Establishment of Population Specific Reference Intervals in Healthy Pakistani Adults for 21 Routine and Special Haematology Analytes.

Q2 Medicine Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2022-10-28 eCollection Date: 2022-10-01
Muhammad Shariq Shaikh, Sibtain Ahmed, Attika Khalid, Muhammad Hasan Hayat, Mohammad Usman Shaikh, Natasha Ali
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Abstract

Background: The reference interval (RI) is an interval between two limits derived from distribution of the results obtained from a sample of the reference population. These population based RIs are of paramount significance for the accurate clinical understanding of the patient's health status. Haematological RIs are heavily influenced by a variety of geographical and environmental factors. Therefore, accrediting bodies also mandate that each laboratory should establish its own RIs in its own population.

Methods: This cross-sectional study was conducted at the Department of Pathology and Laboratory Medicine, the Aga Khan University Hospital, Pakistan.Twenty-one routine and special quantitative analytes were measured in adults aged 18-60 years who passed the initial health screening questionnaire. All samples were handled strictly following standard operating procedures. Microsoft Excel and EP Evaluator software were used for statistical analysis. Nonparametric CLSI EP28-A3C method was used to establish upper and lower confidence limits at 90% significance.

Results: A total of 323 participants passed the questionnaire and were short-listed for blood collection. There were 147 males and 176 females. Reference intervals were established in 297 participants after exclusion of 26 outliers with grossly abnormal test results. Analytes included: 8 red, and 12 white blood cell parameters, platelet count, immature platelet fraction, erythrocyte sedimentation levels, haemoglobin A and A2 levels and glucose-6-phosphatase dehydrogenase levels.

Conclusion: Routine and special haematology RIs established in this study reflect significant differences from RIs in Caucasian population. For meaningful interpretation of test results, each haematology laboratory should establish or verify RIs in the population it serves.

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建立巴基斯坦健康成人21项常规和特殊血液学分析的人群特定参考区间。
背景:参考区间(RI)是从参考人群样本中获得的结果分布得出的两个极限之间的区间。这些基于人群的RIs对于临床准确了解患者的健康状况具有至关重要的意义。血液学RIs受各种地理和环境因素的严重影响。因此,认证机构还要求每个实验室在自己的人群中建立自己的RIs。方法:本横断面研究在巴基斯坦阿迦汗大学医院病理和检验医学系进行。对通过初步健康筛查问卷的18-60岁成人进行了21项常规和特殊定量分析。所有样品均严格按照标准操作程序处理。采用Microsoft Excel和EP Evaluator软件进行统计分析。采用非参数CLSI EP28-A3C方法,在90%显著性下建立上下限置信限。结果:共有323名参与者通过问卷调查并入选采血名单。其中男性147人,女性176人。在排除了26个异常测试结果的异常值后,在297名参与者中建立了参考区间。分析包括:8个红细胞和12个白细胞参数、血小板计数、未成熟血小板分数、红细胞沉降水平、血红蛋白A和A2水平以及葡萄糖-6-磷酸酶脱氢酶水平。结论:本研究建立的常规和特殊血液学RIs与高加索人群的RIs有显著差异。为了对检测结果进行有意义的解释,每个血液学实验室应在其服务的人群中建立或验证RIs。
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