Tests2020-11-03T11:38:40+00:00

COVID-19 Tests

The more testing you do the easier it is to identify who is infected and therefore who needs to be isolated. Singapore, South Korea and Germany are three prime examples where they initiated a testing regime early and as a result, so far, seem to have had a better course of the pandemic in comparison with other countries who don’t have such a high testing capability. It is also clear testing can help alleviate some of the restrictions on movement sooner and give a better idea of what’s going on. It’s vital that testing, whether it’s PCR or antibodies, is ramped up as much as possible to provide clear evidence on what is happening and where we should be going.

PCR Test

PCR tests are considered the gold standard of testing and typically offer the highest levels of sensitivity/specificity (up to 99.9+% infection detection accuracy at 6 days viral ‘load’).  Pillar 5 testing supports PCR tests offering 98% sensitivity and specificity.

LAMP Test

LAMP (which is an acronym for Loop-mediated Isothermal Amplification) is a single tube technique for the amplification of DNA. It provides a low-cost alternative to polymerase chain reaction (PCR) technology to detect certain disease. It involves the design of assay primers and the use of a strand-displacing polymerase to allow rapid amplification at a constant temperature without the need for thermal cycling (required for PCR).

Due to the large number of binding sites on target DNA/RNA, the LAMP method is inherently highly specific.  The isothermal nature of the reaction means that no thermal cycling is required, facilitating the use of a small, portable, analyzer.  LAMP reactions very rapidly generate large quantities of amplified material when pathogenic bacteria/viruses are present in the patient sample; typically time to positive result is 15-25 mins from the start of the reaction, a detection speed which outstrips standard automated PCR.

Antibody Test

The Virtus quantitative antibody test is the best validated and most sensitive commercially available antibody test. It is the only laboratory antibody test registered for use via home/work/school finger prick blood sampling. All other UK testing labs require venous blood drawn by a nurse/phlebotomist. The Virtus test is unique as the only test that has been validated in community Covid cases (as opposed to severe hospitalised cases). The Virtus test sensitivity, when compared to the Abbott test, was 87% vs 68% respectively and when compared to the Roche test 91% vs 69%. Quantitative testing will permit the measurement of antibody levels over time to monitor change. The Virtus test results correlate very closely with neutralising (blocking the virus from entering and infecting cells) antibody levels, so it is highly likely that people with a positive Virtus antibody test are protected against getting Covid. Such people will not need regular swab testing to identify asymptomatic SARS-CoV-2 infection and silent spreaders, until such time as they have become antibody negative.

Antigen Test

Antigen tests recommended to support Pillar 5 testing must meet minimum efficacy/accuracy standards, defined as 98% specificity/90% sensitivity.  For example, a self-contained, sample collection device using lateral flow chromatographic immunoassay administered via nasopharyngeal and oropharyngeal (nose and throat) samples, and one of the world’s first rapid antigen tests, offers 98.7% specificity/sensitivity in infection detection.  This test delivers results in just 15 minutes, on the spot, via a portable immunoassay device.

FAQs

What happens if my test is negative, but I have coronavirus symptoms?2020-11-24T17:27:45+00:00

If you have coronavirus (COVID-19) symptoms please refer to NHS guidance: nhs.uk/conditions/coronavirus-COVID-19.

Should the tests be kept in specific conditions?2020-11-24T17:27:03+00:00

Tests can be stored in typical warehouse conditions; they do not need refrigeration but should be kept out of direct sunlight and not be exposed to heat.

At what stage is Test and Trace informed of the result?2020-11-24T16:54:34+00:00

At the point the confirmatory PCR test result is known, and this is positive, test results will, as per the guidelines, be referred to Test and Trace.

How accurate is the rapid antigen test?2020-11-24T16:41:40+00:00

A clinical evaluation was performed to compare the results obtained by rapid antigen test (swab) and PCR which found that the rapid antigen test was 98.7% effective.

What is the difference between a rapid antigen test and a PCR test?2020-11-24T16:33:32+00:00

A rapid antigen test can detect acute infection in a fraction of the time as PCR tests. Rather than performing all of the analytical steps inside an expensive dedicated machine at a lab done with tests for the DNA or RNA of the virus, antigen tests build most of those steps into a paper-like strip that returns a simple yes or no answer, much like pregnancy tests. The SARS-Cov-2 Antigen Rapid Test Cassette (swab) does not differentiate between SARS-CoV and SARS-CoV-2. Positive results from an antigen test need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative. 

How effective/accurate are Antibody tests?2020-11-02T10:26:29+00:00

The Virtus quantitative antibody test is the best validated and most sensitive commercially available antibody test. It is the only laboratory antibody test registered for use via home/work/school finger prick blood sampling. All other UK testing labs require venous blood drawn by a nurse/phlebotomist. The Virtus test is unique as the only test that has been validated in community Covid cases (as opposed to severe hospitalised cases). The Virtus test sensitivity when compared to the Abbott test was 87% vs 68% respectively and when compared to the Roche test 91% vs 69%. Quantitative testing will permit measurement of antibody levels over time to monitor change. The Virtus test results correlate very closely with neutralising (blocking the virus from entering and infecting cells) antibody levels, so it is highly likely that people with a positive Virtus antibody test are protected against getting Covid. Such people will not need regular swab testing to identify asymptomatic SARS-CoV-2 infection and silent spreaders, until such time as they have become antibody negative.

How do users install the app?2020-10-26T18:59:55+00:00

Every member of your organisation will be sent a text with a link via which you can download the app on your phone. If you have more than one phone, install the app on the one you use most often and carry this with you at all times.

A child or staff member has tested positive. What should the school tell parents?2020-10-26T19:00:05+00:00

Schools have no obligation to inform parents of a positive case in the school. However, in the interests of open communication, schools may wish to inform parents when there is a case, being careful to maintain confidentiality and not give information that may identify the individual concerned.

Parents can be reassured that people who are not identified as close contacts are at no more risk than the general public. Everyone should be following the public health guidance to wash your hands, keep your distance and stay at home if you have a fever, new continuous cough or loss of, or change to, normal sense of smell or taste.

What is a close contact of a confirmed case of COVID-19?2020-11-02T13:27:27+00:00

A person who has been close to a confirmed case from two days before the person was symptomatic to 10 days after the onset of symptoms and:

  • lives in the same household OR
  • has travelled in a car with the case OR
  • has been within 2 metres of a case for more than 15 minutes OR
  • has been within 1 metre of a case and had face-to-face contact including:
    • being coughed on
    • having a face-to-face conversation
    • having skin-to-skin physical contact
A child or staff member from the school has had a COVID-19 test. What does the school need to do?2020-10-26T19:00:23+00:00
  • The individual will receive their result via the app with the advice that they need to isolate for at least 10 days.
  • The user will then be able to choose which of their household and non-school community close contacts they need to advise.
  • The school’s management will then need to notify close contacts that may have been affected.
How will everyone know when their next test is?2020-11-02T13:19:22+00:00

Scheduled weekly testing within the workplace/school will be visible within the app detailing the date, time and location it will be taking place

How do you obtain everyone’s contact data?2020-11-02T13:10:54+00:00

Reactivate uses advanced API integration technology that securely associates the details that are naturally shared between employer and employee e.g. phone number, address, age etc

How will Reactivate help my business?2020-11-02T13:06:48+00:00

Reactivate is a customisable solution that enables businesses to take control of their own unique flow of people. It provides a single interface to manage visitors, employees, and anyone else on premises, while improving safety, efficiency and compliance.

How effective/accurate is the proposed testing?2020-11-23T20:34:03+00:00

Tests sourced to support our testing programmes have to satisfy rigorous efficacy/ accuracy/ reliability standards.

PCR tests are considered the gold standard of testing and typically offer the highest levels of sensitivity/specificity (up to 99.9+% infection detection accuracy at 6 days viral ‘load’. The Circular1 Health testing process involving both LAMP and PCR in series is currently operating at 99.995% specificity and 100% sensitivity.

Antigen tests recommended to support Pillar 5 testing must meet minimum efficacy/accuracy standards, defined as 98% specificity/90% sensitivity.  For example, a self-contained, sample collection device using lateral flow chromatographic immunoassay administered via nasopharyngeal and oropharyngeal (nose and throat) samples, and one of the world’s first rapid antigen tests, offers 98.7% specificity/sensitivity in infection detection.  This test delivers results in just 15 minutes, on the spot, via a portable immunoassay device.

Antibody tests – The Virtus quantitative antibody test is the best validated and most sensitive commercially available antibody test. It is the only laboratory antibody test registered at the MHRA for use via home/work/school finger prick blood sampling. All other UK testing labs require venous blood drawn by a nurse/phlebotomist. The Virtus test is unique as the only test that has been validated in community Covid cases (as opposed to severe hospitalised cases). The Virtus test sensitivity, when compared to the Abbott test, was 87% vs 68% respectively and when compared to the Roche test 91% vs 69%. Quantitative testing permits the measurement of antibody levels over time to monitor change. The Virtus test results correlate very closely with neutralising (blocking the virus from entering and infecting cells) antibody levels, so it is highly likely that people with a positive Virtus antibody test are protected against getting Covid. Such people will not need regular swab testing to identify asymptomatic SARS-CoV-2 infection and silent spreaders, until such time as they have become antibody negative.

What certification do the labs offer?2020-10-26T19:12:21+00:00

The labs use state of the art testing services that are fully CE marked and operated to international standards (ISOs 15189 and 13485). The Virtus antibody test and home sampling kit is registered at the Medicines and Healthcare Regulatory Authority, both companies’ results are reporting to and accepted by Public Health England.

Is there a risk of bottle-necking at the labs?2020-10-26T19:13:39+00:00

Virtus and Circular1 Health provide an extensive private lab network to support testing. Their labs are fully-certified/high grade laboratory facilities approved by relevant authorities (including Government) to carry out Covid testing to the highest quality standards.  The network offers more than sufficient testing capacity to support activity without bottlenecks, and most importantly, without impinging in any way on NHS testing capacity.

How are tests deployed?2020-10-26T19:01:36+00:00

Tests may be deployed at home and in the workplace. 

Quantitative antibody tests are performed using a testing kit on finger-prick blood samples taken at home or at work. Each kit contains a pre-paid return envelope for delivery to the lab within 24hrs. Results are returned typically next day via the App.

LAMP/PCR tests will be performed on nasal /throat swabs which can be despatched to individuals by post or stored in bulk onsite to administer (as each programme determines).  PCR samples will be despatched by courier/post to prescribed laboratories for analysis and result notification within prescribed turnaround times (typically 24 hours).

As an employer am I responsible for reporting a positive test to PHE?2020-10-26T19:01:45+00:00

No. The statutory requirement is to report positive results to PHE. Circular1 Health and Virtus are doing this for antibody and LAMP/PCR. Synoptic will do so for antigen testing.

As an employer, am I in control of who gets tested?2020-11-02T13:07:56+00:00

Yes. Once a member of your organisation has logged feeling symptoms, they will be able to request a test. Pending approval from you (the employer), the test will be deployed to the employee’s home address.

As an employer, how can I ensure everyone updates their status?2020-10-26T19:03:25+00:00

Every member of your business with the app will receive daily reminders to update their health status. Once these have been completed this will be visible within the management console.

What information can antibody testing provide us with?2020-10-26T19:12:35+00:00

Many COVID-19 cases (people with symptoms caused by infection with SARS-CoV-2) had only very mild symptoms and some people with SARS-CoV-2 infection had no symptoms whatsoever. Going forward, close monitoring of previous infections will be critical to:

  • Understanding the strength of immunity to SARS-CoV-2 that you as an individual may have
  • Helping employees to return to work more safely, with a better understanding of their own risk of SARS-CoV-2 infection and the risk they may pose to others
  • Gaining a better understanding of a workforce’s susceptibility to infection
  • Understanding the degree of immunity to SARS-CoV-2 within a community.
Why do we test for antibodies?2020-11-02T10:23:46+00:00

Antibodies are proteins that our immune systems produce in response to infectious agents such as viruses. These antibodies identify specific viruses and bind to them, thus blocking them from entering our cells, multiplying and causing symptoms.

If a person has previously been infected with SARS-CoV-2, they are likely to have these antibodies in their blood (in particular IgM and IgG). Our test detects both of these antibodies in blood samples and measures the levels of each antibody type, thus providing a clear indication of a person’s susceptibility to future infection.

What information can antibody testing provide us with?

Many COVID-19 cases (people with symptoms caused by infection with SARS-CoV-2) had only very mild symptoms and many people with SARS-CoV-2 infection have no symptoms whatsoever. Going forward, close monitoring of previous infections will be critical to:

  • Understanding the strength of immunity to SARS-CoV-2 that you as an individual may have
  • Helping employees to return to work more safely, with a better understanding of their own risk of SARS-CoV-2 infection and the risk they may pose to others
  • Gaining a better understanding of a workforce’s susceptibility to infection
  • Understanding the degree of immunity to SARS-CoV-2 within a community.
If someone is tested positive does the testing facility report to the authorities to start the formal follow-up?2020-10-26T19:04:02+00:00

We have established a procedure to report all positives to Public Health England who receive full details of the individuals concerned.

Who collects the sample for the PCR test?2020-10-27T14:26:01+00:00

Self-collected and/or collected by a medical professional

What accreditations, if any, does the PCR test have?2020-10-26T19:13:16+00:00

For the swab (and shortly, saliva option) 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.

How effective/accurate is PCR testing?2020-11-02T10:24:57+00:00

PCR tests are considered the gold standard of testing and typically offer the highest levels of sensitivity/specificity (up to 99.9+% infection detection accuracy at 6 days viral ‘load’). Pillar 5 testing supports PCR tests offering 99.9+% sensitivity and 100% specificity.

How effective/accurate are Antibody tests?2020-10-23T10:21:00+00:00

The Virtus quantitative antibody test is the best validated and most sensitive commercially available antibody test. It is the only test registered for use via home/work/school finger prick blood sampling. All other UK testing labs require venous blood drawn by a nurse/phlebotomist. The Virtus test is unique as the only test that has been validated in community Covid cases (as opposed to severe hospitalised cases). The Virtus test sensitivity when compared to the Abbott test was 87% vs 68% respectively and when compared to the Roche test 91% vs 69%. Quantitative testing will permit measurement of antibody levels over time to monitor change. The Virtus test results correlate very closely with neutralising (blocking the virus from entering and infecting cells) antibody levels, so it is highly likely that people with a positive Virtus antibody test are protected against getting Covid. Such people will not need regular swab testing to identify asymptomatic SARS-CoV-2 infection and silent spreaders, until such time as they have become antibody negative.

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