusively for POCTs for use by trained health care professionals recognised by one of the 10 health and social care professional bodies recognised by the UKs’ Professional Standards Authority. Hence the professionals permitted to administer and use these tests are qualified doctors; pharmacists, pharmacy technicians; social workers; the optical professions; dental professionals; nurses and midwives and nursing associates; osteopaths; health, psychological and other allied health professionals and chiropractors.
The MHRA documentation makes it clear that “home test” or “lay testing” kits are possible but none have been recognised yet. It is an offence to sell any medical device without a CE mark and both European and US standards currently exclude such non professional kits. However, as such kits are developed and are judged by regulators to be suitable and safe for home use it seems very likely that such consents will be granted.
Roche, a major supplier to the NHS, recently announced that they will soon have available a lateral flow Antigen test developed in partnership with SD Biosensor Inc of Korea which they have clearly created to meet this TPP. Here is what they say:
The World Health Organisation recently announced that it was sourcing many millions of Antigen Rapid Tests from Abbott in the US (Panbio COVID-19 Ag test) and SD Biosensor (STANDARD Q COVID-19 Ag Test) for use in poorer countries.
“As part of this comprehensive, end-to-end effort, the Bill & Melinda Gates Foundation has executed separate volume guarantee agreements with rapid diagnostic test (RDT) producers Abbott and SD Biosensor. These two arrangements will make available to LMICs 120 million antigen rapid diagnostic tests (Ag RDTs) – priced at a maximum of US$5 per unit – over a period of six months. These tests provide results in 15–30 minutes, rather than hours or days, and will enable expansion of testing, particularly in countries that do not have extensive laboratory facilities or trained health workers to implement molecular (polymerase-chain reaction or PCR) tests.
The tests developed by Abbott and SD Biosensor are highly portable, reliable, and easy to administer, making testing possible in near-person, decentralized healthcare settings. Both companies’ tests are faster and cheaper than laboratory-based tests, enabling countries to increase the pace of testing, tracing and treating people for COVID-19 at the point of care particularly in areas with under-resourced health systems. A number of other Ag RDTs are at various stages of development and assessment.”
Abbott have a second Antigen Rapidtest (BinaxNOW™ COVID-19 Ag Card rapid antigen test) intended solely for sale in the United States which is to be supplied with a complimentary App (NAVICA™) which will provide the patient with a temporary COVID-19 Passport on their phone if they receive a negative test. The FDA has approved both Abbott rapid tests and the SD Biosensor test for use in the USA.
There are more than 20 Antigen Rapidtests either seeking approval or under development and the Access to COVID-19 Tools (ACT) Accelerator programme has allocated $50million funding to assist manufacturers in scaling up Antigen rapid tests of the required quality
“A set of agreements to make available, for low and middle-income countries, affordable, high-quality COVID-19 antigen rapid tests were today announced by the Access to COVID-19 Tools (ACT) Accelerator. Organizations involved in the milestone agreement include the Africa Centres for Disease Control and Prevention (Africa CDC), the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative (CHAI), the Foundation for Innovative New Diagnostics (FIND), the Global Fund, Unitaid, and the World Health Organization (WHO).”
Public bodies and private organisations will invariably follow government guidance regarding COVID-19 because to fail to do so invites significant liabilities to staff, customers and suppliers. Accordingly, organisations in the UK would be wise to prepare for the UK national COVID-19 testing strategy changing to utilise rapid Antigene tests within the next few months - since the only current unknown is the exact timing. It would be prudent to
Identify within the organisation’s staff someone who will be entitled to administer the new rapid tests or employ such a person part time to deal with testing in-house. The professionals permitted to administer and use these tests are qualified doctors; pharmacists, pharmacy technicians; social workers; the optical professions; dental professionals; nurses and midwives and nursing associates; osteopaths; health, psychological and other allied health professionals and chiropractors.
Receiving test results quickly is significant since receipt will control both people and medical management decisions for next steps. Delays may result in infected people adding to community transmission, the uninfected avoid isolation and medical treatment is not delayed.
There will generally - as with many things - be a trade off between speed and accuracy so that a fast result from a less accurate test may be more useful in practice than a highly accurate test result received several days later.
Samples can be collected from individuals and pooled into larger samples in order to obtain data with less granularity but more quickly. Where a pool tests positive a quickly administered second test can be used to identify the positive members of the pool.
The testing of sewage systems offers an efficient method of identifying the differing levels of infection of different geographical areas of the community informing the application of greater attention to specific areas, based on the sewage catchment of each sampling point.
First the speed with which an efficient sample can be collected and the test method commenced and second the time before the result will be received. Differing levels of speed and accuracy may be appropriate for different situations.
Given the purpose of testing, here focusing on management of the population and management of medical treatments, it appears difficult to argue that the speed of receipt of the result of a test is not of crucial significance?
Different test systems may have very different levels of accuracy dependent on the technology used, the quality of test production, the quality of test storage before use, the quality of the sample obtained and the quality of the methodology used to run the testing process.
Molecular real-time polymerase chain reaction (RT-PCR) tests detects the virus’s genetic material. This is the normal “gold standard” RT-PCR test used by Public Health England, the NHS and the private sector Lighthouse Labs is a laboratory based analysis system to identify whether or not the RNA of the virus is present in a sample, usually a nasopharyngeal sample.
The antigen test detects specific proteins on the surface of the virus. This uses the same type of sample as the PCR test but instead identifies Antigens of the virus present in the sample - specialist proteins forming part of the virus.
Potentially a simpler process this uses the same type of sample as the PCR test but uses one of several techniques to identify the Antigenes of the virus present the sample. Antigenes are the specialist proteins that the virus uses to make an initial bond with the patient’s own cells.
Similar in some ways to the Antigene process this uses different type of sample, a blood sample from the patient, and seeks to identify the presence of antibodies created by the patient when they were previously infected with the virus.
Viral and/or antigen tests are required for management of the population and patients whereas antibody tests only provide after the event data demonstrating the who has been infected by the virus and recovered. Whilst antibody tests may help ascertain an individual’s Covid-19 health status they are not relevant to the main thrust of public health policy which is to reduce community transmission and to treat those infected as efficiently and effectively as possible through the accurate allocation of necessarily scarce resources.
In the UK the RT-PCR testing programme undertaken by PHE, NHS and Lighthouse Labs was suffered significant organisational challenges as capacity has been increased rapidly from a low starting point. As a result both the availability of sufficient sample collection kits and lab resources for sample testing have on occasion been insufficient to meet local demand. Where testing has been undertaken the delay in the receipt of results has not always meet the 24hr target.
Current Gov UK policy seems now to accord with the views we set out below proposing that fast triaging testing combined with precautionary isolation and followup PCR tests is the obvious solution to the current challenges evident in the UK National Testing Programme.
Since the main purpose of large scale walk-in public testing is to identify positive cases in order to manage people and hence reduce community transmission the elapsed time between a test sample being taken and the result being obtained is very significant.
An Antibody test is to detect the molecules (i.e. antibodies) that people produce after being infected with the virus. Antibodies may take several days to produce after infection, and usually remain in the blood for a period after the patient recovers. There are two types, IgM Antibodies which are produced initially to fight the infection, but which disappear after several weeks and IgG Antibodies which are produced later in the cycle and which generally remain in the body much longer. Therefore, whilst the antibody test has very limited use in the diagnosis of a new COVID-19 infection is essential to indicate potential immunity. However, at present it not know how long such immunity may subsist.
An Antigen test is based on an immune reaction, whilst the nucleic acid test is based on genetic information. Therefore, an Antigen test can be much faster than the nucleic acid test (15 minutes compared with 4 hours). The cost of speed is the sensitivity. That is, an Antigen test is not as sensitive as a nucleic acid test. The nucleic acid test can detect a microscopic amount of SARS-CoV-2 virus due to its sensitivity using the amplification process of virus genetic information. This is why a PCR test takes several hours and is capable of causing aerosol contamination.
It does not require any laboratory processing and hence are suitable for large scale general screening of the population. In North America & Europe all licensed Rapid-test Antigen products are currently required to only be used by qualified professionals. However, it appears likely that Antigen tests for home use, without professional supervision, will eventually be permitted. However, if the human body contains only a very low viral load, with no obvious clinical symptoms, then an Antigen test is likely to give a negative result, thus a false negative. Helpfully, the ability of people with a low viral load to spread the virus is correspondingly lower than heavily infected patients. The Antigen test is suitable as a triaging or screening test to determine whether or not a slow but accurate nucleic acid test should be obtained. An Antigen test will be efficient in quickly identifying people with high levels of infection, those who are most likely to infect others, and distinguishing those people from others with, for example, seasonal influenza. Therefore, Antigen tests can be effective in helping to limit the spread of the pandemic, by identifying those who are most likely to spread the disease and isolating them from others.
As an Antigen test detects the virus itself sample collection is very important because the virus is only present in some areas of the body. This is different to the collection of a blood sample for an Antibody test when we may expect the Antibodies to be present throughout the patient's venous blood, although likely to be less present in capillary blood. Accordingly, we recommend the use of a sputum sample, because sputum is a secretion from respiratory tract where the SARS-CoV-2 virus clusters the most. Hence using sputum provides a more certain method of successfully collecting a reasonable quantity of the virus in the sample, if it is present, when compared with the back of the throat nasopharyngeal sample. Because the virus is unevenly distributed on the nasopharyngeal mucosa, it is not certain that a successful sample with be obtained from this area which may lead to a false negative result. It is much more difficult and requires both expertise and some luck to obtain a truly representative sample from back of the throat. Therefore, the nasopharyngeal sample accuracy will be lower than that of sputum. Studies have shown that after people are infected, the viruses survive, and thus can be detected, in the digestive tract, especially in the intestinal stool. Therefore, if convenient (e.g. in hospital or at home), a stool sample is another option for testing; Saliva samples mixed with sputum also have a certain probability of detection, although the amount of virus contained is lower than pure sputum.
Sputum is the mucus that is coughed up from the lower airways (the trachea and bronchi). When taking a sample one should avoid its contamination / dilution with saliva so far as possible. Saliva (commonly referred to as spit) is an extracellular fluid produced and secreted by salivary glands in the mouth.
The WHO has always been a supporter of Antigen testing. Experts point out that compared with conducting an accurate test every two weeks, conducting a relatively insensitive quick test twice a week can more effectively contain the spread of SARS-CoV-2.
The reason is that it is more helpful in containing the spread of the infection where the focus is on identifying those who are likely to spread SARS-CoV-2, rather than locating anyone who is infected in any way with SARS-CoV-2 - but with a low infection much less likely to spread it.
Delhi is the first place in India to start using rapid Antigen testing in June. By mid-July, the number of cases there had been reduced, and the daily death toll had also stabilized, indicating that Antigen testing contributed to controlling the spread of the virus. After cases declined, India began to lift isolation restrictions and in consequence the infection began to rise again.
The Philippine Association of Microbiology and Infectious Diseases has issued interim guidelines for clinicians and medical staff, stating that Antigen testing can be used as a substitute for PCR to diagnose coronavirus infection in people with symptoms in the early stage, especially during the acute infection period.
Further, the time taken for that test result to be transmitted to the state organised track and trace system is also very significant since that organisation is charged with the responsibility of managing people in order to effect a reduction in community transmission.
Consider the amount of potential community transmission that would be reduced by isolating a patient just 24 hrs earlier when they at at the height of their infectiousness? Earlier isolation of 2 or 3 days will be possible with Antigen rapid tests followed by precautionary isolation and a confirmatory PRC test.
Applying that principle an argument can be made for this large scale testing to use simpler much faster methods of testing in situ, so that a person attending such a centre will know within 30 minutes of the sample being taken whether they are apparently positive or negative, where such a result is immediately transmitted to the state track & trace organisation, to enable them to immediately set to their allotted tasks.
This would require the use of machine readable and/or visually readable lateral flow test products operated in situ by appropriately trained supervisors with the assistance and cooperation of the citizen’s concerned.
CHEAP IN-SITU TESTING CAN BE REPEATED: at a worldwide price of about $5 where millions are purchased these tests could be re-administered to anyone with a positive result as a means of corroborating that result.
COVID-19 Developing a testing strategy Guidance - for campus based educational institutions with residential accommodation.
The frequency of testing for COVID-19 depends on both the purpose & the available test capacity.
1. GovUK and US CDC say only get tested if you have symptoms - but that is to reduce the load on testing given large populations and finite resources.
2. When people have symptoms they are already infectious and hence may have already infected other people in their community. Hence test screening the school population on a precautionary basis should be considered.
3. We recommend test screening or triaging the school population using a Rapid Antigen Test for SARS-CoV-2 (the virus that causes COVID-19). These are now becoming available in the UK at reasonable prices and are ideal to triage individuals in order to identify who requires what treatment quickly and cheaply. Note that these Rapid Test devices are currently only licensed to be administered by a healthcare professional. In the U.K. that is defined as a qualified member of one of the ten health and social care professional bodies recognised by the UKs’ Professional Standards Authority. Hence the professionals permitted to administer and use these tests are qualified doctors; pharmacists, pharmacy technicians; social workers; the optical professions; dental professionals; nurses and midwives and nursing associates; osteopaths; health, psychological and other allied health professionals and chiropractors. Most likely your School Nurse or Matron will fulfil this essential role, otherwise you need to identify an existing member of staff or available local part-timer.
4. You should: - [ ] plan to initially test the whole school community twice, 7 days apart and - [ ] re-test whole school community at about the same time once every fortnight. - [ ] Plan to re-test anyone who has had contact outside the school bubble. - [ ] Hence students would require less frequent testing if they remain in school - [ ] but staff and support staff who live off premises or who have contact off premises should be tested regularly - at least twice a week and immediately if they suspect that they have been in contact with an infected person. - [ ] Students & staff should install the VIGOR-Secure App for iPhone or Android in order to make personal records of their own test history. This will enable them to demonstrate their health status whenever required such as arrival at Immigration Control. - [ ] In order to provide overseas students with “Fit-to-fly” status such students should be tested every 4 days during the 14 days prior to their planned departure flight. - [ ] Staff and students should all install the NHS COVID-19 Test & Trace phone App in England or the equivalent official App in Scotland, Wales & Northern Ireland. This will provide individual warnings of possible infection through close contact. Anyone receiving such a warning should immediately request and receive a Rapid Antigen Test. Properly managed this should provide a reasonable level of protection when combined with effective isolation of positive cases.
5. Positive test cases should be retested with a second RapidAntiGen test. With two positive results they should be put into isolation and consideration be given to whether or not a confirmatory nucleic acid testing (PCR) test is merited?
6. When used for screening testing in congregate settings such schools, test results for SARS-CoV-2 should on the precautionary principle be considered presumptive. A confirmatory PCR test following a positive antigen test may not be necessary when the pretest probability is high, especially if the person is symptomatic or has a known exposure. When the pretest probability is low, those persons who receive a positive antigen test should isolate until they can be confirmed by PCR.
7. Confirmatory PCR testing following a negative antigen test used for screening testing may not be necessary if the pretest probability is low, the person is asymptomatic, or has no known exposures, or is part of a cohort that will receive rapid antigen tests on a recurring basis. PCR testing is also considered presumptive when screening asymptomatic persons, the potential benefits of confirmatory testing should be carefully considered in the context of a person’s clinical presentation.
8. If a PCR test is judged necessary then either use the National U.K. testing scheme or if that is unavailable obtain a private PCR test. If that subsequent PCR test is negative then the patient can then be released from isolation, otherwise they should remain in isolation for 14 days.
9. The positive results of tests should be offered to the NHS through the patient's GP or other responsible medically qualified person.
We welcome VIGOR as our new partner. VIGOR have developed the first secure event certification App with Cloud services for iOS & Android available in the UK. It is suitable for recording and certifying COVID-19 test results and vaccinations as well as other important events. Artificial Intelligence is used to assist the user. The user retains complete control of their data and hence can feel entirely secure. Please see their web site here.
We welcome Jacada Group as our new partner, they are an international product & services sourcing partner working with Chinese suppliers. With over 30 years experience they are experts in this area of business. Please see their web site here.