Implementing a Rapid Antigen Test Program
Over the last few months there has been expansion of rapid antigen testing for use in both health and non-health sectors. However, even with the current COVID outbreaks in Australia, compared with many other countries the prevalence of the disease is low in Australia. In this low prevalence environment, the lower sensitivity and less than 100% specificity of rapid antigen tests will result in some false negative and some false positive results.
A business looking to implement a Rapid Antigen Testing regimen must have protocols in place to manage safety of both the persons performing the test and the persons being tested.
- This includes having adequate infection control protocols in place to ensure the safety of staff and persons and to prevent the spread ofinfection.
- There must be protocols relating to Workplace Health and Safety (WH&S) that are consistent withrelevant national and jurisdictional workplace health and safety requirements.
- Every sample may be infectiousand staff performing the tests should wear appropriate Personal Protective Equipment(PPE) (e.g. gloves, mask, gown, eye protection).
- Any accidents or incidents mustbe reported to the PoCT supervisor and followed up according to local workplacerequirements.
- With the increase in "at home" testing, businesses need to ensure results can be recorded, tracked and verified.
Choosing a Rapid Antigen Test
The following should beconsidered when selecting a rapid antigen test to use:
- Sample type (e.g. nasal, nasopharyngeal swab, saliva) – what sample types do you want to collect and what does it say in the instructions for use that the test can be used with.
- Clinical sensitivity (higher sensitivity will reduce the number of false negatives).
- Clinical specificity (higher specificity will reduce the number of false positives).
- Storage requirements of the test kits (can the test be stored at room temperature prior to use or does it require other storage arrangements).
- Storage requirements of samples once collected (how long can the sample be stored and at what temperature).
- Collection and storage of samples must be performed in accordance with the manufacturer’s instructions. This maybe a consideration for follow-up laboratory confirmatory testing.
It is recommended that businessesimplementing rapid antigen testing take into consideration the following:
- An appropriate rapid antigen test registered in the Australian Register of Therapeutic Goods (ARTG) is sourced for use giving consideration to sample type, clinical sensitivity, clinical specificity, storage requirements of test kits and samples.
- There are appropriately trained medical practitioners or health practitioners available who will be the designated PoCT supervisor(s).These health practitioners will take responsibility and accountability for the conduct, quality and implementation of the testing.
- All health practitioners, and staff performing testing, are trained in the safe and correct performance of the test, including sample collection.
- Suppliers of tests must provide training to health practitioners. Businesses will need to supplement this and put in place additional training protocols for training of staff that will operate under the oversight of the health practitioners. Protocols will need to include on-going training and competency checks and take into consideration the business’ existing COVID safe plan, standard operating procedures and other arrangements.
- Procedures are in place for ensuring any associated equipment and instrumentation is maintained according to manufacturer’s instructions and appropriate records are kept.
- There are protocols for recording all relevant information such as staff training; performance of testing (e.g. when performed, who by and on whom), test results.
- Protocols are in place for when a positive result is received including procedures for recording results and requirements for notification of positive results to State and Territory organisations (for follow up laboratory PCR testing and contact tracing), to individuals and what this means for the work place.
- Procedures are in place for privacy and confidentiality of individuals with appropriate consents.
- The rapid antigen testing site is located in a safe and easily accessible place which includes adequate access to essential services (e.g. power, water), QR check in code for the site, is well lit, secure, offers appropriate weather protection and suitable for COVID safe spacing and flow with adequate PPE, masks and hand sanitizing stations.
- The testing environment is fit for purpose. All equipment is in good working order, all procedures are carried out accurately,efficiently, and safely and the wellbeing and confidentiality of the individual is respected, especially in relation to test result.
- There are appropriate infection control practices and Work Health and Safety (WH&S) protocols are in place.
- There are protocols for reporting any problems or adverse events associated with performance of the test, including false negative or false positive results, to the Therapeutic Goods Administration (TGA).