GeneXpert COVID rapid test approval process There is a limited global supply of COVID-19 cartridges to operate the GeneXpert platforms. Therefore, POC testing should be used for cases where this will provide clinical or public health advantage, compared with usual laboratory based testing. The criteria for decision making are detailed in Attachment 1 COVID-19 Primary Care Response, Guidance for the rational use of Point-of-Care Testing in primary care.

Location Health Service Day/time rapid test available

Approver

Contact number

Metropolitan

Perth PathWest Nedlands Fiona Stanley Hospital

0800-2200 Mon-Fri 1000-2000 Sat, Sun public holidays 24/7

Statewide on call public health physician in consultation with PathWest

93280553

Tertiary hospital inpatients and ED admissions

COVID-19 rapid testing is coordinated internally. Contact the on call infectious disease physician or clinical microbiologist

Goldfields

Esperance Esperance Hospital 0800-1600 Regional Medical Director or Dr Louise Pearn

9080 5888

Kalgoorlie Kalgoorlie Health Campus

0700-2200 daily

Regional Medical Director or the Regional Public Health Physician

9080 5888

Kalgoorlie Bega Garnbirringu Health Service

Internal use only

Senior Medical Officer Bega Garnbirringu Health Service

Internal use only

Blackstone, Kiwirrkurra, Warakuna and Warburton

Ngaanyatjarra Health Service

Internal use only

Senior Medical Officer Ngaanyatjarra Health Service

Internal use only

Laverton Laverton Hospital 0900-1700 Regional Medical Director or the Regional Public Health Physician

9080 5888

Tjuntjunjara Spinifex Health Service

Internal use only

Senior Medical Officer Spinifex Health Service

Internal use only

Wiluna Ngangganawili Aboriginal Health Service

Internal use only

Senior Medical Officer Ngangganawili Aboriginal Health Service

Internal use only

Great Southern

Albany Albany Health Campus

0830-1630 daily

Regional Medical Director or Hospital Medical Director

98922222

Kimberley

Broome Broome Hospital 0800-1600 Regional Physician, Regional Paediatrician or Regional Public Health Physician

9194 2222

9194 1630 (office hours only)

Balgo Balgo Health Centre Internal use only

Senior Medical Officer Balgo Health Centre

Internal use only

Beagle Bay Beagle Bay Health Centre

Internal use only

Senior Medical Officer Balgo Health Centre

Internal use only

Bidyadanga Bidyadanga Health Centre

Internal use only

Senior Medical Officer Bidyadanga Health Centre

Internal use only

Bililuna Bililuna Health Centre Internal use only

Senior Medical Officer Bililuna Health Centre

Internal use only

Derby Derby Aboriginal Health Service

Internal use only

Senior Medical Officer Derby Aboriginal Health Service

Internal use only

Derby Derby Hospital 0800-2200 daily

Regional Physician, Regional Paediatrician or Regional Public Health Physician

(08) 9193 3333

9194 1630 (office hours only)

Fitzroy Crossing

Fitzroy Crossing Hospital

Internal use only

Regional Physician, Regional Paediatrician or Regional Public Health Physician

(08) 9193 3333

9194 1630 (office hours only)

Halls Creek Yuri Yungi Medical Service

Internal use only

Senior Medical Officer Yuri Yungi Medical Service

Internal use only

Kalumburu Kalumburu Clinic Internal use only

Regional Physician, Regional Paediatrician or Regional Public Health Physician

(08) 9193 3333

9194 1630 (office hours only)

Kununurra Kununurra Hospital 0800-1600 Regional Physician, Regional Paediatrician or Regional Public Health Physician

9194 2222

9194 1630 (office hours only)

Kununurra Ord Valley Aboriginal Health Service

Internal use only

Senior Medical Officer Ord Valley Aboriginal Health Service

Internal use only

Midwest

Geraldton Geraldton Regional Hospital

0800-1700 daily

Hospital Medical Director, Regional Medical Director or Regional Public Health Physician

9956 2222

Carnarvon Carnarvon Hospital 0800-1700 daily

Hospital Medical Director, Regional Medical Director or Regional Public Health Physician

9956 2222

Carnarvon Carnarvon Medical Service Aboriginal Corporation

Internal use only

Senior Medical Officer Carnarvon Medical Service Aboriginal Corporation

Internal use only

Meekatharra Meekatharra Hospital Internal use only

Hospital Medical Director, Regional Medical Director or Regional Public Health Physician

9956 2222

Mt Magnet Geraldton Regional Aboriginal Medical Service, Mt Magnet clinic

Internal use only

Senior Medical Officer Geraldton Regional Aboriginal Medical Service, Mt Magnet clinic

Internal use only

Wiluna Ngangganawili Aboriginal Health Service

Internal use only

Senior Medical Officer Ngangganawili

Internal use only

Aboriginal Health Service

Pilbara

Port Hedland Hedland Health Campus

0830-1630 Mon-Fri

Regional Medical Director

9174 1000

Jigalong Puntukurnu Aboriginal Medical Service

Internal use only

Senior Medical Officer Puntukurnu Aboriginal Medical Service

Internal use only

Karratha Karratha Hospital 0830-1630 Mon-Fri

Regional Medical Director

9174 1000

South West

Bunbury Bunbury Hospital 0800-1800 Mon-Fri; 1000-1700 Sat-Sun

Regional Medical Director

9791 2244

Wheatbelt

Narrogin Narrogin Hospital 0800-1700 Mon-Fri; 0800-1100 Sat-Sun

Regional Medical Director

9690 1300

Northam Northam Hospital 0800-1700 Mon-Fri; 0800-1100 Sat-Sun

Regional Medical Director

9690 1300

Attachment 1. COVID-19 Primary Care Response, Guidance for the rational use of Point-of-Care Testing in primary care

Insert POCT Clinical guidance for cartridges - endorsed 2 July 2020.pdf

Last updated 24 Sept 2020

This document can be made available in alternative formats on request for a person with disability.

© Department of Health 2020

Copyright to this material is vested in the State of Western Australia unless otherwise indicated. Apart from any fair dealing for the purposes of private study, research, criticism or review, as permitted under the provisions of the Copyright Act 1968, no part may be reproduced or re-used for any purposes whatsoever without written permission of the State of Western Australia.

health.wa.gov.au

1

COVID-19 Primary Care Response

Guidance for the rational use of Point-of-Care Testing in primary care

Purpose

This document is intended for use by primary care services in rural and remote Australia who have access to point of care testing (POCT) for SARS-CoV-2 (the virus causing COVID-19). This document provides guidance for rational use of POC tests in the context of potentially limited cartridge supply. It is important to note that decisions on the appropriateness of testing and use of POC test versus conventional laboratory PCR will ultimately need to be made at the service level and should be guided by clinical judgement.

This document should be read in conjunction with:

Aboriginal and Torres Strait Islander COVID-19 Point-of-care (POC) Testing Program Guidelines, and standard operating procedures

CDNA COVID-19 Series of National Guidelines CDNA Interim National Guidance for remote Aboriginal and Torres Strait Islander communities for

COVID-19

Relevant jurisdictional guidelines for COVID-19

Background

Importance of early diagnosis in Aboriginal and Torres Strait Islander communities: A case of COVID-19 in an Aboriginal and Torres Strait Islander community has the potential to rapidly cause an outbreak which may have high levels of mortality and morbidity. Because of this, early identification and isolation of first cases achieved through adequate surveillance (enhanced testing and identification and testing of suspect cases), and minimising time to results is important to reduce transmission and allow possible containment of an outbreak. POC testing will help to facilitate quicker turn-around times for tests and therefore quicker public health response.

Who should be tested for COVID-19? Clinicians should follow testing criteria outlined in jurisdictional guidelines or the COVID-19 SoNG regarding when it is appropriate to test for COVID-19. This will include those that meet suspect and probable case definitions and those that meet enhanced testing criteria. Recognising and proactively offering COVID-19 testing to presentations consistent with possible COVID-19 disease, is a key element of early detection of disease in remote areas. Reduction in border restrictions may increase risk of cases occurring in remote areas and so should be accompanied by an increase in surveillance with rapid turnaround times.

https://www.health.gov.au/resources/publications/covid-19-national-health-plan-primary-care-covid-19-remote-community-preparedness-and-retrievalhttps://www.health.gov.au/resources/publications/covid-19-national-health-plan-primary-care-covid-19-remote-community-preparedness-and-retrievalhttps://www1.health.gov.au/internet/main/publishing.nsf/Content/7A8654A8CB144F5FCA2584F8001F91E2/$File/COVID-19-SoNG-v2.10.pdfhttps://www.health.gov.au/sites/default/files/documents/2020/04/cdna-interim-national-guidance-for-remote-aboriginal-and-torres-strait-islander-communities-for-covid-19.pdfhttps://www.health.gov.au/sites/default/files/documents/2020/04/cdna-interim-national-guidance-for-remote-aboriginal-and-torres-strait-islander-communities-for-covid-19.pdf

2

Cartridge Prioritisation

The TGA-approved GeneXpert Xpress SARS-CoV-2 test for use on the Xpert platform (Cepheid) enables the rapid molecular detection of SARS-CoV-2 infection at the point-of-care. However, there is a limited global supply of COVID-19 cartridges to operate the GeneXpert platforms. Therefore, there may be occasions or situations where supply does not meet demand, and if so, POC testing should be used for cases where this will provide clinical or public health advantage, compared with usual laboratory based testing.

Below are recommendations for individuals to be prioritised for POC testing. However these are guidelines only and ultimately decisions on prioritisation of POC testing should be made based on clinical judgement, in discussion with a senior medical officer and/or Public Health Unit where necessary.

Consider prioritisation of the following groups:

Individuals meeting the suspect or probable case definition for COVID-19 (as defined in jurisdictional guidelines or the COVID-19 SoNG:

o Note that this includes clinical AND epidemiological criteria Aboriginal and Torres Strait Islander people who meet the criteria for enhanced testing (e.g.

respiratory symptoms, or unexplained fever or history of fever) and where delays in testing or longer periods of self-isolation places others at higher risk of transmission (e.g. due to overcrowded or inadequate housing). Within this category, the following could be considered as priorities:

o Individuals who are likely to leave the community prior to a result becoming available o Individuals who are likely to have or have had multiple contacts e.g. where an individual is

intending to attend a mass gathering before a result will be available and would be at risk of not following guidance to self-isolate

o Individuals who are likely to have major barriers to any kind of self-isolation (e.g. those who have difficulty following directions due to barriers in understanding)

Non-Aboriginal and Torres Strait Islander residents and visitors to Aboriginal and Torres Strait Islander communities, who meet criteria for enhanced testing and have had direct contact with community members in the 14 days prior to onset of illness (that may have resulted in disease transmission), or will need to have direct contact with community members as part of their role, where waiting for a conventional PCR test could lead to risk of service failure.

Note that:

When making local decisions, it is acknowledged that services may consider reserving cartridges (50 -100) to allow for testing within the first 24-48 hours of a confirmed COVID-19 case or outbreak. This could occur if the capacity to test close contacts and community members is identified, planned for within the outbreak management plan, and should articulate with the relevant jurisdictional COVID-19 remote outbreak plan

To best understand issues faced by Aboriginal and Torres Strait Islander people being tested, non-Aboriginal and Torres Strait Islander staff should consult with Aboriginal and Torres Strait Islander colleagues.

GeneXpert COVID rapid test approval process