Advisory

ADVISORY ON THE USE OF ANTIGEN RAPID DIAGNOSTIC KITS

Last Updated on 1 month by Publishing Team

ADVISORY ON THE USE OF ANTIGEN RAPID DIAGNOSTIC KITS

FOR DIAGNOSIS OF COVID-19 INFECTION IN FIJI

Background

The World Health Organization (WHO) has provided Emergency Use Authorization for a small number of Antigen (Ag)-based Rapid Diagnostic Tests (AgRDTs) to be used in specific circumstances for the diagnosis of COVID-19 infection. The Ministry recently started using WHO approved AgRDTs in combination with the existing gold standard RT-PCR testing to increase testing capacity and test turnaround time in high prevalence areas. AgRDT is not recommended in areas where the prevalence of COVID-19 infection is low due to reduced accuracy compared to RT-PCR. The Ministry has also received many enquiries from health care providers and suppliers on the use of AgRDT in Fiji. In this regard, the Ministry is stating the following:

Types of AgRDT

  • The Ministry endorses the use of AgRDT that have been approved by the WHO. The list of approved AgRDT are published by WHO and can be accessed via the following WHO website: https://extranet.who.int/pqweb/sites/default/files/documents/210126_eul_sars_cov2_product_list.pdf
  • The Ministry also approves use of AgRDT that have been approved by the Australia Therapeutic Goods Administration (TGA) for inclusion in the Australian Register of Therapeutic Goods (ARTG) https://www.tga.gov.au/covid-19-test-kits-included-artg-legal-supply-australia

Where can AgRDTs be used

The Ministry endorses the use of AgRDT to test symptomatic patients in areas of Fiji where there is a high prevalence (community transmission) of the disease. Within these high prevalence areas this will include highly populated communities, large worksites, and healthcare settings. In these settings, AgRDT should be used alongside PCR testing for completion of testing protocols. The use of AgRDT in low prevalence settings, including places that are COVID-19 contained, is not recommended.

Samples to be collected for AgRDT

Nasopharyngeal samples are to be collected for AgRDT. However, if conducting regular (e.g. daily or every 2nd day) screening of the same group of people (e.g. healthcare workers) then nasal mid turbinate samples may be collected. AgRDT that require saliva or other samples are currently not acceptable.

Collection of samples for AgRDT

Only trained healthcare workers are to collect samples and conduct AgRDT. The Ministry recommends that health workers who collect respiratory samples for AgRDT testing wear gloves, gown, masks, and face shield or goggles to protect themselves.

Interpretation of AgRDT results

In settings with high prevalence, a positive AgRDT test means the patient is considered positive for COVID-19. Patients who test RDT negative and have COVID-19 like signs and symptoms must have a repeat test with RT-PCR due to increased risk of false negative results and self isolate while awaiting this result. Note that any testing done in low prevalence settings should be confirmed with a PCR test due to the increased risk of false positives.

Use of AgRDT Results

  • If an individual has symptoms and returns a negative result on AgRDT, the individual should self-isolate while waiting for a PCR test result.
  • AgRDT must not be used to clear contacts of cases from having to undergo 14 day quarantine.
  • AgRDT must not be used to clear an individual to travel from a high prevalence area to a low prevalence area
  • The use of AgRDT as a screening tool for asymptomatic people (e.g. in a workplace) is only appropriate when testing is done regularly, that is, every day or every second day, noting that the risk of a false negative result is higher in asymptomatic people.

Reporting of Results

All AgRDT testing results (positive and negative results) should be reported to the Ministry of Health and Medical Services daily. Testing results should be submitted to fijicovidrdt@gmail.com. Please email to receive the accepted reporting template.

Acquiring AgRDT testing capability

Organizations that wish to import AgRDT kits into the country must apply for import permit to the Fiji Medicinal Products Board for approval.  All applications must be addressed to:

The Secretariat

Fiji Medicinal Products Board

GPO Box 106

Suva

Or emailed to the following address: emi.lewatoro@govnet.gov.fj