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What tests do you have for COVID-19?

We have two tests for COVID-19. One test (the PCR test) is for detecting the presence of virus, the other test (serology) is for detecting the presence of IgG antibodies to COVID-19 (SARS-CoV-2).

PCR test – a number of different RT-PCR tests are used according to the requirements of the laboratory. Sensitivity and specificity of the tests are at least 98 % and 100 % respectively.

Serology test – we are currently using the Abbott Laboratories serology test, approved by Public Health England. However, in the current, quickly changing situation, the tests are constantly being reviewed and evaluated. Alternative tests with equal or greater performance may therefore be subsequently introduced without formal notification.

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How are the two tests different?

The PCR test:

This is the ‘Do I have COVID-19?’ test. The aim of the PCR test is to understand who has virus present in their upper respiratory tract. It looks for the presence of viral RNA in nasal/throat swabs.

The serology test:

This is the ‘Have I had COVID-19?’ test. The aim of serology testing is to understand more about who may have come into contact with the virus. The serology test measures for the presence of IgG antibodies to SARS-CoV-2 using an ELISA technique. It looks for the presence of antibodies in venous blood.

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What is the intended use for PCR testing?

This is the ‘Do I have COVID-19?’ test. The aim of the PCR test is to understand who has virus present in their upper respiratory tract. It looks for the presence of viral RNA in nasal/throat swabs.

As with all viral PCR assays, patients with very low viral loads are less likely to be detected. Negative results do not mean there is no possibility of infection with the SARS-CoV-2 virus. Where there is a strong clinical suspicion of an early SARS-CoV-2 infection you should consider repeat sampling 24-48 hours later.

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What is the intended use for serology testing?

This is the ‘Have I had COVID-19?’ test. The aim of serology testing is to understand more about who may have come into contact with the virus. The serology test measures for the presence of IgG antibodies to SARS-CoV-2.

Most patients have been found to produce antibodies to SARS-CoV-2 once they have recovered from SARS-CoV-2 infection. However, whether the presence of IgG following infection can infer protection (either fully or partially) from future infection is yet to be determined, as it is still unclear if the antibodies being detected are neutralising/functional antibodies, nor does it give an indication of how long those antibodies may remain in the individual.

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How long after exposure should I take the test?

The PCR test:

Collect samples 1-5 days after detection of initial COVID-19 symptoms.

The serology test:

Collect samples >14 days after exposure, or onset of symptoms. The antibody response takes time to develop, so if the test is performed early in the infection there is an increased risk of an inaccurate result. It has been recognised that there can be delayed responses in immunocompromised patients.

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How accurate are the COVID-19 tests?

The PCR test:

The sensitivity and specificity provided by the manufacturers in their package inserts are at least 98 % and 100 % respectively.

The serology test:

The sensitivity and specificity provided by the manufacturer in their package insert are 98 % and 100 % respectively.

The serology test has undergone a rapid evaluation test by PHE who said ‘the Abbott SARS-CoV-2 is a highly specific assay with a specificity of 100 % (95 % CI 97.79-100). The manufacturer-reported specificity is 99.63 %. The full report is available here.

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What regulatory approvals do the COVID-19 tests have?

Both PCR and serology tests carry the CE mark, and can therefore be marketed for diagnostic use in the EU. Furthermore, both tests have been approved under emergency use authorisation (EAU) from the FDA for use in the US.

The serology test has undergone a rapid evaluation test by PHE who said ‘the Abbott SARS-CoV-2 is a highly specific assay with a specificity of 100 % (95 % CI 97.79-100). The manufacturer-reported specificity is 99.63 %. The full report is available here.
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How will I receive my test results?

Test results will be communicated to the designated person(s) identified in the New Customer Registration Form. Results will be sent via encrypted email. Please discuss your preferred format with our Customer Services Team – csuk@oxfordimmunotec.com.

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How are test results reported?

PCR test – results are currently reported as ‘Not detected’ if no viral RNA can be detected on the swabs and ‘Detected’ if viral RNA is present. This will soon change to Negative (Not detected) and Positive (Detected)

Serology test – results are currently reported as ‘Not detected’ if the ELISA measures < 1.4, and ‘Detected’ if the ELISA measures >= 1.4. This will soon change to Negative (Not detected) and Positive (Detected)

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How can I start sending samples to the laboratory?

Getting started is a simple, easy process. Contact Oxford Diagnostic Laboratories on 01235 433164 or email csuk@oxfordimmunotec.com and we will review the steps with you.

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How much does the test cost?

Please contact Oxford Diagnostic Laboratories on 01235 433164 or email csuk@oxfordimmunotec.com. We will put you in touch with your local area representative who will offer you a tailored package, according to your needs.

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When will I get the results?

Results are usually reported within 3 working days following receipt of the sample. If same day samples couriers arrive after test processing start time, they may be carried over until the next day, which means that results will be available one day later than usual. The only exceptions are during public holidays, weekends, the Christmas to New Year period and for high volume screenings. During these times, we endeavour to return results within 5 working days.
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Do samples need to be collected in special collection tubes?

PCR test – this test uses nasal/throat swabs and collection tubes to place the swab in for transfer to the laboratory – both are supplied by ODL. Samples should be sent on the day they are taken for best results. However, samples are stable at ambient temperature for up to 6 days.

Serology test – blood samples should be collected in serum separating tubes (SST tubes) from BD (Gold topped tube). Blood samples should be shipped on the same day that they were collected.
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Can blood collection tubes containing EDTA (purple top tubes) be used?

No, blood for the serum test must be collected in serum separating tubes (SST tubes) from BD (Gold topped tube) which can be supplied by ODL where required.

The PCR test uses nasal/throat swabs and collection tubes – both are supplied by ODL.

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How much blood is needed for the serology test?

The blood volume required to run the serology test is 5 mL collected in a serum separating tube (BD SST tube).

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What information is required on the collection tubes?

The tube should be labelled with the individual’s identifier as well as the date and time of sample collection. This information must correspond to the information on the request form. The tubes should also be labelled as containing HIGH RISK specimen.

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When can samples be sent to Oxford Diagnostic Laboratories?

Samples are accepted before 2:00PM Monday through Saturday (excluding public holidays).

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How should samples be stored prior to sending to the laboratory?

Samples for both PCR test and serology test should be stored at ambient temperature prior to shipping. Shipping should also be performed at ambient temperature. Samples should not be refrigerated as this may affect the sample and mean that the test cannot be performed.

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Which requisition form should be used?

The Oxford Diagnostic Laboratories SARS-CoV-2 Request Form should be used. This will be produced upon set up of your account and sent to you in PDF and Word format.

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After collecting a sample, how long do I have to send it to the laboratory?

Both samples in swabs for PCR testing and blood samples for serology test should be shipped on the same day or overnight, as long as they are received by the laboratory no later than 2:00 pm the day following venepuncture/swab.

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How are samples shipped to the laboratory?

There are at least 3 shipping methods available. If you need help in choosing a method, or would like help with packing materials, please contact Oxford Diagnostic Laboratories on 01235 433164 or csuk@oxfordimmunotec.com for assistance.

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How should samples be packaged?

Ensure blood samples are securely packaged in a robust blood transport container for secure and safe transit (in accordance with IATA Packing Instructions 650). These must be marked with ‘Biological Substance Category B’ and must display the Diamond Mark and UN3373, ensuring that this is not obscured by any address labelling. Please contact Oxford Diagnostic Laboratories on 01235 433164 or csuk@oxfordimmunotec.com for further details.

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In which circumstances would the laboratory reject a sample?

If a blood sample is rejected, this will be outlined on the report. Additionally, someone may contact you. Examples of reasons why a blood sample would be rejected are listed below:

  • Sample received more than 48 hours after collection
  • Specimen is collected in tubes other than those specified by us
  • Sample collection tube is not correctly labelled
  • Sample damaged in transit (leakage)
  • Sample frozen on arrival
  • Sample received during a public holiday
  • Blood sample clotted on arrival
  • Blood collection tube is under filled

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Click here for more information on COVID-19 Testing

For more information on COVID-19, please click here

 

The COVID-19 tests may be performed by a 3rd party laboratory. Any 3rd party laboratory used is UKAS accredited and situated in the UK. UKAS accreditation specifically for the COVID-19 testing has been applied for as an extension of scope and is awaiting UKAS accreditation.
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