How do you establish reference values?

How do you establish reference values?

However, reference ranges may also be established by taking samples from the whole population, with or without diseases and conditions. In some cases, diseased individuals are taken as the population, establishing reference ranges among those having a disease or condition.

What are reference values?

Listen to pronunciation. (REH-frents VAL-yooz) In medicine, a set of values that a doctor uses to interpret a patient’s test results. The reference values for a given test are based on the results that are seen in 95% of the healthy population.

Which of the following should be taken into consideration when establishing a reference range?

Some factors to consider are: timing of collection; food, water, and alcohol consumption in the past 24 hours; venipuncture site; tourniquet time; and type of collection tube. Samples to be used for reference range determination should be collected and processed the same as routine laboratory work.

What is the importance of reference interval when interpreting results?

Reference intervals are the most common decision support tool used for interpretation of numerical pathology reports. As laboratory results may be interpreted by comparison with these intervals, the quality of the reference intervals can play as large a role in result interpretation as the quality of the result itself.

What is the purpose of reference range?

Reference ranges help describe what is typical for a particular group of people based on age, sex, and other characteristics. In the context of your personal information, you and your provider can use reference ranges as a guide to what your results mean and to help make decisions about managing your health.

What is normal reference range?

Lab results are often shown as a set of numbers known as a reference range. A reference range may also be called “normal values.” You may see something like this on your results: “normal: 77-99mg/dL” (milligrams per deciliter). Reference ranges are based on the normal test results of a large group of healthy people.

What is a normal reference range?

What is a reference value in marketing?

The Reference Value is the price of the closest perceived substitute. This is extremely important – understand what alternatives and substitutes the customer sees in the market. The Differentiation Value is the value of your product’s attributes that exceed the reference value.

How are reference intervals calculated?

The reference interval is calculated using 3 different methods: (a) using the Normal distribution (Bland, 2000; CLSI 2008), (b) using a non-parametrical percentile method, and (c) optionally a “robust method” as described in the CLSI Guidelines C28-A3. 90% Confidence Intervals are given for the reference limits.

What concept is the phrase within the normal range referring to?

In medicine, a set of values that a doctor uses to interpret a patient’s test results. The normal range for a given test is based on the results that are seen in 95% of the healthy population.

What is normal range for blood sugar?

A blood sugar level less than 140 mg/dL (7.8 mmol/L) is normal. A reading of more than 200 mg/dL (11.1 mmol/L) after two hours indicates diabetes. A reading between 140 and 199 mg/dL (7.8 mmol/L and 11.0 mmol/L) indicates prediabetes.

What are the normal values of blood test?


Red blood cell count Male: 4.35-5.65 trillion cells/L* (4.35-5.65 million cells/mcL**) Female: 3.92-5.13 trillion cells/L (3.92-5.13 million cells/mcL)
Hemoglobin Male: 13.2-16.6 grams/dL*** (132-166 grams/L) Female: 11.6-15 grams/dL (116-150 grams/L)
Hematocrit Male: 38.3-48.6 percent Female: 35.5-44.9 percent

What does a certified value of a reference material do?

With reference materials, the certified value of the standard usually serves as the centre line with either established limits or experimentally estimated standard deviation to establish the control and warning limits.

When do you need a different reference material?

Where an international or national standard is available and appropriate, reference materials should be calibrated against it. While it is desirable to use the same reference material for both biological assays and physicochemical testing, in some cases, a separate reference material may be necessary.

Where do you get a reference standard from?

“A reference standard (i.e., primary standard) may be obtained from the USP/NF or other official sources (e.g., CBER, 21 CFR 610.20). If there are questions on whether a source of a standard would be considered by FDA to be an official source, applicants should contact the appropriate chemistry review staff.

What are regulatory expectations for the use of reference standards?

The qualitative and quantitative analytical procedures used to characterize a reference standard are expected to be different from, and more extensive than, those used to control the identity, strength, quality, purity, and potency of the drug substance or the drug product. Analytical procedures used to

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