Maintaining point of care testing capacity and pandemic preparedness in the post-COVID-19 era

ABSTRACT

Introduction

Testing at the point of care (we also refer to the ‘point of need’), with rapid, actionable results reported to the patient and provider within hours can impact the individual as well as public health. Faster testing is good for patients and public health outcomes during ‘peace time’ (outside of the pandemic setting).

Areas covered

Testing at the point of need was important during the COVID-19 pandemic to meet testing capacity demands, providing actionable results, and for providing testing within communities to increase access for all populations. Resources were acquired and built up dramatically during the pandemic as part of the response. With the end of the COVID-19 public health emergency and transition back to ‘peace time’ some testing sites have successfully shifted to using this capacity for testing for other critical needs, like sexually transmitted infection (STI) testing, and response to other seasonal diseases and for outbreak response.

Expert opinion

The increased testing capacity added to handle unprecedented testing volume during the COVID-19 pandemic can be repurposed for other critical infectious diseases during ‘peace time’ (post-COVID-19 pandemic). This maintains testing capacity for the next pandemic.

KEYWORDS:

• Point of care testing
• point of need testing
• SARS-CoV-2
• testing capacity
• COVID-19

1. Introduction

Diagnosis of infectious diseases with actionable results available to the patient and provider at the point of care/need on the day of visit has impact on patients and public health. When quality testing is available to patients in settings that are accessible and trusted (‘low threshold settings’), public health needs, health inequity and access issues, as well as individual health needs are addressable. This is true during ‘peace time’ when public health issues such as rising STI rates can be addressed by providing access to screening testing and services. This capacity can be shifted as needed to address seasonal needs, such as influenza testing, local outbreaks, and global outbreaks such as the 2022 mpox outbreak. When the capacity is maintained, it is available for rapid shift to testing to respond to the next pandemic. The use of platforms that provide lab quality molecular diagnostic testing for a variety of infectious diseases and are easy for staff to operate is critical to being able to maintain this warm lab capacity during peace time for rapid pivot to ‘pandemic time’ when needed.

2. Body

2.1. Point of care testing – pre-pandemic

Point of care testing (also referred to as point of need, or near patient testing) is defined as testing that occurs at or close to where the patient interaction occurs. This includes testing performed in Clinical Laboratory Improvement Amendments (CLIA)-waived/non-laboratory environments such as provider offices, emergency departments and urgent care centers, at health fairs or community-based sites, and testing performed in laboratories co-located with clinics or collection sites. As there is little to no time required to transport specimens for testing, results may be reported during the patient visit, within hours of the visit, or on the same day. Reporting of results to patients may occur via an app or by direct outreach to the patient if they have left the site; point of need testing enables testing and follow-up action (treatment, isolation, etc.) to happen on the same day and sometimes within a single visit. This decentralized model of testing can increase access to testing for all populations. Testing can be provided by, or associated with, trusted community organizations, near to where people live and work, at times of day that meet scheduling needs, and in environments that feel safe and welcoming. Point of need testing can be a tool to address systemic health inequities by enabling access to all populations.

Prior to the COVID-19 pandemic, most (but not all) of the point of need testing for infectious diseases in the US was limited to CLIA-waived tests for a handful of diseases [1]. In response (in part) to economic constraints, laboratories were consolidated and services were centralized for efficiency of scale [2]. Public health laboratories, in accordance with CDC’s Laboratory Efficiencies Initiative [3], were consolidating testing to fewer platforms and standardizing testing across the network. These changes pushed laboratory-based testing away from near patient sites, leaving CLIA-waived tests as the primary type of test available near patient. Pre-pandemic, most of the CLIA-waived tests available for infectious diseases were antigen or antibody based, single throughput tests that did not require significant instrumentation; the sensitivity and specificity of this type of testing, in general, is lower than diagnostic testing performed in a laboratory setting. Prior to 2021, molecular-based testing in the CLIA-waived setting was limited to a small number of respiratory tests [1].

There are, however, some pre-pandemic models of the innovative use of near patient testing to address patient, community, and public health needs. One such model is the Dean Street Express (DSE) in London. At DSE, screening testing for sexually transmitted pathogens including Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) is offered to asymptomatic individuals. The facility provides low threshold access in a welcoming environment. Cartridge-based PCR testing for CT/NG is performed on-site in a co-located laboratory space and results are reported back to patients on the same day via text messaging. Patient volumes, time to result, and outcome were compared to patients visiting the ‘standard’ sexual health clinic, 56 Dean Street (56DS), where testing for CT/NG was performed at reference lab with a turn-around time of several days. Other testing was performed per standard of care at both sites. Data collected at both sites over a one-year period showed patient volumes at DSE increased by 58% while volumes at 56DS were unchanged. CT/NG results were reported back to DSE patients within an average of 0.27 days versus 8.95 days for 56DS patients. Modeling estimated that in the one-year study period (60,266 visits at DSE/21,086 visits at 56DS), the testing at DSE resulted in 854 partner notifications and attendances averted (due to decreased exposures because patients knew their status) and 196 CT and/or NG infections prevented and saved over £124,000 [4].

Subsequently, a few sites based on the DSE model opened in US locations, including the Sexual Health Express Quickie Lab at the Chelsea Sexual Health Clinic in New York City. This site opened in 2019 and was noted to reduce the wait time for CT/NG results from days to hours [5].

2.2. Expansion of point of need testing during the pandemic – staff, space, and stuff

The impact of the COVID-19 pandemic on testing was unprecedented. Testing was needed at volumes never before anticipated, and the availability of testing with rapid results was critical to the response. Initially only available at centralized labs, access to testing was limited and turn-around times were long; at times too long to be of any clinical or public health relevance [6,7]. Delayed results were less impactful to inform individual patient actions (i.e.: isolation, treatment) [8] and public health actions (i.e.: contact tracing, implementation of mitigation policies like masking and school closures). The recognition of the spread of infection by asymptomatic people made diagnostics even more important for generating data to inform patient and public health actions. As antiviral therapy for SARS-CoV-2 infection became available, reliable, rapid test results were needed to make treatment decisions regarding therapies that needed to be initiated within several days of onset to be effective [9]. Quality testing available at the point of need became increasingly critical.

As additional test platforms received Emergency Use Authorization from the Food and Drug Administration in the US, including tests that could be used in CLIA-waived settings (i.e. outside moderate/high complexity laboratories), the availability of testing expanded from centralized labs to include more decentralized, near patient settings. This increased the overall availability of testing and access for all populations needing testing. Sites for testing (not just specimen collection) opened to serve underserved and vulnerable populations.

Significant infrastructure was built across the globe to accommodate the need for COVID-19 diagnostic testing. Laboratories built out space and added platforms to meet testing demand in the context of severe supply shortages. Infrastructure for point of need testing was built in existing clinical and community settings. Home-based collection of specimens for testing in a lab as well as home-based (i.e. over the counter) testing also increased access to testing.

Strategies to increase testing capacity (and manage as best as possible the limited supply of commercial SARS-CoV-2 test reagents) included acquisition of multiple test platforms, implementing laboratory-developed tests (LDTs) and establishment and certification of new testing sites, particularly community-based sites offering near patient testing. Laboratories and non-laboratory testing sites also hired additional staff, cross-trained staff, and in some cases performed SARS-CoV-2 testing 24 hours a day/7 days a week [10,11]. Increased infrastructure included establishment of incident command systems to monitor test volumes and supplies [12]. Testing sites implemented algorithms to restrict test ordering or to drive testing toward one method or another [10]. COVID-19 brought a new awareness of the relevance of the supply chain. Patient modeling was utilized to project test volumes and anticipate needed test reagents and specimen collection supplies [11].

As the pandemic progressed, it became clear that testing need was not always met with testing availability, and communities already impacted by known health inequities did not have the same access to testing as wealthier, whiter communities [13]. Jurisdictions addressed these issues in different ways. For example, New York City leveraged existing Health Department clinic sites to increase access in impacted communities. Health Department clinics already existed throughout the city, and, until pandemic-related closures occurred, these clinics provided sexual health, tuberculosis, and immunization clinical services and served as trusted sources of health information and other services. Using the Chelsea Sexual Health Express Quickie Lab as a model, space within each of the clinics was renovated to create a lab to accommodate COVID-19 testing. These lab spaces were adjacent to clinic space and testing was performed on site. Patients arrived at the clinic and were registered for electronic reporting of results, and had specimens collected, and the patient left the facility. Testing was performed on site using a rapid, lab quality RT-PCR based test and results were reported back to the patient on the same day [14].

There are pre-pandemic examples of multi-disease testing at the point of need on platforms that were originally installed for single disease testing. Ndlovu et al. described how a molecular platform initially used solely for detection of Mycobacterium tuberculosis in rural point of care testing settings was adapted for qualitative and quantitative HIV tests in addition to M. tuberculosis detection [15]. The authors reported operational feasibility of integrated testing in challenging near patient sites.

2.3. Maintaining capacity post-pandemic

Now that the public health emergency (PHE) has been declared over by the US Secretary for the Department of Health and Human Services [16], and the global PHE declared over by the WHO [17], and as lab and point of need testing demand has decreased (as testing has shifted largely to home-based testing), decisions need to be made about instruments, infrastructure, and staff (‘stuff, space, and staff’). These decisions must be made with an eye toward continuing the work to increase access to services including critical diagnostic testing for all populations, and to maintaining preparedness for the next outbreak and pandemic (Figure 1). Infrastructure must be maintained. Instruments require routine maintenance, and staff need to maintain competency in using the instruments for diagnostic testing. Trained staff need to be available to respond.

Figure 1. Maintaining testing capacity and pandemic preparedness in the post-COVID-19 era.

The infrastructure built in the NYC Health Department clinics for point of need testing has now shifted to providing more ‘routine’ services such as sexual health screening as well as response to the influenza season and the mpox outbreak [14]. This ‘peace time’ use of stuff, space, and staff helps to maintain a warm testing capacity that can be very quickly leveraged as needed for localized outbreak responses or for responding to a global pandemic.

Globally, it has been recognized that services for other infectious diseases, tuberculosis and HIV in particular, suffered during the pandemic, and that post-pandemic these services need to improve over what was available pre-pandemic [18]. Post-pandemic, integrated services for infectious disease that replace vertical programs will help to maximize efficiency, increase access, and lower costs. When resources, including human resources, are limited, testing platforms that can be used for many diseases increase efficiency, and testing that can be available in near patient settings at or near the point of care can allow testing to be available in affected communities. Appropriate funding and political will be necessary for successful implementation and sustainment [19].

3. Conclusion

Testing at the point of care/need, with rapid, actionable results reported to the patient and provider within hours can impact the individual as well as public health. Whitlock et al. demonstrated that faster testing is good for patients and public health outcomes during ‘peace time’ when testing is for ‘routine’ infections like chlamydia and gonorrhea, and that when testing is provided in a safe and welcoming environment with low barriers to entry, patients will access testing (even when asymptomatic) [4]. In the context of a global pandemic, testing at the point of need is important for providing testing capacity, providing testing with rapid resulting, and for providing testing within communities to increase access for all populations. As testing became more available at the point of need in communities, populations that had high prevalence of disease, but low levels of testing shifted to increased levels of testing. Staff, space, and stuff that was hired and trained, built up, and procured during the pandemic as part of the response. Some sites have successfully shifted to using this capacity for testing for other critical needs, like STI testing, and response to other seasonal diseases and for outbreak response.

4. Expert opinion

Point of care/need testing infrastructure built up during the pandemic can shift to ‘peace time’ testing in the current post-public health emergency era. Shifting the increased capacity for point of need testing – the staff, stuff, and space – to ‘routine’ testing that addresses other critical public health needs maintains this capacity that would be lost if not used. Instruments need routine maintenance per regulatory requirements and manufacturer’s instructions. Staff are a critical need, and hiring and training staff as an emergency unfolds delays the response. Space needs to remain carved out for testing.

The unique opportunity to repurpose pandemic infrastructure and capacity to address issues such as rising STI rates, work toward HCV elimination goals, and to continue work addressing health inequities and access to testing must be met with sustained funding. The lack of sustained infrastructure and capacity prior to 2020 due to years of decreased funding to public health in particular created the situation where the ‘plane was being built as it was flying through a thunderstorm’ as we responded to the COVID-19 pandemic [20]. It has been demonstrated that infectious disease testing at the point of need with rapid return of actionable results to patients and providers is good for patients and public health, and it has been shown that access to testing is important for all populations. Without the availability of decentralized, low threshold, quality testing, communities already burdened by long standing health inequities suffer higher prevalence of disease.

To maintain infrastructure and address on-going public health needs, sustained funding needs to be available. We need to address the syndemics of STI, HIV, HCV, and stigma (in the context of racism, health inequities, poverty, unstable housing and other issues impacting health); diagnostics are a critical tool and point of need testing is a mechanism to enable access.

In five years, these authors would like to see maintained capacity, with sustained, adequate funding, for point of need infectious disease diagnostics addressing critical public health needs in ‘peace time’ that is able to rapidly shift to address public health emergency needs during ‘pandemic time.’ If we are not able to maintain what we have built, we will again fall short at rapid response to an emerging pandemic which will have a cost measured in lives. The NYC Quickie Labs have proven successful at addressing peace time public health needs and responding in pandemic time; resources should be made available to expand on these models. The critical piece is to implementation and sustainment of integrated near patient testing globally that can provide ‘peace time’ services and nimbly respond to future outbreaks/pandemics is sustained funding support.

Article highlights

• Prior to the COVID-19 pandemic most point of care testing for infectious diseases was limited to a few CLIA waived tests in the U.S.

• The COVID-19 pandemic put an unprecedented demand on testing and highlighted its critical role.

• Significant infrastructure was created to accommodate the need for SARS-CoV-2 diagnostic testing and screening of symptomatic and asymptomatic persons.

• Since the expiration of the COVID-19 public health emergency and subsequent decreased demand for testing, some sites have successfully shifted to using this capacity for testing for other critical needs.

• By maintaining post-COVID-19 testing capacity and converting it other uses, rather than dismantling it, testing sites maintain their readiness for the next pandemic.

Declaration of interests

All authors receive salary from Cepheid and equity compensation from Danaher. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.