On 2nd January 2023 I made the following enquiry under the Freedom of Information (FOI) Act 2000 to the Hywel Dda University Health Board:
1) With regards to detection of SARS-CoV-2 does the Hywel Dda University Health Board (UHB) use a reference Labarotory or an in-house service, and if an external Labarotory is used please provide information as to which which one?
2) Which company's test kit and what is the name of the IVD (in vitro diagnostic) device used by the Hywel Dda University Health Board (UHB) to detect SARS-CoV-2?
3) How many cycles is the test run for detection of SARS-Cov-2?
4) What is the threshold for considering positivity of the test?
5) What is the diagnostic sensitivity and specificity of the test and device used?
6) What is the cross reactivity of the SARS-CoV-2 test with other coronaviruses (non SARS- CoV-2) and infuenza A or influenza B?
On 28th March 2023 I received the following response.
“Hywel Dda University Health Board (UHB) regrets to inform you that it does not hold the information requested”. The Health Board recommended that I redirect your request to the Freedom of Information Team in Public Health Wales (PHW).
I am therefore making a enquiry to yourselves under the Freedom of Information (FOI) Act 2000.
Please see below.
1) With regards to detection of SARS-CoV-2 does the Hywel Dda University Health Board (UHB) use a reference Labarotory or an in-house service, and if an external Labarotory is used please provide information as to which which one?
2) Which company's test kit and what is the name of the IVD (in vitro diagnostic) device used by the Hywel Dda University Health Board (UHB) to detect SARS-CoV-2?
3) How many cycles is the test run for detection of SARS-Cov-2?
4) What is the threshold for considering positivity of the test?
5) What is the diagnostic sensitivity and specificity of the test and device used?
6) What is the cross reactivity of the SARS-CoV-2 test with other coronaviruses (non SARS- CoV-2) and infuenza A or influenza B?
Thank you for your recent request dated 2nd May 2023.
1) With regards to detection of SARS-CoV-2 does the Hywel Dda University Health Board (UHB) use a reference Labarotory or an in-house service, and if an external Labarotory is used please provide information as to which which one?
a. Samples for the detection of SARS-CoV-2 from HDUHB were/are either tested in the in-house laboratory at Withybush Hospital or tested within the Public Health Wales network. In this case they may be tested in laboratories in Glangwili, Bronglais or Prince Phillip Hospitals, or laboratories at Singleton Hospital or University Hospital of Wales, or at the central laboratory at Imperial Park 5.
2) Which company's test kit and what is the name of the IVD (in vitro diagnostic) device used by the Hywel Dda University Health Board (UHB) to detect SARS-CoV-2?
a. Across the Network there are a number of platforms used, primarily BioFire, Cepheid, ePlex, Roche, Perkin Elmer, SeeGene, and Luminex.
3) How many cycles is the test run for detection of SARS-Cov-2?
a. The number of cycles that are run is determined by each platform manufacturer, but is typically 40-45 cycles.
4) What is the threshold for considering positivity of the test?
a. The threshold is determined by each platform manufacturer, and is typically between 27 to 43 cycles.
5) What is the diagnostic sensitivity and specificity of the test and device used?
a. The specificity of the tests is more than 99.9%. The sensitivity of the tests in terms of detecting the presence of SARS-CoV-2 genetic material is extremely high. However, the clinical sensitivity of the whole testing process (including sampling) is dependent on a number of additional factors and overall sensitivity may be reduced to around 90%.
6) What is the cross reactivity of the SARS-CoV-2 test with other coronaviruses (non SARS- CoV-2) and infuenza A or influenza B?
a. There is no evidence of cross-reactivity of the SARS-C0V-2 assay with seasonal coronaviruses or influenza A or B.
If you are unhappy with the service you have received in relation to your request and wish to make a complaint or request a review of the decision, you should write to the Corporate Complaints Manager, Public Health Wales NHS Trust, 3, Number 2, Capital Quarter, Tyndall Street, Cardiff, CF10 4BZ.
If you are not content with the outcome of your complaint or review, you may apply directly to the Information Commissioner for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Trust. The Information Commissioner can be contacted at:
Information Commissioner for Wales
2nd Floor
Churchill House
Churchill Way
Cardiff
CF10 2HH
Telephone: 029 2067 8400
Email: wales@ico.org.uk