The regulations state that all COVID-19 and influenza positive, indeterminate, negative and void results from point of care testing (POCT) are mandated by law to be reported to Public Health England (PHE). POCT is defined as a diagnostic test that is performed outside of the laboratory setting. This will be set out in amendments to The Health Protection (Notification) Regulations 2010 (the 2010 Regulations).
The 2010 Regulations are also being amended to require that, in addition to positive cases, laboratories must now report indeterminate, negative and void test results to identify the causative agents for COVID-19 and influenza.
The updated regulations will require test providers who provide or have overall responsibility for the provision of POCT for COVID-19 and/or influenza, to report positive, indeterminate, negative and void results to PHE. This includes organisations offering POCT testing such as, but not limited to, third-party test providers, occupational health providers and employers running internal testing programmes not using a third party.
What to report
In the case of POCT for COVID-19 and influenza, it is a requirement that the following information is transferred to PHE. This data must follow a specific format, with the template available from the PHE POCT support team, which can be contacted at email@example.com.
In relation to the person being tested:
- first name
- date of birth
- NHS number (if known)
- current address (including postcode)
- telephone number (only in the case of SARS-CoV-2 positive or indeterminate results)
- email address (only in the case of SARS-CoV-2 positive or indeterminate results)
In relation to the test:
- name of the test provider
- the type of establishment of the test provider (for example school)
- test result code (such as COVID-19 +ve/-ve or influenza A +ve/-ve)
- specimen identification number (if applicable)
- specimen type
- specimen date
- date test performed
- test method (for example PCR)
- name of the testing equipment manufacturer
This information will be stored in the Second-Generation Surveillance System (SGSS), which is the national laboratory surveillance system that holds all notifiable test results and results from infections of public health interest.
When to report
Positive and indeterminate COVID-19 test results should be reported to PHE as soon as they are available from the test device and, at the latest, within 24 hours, which will be the statutory requirement. Negative and void COVID-19 test results, and positive, indeterminate, negative and void influenza test results, can be sent to PHE within 7 days of testing.
How to report
PHE has provided a simple mechanism for securely recording the results from POCT. Contact the PHE POCT support team on firstname.lastname@example.org to register your organisation and receive guidance for sending test results to PHE. Include the name of the organisation and the email address that you wish to use for sending records.