Quality Assurance and Standardization Division, Secretariat, Ministry of Health, Thimphu, Bhutan.
Faculty of Postgraduate Medicine, Khesar Gyalpo University of Medical Sciences of Bhutan, Thimphu, Bhutan.
PLoS One. 2022 Sep 1;17(9):e0273778. doi: 10.1371/journal.pone.0273778. eCollection 2022.
Laboratory medicine plays a critical role in the modern healthcare system, and it is reported to influence 60-70% of clinical decision makings. The quantitative laboratory test results are interpreted by comparing to the Reference Intervals (RIs) and therefore the use of appropriate RIs is critical. Clinical laboratories in Bhutan have been randomly using RIs from textbooks and manufacturer's package inserts without even verifying their applicability and therefore lessening their contribution to clinical decision makings. To improve the healthcare service delivery in Bhutan, this study aims to establish routine clinical chemistry and haematological test RIs for healthy adults in the Bhutanese population. Out of 1150 (male, n = 570; female, n = 580) healthy Bhutanese adults listed for the study through a simple random sampling technique, 1002 (male, n = 405; female, n = 597) individuals were assessed and 815 (male, n = 372; female, n = 443) individuals were enrolled in the study. An adequate volume of venous blood was drawn from these participants with the use of standard phlebotomy technique for clinical chemistry and haematological analysis. The laboratory data were analysed with the use of statistical methods recommended by the International Federation of Clinical Chemistry and Laboratory Medicine and Clinical and Laboratory Standards Institute. After excluding the test results indicating underlying pathology and statistically detected outliers, a maximum of 775 (male, n = 346; female, n = 429) and 784 (male, n = 351; female, n = 433) individuals test values were eligible for clinical chemistry and haematology RIs establishment respectively. Statistically, there were no significant differences between age groups of same-sex for both test categories; however, significant differences between sex were observed for various test parameters in both test categories. Our RIs are generally comparable to other published literature. The established RIs are applicable to all the adult Bhutanese population; however, clinical laboratories should validate the transference of these RIs before using them for clinical purposes.
实验室医学在现代医疗体系中起着至关重要的作用,据报道,它影响了 60-70%的临床决策。实验室的定量检测结果通过与参考区间(RIs)进行比较来进行解读,因此,使用适当的 RIs 至关重要。不丹的临床实验室一直随机使用来自教科书和制造商说明书中的 RIs,甚至没有验证其适用性,从而降低了它们对临床决策的贡献。为了改善不丹的医疗保健服务,本研究旨在为不丹人群中的健康成年人建立常规临床化学和血液学检测 RIs。通过简单随机抽样技术,从 1150 名(男性,n = 570;女性,n = 580)健康不丹成年人中列出了 1002 名(男性,n = 405;女性,n = 597)参与者进行评估,其中 815 名(男性,n = 372;女性,n = 443)参与者被纳入研究。使用标准采血技术从这些参与者中抽取足够量的静脉血,用于临床化学和血液分析。使用国际临床化学和实验室医学联合会和临床和实验室标准研究所推荐的统计方法分析实验室数据。排除表明潜在病理和统计学检测到的异常值的检测结果后,分别有最多 775 名(男性,n = 346;女性,n = 429)和 784 名(男性,n = 351;女性,n = 433)个体的检测值符合临床化学和血液学 RIs 建立的要求。统计学上,对于两个检测类别,同一性别组之间的年龄没有显著差异;然而,在两个检测类别中,各种检测参数之间观察到了性别差异。我们的 RIs 与其他已发表的文献大致相当。所建立的 RIs 适用于所有不丹成年人群;然而,临床实验室在将这些 RIs 用于临床目的之前,应验证其适用性。