CRITERIA FOR RELEASING COVID

Background

On 27 May 20trăng tròn, vuialo.net published updated interim guidance on the clinical management of COVID-19,1,2 và provided updated recommendations on the criteria for discharging patients from isolation.

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The updated criteria reflect recent findings that patients vuialo.netse symptoms have resolved may still thử nghiệm positive sầu for the COVID-19 virus (SARS-CoV-2) by RT-PCR for many weeks. Despite this positive sầu thử nghiệm result, these patients are not likely khổng lồ be infectious và therefore are unlikely lớn be able lớn transmit the virus lớn another person.

This scientific brief provides the rationale for the changes made to lớn the clinical management of COVID-19 guidance, based on recent scientific evidence. vuialo.net will update these criteria as more information becomes available. For more information about clinical care of COVID-19 patients, see vuialo.net’s full guidance.1

Previous recommendation

Initial recommendation (published on 12 January 2020)

vuialo.net’s first technical package of guidance for the clinical management of the novel coronavirus, now known as COVID-19, was published in early January 20trăng tròn, shortly after a cluster of atypical pneumonia cases was first reported in Wuhan, People’s Republic of China,3 and included recommendations on when a patient with COVID-19 is no longer considered infectious.

The initial recommendation to confirm clearance of the virus, & thus allow discharge from isolation, required a patient lớn be clinically recovered và lớn have sầu two negative RT-PCR results on sequential samples taken at least 24 hours apart.4 This recommendation was based on our knowledge & experience with similar coronaviruses, including those that cause SARS & MERS.5

Updated recommendation

New recommendation (published on 27 May 2020 as part of more comprehensive clinical care guidance1)

Within the Clinical Management of COVID-19 interyên ổn guidance published on 27 May 20đôi mươi,1 vuialo.net updated the criteria for discharge from isolation as part of the clinical care pathway of a COVID-19 patient. These criteria apply khổng lồ all COVID-19 cases regardless of isolation location or disease severity.

Criteria for discharging patients from isolation (i.e., discontinuing transmission-based precautions) without requiring retesting<1>:

For example, if a patient had symptoms for two days, then the patient could be released from isolation after 10 days + 3 = 13 days from date of symptom onset; for a patient with symptoms for 14 days, the patient can be discharged (14 days + 3 days =) 17 days after date of symptom onset; for a patient with symptoms for 30 days, the patient can be discharged (30+3=) 33 days after symptom onset).

*Countries may choose to continue lớn use testing as part of the release criteria. If so, the initial recommendation of two negative PCR tests at least 24 hours apart can be used.

What is the reason for the change?

In consultations with global expert networks & Member States, vuialo.net has received feedback that applying the initial recommendation of two negative RT-PCR tests at least 24 hours apart, in light of limited laboratory supplies, equipment, và personnel in areas with intense transmission, has been extremely difficult, especially outside hospital settings.

With widespread community transmission, these initial criteria for SARS-CoV-2 posed several challenges:

Long periods of isolation for individuals with prolonged viral RNA detection after resolution of symptoms, affecting individual well-being, society ,and access to lớn healthcare.13Insufficient testing capathành phố to comply with initial discharge criteria in many parts of the world. Prolonged viral shedding around the limit of detection, having negative results followed by positive sầu results, which unnecessarily challenges trust in the laboratory system.23-28

These challenges & newly available data on the risk of viral transmission over the course of the COVID-19 illness provided the framework for updating vuialo.net’s position on the timing of discharging recovered patients from isolation in and outside health care facilities. vuialo.net continuously Review scientific literature on COVID-19 through its Science Division và its COVID-19 technical teams. All aspects of clinical management of COVID-19 patients & laboratory testing strategies are discussed within vuialo.net & with Member States and vuialo.net’s global expert networks of public health professionals, clinicians, and academics around the world. These expert networks and the Strategic and Technical Advisory Group for Infectious Hazards (STAG-IH)7 considered the challenges & reviewed the available data in the decision process to change the initial recommendation.

The updated criteria for discharge from isolation balances risks và benefits; however, no criteria that can be practically implemented are without risk. There is a minimal residual risk that transmission could occur with these non–test-based criteria. There can be situations in which a minimal residual risk is unacceptable, for example, in individuals at high risk of transmitting the virut lớn vulnerable groups or those in high-risk situations or environments. In these situations, & in patients vuialo.net are symptomatic for prolonged periods of time, a laboratory-based approach can still be useful.

vuialo.net encourages the scientific community lớn compile additional evidence khổng lồ further improve sầu isolation discharge criteria and establish the conditions under which isolation can be abbreviated or where the possible risks of the current discharge criteria require further adaptation. Better understanding of transmission risk among mỏi individuals with different clinical presentations or comorbidities & in different settings will aid further refinement of these criteria. For situations that might still require a laboratory-based approach, we encourage the further optimization of such a laboratory algorithm.

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vuialo.net encourages countries to lớn continue testing patients, if they have the capacity to vì so, for systematic data collection that will enhance understanding và better guide decisions about infection prevention and control measures, especially amuốn patients with prolonged illness or those vuialo.net are immunocompromised.

Current understanding of transmission risk

Infection with the virut causing COVID-19 (SARS-CoV-2) is confirmed by the presence of viral RNA detected by molecular testing, usually RT-PCR. Detection of viral RNA does not necessarily mean that a person is infectious & able lớn transmit the virus to lớn another person. Factors that determine transmission risk include whether a vi khuẩn is still replication-competent, whether the patient has symptoms, such as a cough, which can spread infectious droplets, và the behavior và environmental factors associated with the infected individual. Usually 5-10 days after infection with SARS-CoV-2, the infected individual starts khổng lồ gradually produce neutralizing antibodies. Binding of these neutralizing antibodies lớn the virus is expected to reduce the risk of vi khuẩn transmission.10,11,29,35

SARS-CoV-2 RNA has been detected in patients 1-3 days before symptom onset, and viral load in the upper respiratory tract peaks within the first week of infection, followed by a gradual decline over time.10,12,15,19,21,22,36-39 In the feces & lower respiratory tract, this viral load seems lớn peak in the second week of illness.19 Viral RNA has been detected in upper respiratory tract (URT) và lower respiratory tract (LRT) & feces, regardless of severity of disease.19 There seems to lớn be a trend in longer detection of viral RNA in more severely ill patients.10,14,15,18,19,41-43 Studies of viral RNA detection in immunocompromised patients are limited, but one study suggested prolonged detection of viral RNA in renal transplant patients.33 Some studies analyzed the risk of transmission related lớn symptom of onmix, & the estimated risk of transmission was highest at or around the time of symptom onset and in the first 5 days of illness.13,15

The ability of the virus to replicate in cultured cells serves as a surrogate marker of infectivity but requires special laboratory capabilities & may not be as sensitive sầu as PCR.10,đôi mươi Animal models can aid understanding of transmission risk. In a study by Sia, et al., hamsters infected with SARS-CoV-2 were housed with healthy hamsters on either day 1 or day 6 after infection. Transmission to healthy hamsters occurred in the day 1 group, but not in those exposed 6 days after inoculation. In this mã sản phẩm, the timing of transmission correlated with the detection of vi khuẩn using cell culture, but not with detection of viral RNA in donor nasal washes.31

Studies using viral culture of patient samples lớn assess the presence of infectious SARS-CoV-2 are limited.8-10,21,29,30,34 Viable virus has been isolated from an asymptomatic case.9 A study of 9 COVID-19 patients with mild to moderate disease found no SARS-CoV-2 virut able khổng lồ be cultured from respiratory samples after day 8 of symptom onmix.10 Three studies of patients with undisclosed or variable degree of illness showed an inability lớn culture vi khuẩn after days 7-9 of symptom onset.8,29,30 Patients vuialo.net were RT-PCR positive on retesting after an initial negative sầu RT-PCR on discharge from isolation were also studied, và none of these patients yielded positive sầu viral cultures.29 One possible outlier is a case report of a patient with mild COVID-19 vuialo.net remained PCR-positive for 63 days after symptom onphối. In this patient, viral cultures were positive sầu from upper respiratory tract specimens only on the day of symptom onmix, but were culture-positive sầu from sputum samples until day 18.22 It is unclear whether this posed a transmission risk as the patient had no respiratory symptoms. In a hospital-based study of 129 patients severely or critically ill with COVID-19, 23 patients yielded at least one positive sầu viral culture. This study included 30 patients vuialo.net were immunocompromised. The median duration of viral shedding as measured by culture was 8 days post onphối, the interquartile range was 5-11, & the range was 0-trăng tròn days.11 The probability of detecting vi khuẩn in culture dropped below 5% after 15.2 days after of symptoms. In this study, patients testing positive sầu by viral culture were still experiencing symptoms at the time of sample collection.11 This & other studies have described the correlation between reduced infectivity with the decrease in viral loads10,11,29,34 và a rise in neutralizing antibodies.10,11,29 Although viral RNA can be detected by PCR even after the resolution of symptoms, the amount of detected viral RNA is substantially reduced over time và generally below the threshold where replication competent vi khuẩn can be isolated. Therefore, the combination of time after onmix of symptoms and the clearance of symptoms seems to be a generally safe approach based on current data.

Conclusion

Based on evidence showing the rarity of vi khuẩn that can be cultured in respiratory samples after 9 days after symptom onmix, especially in patients with mild disease, usually accompanied by rising levels of neutralizing antibodies and a resolution of symptoms, it appears safe to release patients from isolation based on clinical criteria that require a minimum time in isolation of 13 days, rather than strictly on repeated PCR results. It is important to lớn note that the clinical criteria require that patients’ symptoms have been resolved for at least three days before release from isolation, with a minimum time in isolation of 13 days since symptom onphối.

These modifications to lớn the criteria for discharge from isolation (in a health facility or elsewhere) balance the understanding of infectious risk and the practicality of requiring repeated negative PCR testing, especially in settings of intense transmission or limited testing supplies. Although the risk of transmission after symptom resolution is likely lớn be minimal based on what is currently known, it cannot be completely ruled out. However, there is no zero-risk approach, & strict reliance on PCR confirmation of viral RNA clearance creates other risks (e.g. straining resources và limiting access to health care for new patients with acute disease). In patients with severe disease vuialo.net are symptomatic for prolonged periods of time, a laboratory-based approach might also aid decision-making on the need for prolonged isolation. Such a laboratory-based approach can include measuring viral load and neutralizing antibody toàn thân (or proven equivalent antibody) levels.10,11,29 More research is needed to further validate such an approach.

vuialo.net will update these criteria as more information becomes available. For more information about clinical care of COVID-19 patients, see vuialo.net’s full guidance.1