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Journal of the Saudi Heart Association logoLink to Journal of the Saudi Heart Association
. 2025 Dec 15;37(4):15. doi: 10.37616/2212-5043.1466

Saudi Heart Association Position Statement on NT-proBNP for Cardiovascular Risk Screening in Asymptomatic Adults With Type 2 Diabetes Mellitus

Waleed AlHabeeb a,*, Adel Tash b, Abdullah M Abdullah Arabe c, Lamya AlZubaidi d, Ayman Al Hayek e, Mohammed R Al Safi f, Malak A Almashali g
PMCID: PMC12948633  PMID: 41769674

Abstract

Background

Type 2 diabetes mellitus (T2DM) is a chronic disease with a rapidly increasing prevalence, posing a significant public health challenge worldwide and in Saudi Arabia. Cardiovascular disease (CVD) is the leading cause of death among patients with T2DM, necessitating early detection and intervention to prevent disease progression. Elevated natriuretic peptide levels, particularly N-terminal pro–B-type natriuretic peptide (NT-proBNP), are promising biomarkers for CVD risk stratification in individuals with T2DM. However, the integration of these biomarkers in clinical management remains limited.

Methods

Published evidence and existing guidelines/consensuses related to the use of NT-proBNP for CVD risk stratification in T2DM patients were reviewed and discussed by a multidisciplinary expert panel from Saudi Arabia. The panel also considered the unique characteristics of the local Saudi population, healthcare system, resources, and medical expertise.

Results and conclusions

NT-proBNP-based screening holds significant promise for improving CVD outcomes in T2DM patients by identifying at-risk individuals and guiding management approaches. Based on available evidence, the Saudi Heart Association (SHA) developed an evidence-based position statement on the use of NT-proBNP for CVD risk stratification in patients with T2DM who have no established CVD (asymptomatic). The proposed algorithm for NT-proBNP-based screening aims to improve the early identification of at-risk patients with T2DM, inform clinical management decisions, and enhance patient outcomes in Saudi Arabia. The algorithm includes age-adapted thresholds to reduce unnecessary referrals and medical testing. The SHA recognizes the need for further research and local data collection on NT-proBNP-based screening, in addition to clinician training to address the limitations and improve the practical implementation of NT-proBNP screening in routine clinical practice.

Keywords: NTproBNP, Cardiovascular disease, Type 2 diabetes mellitus, Screening, Risk stratification, Saudi Arabia

1. Introduction

Type 2 diabetes mellitus (T2DM) is a chronic disease with a rapidly increasing prevalence worldwide, posing a significant public health challenge. Globally, 529 million people were living with diabetes in 2021, corresponding to a prevalence of 6.1 % [1]. In contrast, the burden in Saudi Arabia is ubstantially higher; the prevalence in the same year was estimated at 11.3 %–18.7 %, translating to more than 4.2 million cases [1,2]. This indicates that the proportion of people living with diabetes in Saudi Arabia is nearly two to three times higher than the global average. Looking ahead, projections indicate that the prevalence of T2DM in Saudi Arabia will double by 2050 [2,3], further straining the healthcare system in the Kingdom [4].

CVD is the leading cause of death and is expected to remain a major public health concern in the coming decades both globally [5,6], and in Saudi Arabia [7]. In general, approximately one-third of people with T2DM have established CVD [8], and diabetes significantly increases the risk of developing CVD and experiencing cardiovascular events, such as myocardial infarctions and strokes [9–14]. Diabetic patients are not only more likely to experience these events earlier in life but also face greater severity and higher mortality rates, particularly with poor glycemic control [9–14].

Local data highlight the distinctiveness of the CVD burden in Saudi Arabia compared with Western populations, with patients experiencing higher mortality rates, an earlier age of onset (on average a decade younger), and a notable prevalence of cardiovascular risk factors [7,15–26]. In particular, more than half of Saudi patients with chronic CVD also have a history of diabetes [21,22,24,27,28]. Despite the high cardiovascular risk associated with T2DM, less than 25 % of T2DM patients in Saudi Arabia who are on glucose-lowering therapy are prescribed agents with proven cardiovascular benefits [29]. This gap in management and the projected exponential increase of diabetes-related CVD burden in Saudi Arabia underscores the need for early detection and intervention to prevent the progression of CVD in patients with T2DM [30].

Early detection of subclinical CVD is crucial for initiating preventive measures and effectively mitigating disease progression. Biomarkers such as elevated natriuretic peptide levels, particularly N-terminal pro–B-type natriuretic peptide (NTproBNP), have shown strong associations with CVD risk in both healthy populations [31] and T2DM patients [32]. However, the integration of these biomarkers in diabetes management remains limited, with international guidelines only recently recommending natriuretic peptide-based screening for the prevention of stage C heart failure (HF) in patients with T2DM [33].

Context-specific strategies for early CVD detection in patients with T2DM are currently lacking but are crucial in Saudi Arabia given the high prevalence and burden of both diseases. To address this, the Saudi Heart Association (SHA) developed an evidence-based position statement on the use of NT-proBNP for cardiovascular risk stratification in patients with T2DM who have no established CVD (asymptomatic). This initiative is expected to improve the early identification of at-risk patients with T2DM, inform clinical management decisions, and enhance patient outcomes in Saudi Arabia.

2. Methods

2.1. Expert panel and consensus methodology

An expert panel comprising a HF cardiologist, cardiac surgeon, podiatrist, diabetologist, diabetes health educator, a biochemical and laboratory scientist, and a clinical scientist with point-of-care testing expertise was convened, representing key specialties in the field.

The expert panel reviewed and discussed evidence in two online meetings, taking into consideration local guidelines, expertise and practice in order to formulate consensus recommendations on the use of NT-proBNP for cardiovascular risk stratification in asymptomatic patients with T2DM. Major disagreements were resolved in real time during the discussions, and consensus recommendations were developed based on majority agreement. The recommendations followed the standard methodology of the SHA guidance (recommendations set as recommended, should be considered, may be considered, or not recommended, without formal evidence grading). Draft recommendations were then circulated for review to ensure it was accurate, scientifically sound, and pertinent to the Saudi Arabian context. The final position statements were then approved by all participating experts.

The expert panel convened for two structured virtual meetings to review relevant evidence and local clinical practice considerations. Evidence appraisal incorporated international cardiovascular guidelines, available local data, and the collective clinical expertise of the panel, with the objective of developing contextual recommendations for the use of NT-proBNP in cardiovascular risk stratification among asymptomatic individuals with T2DM.

Consensus was reached through open discussion and real-time deliberation. Areas of disagreement were addressed through moderated dialogue. Recommendations were finalized only when unanimous consensus was reached among all experts, consistent with the established methodological approach of SHA guidance.

2.2. Literature review

An extensive literature review was conducted using PubMed as the primary database, supplemented by searches in Embase, the Cochrane Library, and Scopus. No restrictions were applied regarding publication date or language.

The search strategy utilized keywords related to biomarkers (“NT-proBNP”, “BNP”, “B-type natriuretic peptide”, “natriuretic peptides”, “cardiac biomarkers”); CVD and T2DM (“type 2 diabetes mellitus”, “T2DM”, “cardiovascular disease”, “CVD”); clinical outcome terms (“screening”, “risk prediction”, “risk stratification”, “primary prevention”); and study design terms (“randomized controlled trial”, “RCT”, “observational study”, “registry”, “systematic review”, “meta-analysis”). Additional relevant publications were identified by reviewing the reference lists of included articles and from the expert knowledge of the panel members.

All identified evidence and existing guidelines/consensuses related to the use of NT-proBNP for CVD risk stratification in diabetic patients were reviewed and discussed by the expert panel. Priority was given to high-quality evidence from systematic reviews, meta-analyses, and randomized controlled trials (RCTs), where available. Observational studies, real-world data, and existing international and regional guidelines were also reviewed to provide a comprehensive overview. The panel further considered the unique characteristics of local Saudi population, healthcare system, resources and medical expertise.

3. Overview of natriuretic peptides

Natriuretic peptides are a family of hormones that share structural similarities and are involved in the regulation of several processes such as cell proliferation, blood pressure and fluid/electrolyte balance [34,35]. Natriuretic peptides are produced primarily by the heart and vessels and comprise three main types in humans, namely atrial natriuretic peptide (ANP), B-type natriuretic peptide (BNP), and C-type natriuretic peptide (CNP). While CNP is mainly synthesized by endothelia cells and acts as a vasodilator, both ANP and BNP are produced by the heart as a response to mechanical stretching caused by volume overload. As the name suggests, ANP is mainly synthesized in the cardiac atria, while BNP is released by the ventricles. Once released, ANP and BNP have similar effects, namely promoting natriuresis and vasodilation [34,35].

4. Natriuretic peptides for CVD diagnosis and prognostication

Natriuretic peptides (ANP and BNP) are useful substrates for the diagnosis and stratification of patients with HF [36–40]. The measurement of circulating levels of natriuretic peptides is widely used as a biomarker of cardiovascular function [41,42]. However, their applicability and use in clinical practice differ as they are affected by substrate-related and assay-related considerations.

While ANP’s short half-life (2–5 minutes) suggests it might offer faster control of hemodynamics in chronic HF patients compared to BNP, this short half-life also limits its applicability as a clinical biomarker [43,44]. ANP’s precursor, N-terminal pro atrial natriuretic peptide (NT-proANP), lends itself as a more stable and more reliable biomarker, but is not used in clinical practice due to the inferior diagnostic and prognostic performance of available assays in comparison with BNP and its amino terminal fragment NT-proBNP [45–48]. The mid regional epitope of the ANP prohormone MRproANP has a longer half-life and has recently emerged as a promising biomarker that is more robust and reliable for the diagnosis and prognostication of HF [49–52].

That being said, BNP and its precursor NTproBNP are currently the natriuretic peptides of choice in clinical practice as they both have shown excellent diagnostic and prognostic performance particularly in the context of HF [53–59]. The half-life of NT-proBNP of approximately 60–120 minutes greatly exceeds that of the active hormone BNP, which stands at around 22 minutes [60]. This difference in half-life is likely responsible for the six-fold higher serum levels of NT-proBNP than BNP [60]. Regardless, the measurement of both BNP or NT-proBNP is recommended in patients with symptoms suggestive of HF such as dyspnea and/or fatigue as it aids in the early diagnosis and prognostication/risk stratification of HF [61–66]. Both BNP and NT-proBNP can reliably distinguish HF from other causes of dyspnea, which allows the use of these biomarkers to rule out acute HF [67,68]. BNP and NT-proBNP can also be used for the prevention of HF in at-risk patients [69]. The prognostic role of BNP and NT-proBNP has been reported in HF, where they have high accuracy in predicting death and hospitalization with HF, but has also been recognized in other indications and CVDs such as myocardial infarction, valvular heart disease and pulmonary embolism [70–72]. Other applications of BNP and NT-proBNP include monitoring treatment effectiveness and expected treatment outcomes in HF patients [53,73] and risk stratification of patients with pulmonary arterial hypertension [74].

5. Role of natriuretic peptides in the management of people with T2DM

Several key RCTs have shown that measuring BNP and NT-proBNP helps identify T2DM patients who are at risk for HF development and progression, and guide their treatment.

Results from the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) trial reported an increased risk of hospitalization in patients with T2DM and elevated NTproBNP levels [75]. The EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial associated increased baseline NTproBNP levels with a higher risk of symptomatic HF [76]. The CANVAS (Canagliflozin Cardiovascular Assessment Study) trial later established a baseline NT-proBNP level of ≥125 pg/mL as a predictor of HF hospitalization and all-cause mortality [77]. Further supporting these findings, a combined analysis of the ARIC (Atherosclerosis Risk in Communities), Dallas Heart Study, and MESA (Multi-Ethnic Study of Atherosclerosis) cohorts, which included participants with diabetes and prediabetes, demonstrated that biomarker screening which includes NT-proBNP effectively stratifies individuals at high risk for incident HF [78]. NTproBNP may also be utilized for risk stratification in patients with pre-diabetes, as 66 % of patients in the combined analysis of the ARIC, Dallas Heart Study, and MESA cohorts had prediabetes [78], and a separate study including more than 3 thousand prediabetic individuals confirmed NT-proBNP as an independent predictor of increased long-term major adverse cardiovascular events and mortality risks [79]. Although most of the available evidence on NT-proBNP and cardiovascular outcomes comes from patients with T2DM, emerging data suggest a potential association in individuals with type 1 diabetes mellitus as well [80]. However, routine NTproBNP screening is not currently recommended in type 1 diabetes mellitus, pending more robust and disease-specific evidence.

Additionally, RCTs have shown that more intensive treatment of risk factors in patients with elevated natriuretic peptide levels reduces the risk of symptomatic HF, HF hospitalization, and newly diagnosed left ventricular dysfunction [53,69,81]. The PONTIAC (NT-proBNP selected prevention of cardiac events in a population of patients with DM without a history of cardiac disease) trial, for example, revealed that intensified preventive risk factor treatment in patients with T2DM without clinical evidence of CVD and elevated NT-proBNP levels significantly reduced the primary outcome of hospitalization or death due to cardiac disease [81]. Similarly, the STOP-HF (The St Vincent’s Screening to Prevent Heart Failure) trial demonstrated that BNP-guided intervention significantly reduced the risk of left ventricular dysfunction and HF [69]. These studies collectively underscore the critical role of NT-proBNP in cardiovascular risk stratification and management in patients with diabetes. The ongoing PONTIAC 2 trial (NCT02817360) will provide important insights into the role of NT-proBNP in the treatment of T2DM patients with no clinically evidence CVD for the primary prevention of cardiac events.

6. Natriuretic peptides for cardiovascular risk stratification of asymptomatic patients with T2DM: SHA recommendations

NT-proBNP-based screening has shown that more than 25 % of patients with T2DM and concomitantly elevated blood pressure are already at risk of cardiac damage, referred to as “heart stress” [82]. Elevations in BNP or NT-proBNP have actually been shown to occur in the months leading to a cardiac event in patients with T2DM [83]. This supports the notion of progressive cardiac deterioration and highlights the role of early risk identification and stratification in this population through natriuretic peptide monitoring. Elevated NT-proBNP levels have been linked to an increased risk of cardiovascular outcomes and mortality among patients with T2DM in both unselected populations and those at high-risk for CVD [32,84–87]. A cut-off of 125 pg/mL has generally been shown to be predictive of cardiovascular events or death in unselected cohorts of patients with T2DM [88]. Moreover, NT-proBNP levels below this threshold can reliably identify patients who are not at intermediate or high risk of experiencing a cardiovascular event, with a negative predictive value of 97.6 % and a sensitivity of 0.795 % [88].

The negative predictive value of NT-proBNP below the threshold of 125 pg/mL makes it a valuable biomarker for identifying T2DM patients at risk for developing CVD. Collectively, evidence suggests that NT-proBNP is a promising biomarker for improving CVD risk prediction in patients with T2DM [89]. Several studies have assessed NTproBNP-based risk stratification in comparison with established approaches, finding that it generally improves the performance of risk stratification models in clinical practice. In an unselected cohort of patients with T2DM, NT-proBNP as a single assessment reliably predicted 10-year CVD and all-cause mortality, with robust performance across all patient groups. By comparison, established models such as Systematic COronary Risk Evaluation (SCORE) and the European Society of Cardiology (ESC) and European Association for the Society of Diabetes (EASD) risk stratification model had inferior or limited performance [87]. This confirmed previous findings from a subanalysis of the ALTITUDE (Aliskiren in Type 2 Diabetes Using Cardiorenal Endpoints) trial, which showed that the discriminatory ability of NT-proBNP by itself was comparable to multivariable models in the context of cardiovascular events and mortality prediction [32]. With its good discriminative ability, NT-proBNP can also be incorporated into established clinical risk models to improve their ability to predict cardiorenal endpoints, including chronic HF, atrial fibrillation and kidney failure [90].

NT-proBNP can help identify T2DM patients who are at risk for cardiac events independently of traditional risk factors [91] and potential confounders [92]. At very elevated levels (e.g., ≥450 pg/mL), NT-proBNP might be considered a “risk equivalent” for CVD, indicating the need for appropriate treatment [93]. The use of point-of-care NT-proBNP has also been shown to be practical in clinical practice and may be used for screening T2DM patients for CVD [94].

Based on the evidence outlined in this document, the SHA proposes the approach shown in Fig. 1 for NT-proBNP-based cardiovascular screening, which is recommended in all asymptomatic patients with T2DM. T2DM patients with NT-proBNP levels below the 125 pg/mL threshold are considered to be very unlikely to have CVD (rule-out), while NTproBNP levels above this threshold likely reflect underlying CVD (rule-in). Necessary clinical evaluations should follow CVD rule-in to confirm the diagnosis of CVD and initiate appropriate treatment. Highly elevated NT-proBNP levels of 2000 pg/mL or above are indicative of very high-risk of HF-related hospitalization or mortality [95], and should trigger accelerated cardiac evaluation. The proposed algorithm takes into account the variations in NT-proBNP levels observed with age by including age-adapted thresholds for the rule-in of HF. This is expected to reduce the burden of unnecessary referrals and medical testing that is anticipated with a single rule-in threshold [66,96–99]. To note that in the absence of local data, age-adapted thresholds were based on the 95th percentile of the Generation Scotland cohort [99]. However, the SHA recognizes this as a notable gap in local data, which must be addressed in future studies through the establishment of NT-proBNP reference levels in Saudi populations.

Fig. 1.

Fig. 1

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Practical algorithm for CVD screening in asymptomatic individuals with T2DM. Abbreviations: ARNI: Angiotensin Receptor Neprilysin Inhibitor; CVD: Cardiovascular disease; ECG: Electrocardiogram; HF: Heart failure; NT-proBNP: N-terminal Pro-B-type Natriuretic Peptide; RAAS: Renin-Angiotensin-Aldosterone System; SGLT2: Sodium-Glucose Cotransporter 2.

It is also important to recognize that the practical implementation of NT-proBNP screening in routine clinical practice may face several challenges. Overuse of diagnostic testing remains substantial in many healthcare settings [100], underscoring the need for clear definitions and indications to optimize screening and avoid unnecessary resource utilization. Clinicians should also carefully consider factors that may influence NT-proBNP concentrations to minimize misdiagnosis. NT-proBNP screening has been shown to be cost-effective in high-risk populations in international studies [101]. Given that test availability and cost remain key considerations, local evaluation of cost-effectiveness is needed to improve accessibility and ensure efficient resource use. While NT-proBNP is currently preferred for screening and preventive strategies in asymptomatic patients with T2DM due to its stability, reproducibility, and greater validation for long-term risk prediction, BNP remains a suitable alternative when NT-proBNP is unavailable or resources are limited.

Addressing these limitations through further research, local data collection, and clinician training on interpreting NT-proBNP levels is crucial to improve CVD screening in T2DM patients and improve clinical outcomes in Saudi Arabia. The adoption of routine point-of-care (POC) NTproBNP testing can be an alternative to traditional in-hospital laboratory immunochemistry methods [94], enhancing accessibility in low-resource settings. This approach has been recommended in Saudi Arabia in different clinical scenarios such as anticoagulation testing [102], and could facilitate timely treatment adjustments, prompt cardiologist referrals, and ultimately enhance the identification of high-risk T2DM patients in everyday clinical settings.

7. Limitations and influencing factors of natriuretic peptides as CVD biomarkers

Despite being the current “gold standard” of biomarkers in HF diagnosis and risk stratification, natriuretic peptides have certain limitations. Their levels can be influenced by various factors, which necessitates careful interpretation within the clinical context. It is important to recognize that normal natriuretic peptide levels are observed in around 20–35 % of patients with HF with preserved ejection fraction [103], in which case diagnosis cannot rely solely on BNP/NT-proBNP. Moreover, conditions other than HF can lead to elevated levels of natriuretic peptides. These include acute coronary syndrome, chronic kidney disease, pulmonary embolism, sepsis, and atrial fibrillation [104]. The utility of these peptides may also be subject to debate in the context of HF with preserved ejection fraction, where their levels tend to be lower [103]. However, ejection fraction has not been shown to significantly impact the prognostic value derived from natriuretic peptide levels [105,106] and guidelines currently recommend using the same cutoff levels across different ejection fraction categories.

Another important consideration is the variation of natriuretic peptide levels that can occur due to factors such as age, gender, and body mass index, which may complicate their interpretation [107,108]. Natriuretic peptide levels tend to increase with age [99]. This is in part due to age-related changes in cardiac structure and function as well as the higher prevalence of comorbid conditions in older adults, such as hypertension and renal dysfunction. The progressive increase in BNP and NT-proBNP levels with age has been taken into account by clinical guidelines through the use of age-stratified cut-off levels, which have been shown to improve the performance of these biomarkers in clinical practice [66]. Gender-specific differences in natriuretic peptide levels have also been noted, with higher baseline levels of BNP and NT-proBNP typically observed in women compared to men [99]. An inverse relationship also exists between obesity and BNP/NT-proBNP levels [109,110], necessitating careful clinical assessment since the lower levels of natriuretic peptides associated with obesity may mask the severity of HF.

Circulating levels of natriuretic peptides can also be affected by some medications. For example, commonly used drugs for the treatment of HF may lower BNP and NT-proBNP levels [111–116]. SGLT2 inhibitors have been shown to significantly reduce NT-proBNP levels in patients with chronic HF, but their effect on BNP did not reach statistical significance due to high heterogeneity in study results [117].

By contrast, these levels may be elevated by the use of other drugs [105,118]. For example, beta-blockers may lead to an increase in BNP and NTproBNP levels, with the same effect observed with digitalis compounds such as digoxin [119–121]. Aspirin has also been linked to increases in BNP and NT-proBNP levels, particularly with higher doses [122,123]. Neprilysin inhibition through the use of angiotensin receptor neprilysin inhibitors (ARNIs) affects BNP levels by preventing its breakdown and leading to increased levels of this biomarkers [124]. Although this effect enhances the beneficial actions of BNP, such as vasodilation and natriuresis, it requires careful consideration when interpreting BNP levels in patients on these medications. NT-proBNP does not require the same caution, as its metabolism is unaffected by ARNIs since it is not a substrate for neprilysin. This makes NT-proBNP a more reliable biomarker for HF in patients receiving ARNI therapy [124].

8. Conclusion

Improving early detection and management of CVD is crucial in patients with T2DM, who are at high risk of developing cardiac events. This improvement can be achieved through the implementation of a robust, evidence-based framework for the use of NT-proBNP for CVD screening in asymptomatic patients with diabetes mellitus. By incorporating NT-proBNP as a biomarker, the proposed algorithm aims to enhance the accuracy of CVD risk stratification, thereby facilitating timely and appropriate clinical interventions. The inclusion of age-adapted thresholds is particularly valuable in minimizing unnecessary referrals and medical testing, optimizing resource utilization. However, careful consideration is necessary to ensure the practical implementation of NT-proBNP screening in light of potential challenges and confounders, including the availability of testing in low-resource settings, cost considerations, and the influence of various factors on NT-proBNP levels. Further research and local data collection are essential, particularly to establish NT-proBNP reference levels specific to the Saudi population and therefore enhance the algorithm’s applicability and accuracy. Moreover, ongoing education and training for healthcare providers will be crucial in ensuring the successful integration of NT-proBNP screening into routine clinical practice.

Acknowledgments

The authors also thank Konoz Retaj, Saudi Arabia and Nancy Al Akkary MSc, BSc of Clinical Research for providing editorial and medical writing assistance for the preparation of this manuscript. This medical writing fee was funded by Roche Diagnostics Saudi Arabia.

Abbreviation list

ANP

Atrial Natriuretic Peptide

ARNI

Angiotensin Receptor Neprilysin Inhibitor

BNP

B-type Natriuretic Peptide

CNP

C-type Natriuretic Peptide

CVD

Cardiovascular Disease

T2DM

Type 2 Diabetes Mellitus

EASD

European Association for the Society of Diabetes

ESC

European Society of Cardiology

HF

Heart Failure

MR-proANP

Mid-Regional Pro-Atrial Natriuretic Peptide

NT-proANP

N-terminal Pro-Atrial Natriuretic Peptide

NT-proBNP

N-terminal Pro-B-type Natriuretic Peptide

RAAS

Renin-Angiotensin-Aldosterone System

RCT

Randomized Controlled Trial

SHA

Saudi Heart Association

SGLT2

Sodium-Glucose Cotransporter 2

Funding Statement

There was no financial reward associated with writing the paper. Konoz Retaj (Saudi Arabia) provided editorial assistance for preparing this manuscript based on the Good Publication Practice (GPP 2022) and the ICMJE requirements. This work was funded by Roche Diagnostics Saudi Arabia. The views and opinions expressed are those of the authors. Roche Diagnostics had no role in the decision to publish, or preparation of the manuscript

Footnotes

Ethics statement: This position statement is based on a comprehensive review of previously published studies and expert opinion. It does not involve any new data collection or analysis of patient data. As such, ethical approval from an ethics committee was not required for the preparation of this manuscript. All sources used in this manuscript have been appropriately cited to ensure proper attribution and to maintain the integrity of the research process.

Author contribution: Conception and design of Study: WA. Literature review: WA, AT, AMAA, LA, AAH, MRAS, MAA. Acquisition of data: WA. Drafting of manuscript: WA, AT, AMAA, LA, AAH, MRAS, MAA. Revising and editing the manuscript critically for important intellectual contents: WA, AT, AMAA, LA, AAH, MRAS, MAA. Data preparation and presentation: WA, AT, AMAA, LA, AAH, MRAS, MAA. Supervision of the research: WA. Research coordination and management: WA. Funding for the research: WA.

Funding: There was no financial reward associated with writing the paper. Konoz Retaj (Saudi Arabia) provided editorial assistance for preparing this manuscript based on the Good Publication Practice (GPP 2022) and the ICMJE requirements. This work was funded by Roche Diagnostics Saudi Arabia. The views and opinions expressed are those of the authors. Roche Diagnostics had no role in the decision to publish, or preparation of the manuscript.

Conflict of interest: None declared.

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