Establishment of reference intervals in Indian population
Tester F Ashavaid1, Seema P Todur, Alpa J Dherai
1Research Laboratories, P.D. Hinduja National Hospital & Medical Research Centre, Veer Savarkar Marg, Mahim, 400 016 Mumbai, India ; Dept. of Biochemistry, P.D. Hinduja National Hospital & Medical Research Centre, Veer Savarkar Marg, Mahim, 400 016 Mumbai, India.
Indian Journal of Clinical Biochemistry : IJCB
|October 30, 2012
Summary
Establishing local reference values is crucial for accurate clinical interpretation in India. This review explores methods for creating population-specific laboratory reference ranges, addressing limitations of Western data.
Area of Science:
- Clinical Laboratory Science
- Biochemistry
- Population Health
Background:
- Laboratory scientists support clinicians by providing essential reference values for interpreting patient results.
- Current laboratory reference values in India are largely based on Western populations, potentially leading to inaccuracies.
- Genetic, lifestyle, and dietary variations between populations necessitate the establishment of local reference values.
Purpose of the Study:
- To review the methodology for establishing population-specific reference values in India.
- To compare local laboratory data with existing reported values.
- To highlight the importance of adhering to International Federation of Clinical Chemistry (IFCC) guidelines.
Main Methods:
- Review of existing literature on establishing reference values.
- Analysis of internal laboratory data.
- Comparison of Indian population data with Western reference values.
- Application of IFCC guidelines for reference value determination.
Main Results:
- Significant discrepancies exist between Western and Indian population reference values.
- Local data suggests a need for revised reference ranges in Indian laboratories.
- The IFCC guidelines provide a robust framework for establishing accurate local values.
Conclusions:
- Western reference values are inadequate for the Indian population.
- Establishing Indian-specific laboratory reference values is essential for improved clinical diagnostics.
- Adoption of IFCC guidelines will enhance the reliability of laboratory testing in India.
Related Concept Videos
01:30Measurement of Bioavailability: Pharmacokinetic Methods
Pharmacokinetics is a vital branch of pharmacology that examines how drugs are absorbed, distributed, metabolized, and excreted by the body. Two key methodologies in pharmacokinetics are plasma drug concentration studies and urinary drug excretion analyses, both of which provide critical insights into a drug's therapeutic efficacy and bioavailability.Plasma Drug Concentration-Time StudiesPlasma drug concentration-time studies involve analyzing blood samples at specific intervals to quantify...
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
01:24Dosage Regimen: Individualization
Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
01:25Confidence Interval for Estimating Population Mean
A point estimate of the population mean is obtained from a single sample. Such a point estimate does not represent a population well because it needs to account for variability in the population. Single point estimate can also be biased despite the sample being selected randomly. Thus, a point estimate is often unreliable. A confidence interval is needed to reduce this unreliability.
A confidence interval for the mean is a range of values that provides an estimate of the population mean. As the...
A confidence interval for the mean is a range of values that provides an estimate of the population mean. As the...
01:21Confidence Intervals
An unbiased point estimate is often insufficient to predict a population estimate, such as population mean or population proportion. In this scenario, a confidence interval is used. A confidence interval is an estimate similar to a sample proportion. However, unlike the point estimate which is a single value, the confidence interval contains a range of values. These values have lower and upper limits, known as confidence limits, and can be designated as L1 and L2, respectively.
A confidence...
A confidence...
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...