Clinical Need for Point-of-Care Testing for Diabetes in Clinical and Laboratory Improvement Amendments–Waived Settings Free

Perhaps the most important benefits of POCT are those related to clinical utility, with operational and interpersonal advantages in patient care settings, as opposed to laboratory testing. POCT can increase patient engagement by allowing more interpersonal interaction with their clinicians about test results (3). Additionally, implementation of POCT in outpatient pharmacies can increase convenience and access to testing, as well as promote convenient and more frequent monitoring of chronic diseases (12–14).

An important aspect of the clinical utility of POCT is its impact on clinician decision-making. However, this factor was addressed in only 8% of studies in a recent systematic review, with the majority of the investigations assessing user‐friendliness, turnaround‐time, and technical performance (15). In 2022, Tenorio-Mucha et al. (16) evaluated 20 studies of facilitators of and barriers to the implementation of POCT for cardiometabolic diseases (Table 1). Barriers to implementation included time constraints within clinical settings, the need for additional training to handle new responsibilities, and a lack of clear regulatory and accreditation mechanisms (16). Facilitators of POCT implementation included improvements in patient engagement, convenience, and efficiency. Advantages not considered in the 2022 review are that proper use and implementation of POCT can improve health equity and achievement of HEDIS measures to ultimately improve patient outcomes (17–20).

In the current model of health care testing, a clinician sees a patient and orders tests. Clinic staff either collect the patient’s blood and/or urine to send to a laboratory or send the patient to the laboratory for testing. The laboratory then reports test results back to the clinic, after which the clinician interprets the results and takes clinical action (3). In this model, the variable turnaround time of results depends on the distance to transport specimens and the analytical time for laboratory instrumentation, among other factors (3). Delays in test results can increase delays in care, contribute to therapeutic inertia, and reduce patient engagement (21). In contrast, POCT essentially brings the laboratory to the patient, simplifying the testing process and reducing turnaround time to results and clinical action (3,21). Furthermore, there is a substantial shortage of medical laboratory professionals in the United States and in Canada, which may lead to longer delays in test results (22). In addition to other operational benefits, POCT offers a complementary testing method to reduce central laboratory testing volume.

Although A1C testing plays a key role in managing diabetes, low adherence to recommendations on testing frequency and treatment modifications to achieve glycemic targets is challenging (21). The rapid availability of A1C test results, as obtained with POCT, has been shown to enhance diabetes management (23). POCT for A1C is recommended by the American Diabetes Association (ADA) and the International Diabetes Federation because it affords the opportunity for more timely treatment changes (21). Despite these recommendations, only about two-thirds of people with diabetes have at least two A1C tests per year, and more than one-fourth have A1C levels ≥8.0%, which increase the risk of complications. A1C POCT is frequently used in endocrinology clinics but is rarely available in primary care, where ∼90% of people with type 2 diabetes receive treatment (24). Increased implementation of A1C POCT in primary care settings has the potential to make testing easier, strengthen patient-clinician communication, and lead to improved A1C levels (24). A study by Crocker et al. (18) showed that A1C POCT led to a 3.7 times decreased likelihood of missing recommended A1C testing.

Although POCT is not widely recommended by clinical guidelines for screening and diagnosis of diabetes, there could be several advantages to the use of A1C POCT for these purposes (25–27). The potential benefits of POCT include faster diagnosis, reduction in treatment delays, improved blood glucose control, and greater adherence to recommended diabetes screening standards. When their accuracy is in doubt, A1C POCT results can be confirmed in a laboratory, in alignment with ADA diagnostic guidelines recommending two tests in asymptomatic individuals.

A cross-sectional study of A1C POCT in general practitioner offices in Norway assessed its effects on glycemic control (28). Using data on 22,788 people with type 2 diabetes, the study assessed the availability and analytical quality of A1C POCT. Of 393 general practitioner offices evaluated, 28 (7%) did not conduct A1C POCT, and patients seen at these locations had an average A1C 0.15% (95% CI 0.04–0.27%) higher than those in practices that did use A1C POCT. Patients at locations that participated in more external quality assurance surveys and had better analytical accuracy (components of a POCT “trueness” score) also had lower mean A1C values. Use of A1C POCT of high analytical quality was associated with improved diabetes care (28).

A single-center observational cohort study in Saudi Arabia showed that A1C POCT improved adherence to A1C testing frequency recommendations and resulted in better glycemic control (29). Adherence to clinical recommendations for A1C testing frequency increased from 24 to 85% after implementation of POCT at the study site. Mean A1C before POCT implementation was 8.34 ± 0.67%. After POCT implementation, it was 8.06 ± 0.62% (P <0.001) (29).

For diagnosis and monitoring of chronic kidney disease (CKD), including diabetic kidney disease (DKD), quantitative or semiquantitative measurement of UACR is essential (30,31). According to the ADA, semiquantitative testing should be positive in >85% of cases of moderately increased albuminuria (>30 mg/g) to be useful for screening (32). However, KDIGO recommends quantitative analysis of UACR for greater accuracy in the classification of albuminuria status. UACR testing can be performed in the laboratory or as POCT, which has been shown to deliver valid UACR results that correlate well with laboratory-based testing (33–35). The KDIGO C-G-A CKD classification is based on cause, estimated glomerular filtration rate (eGFR), and albuminuria (UACR) categories (A1, A2, and A3) (11). Additionally, albuminuria is frequently the first sign of CKD and often precedes a decline in eGFR (33).

Guidelines from the ADA also recommend UACR screening at least annually for individuals with diabetes; for people with diabetes and CKD, the ADA recommends more frequent monitoring (up to four times per year), depending on CKD stage (30). However, UACR testing rates in clinical practice are suboptimal and much lower than rates of eGFR testing. Based on real-world health care organization–level data, 1-year median testing rates in the United States have been estimated at 51.6% for both UACR and eGFR, 89.5% for eGFR, and 52.9% for UACR (36). UACR testing varied from 13.3 to 75.4% across sites. Most patients with diabetes are tested for eGFR, but only about half receive UACR tests, despite their predictive power and cost-effectiveness (36).

Use of POCT for UACR realizes the benefits of POCT discussed above for chronic conditions, including optimization of clinical action and potentially improved medication adherence resulting from the rapid availability of results (33,37,38). An observational study of UACR POCT for the diagnosis and monitoring of DKD found positive effects on diagnosis and treatment initiation or modification; 39.1% of 717 patients had a confirmed/suspected diagnosis of DKD (33). Based on the UACR POCT values, 8.6% were newly diagnosed with confirmed DKD, and an additional 9.9% had suspected DKD. Within the group of patients with confirmed/suspected DKD (n = 280), treatment modification occurred in 46.1%, based on the actual UACR POCT values (33).

Clinical practice guidelines recommend measuring NT-proBNP to support or exclude heart failure diagnoses (39,40). Similar to A1C and UACR, NT-proBNP can be measured in a central laboratory or with POCT devices. A recent observational study evaluated the use of NT-proBNP POCT in people with type 2 diabetes and hypertension as a screening tool to support the diagnosis of heart failure (40). Results indicated that more than one-third of the 259 patients (n = 102 [39%]) were identified as having suspected heart failure, with NT-proBNP values ≥125 pg/mL. The findings are consistent with those reported in multiple biomarker central laboratory–based methods of predicting heart failure in a similar population (40,41).

Clinicians tend to have positive perspectives regarding POCT use but may express concerns about related costs and reimbursement issues (42–45). A 2020 POCT survey of 287 U.S. clinicians found that the majority (92.0%) perceived improved patient management, 87.5% supported improved confidence in decision-making, and 83.6% noted more effective targeted treatment with POCT (43). Concerns about POCT that clinicians reported included the possibility of over-testing (30.0%), lack of reimbursement (29.3%), and high equipment costs (23.7%). Overall, clinicians are supportive of the benefits of POCT but also aware of potential concerns, and collaboration among HCPs, patients, laboratories, and industry partners can help clarify the role of POCT in clinical practice (43).

Other key POCT stakeholders include laboratory staff, industry leaders, and regulators (46). A qualitative analysis evaluated the perceptions of these stakeholders regarding the use of POCT and identified 32 barriers to and 27 facilitators of the adoption of POCT technology. Motivations for POCT adoption varied by stakeholder; for example, patients focused on personal experiences with POCT, whereas commissioners and regulators focused on pathway benefits and effects on a societal level. Many identified barriers were related to the costs of the tests compared with potential cost savings through the POCT pathway. Overall, the identified barriers to POCT implementation can be predicted and mitigated during development of POCT devices to maximize the likelihood of widespread adoption (46).

HEDIS is one of the most widely used performance improvement tools and includes metrics for clinicians, payers, and other organizations (17). HEDIS measures are intended to assess health care performance that makes a meaningful impact on patient care. HEDIS domains include effectiveness of care, access to/availability of care, utilization, risk-adjusted utilization, and measures reported with electronic clinical data systems. A1C screening, A1C control, and UACR testing are part of the individual metrics within HEDIS quality measures; POCT can help to achieve these measures (17–19).

Health care organizations are often incentivized by payers for achieving HEDIS metrics in their patient populations, and POCT for A1C and UACR provides a fast, easy, and reliable method for monitoring these values in outpatient settings (18). Implementation of A1C POCT in primary care practices has demonstrated significantly improved HEDIS-based A1C testing frequency occurring synchronously with office visits (18). Less than 40% of patients with diabetes receive guideline-recommended testing for CKD, limited primarily by UACR testing (based on health insurance population data). Achieving the kidney health evaluation HEDIS measure for people with diabetes, which may be aided using POCT, can lead to timely and equitable detection and treatment of CKD (19).

Key stakeholders may lack recognition of the benefits of POCT in settings that experience health inequalities (1). The benefits of POCT in remote settings include improved diagnostic accuracy and patient triage, decreased patient transfers to other hospitals, rapid turnaround time, increased accessibility and affordability, and economic benefits (47). For chronic cardiometabolic diseases, improvement in glycemic control and enhanced CKD management are documented benefits of POCT (48). Patients in rural and remote locations are likely to experience greater convenience from POCT because they may live far away from the nearest laboratory or even from a clinic (48). Handling testing, results, and treatment adjustment for cardiometabolic diseases with POCT in patients negatively affected by social determinants of health (SDOH) and/or who live in rural or remote locations can be of even greater benefit compared with populations unaffected by these factors.

Negative SDOH such as inadequate access to healthy foods, safe exercise opportunities, stable housing, steady employment with a livable wage, adequate transportation, and education represent barriers to diabetes self-care (49). In populations affected by SDOH, the risk of clinical inertia and lack of disease control are significant challenges because of missed medical appointments and difficulty contacting patients. POCT can improve care for these individuals by capitalizing on testing, results, and treatment adjustments all within a single appointment. Implementation of A1C POCT and face-to-face diabetes self-management education in an under-resourced population of patients with type 2 diabetes yielded significant reductions in A1C and reduced clinical inertia, as evidenced by increased rates of medication intensification (49).

Patients of racial and ethnic minority groups also experience kidney health disparities, including lower quality of care (50). The National Kidney Foundation (NKF) and American Society of Nephrology (ASN) recently reassessed inclusion of race in diagnosis, risk stratification, and classification of kidney diseases (51). The NKF-ASN recommendations include testing of UACR as part of an overall approach to kidney health equity.

A retrospective cohort study assessing the fulfillment and validity of the kidney evaluation for people with diabetes HEDIS measure showed associations with lower fulfillment of the metric among Black/African Americans, individuals dually eligible for Medicare and Medicaid, those living in lower-income neighborhoods, and those with lower education attainment (19). Implementing guideline-recommended testing for CKD, which includes eGFR and UACR testing, will improve equitable and timely identification and treatment of CKD and can be aided by the convenience of POCT in these populations (19).

There is a relatively small body of evidence related to the cost-effectiveness of POCT (21). Direct unit costs of POCT are higher than testing at a central laboratory (52–54). However, taking indirect costs into account is essential when considering the overall cost-effectiveness of POCT. For example, A1C POCT can result in a reduction in health care costs from enhanced operational efficiencies such as decreased need for follow-up telephone calls, fewer results letters mailed to patients, and reduced numbers of follow-up visits for an abnormal laboratory result (21,38). Clinical benefits such as improved time to diagnosis and therapeutic intervention, enhanced diabetes-related outcomes, and reduction in complications also have a significant impact on cost analysis (55). Additionally, use of UACR POCT is likely an overall cost-saving measure for outpatient clinics versus laboratory UACR testing (33). With increasing focus on financial health care models such as pay for performance and care accountability, improvements in clinical outcomes such as glycemic control can lead to cost savings for chronic disease management through reductions in disease complications and hospital admissions (21).

The value proposition of POCT includes rapid turnaround time, improved real-time decision-making, and flexibility in how and when testing occurs (56). To capture the cost-effectiveness potential of POCT in specific settings, all stakeholders should participate, because benefits or risks will affect all stakeholders in the care pathway, while the investment is typically made by one stakeholder (2,56). Stakeholders include patients, the clinical team, laboratory professionals, the health system, and health care policymakers (2). Accurately assessing the cost-effectiveness of POCT with regard to all stakeholders based on overall health care costs and not just direct costs is a substantial challenge (2,54,57).

According to a systematic review by Lingervelder et al. (58), of a sample of publications that have addressed the cost-effectiveness of POCT, >75% concluded that implementation of POCT is recommended. Most of these publications were evaluations of POCT in primary care settings and assessed POCT for the purposes of diagnosis, screening, or monitoring. Although long-term benefits were not addressed in many of the studies, the health economic evidence assessed from the 44 studies included in the analysis favored financial benefits of POCT. However, despite the cost-effective benefit observed from POCT implementation, uptake of POCT remains low (58).

The cost-effectiveness of implementing POCT should be assessed by each clinical organization, based on overall costs and benefits of POCT (54). Certain aspects of a cost-effectiveness analysis are specific and difficult to generalize. For example, POCT can significantly reduce clinical time for patients compared with traditional laboratory testing in settings where clinics and central laboratories are geographically far apart (59). Thus, benefits and risks of POCT related to cost-effectiveness for individual organizations and populations are difficult to generalize.

In recent years, the trend in U.S. Food and Drug Administration (FDA) approvals of CLIA-waived POCT applications has generally mirrored that of moderate/high complexity approvals, although the number of CLIA-waived POCT approvals is much lower (Figure 1). Regulatory barriers to POCT approval include the rigor of certain CLIA waiver criteria, which may exceed requirements of laboratory tests (60). For a test to be waived by the FDA, the manufacturer must submit data demonstrating that the test has an insignificant risk of yielding an erroneous result in the hands of nonlaboratory-trained personnel. This criterion is not necessary for nonwaived laboratory tests (60).

To help ensure the accuracy and reliability of waived testing, the laboratory directors of facilities using POCT should provide training and oversight of testing personnel, as required by the Centers for Medicare & Medicaid Services (61). In the scoping review of facilitators of and barriers to implementation of POCT devices for cardiometabolic diseases by Tenorio-Mucha et al. (16), lack of clear regulatory mechanisms was a primary factor hindering the growth and sustainability of POCT use.

Since 2019, the FDA has approved fewer POCT devices, on average, compared with the 2016–2018 period (Figure 2). Between 2016 and 2018, an average of 132 CLIA-waived POCT applications were approved per year, and from 2019 to 2023, only an average of 92 applications were approved each year, despite fairly consistent submissions of POCT applications and steady approval rates of laboratory tests during this time period (62). This decline in POCT waiver application approvals could be, in part, the result of revised guidance issued in late 2018, after passage of the 21st Century Cures Act (21st CCA) (63). However, there may continue to be a large influx of approved POCT devices in the near future, as tests that had emergency authorization during the coronavirus disease 2019 pandemic transition to full approval.

POCT device approvals in the United States have seemingly lagged behind international approvals for many years. For example, in the past decade, several A1C POCT instruments have been recommended for use in diagnosing diabetes (21), but only one has received FDA clearance for the purpose of diagnosis in the United States (64). High-income countries outside of the United States that regularly use POCT in clinical settings include the Netherlands, Norway, England, Australia, and Germany (45,65,66). In Germany, POCT devices for diabetes diagnosis and monitoring are the most widely used among many available POCT devices (45). Other countries have also studied POCT as an intervention to improve access to care for people in resource-limited settings (67,68).

Agreement on evaluation parameters, including patient-centered outcomes and accuracy, in an integrated approach may be warranted in that assessment of the benefits and harms associated with POCT must consider impacts on individual and population health outcomes rather than analytical accuracy alone (21). Such an innovative approach to incorporating patient care and cost-effectiveness into regulatory decisions on POCT devices is expected to advance patient care and improve outcomes for people with chronic diseases (21).

Despite documented clinical accuracy of POCT instruments in the hands of nonlaboratory-trained personnel and the cost-effectiveness benefits of POCT, few such devices are approved for chronic disease, especially in the United States (33,58,69). The lack of new POCT device approvals may contribute to reduced availability and awareness of POCT among stakeholders and prevent key populations (e.g., those in rural or remote locations and those adversely affected by SDOH) from sharing in the benefits of POCT. Although difficulties with POCT should not be dismissed, institutions can implement corresponding solutions to specific challenges to improve POCT use in clinical settings (Table 2) (54).

CLIA generally requires all facilities that perform POCT, including waived tests, on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet certain federal requirements (61). If a facility performs tests for these purposes, it is considered a laboratory under CLIA and must apply for and obtain a certificate from the CLIA program that corresponds to the complexity of the tests performed, with an exception in the states of New York or Washington, where state-operated laboratory regulatory programs are to be followed. All types of CLIA certificates are generally effective for 2 years.

The analytical accuracy and performance of POCT has been a longstanding barrier for new POCT application approvals (70). Some POCT systems demonstrate acceptable analytical performance within established criteria, but others do not. Institutions that use POCT for chronic conditions, including cardiometabolic diseases, can implement ongoing evaluation of key performance indicators of POCT devices to ensure their accuracy and safety (71).

Several A1C POCT assays are certified by the National Glycohemoglobin Standardization Program, but the ADA cautions against using POCT devices for diagnosis of or screening for diabetes based on concerns about a lack of proficiency testing in CLIA-waived environments and potential problems with the accuracy of POCT devices (32). However, certain POCT systems have shown accuracy equivalent to that of laboratory testing when operated by nonlaboratory-trained personnel (70). Several studies have indicated that, with certain A1C POCT devices that meet standards of accuracy equivalent to laboratory A1C testing, each device must be considered individually for accuracy rather than as part of a class of devices (68,70,72–75). Technological advances and stricter design criteria have promoted the development of improved hardware and software that has, in turn, improved the accuracy and performance of newer POCT devices (21).

POCT errors by operators have been a longstanding concern for test accuracy, but this issue is mitigated by proper training and oversight of personnel performing the tests (8,10,76). With proper training and implementation, many CLIA-waived tests can achieve a high correlation with laboratory testing (21,77).

Training of POCT device operators should include 1) the operation of the POCT device/test, 2) how and why quality control checks are performed, 3) performance of routine maintenance and troubleshooting, and 4) appropriate documentation of results (8,78). Theoretical components of POCT training should include knowledge of quality control measures, storage requirements, test method interferences and limitations, and troubleshooting and technical issues (10). Practical components include assessment of correct operation of the device or kit, handling and storage of reagents and devices, collection of samples, and maintenance of the device. At each organization, criteria should be established for passing a basic knowledge and skills assessment, and competency checks should occur and be documented regularly during the time the operator uses the POCT device (10). Sample CLIA-waived training and educational materials can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/lab-quality/php/waived-tests/?CDC_AAref_Val=https://www.cdc.gov/labquality/waived-tests.html).

Operators performing POCT in outpatient settings are typically involved in the patient care pathway as a part of standards of practice. Familiarization of POCT operators with controls or training samples prior to using POCT on patients would reduce the risk of errors when operating POCT devices.

In addition, POCT systems often include fail-safe or failure-alert mechanisms to mitigate user errors. According to FDA criteria, waived tests must demonstrate that they are simple to use, such that there is an insignificant risk of an erroneous result. “Flex studies” (i.e., studies designed to stress the system and show robustness against misuse) are required (60). Furthermore, consequences of inaccurate POCT results for monitoring of cardiometabolic disease are arguably less severe than inaccuracies in widely used acute tests (e.g., for infectious disease or pregnancy).

Clinicians treat patients holistically and order tests based on each patient’s condition; thus, a treating clinician ultimately makes decisions based on all available information, including patient presentation and medical history, and POCT results are interpreted in that context.

Establishing a POCT workflow that effectively and safely captures the benefits of rapid results from POCT compared with laboratory testing should complement the training of operators (Figure 3) (21,79). A German POCT workflow study showed that implementing POCT for A1C can lead to an improved and more efficient workflow in outpatient health care settings (80). Three practice sites that manage patients with diabetes implemented A1C POCT for 8 months in 2015. Implementation of POCT reduced the number of required visits scheduled by 80% (88 vs. 17.6%, P <0.0001) and the number of venous collections by 75% (91 vs. 23%, P <0.0001). Satisfaction surveys indicated improved workflow, relief of testing burden for patients and staff, and perceived advantage of the immediate availability of A1C results. The POCT workflow saved 20–22 working days per 1,000 patients annually, showing significant time savings for two practice sites (80). Notably, challenges with POCT workflow and operator competency are universal to all POCT, including tests that have been approved for many years. Thus, adopting competencies with a new POCT device should be less time-consuming for institutions that already have procedures in place for previously implemented POCT devices.

POCT is an increasingly popular method of providing convenient and effective testing, with a rapid turnaround of results, in diabetes and its comorbidities (3). Benefits of POCT include reduction in diagnostic delays, greater patient engagement, faster treatment changes that should lead to better therapeutic outcomes, and improved clinician-patient rapport. Challenges of POCT include perceptions of cost, analytical accuracy, workflow, and limited regulatory approval in the United States. Key stakeholders must consider all aspects of POCT when evaluating its benefits, risks, and cost-effectiveness. Although this review primarily focused on the use of POCT in diabetes, POCT continues to evolve and provide value for the management of many other chronic diseases and acute conditions.

If the regulatory environment in the United States shifts toward favoring increased availability of POCT devices, access to POCT for chronic disease management in clinical settings is expected to expand. The future of POCT promises improved technologies that are even more convenient, accurate, and reliable (3). Increasing the availability of POCT through streamlined regulatory guidance and decision-making will help clinicians and patients in multiple health care settings realize its benefits for diabetes and other chronic diseases.

Medical writing support was provided by Austin Ulrich, PharmD, BCACP, of the Primary Care Education Consortium.

This review was funded by Abbott Laboratories.

P.R.K. is a speaker for AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, and Eli Lilly and an advisor for Abbott Diabetes Care, AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Intuity. V.F. has received grants to his institution from Fractyl and Jaguar Gene Therapy; consulting fees from Abbott Diabetes Care, Abbvie, Asahi, Bayer, Boehringer Ingelheim, Corcept Therapeutics, and Eli Lilly; and honoraria from Abbott Diabetes Care, Abbvie, Asahi, Bayer, Boehringer Ingelheim, Corcept Therapeutics, and Eli Lilly. He has patents planned or issued for the BRAVO risk engine for predicting diabetes complications and PAX4 gene therapy for type 1 diabetes, and he holds stock options from BRAVO4Health and Mellitus Health and stock from Abbott Diabetes Care and Amgen. J.H.S. has received consulting fees from Abbott Diabetes Care, Bayer, Eli Lilly, Madrigal, Nevro, and Novo Nordisk. E.M. has received honoraria from Abbott Diabetes Care, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. E.W. has received consulting fees from Abbott Diabetes Care, Bayer, Boehringer Ingelheim, Eli Lilly, Embecta, GlaxoSmithKline, Medtronic, Renalytix, and Sanofi and honoraria from Abbott Diabetes Care, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Medtronic, Renalytix, and Sanofi and has been on speakers’ bureaus for Abbott Diabetes Care, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Renalytix, and Sanofi. C.D. has received grants from Abbott Diagnostics, Baxter Diagnostics, Fujirebio, Quidel:Ortho, Roche Diagnostics, and Siemens Healthineers; royalties or licenses from UpToDate; consulting fees from Abbott Diagnostics, Fujirebio, Quidel:Ortho, Roche Diagnostics, Siemens Healthineers, and Tosoh; and honoraria from Pathfast. He has patents planned or issued (#10509044); has participated on a data safety monitoring board or advisory board for Abbott Diagnostics, Quidel:Ortho, and Roche Diagnostics; and has a leadership role in the American College of Cardiology. J.A.V. has received consulting fees from Renalytix and Sanofi and has participated on an advisory board for Renalytix. No other potential conflicts of interest relevant to this article were reported.

All of the authors contributed to the discussion and reviewed the manuscript. P.R.K. is the guarantor of this work and, as such, had full access to all the data reported and takes responsibility for the integrity of the data and the accuracy of the review.