Australian Health Protection Principal Committee (AHPPC) coronavirus (COVID-19) statements on 7 April 2020

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Advice on off-label medicines for treatment and prophylaxis of COVID-19

AHPPC notes that there is currently very limited evidence to support the use of medications for the treatment of COVID-19. Several medications have been proposed as likely candidates to treat COVID-19. There are currently clinical trials both within Australia, and internationally, to test their efficacy and safety.

Broadly, the medication classes that have been suggested may help manage those with COVID-19 include:

• Antimalarial drugs (such as chloroquine and hydroxychloroquine)
• Antivirals (such as favipiravir, umifenovir, remdesivir)
• Antiretrovirals (such as Ritonavir + Lopinavir (“Kaletra”))
• Immune modulators (Interferon α, β, γ or λ; β looks most promising)
• Biologic Disease Modifying Anti-Rheumatic Drugs (Interleukin-6 inhibitors, such as tocilizumab and sarilumab)

Some of these medications are marketed within Australia for indications other than COVID-19, and have known pharmacokinetics, pharmacodynamics and side effect profiles. Others are novel drugs that have either not yet been tested in clinical trials, are undergoing testing, or are used in countries overseas, but not registered with the TGA.

Off-label medication use in Australia

Lopinovir/ritonavir and hydroxychloroquine (hydroxychloroquine; +/- azithromycin) are the most common drugs prescribed for therapy or prophylaxis against COVID-19. There are several clinical trials being undertaken to assess the efficacy of antiviral therapies in COVID-19 infection.

Summary

Due to safety concerns, and the unknown effects of prescribing these medications for off-label usage, such as for COVID-19 infection, there are no current recommendations to treat patients with mild to moderate COVID-19 illness. It is also not recommended to use medications prophylactically (McCreary 2020).

Appropriate dosage of medications for use in COVID-19 are not yet determined, and there is concern that if used inappropriately, off-label use of medications may cause toxicity and lead to adverse patient outcomes.

AHPPC recommends symptomatic support and supplemental oxygen therapy for those with severe illness because of COVID-19 infection. If the patient experiences extreme respiratory distress, or continues to deteriorate and cannot be effectively managed with supplemental oxygen, intubation and mechanical ventilation may be necessary. In cases of septic shock or haemodynamic instability, haemodynamic support including vasopressors, may be required in an Intensive Care Unit setting.

For deteriorating or critically ill patients, supportive care is still currently recommended as best practice. Experimental use of medications is not recommended, and should only be prescribed as part of a clinical trial.

Medications can continue to play a role in the management of a patient infected with COVID-19, but only if being prescribed for their original purposes. For example, administering oseltamivir if the patient is co-infected with influenza, or the use of corticosteroids in those critically ill where they would normally be used, for example COPD.

The health and safety of all Australians is of paramount importance, and at this time, the AHPPC considers the evidence supporting off-label usage of medications for COVID-19 is not sufficient. We will continue to monitor the outcomes of clinical trials, and will update our recommendations as more information becomes available.

Background

Chloroquine/hydroxychloroquine

Long acting immunomodulatory drugs that may prevent viral replication in cell phagolysosome. In vitro activity of hydroxychloroquine generally has greater efficacy than chloroquine. The optimal dose is uncertain and recommended regimens vary.

• A Chinese group reported “apparent efficacy” of chloroquine therapy with clinical and virologic benefit versus a comparison group and no severe adverse drug reactions. Potential cardiotoxicity was a concern (Gao et al, Biosci Trends, 2020). Results of peer-reviewed trials in China awaited.
• There have been two reports of experience with hydroxychloroquine +/- azithromycin in 20 patients and hydroxychloroquine + azithromycinin in 80 patients from French studies (Gautret et al., Int J Antimicrob Agents[1], 2020; Gautret, preprint only[2]). The second study included 80 admitted patients. They planned patients to receive hydroxychloroquine (200mg t.i.d for ten days) and azithromycin (500mg on the first day, 200mg q.d. for the next four days). Results: Claimed clinical and virological improvement with the combination. There are many problems with this study. This combination has increased risk of cardiac toxicity.

There are still several clinical trials in play, including a prophylaxis trial by Boulware et al in the United States of America against COVID-19.

Lopinivir/ritonavir

A protease inhibitor used in HIV directed against a specific sequence of the virus not present in SARS-CoV-2. It appears however, to block the main protease of SARS-CoV-1 and inhibit viral replication. It has shown mortality reduction in SARS. Early anaecdotal mono- or combination therapy reports of value are not interpretable.

There has been a recent open label randomised trial in hospitalised patients with severe pneumonia that compared 99 patients undergoing medication-based care versus 100 patients receiving standard care. The study showed no difference in reduction in viral load or primary composite EP (Cao et al., NEJM, 2020).

Note: median time to treatment was 13 days and in SARS-CoV-1 infection effective therapy is given early. However, there was significant toxicity. Conclusion: Ongoing clinical trial results are awaited, including combination therapy.

References

1. EK McCreary, J M Pogue JM. COVID-19 Treatment: A Review of Early and Emerging Options. Open Forum Infectious Diseases: http://doi.org/10.1093/ofid/ofaa105 (accessed 1 April 2020).

2. J Gao, Z Tian, X Yang. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends: http://doi.org/10.5582/bst.2020.01047 (accessed 1 April 2020).

3. P. Gautret, J.C. Lagiera, P. Parolaa, V.T. Hoanga, L. Meddeba, M. Mailhea, et al.

Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open label non-randomized clinical trial. Int J Antimicrob Agents http://doi.org/10.1016/j.ijantimicag.2020.105949 (accessed 17 March 2020).

4. B Cao, Y Wang, D Wen, W Liu, J Wang, G Fan et al. A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19. New England Journal of Medicine: http://doi.org/10.1056/NEJMoa2001282 (accessed 1 April 2020)

Footnotes

[1] Gautret: Unusual approach to reporting results – clinical correlation with nasopharyngeal clearance on day 6 unknown; several patients changed status converted from negative to positive within a few days of endpoint. The choice of this endpoint (EP) was not explained. 4/6 excluded patients had adverse outcomes (admission to ICU or death) at EP but were not counted in the analysis. Patients who refused to consent to the study group were included in the control arm, indicating unorthodox study enrolment

[2] Non randomised; many concerns about this trial design and conclusions; useful discussion Lowe D Science Translational Med Blog accessed through Nature Briefing: briefing [at] nature.com 31/3/20

Statement on healthcare worker use of PPE when caring for suspected, or confirmed COVID-19 patients

AHPPC provides the following advice to the Australian community following advice from the Infection Control Expert Group.

AHPPC notes the concern expressed by a number of healthcare worker (HCW) groups in relation to risk of contracting COVD-19 in the workplace. There have been calls for the universal use of Personal Protective Equipment (PPE) of various types, including surgical masks and P2/N95 respirators, for HCW.

AHPPC notes the current advice that defines high risk situations where transmission-based precautions, including appropriate use of PPE, should be taken by all HCW.

In summary, national guidelines recommend:

• Contact and droplet precautions for routine care of patients with suspected or confirmed COVID-19
• Contact and airborne precautions for care of patients undergoing aerosol generating procedures and/or critically ill patients with COVID-19 in the Intensive Care Unit

These guidelines are based on the best available evidence, including trials in which transmission risks have been assessed, comparing surgical masks and P2 respirators¹. They are consistent with other international guidelines and have been recently re-endorsed by WHO² and supported by an updated systematic review³. Other types of PPE, such as powered air-purifying respirators, may be considered for specific situations, but their supply is extremely limited and they require extensive training to be used safely.

AHPPC notes that recent instances of HCW infection in the workplace in Australia have generally occurred in situations where respiratory symptoms were present and PPE was not used. AHPPC reiterates the importance of using PPE in managing any patient with symptoms of an acute respiratory infection, including those with suspected COVID-19.

As the epidemiology in Australia changes, there may be justification for the broader use of PPE, but this needs to be balanced against supply considerations. Whilst there is significant work being undertaken on procurement of more surgical masks and P2/N95 respirators, at this time it is important to prioritise allocation of PPE to the identified high risk environments. When the supply chain improves and if the general risk of contracting COVID-19 in the healthcare workplace increases, these recommendations will be reconsidered.

References

1. Radonovich LJ, Simberkoff MS, Bessesen MT, et al. N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel: A Randomized Clinical Trial. JAMA. 2019;322(9):824–833. https://doi.org/10.1001/jama.2019.11645

2. World Health Organisation. Advice on the use of masks in the community, during home care and in health care settings in the context of the novel coronavirus (2019-nCoV) outbreak. https://www.who.int/docs/default-source/documents/advice-on-the-use-of-masks-2019-ncov.pdf

3. Long Y, Hu T, Liu L, Chen R, Guo Q, Yang L, Cheng Y, Huang J, Du L. Effectiveness of N95 respirators versus surgical masks against influenza: A systematic review and meta‐analysis. Journal of Evidence-Based Medicine, March 2020 https://doi.org/10.1111/jebm.12381

Statement on home isolation

The AHPPC met on the 2 April 2020 to review and update guidance for the assessment of candidates suitable for home isolation following a positive test to SARS-CoV-2. In addition, to review and update the guidance protocols for people who will be managed in home isolation.

AHPPC considers that when assessed as appropriate by the treating clinical team and public health unit, that caring for clinically well patients with COVID-19 in their homes allows the provision of appropriate care while minimising the impact on the community, health system and frees hospital beds for more severe cases. This decision could be made when the patient is diagnosed, or during their care as their condition improves.

Any decision to isolate patients in their home rather than a hospital must take into account the patients circumstances, health and wellbeing, and the capacity for them to be managed in the outpatient setting.

Particular consideration must be given to:

• Ensuring compliance with home isolation measures
• Proportionality with current hospital capacity
• Jurisdictional legal requirements [1], particularly in relation to liability for healthcare providers caring for those in isolation.

States and territories will ensure that there is capacity to provide clinical care to those in home isolation if required, and will be responsible for implementing protocols to identify and provide care for patients if their condition deteriorates during home isolation.

Epidemiology

There are several characteristics of the virus important in the consideration of home isolation for confirmed cases:

• There have been multiple reports of cluster cases within household groups
• The majority of confirmed cases of COVID-19 only experience mild symptoms
• Most patients with severe symptoms are elderly and/or have underlying medical conditions
• There is evidence of asymptomatic and pre-symptomatic transmission of the virus, however the risk of transmission from asymptomatic infections is presumed to be lower than for symptomatic infections [2].

Eligibility for home isolation

AHPPC considers that the treating clinical team in consultation with the public health unit will consider whether it is appropriate for the patient to be managed in home isolation.

AHPPC have developed the following advice to inform this decision making process.

Requirement type	Requirement	Assessor
Clinical	Asymptomatic or has mild symptoms AND/OR recovered from acute illness but has not yet met criteria for release from isolation. Does not require regular medical or nursing isolation. Will be able to access to an appropriate level of medical care should their condition deteriorate. Has no significant comorbid conditions which are likely to require medical care during the isolation period.	Treating clinical team
Environmental	Access to a single bedroom, ideally with own bathroom/ensuite. A willing and able caregiver. Able to easily access medical care if condition deteriorates (close proximity to hospital and mobile). No persons at higher risk of serious illness live in the household (as identified on the Department of Health website). Access to food (e.g. food delivered by family or friends, home doorstep delivery packages). Access to psychological and social support (e.g. telephone, internet contact with social supports).	Clinical team in consultation with patient OR Public health unit where the clinical team believes additional advice is required
Competency	Has capacity to understand and comply with isolation requirement. Access to appropriate educational materials (including appropriate languages) on disease transmission and infection control measures. Understanding of infection control requirement (e.g. access to appropriate guidelines on cleaning and hygiene) and access to equipment for infection control (e.g. masks, cleaning agents, gloves, contaminated waste disposal).	Clinical team in consultation with patient OR Public health unit where the clinical team believes additional advice is required

Public health responsibilities for provision of care during home isolation

• Patients in home isolation should have ongoing communication with their treating clinical team and/or public health unit for medical education, support and monitoring.
• The treating clinical team in consultation with the patient must establish a plan for monitoring the patient. Patients should be advised to seek medical advice if:
  • They develop new symptoms
  • They or their carer has concerns about their wellbeing
• If specimens are required, provision should be made to take specimens should this be required for public health or clinical purposes.

Exclusion criteria for home isolation

Some patients with COVID-19 may not be considered appropriate for home isolation, and should be isolated in a hospital or alternative accommodation as deemed appropriate by the state or territory public health authority. In making this decision, the treating clinical team should give particular consideration to patients in the following circumstances:

• Residence is isolated and/or far from medical care.
• Patient or carer has poor understanding of, or resistance to, infection control measures (e.g. treating clinical team is concerned that the patient will fail to comply with isolation recommendations).
• The patient resides with multiple other persons, for example in high density housing, and other residents are at high-risk (as identified on the Department of Health website).

Review of home isolation and return to hospital or residential isolation

• Patients who breach home isolation, experience significant disease progression, or feel unable to cope with home isolation, should be reviewed by their treating clinical team and public health unit.
• Detecting breaches of home isolation is predicted to be difficult and would likely occur too late to avoid community contact and the risk of transmission. States should consider the role of public health orders. Checks may occur through random checks via phone calls, or video or police checks for
• Breach may be determined by:
  • Reported non-compliance (with isolation protocols by the patient or carer example going out into the community or attending a public gathering).
  • Secondary infection of a contact who is not the caregiver after home isolation has commenced.
• Patients in the following circumstances should also be reviewed:
  • Significant disease progression (for example persisting or recurrent fever temperatures, shortness of breath, new onset productive cough).
  • The patient or carer feeling they are unable to continue in home isolation.
• If assessed as not suitable to continue home isolation due to one of the above circumstances, the patients should complete isolation in a hospital, hotel or residential setting as deemed appropriate by their jurisdiction.

References

ACT: Public Health Regulation 2000 – Reg. 21

NT: Notifiable Diseases Act 1981 (NT), sections 9-10.

QLD: Public Health Act 2005 (QLD) Section 143

SA: South Australian Public Health Act 2011, Section 14; and, section 75 – The Chief Public Health Officer may give directions. Under section 81, anyone subject to such an order has a duty to comply with a maximum penalty of $25,000 for non-compliance.

TAS: Public Health Act 1997. A person found guilty of an offence under section 51 is liable to a fine or imprisonment for up to 12 months, or both.

VIC: Public Health and Wellbeing Act 2008 (VIC) section 111

WA: Public Health Act 2016 (WA) s88

Coronavirus disease 2019 (COVID-19) pandemic: increased transmission in the EU/EEA and the UK – seventh update, 25 March 2020. Stockholm: ECDC; 2020.

Statement on organ donation and transplantation during the COVID-19 pandemic

AHPPC has considered the impact of the COVID-19 pandemic on organ donation and transplantation. The committee recognises the important contribution of the COVID-19 National Transplantation and Donation Rapid Response Taskforce.

With the rapid evolution of the COVID-19 pandemic, a reduction in the number of organ transplantation surgeries within Australia has been observed. The AHPPC notes the following changes to transplant programs as of 25 March 2020:

• Kidney — living donor and deceased donor programs suspended
• Kidney-pancreas (and islet) — suspended
• Liver, Heart, Lung, Paediatric and multi-organ transplant programs — restricted to those likely to die within four months if not transplanted, subject to case by case review of donor-recipient characteristics.

AHPPC notes that in early March 2020, some Sydney hospitals suspended elective surgeries, including living kidney transplants. This resulted in the Australian and New Zealand Kidney Exchange Program (ANZKX) commencing a hold on ANZKX transplants from 6 March 2020. All other hospitals have since followed with suspension of all living donation programs (there have been some exceptions for paediatric patients).

The suspension of living donations has occurred due to a number of considerations, namely:

• the risk of COVID-19 infection to patients during the highly-immunosuppressive post‑transplantation phase; and
• the impact that expected increased pressure for intensive care unit (ICU) beds due to COVID-19 could have on recipient hospitalisation post-transplant.

AHPPC notes that these risks are clinically assessed with consideration of patient risks without transplantation.

Risks posed by COVID-19 to tissue and organ transplant safety

SARS-CoV-2 virus is transmitted from human to human via droplets, however uncertainties about the presence of the virus in the blood and bodily fluids of an asymptomatic donor may be considered a potential threat to the viral safety of the donated tissue or organ. Based on current knowledge, the risk of COVID-19 transmission through donated tissue and organs appears to be theoretical. However, uncertainties surrounding viraemia during the incubation period, during an asymptomatic course of infection, or after symptom resolution continue to be of concern in relation to the viral safety of the donated tissue or organ.^{[3],[4],[5],[6]} Therefore, precautionary measures are suggested to mitigate the theoretical risk.

The expected increased burden on ICU beds during the COVID-19 pandemic poses a risk to availability for recipients post-operatively. The immunosuppressed transplant recipient may also be exposed to the SARS-CoV-2 which increases the risk of being infected or developing severe illness. It is suspected, but not established that COVID-19 may increase mortality in transplant recipients.

The nature of COVID-19 transmission and extensive spread indicates that the COVID-19 pandemic may pose a significant risk to maintaining a sufficient and sustainable supply of tissues and organs. COVID-19 may affect:

• the donor and recipient population
• retrieval and transplant staff availability
• demand or supply of critical materials and equipment (including blood products and haematopoietic stem cells)

Due to the inherent complexity and often time-sensitive nature of transplantation, AHPPC notes that the impact of the COVID-19 pandemic on the organisation, co-ordination and control of all crucial activities and services at local, regional, national and international level needs to be supported.

Recommendations

Support to organ donation and transplant programs

To support the critical programs that provide life-saving transplants (deceased donor), AHPPC recommends the following:

• Inclusion of deceased donors and transplant recipients in the testing criteria in the CDNA National Guideline for COVID-19
• Prioritisation of testing of samples or specimens to allow the logistics for retrieval and transplantation teams to be expedited

This will help to ensure tissue and organ donation and transplantation is conducted as safely as possible.

There is no licensed test for the screening of blood, plasma or cell and tissue donations. Laboratory screening of blood, plasma, cells and tissues is currently not recommended. This is because transmission of COVID-19 through donated tissues and organs has not been reported; and levels of detected RNA in plasma coinciding with clinical symptoms are very low.

Interstate travel for tissue and organ retrieval and transplantation teams

To protect the health and safety of all involved in organ recovery and transplantation during the COVID-19 pandemic, AHPPC recommends that arrangements are made for the surgical recovery of organs by local teams whenever possible, including by recovery surgeons who may be available within the donor hospital.

Where this is not possible, AHPPC considers that organ and tissue retrieval and transplantation teams must not be restricted from interstate travel for the purpose of tissue and organ procurement or delivery. These teams must, however, continue to adhere to social distancing measures when travelling; as well as hand hygiene, respiratory hygiene and cough etiquette.

International Guidance

ECDC

Coronavirus disease 2019 (COVID-19) and supply of substances of human origin in the EU/EEA (PDF, 470 KB) — 20 March 2020

Aims to provide a risk assessment and management options for the safe and sustainable supply of substances of human origin (SoHO).

Laboratory screening

There is no licensed test for the screening of blood, plasma for fractionation or cell and tissue donors/donations. Laboratory screening of donors/donations of blood, plasma for the manufacture of medicinal products, and cells and tissues is currently not recommended. This is because transmission of COVID-19 through SoHO has not been reported; levels of detected RNA in plasma coinciding with clinical symptoms are very low [14] and a screening policy has not been implemented for other viral respiratory illnesses for which transfusion transmission remains theoretical, including influenza.

Testing of donors and recipients may be considered in organ and HSC transplantation settings.

The Transplantation Society (TTS)

The Transplantation Society is a non-profit NGO providing global leadership in transplantation

Guidance on Coronavirus Disease 2019 (COVID-19) for Transplant Clinicians — Updated 16 March 2020

Deceased Donors

Persons who returned from countries with >10 infected patients or who have been exposed to a patient with confirmed or suspected COVID-19 within 14 days should not be accepted as a donor. Likewise donors with unexplained respiratory failure leading to death should be excluded.

Where available, testing of upper and lower airway specimens by PCR/NAT of donors with concern for COVID-19 should be considered. Some national guidelines recommend routine testing of donors for SARS-CoV-2. Routine screening should only be performed in areas with significant ongoing community transmission to minimise the risk of false positive testing and organ wastage.

While the true risk of donor-derived transmission is unclear, RNAemia was reported in at least 15% in one case series.

In a country with widespread community transmission, temporary suspension of the deceased donor program should be considered, especially when resources at the transplant center may be constrained.

A tiered suspension may also be considered (i.e. deferral of more elective transplants, i.e. kidney, pancreas and heart transplantation for patients with VADs).This was the approach in Toronto during the SARS outbreak in 2003.

There is no clear reason to suspend deceased donor transplants in countries only experiencing sporadic cases of COVID-19 cases.

American Society of Transplant Surgeons (ASTS)

Organ Retrieval for Transplantation in the COVID-19 Era — March 27, 2020

Deceased Donor Evaluation

Until more is learned about transmissibility of the virus from deceased donors to organ recovery teams and/or to recipients, the ASTS recommends that organs from COVID-19-positive donors should NOT be recovered or transplanted. The ASTS recommends that deceased donor COVID-19 testing be performed on ALL deceased donors, while acknowledging that COVID-19 testing is rapidly evolving. With the current PCR-based testing, the most reliable specimen sample for testing is a BAL (90+%). The diagnostic value of BAL samples must be balanced against provider risk associated with aerosolization of respiratory secretions. Nasopharyngeal swab has a lower detection rate (60-75%). Viremia has been (uncommonly) detected, but raises the possibility of transmission through blood and organs. Recognition that current testing leaves a relative uncertainty about a negative diagnosis, it is important to consider the extent of community penetration in the donor hospital area.

Local Deceased Donor Recovery: The best way to prevent COVID-19 spread by a donor organ recovery team is to AVOID TRAVEL BY THE TEAM. ASTS strongly recommends that local teams be requested to recover organs and ship them to the recipient centre for transplantation. There may be associated trust and quality issues, but the COVID-19 transmission risks (in and out of the area) will be reduced through implementation of local organ recovery. The ASTS recognizes that local recovery is a practice deviation for many programs, but considers the aggregate benefit to greatly outweigh the inconveniences.

Deceased Donor Recovery Teams: The general principles of respiratory and contact protection should be practiced in all phases of travel/organ recovery. Travel wearing masks (Chinese recommendation is to change face mask every four hours) and eye protection. Wear clean scrubs from the home institution to the donor hospital, wash hands frequently, bring and use hand sanitizer after touching surfaces (wearing gloves still means that one must avoid touching face near nares or mouth). Change scrubs upon arrival to the donor facility. Be as purposeful with activity and avoid intra-hospital movement as feasible, such as to ICU or cafeteria). Discussions of procedural strategies with OPO and operative staff to minimize potential exposures should done prior to incision. Use of N95 masks and face shields during the retrieval procedure is prudent and recommended, especially if lungs are recovered. After organs are packaged, change scrubs and wash skin that was exposed to donor secretion (showering may be prudent) prior to traveling back to transplant centre (either leave or package first set of travel scrubs in separate bags). Travel back with respiratory barriers, clean scrubs and clean hands. All teams should be cognizant of the stressful COVID-19 environment and be respectful of the OPO and local hospital staff.

Footnotes

[3] Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506

[4] Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, et al. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 3 March 2020.Peng L, Liu J, Xu W, Luo Q, Deng K, Lin B, et al. 2019 Novel Coronavirus can be detected in urine, blood, anal swabs and oropharyngeal swabs samples. www.medrxiv.org. 21 February 2020:20026179.

[5] Peng L, Liu J, Xu W, Luo Q, Deng K, Lin B, et al. 2019 Novel Coronavirus can be detected in urine, blood, anal swabs and oropharyngeal swabs samples. www.medrxiv.org. 21 February 2020:20026179.

[6] Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 11 March 2020.Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, et al. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 3 March 2020.

Statement on rapid point of care lateral flow devices to detect antibodies to SARS-COV-2

The AHPPC met on 2 April 2020 to discuss the use of rapid finger-prick point of care lateral flow devices to detect antibodies to SARS-COV-2.

Background

The Australian Government has purchased large quantities of these devices to assist in the control of COVID-19.

The Therapeutic Goods Administration has published guidance on conditions of supply of those devices in addition to listing devices which have been assessed on the Australian Register of Therapeutic Goods.

The Public Health Laboratory Network and Communicable Diseases Network Australia has provided advice to AHPPC on the use of these devices.

AHPPC statement

There has been a lot of interest in these tests recently, which are rapid finger prick point-of-care lateral flow devices. These tests are rapid IgM/IgG immunoassays.

As with all serological tests, the results from these devices are not useful in the acute phase of infection.

Further post-market performance validation work is being undertaken to assess the diagnostic performance of these tests. This work will determine the potential cross reactivity of previous infection with other coronaviruses, and to provide clear guidance on interpretation of results and use. Until this work is done, we advise against the general use of these tests in primary care and residential care environments.

The tests may have a clinical role in diagnosis of persons presenting after a week to ten days from the onset of symptoms, when it may be more difficult to detect SARS-COV-2 by standard methods. Until more data is available, the significance of test results at this time is not yet certain. In addition, if positive test results are found to predict immunity to COVID-19 then potential roles may exist for these devices in establishing that it is safe for individuals to be exposed to persons with COVID-19, and/or that they are unlikely to pose an exposure risk to others .

PHLN and CDNA in collaboration with officials from the department will develop a concept of use including an implementation plan for using these devices in primary health and residential care environments.