key: cord-270935-t9pym9k0
authors: Dumyati, Ghinwa; Gaur, Swati; Nace, David A.; Jump, Robin L.P.
title: Does Universal Testing for COVID-19 Work for Everyone?
date: 2020-08-15
journal: J Am Med Dir Assoc
DOI: 10.1016/j.jamda.2020.08.013
sha: 
doc_id: 270935
cord_uid: t9pym9k0

Abstract The COVID-19 pandemic has been especially devastating among nursing home residents, with both the health circumstances of individual residents as well as communal living settings contributing to increased morbidity and mortality. Preventing the spread of COVID-19 infection requires a multipronged approach that includes early identification of infected residents and healthcare personnel, compliance with infection prevention and control measures, cohorting infected residents, and furlough of infected staff. Strategies to address COVID-19 infections among nursing home residents vary based on the availability for SARS-CoV-2 tests, the incorporation of tests into broader surveillance efforts, and using results to help mitigate the spread of COVID-19 by identifying asymptomatic and presymptomatic infections. We review the tests available to diagnose COVID-19 infections, the implications of universal testing for nursing home staff and residents, interpretation of test results, issues around repeat testing, and incorporation of test results as part of a long-term response to the COVID-19 pandemic. We propose a structured approach for facility-wide testing of resident and staff and provide alternatives if testing capacity is limited, emphasizing contact tracing. Nursing homes with strong screening protocols for residents and staff, that engage in contact tracing for new cases, and that continue to remain vigilant about infection prevent and control practices, may better serve their residents and staff by thoughtful use of symptom- and risk-based testing strategies.

Dr. Jump reports support for this work in part through the Cleveland Geriatric Research 50 While there is general agreement that increased access to testing is important for personal and 23 public health, the selection and use of diagnostic tests to mitigate COVID-19 infections in post-24 acute and long-term care settings is complex and should be tailored to individual sites. He responded to antibiotics and his fever resolved within 12 hours. Because he met the nursing 36 home's enhanced screening criteria for COVID-19 (Table 1) , 1 he was placed on transmission-37 based precautions and a laboratory test for SARS-CoV-2 was ordered. 38 39

The Food and Drug Administration (FDA) has authorized several diagnostic and serologic 41 (blood-based) tests as part of the Emergency Use Authorization (EUA) process ( Table 2) . reported that RT-PCR was 70% sensitive when compared to a computed tomography (CT) scan 54 of the chest. 4 This study was conducted in the early stages of the pandemic on 1014 patients. 55

Since then, the number of RT-PCR-based tests and availability of those tests, as well as the 56 prevalence and clinical recognition of signs and symptoms of COVID-19 infection, has changed 57 dramatically. All of these factors influence the sensitivity and specificity of diagnostic RT-PCR 58 tests. Even if the sensitivity of RT-PCR based testing has increased to an optimistic 90% to 95%, 59 it still means that 1 out of every 10 to 20 negative results will be a false negative and miss a 60 COVID-19 infection. A lower level of sensitivity may not be an issue in settings or regions 61

where the disease prevalence is low. Where the disease is prevalent however, such as during a 62 facility outbreak, negative results must be viewed with caution. The sensitivity of the test also depends on when testing is done during the course of illness, with 65 the peak of viral shedding occurring around the time of symptom onset. 5 A Bayesian hierarchical 66 model, fit to previously published studies describing the performance of SARS-CoV-2 RT-PCR 67 tests, reported the probability of a false negative RT-PCR test over time. 6 From exposure (day 0) 68 to the typical time of symptom manifestation (day 5), the probability of a false negative results 69 changes from 100% on day 1, to 67% on day 4, reaching a nadir of 20% three days after 70 symptom onset on day 8. In some individuals, RT-PCR tests will remain positive for weeks after 71 symptom resolution. 10 staff, particularly in areas with mandates for serial testing of healthcare workers. This also offers 97 the possibility that staff may effectively collect their own samples. Self-collected samples have 98 the advantage of decreasing staff exposure and their use of PPE. 10 99 100 Antigen Tests On May 9 th , 2020, the FDA provided the first EUA for a test designed to detect 101 an antigen specific to SARS-CoV-2; a second antigen-based test received an EUA on July 2 nd , 102 2020. 11,12 Antigen tests target markers on the outer surface of the viral capsule and do not 103 require extraction of RNA. Viral structures that represent good candidates for antigen-based 104 testing include nucleocapsid phosphoproteins and spike glycopeptide proteins. 13 Advantages to 105 antigen-based tests are the relatively lower cost compared to RT-PCR tests, the ease of collection 106 samples from the anterior nares, the potential to scale the number of tests, and the rapid turn-107 around-time, providing answers within minutes. 12 A disadvantage to antigen-based tests, 108 however, is lower sensitivity, which can lead to false negative results. This is a particular issue 109 in the setting of outbreaks or in regions with increased prevalence rates of SARS-CoV-2. The 110 J o u r n a l P r e -p r o o f FDA recommends that a second PCR-based test should be used to confirm negative results for 111 individuals likely to have COVID- 19. 11 Given that only 2 of the 164 diagnostic tests given EUAs 112 are antigen-based, 12 the role for these tests is still evolving and may be best suited for diagnosing 113 symptomatic individuals seeking medical care, rather than screening asymptomatic individuals 114 or healthcare workers. . Regardless, CMS recently announced a plan to deploy the two available 115

antigen test kits to all U.S. nursing homes to assist in universal screening efforts, 14 though noting 116 caution in interpreting negative results. 15 Facilities using antigen tests need to make sure they 117 have obtained the required federal and/or state Clinical Laboratory Improvement Amendments 118 (CLIA) waivers, competency trained staff, a recording system to document and track results, and 119 are able to report results to state and/or federal agencies as required. 15 Unfortunately, many nursing homes may not be able to implement universal testing for a 169 multitude of reasons, including lack of access to testing, inadequate supplies of PPE, limited 170 personnel, and insufficient resources to pay for testing. 27-30 As they attempt to respond to 171 federal 31 and state 32 recommendations and requirements, many nursing homes will need to 172 consider other approaches to testing such as unit-based testing and/or risk-based testing. 173

Regardless of how they proceed, it is essential that nursing homes work with their laboratory 174 provider to prioritize residents and staff tests and ensure rapid turnaround times (48 hours or 175 less). 33 176 177 Unit-based strategies, while not desirable, would be most suitable for situations in which testing 178 capacity is limited. For this approach, the building focuses testing on residents and staff members 179 who had close contact with the index case. Testing can also be extended to include high risk 180 individuals such as those leaving the facility frequently (e.g., for hemodialysis, radiation therapy, 181 or off-site chemotherapy) and those recently admitted. Determination of whom to test first is 182 inherently complex and may be best approached by a multi-disciplinary team that includes the 183 infection preventionist, medical director, director of nursing, and administrator. the need and frequency of staff and resident testing in that particular facility. As mentioned 277 above, however, insufficient access to rapid diagnostic testing, PPE, staff, and resources may 278 render seemingly insurmountable challenges. Even under these dire circumstances, nursing 279 homes will continue to strive to provide the best care they can offer for residents entrusted to 280 their care ( Table 3) . 

The prospect of reopening nursing homes, which includes permitting visitors, presents additional 297 complexities. Efforts by states to relax stay-at-home orders, reopen businesses, and even 298 encourage tourism 38 contribute to increased spread of SARS-CoV-2 in the community which in 299 turn means increased risk for nursing home staff to acquire and transmit the virus to their 300 residents. As part of plans to reopen nursing homes, CMS recommended "baseline" testing for 301 all nursing residents and staff, along with the capacity to continue weekly tests for staff. 31 After 302 the initial response to the CMS recommendation, most, if not all, nursing homes should continue 303 surveillance testing. Older adults often manifest atypical signs and symptoms of infection. While 304 it may be tempting to attribute a change in condition to exacerbation of known heart failure or 305 sinus congestion to allergies or a "summer cold", the severity of the illness experienced by some If testing many residents, consider using two teams with staff not assigned to frontline care -one to prepare each resident and room, and one to obtain the specimen. Identify the ordering provider for the laboratory requisition, which can be the medical director. Ensure that PPE is available for the staff obtaining NP swab.

Ideally, PPE worn during sample collection includes a respirator, eye protection, a gown, and gloves. In settings without respirators, a surgical mask and face shield may be used instead.

Testing of Staff Identify the list of staff that will need to be tested. Decide on the source of the SARS-CoV-2 specimen (NP, nasal, oropharyngeal, oral). If using PCR, identify and train staff to perform testing including need to change PPE between staff members. Chose a room for testing and ensure that staff are able to social distance while waiting for testing. If testing is done in the facility, identify the ordering provider, which might be the medical director or an employee health provider. If testing is done outside the facility, evaluate the process of obtaining the results. Identify and communicate with the laboratory to ensure that the testing supplies are available and the laboratory can run the Some states do not need a provider order for the staff testing but this is requested by the laboratory.

Some insurance providers are not covering testing of asymptomatic nursing home staff.

When possible, sample collection should be in a well-ventilated area, which includes outdoors and, weather permitting, may be feasible to accomplish with staff members.

J o u r n a l P r e -p r o o f 5 large number of tests and provide the results within 24-48 hours. Dealing with SARS-Cov-2 testing results from residents Create a process to communicate the test results with residents and their families or responsible party. Identify how information is shared with the local or state health department. Ensure that a cohorting plan is in place before testing. Assess the availability of personal protective equipment (PPE). Ensure that shared equipment is available to dedicate to the COVID-19 cohort Develop a policy for when COVID-19 positive residents should be transferred to an outside COVID-19 facility, another nursing home or hospital.

One option is to communicate with resident's family that they will only be informed of positive test results.

Plan for use of multiple means of communication to residents, family members, and/or responsible parties. This may include use of recorded phone systems, email, website updates, town-hall updates, and direct phone communication.

Communication about resident results should ensure individual privacy.

Prepare for the additional works of moving residents and their belongings to a COVID-19 cohorting area. Dealing with SARS-Cov-2 results from staff Create a process to communicate the test results with staff, respecting employee privacy. Create a process to communicate with residents and their families or responsible party that the facility has staff that tested positive. Identify a process to communicate results with the local or state health department, including plans for monitoring of isolation, return to work and contact tracing for quarantine. For staff that test positive and work at multiple facilities, inform the health department so the information can be communicated to other facilities. Assign a staff member the role of monitoring staff furloughs and review of criteria to return to work. They also should monitor adverse effects such as hospitalization and death Establish a process to deal with staff shortages: 1) train non-medical staff at your facility to assist with resident related tasks, 2) establish relationship with nursing agencies, 3) collaborate with hospital systems and evaluate if they can assist with staffing needs, 4) evaluate other staffing options such as reaching out to nursing schools.

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