Reference Interval Flashcards

1
Q

Reference value
is a term used in medicine to denote a laboratory value used as a reference for values obtained by laboratory examinations of patient samples (blood, urine or other materials)
T/F

A

T

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2
Q

A reference range
-is a set of reference values used by a health professional to interpret a set of medical test results.
T/F

A

T

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3
Q

A reference range

The range is usually defined as the set of values that ___% of the healthy population falls within

A

95

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4
Q

Reference individual:
-An individual selected for comparison using defined criteria

T/F

A

T

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5
Q

Reference Value:
-observation/measurement of a quantity on a reference individual

T/F

A

T

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6
Q

Observed value:
-value of a particular quantity obtained by observation/measurement & produced to make a medical desicion

T/F

A

T

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7
Q

Relationship of Recommended Terms

Reference ___ make up a Reference Population from which is selected Reference ____on which Reference ____ are determined
on which is observed a Reference ___ on which are calculated Reference ___ that may define Reference Intervals

A

individual

Sample Group

Values

Distribution

Limits

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8
Q

Types of Reference Ranges
-___ based reference ranges
-____ associated reference ranges
-_____ based reference ranges
-____ Specified ranges

A

Subject

Health

Population

Time

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9
Q

Subject based reference ranges
-Comparison of _____
-Often more sensitive in that it rules out ______

A

an individuals current value with an historical one

biological variation effects.

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10
Q

Biological factors

Age: e.g. (higher or lower?) plasma urea levels are found in the elderly. Also , (higher or lower?) ALP activity in growing children compared with adults.

A

Higher

Higher

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11
Q

Sex: e.g. (higher or lower?) values of plasma urea, creatinine and urate are found in men
compared with women during the
reproductive phase of life.

A

Higher

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12
Q

serum iron levels (rise or declines ?) as the day progresses.

A

Rise

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13
Q

plasma protein levels are (higher or lower?) in samples collected from patients when they are lying down.

A

Lower

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14
Q

Determination of Reference Limits

-Mean ____ – Parametric statistic for
Gaussian or normal frequency distribution
-_____– Non-Parametric statistic for
Skewed or Non-Gaussian distribution
-Log transformation of data for Skewed or
Non-Gaussian distribution – Mean ± 2SD

A

± 2SD

Percentiles

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15
Q

Unit:______

Sodium-
Potassium-
Bicarbonate-

A

Mmol/L

135-145
3.3-5.0
18-31

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16
Q

Unit:_____

Calcium-
Phosphate-
Magnesium-

A

Mmol/L

2.1-2.55
0.83-1.48
0.66-1.07

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17
Q

Unit: ______

Chloride-
UREA-
Blood urea nitrogen-

A

Mmol/L

95-105
2.5-6.4
1.7-9.1

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18
Q

Creatinine in serum (___) - _____

Creatinine in 24hr urine( ___)-____

A

Umol/L
53-115

Mmol/day
7.1-17.1

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19
Q

Unit:_____

Fasting plasma glucose:
Random plasma glucose:

A

Mmol/L

3.5-5.8
3.6-7.8

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20
Q

Total bilirubin(____)?

A

Umol

1.7-17.1

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21
Q

Creatinine clearance( _____) -??

A

Ml/min

90-125

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22
Q

Conjugated bilirubin (—-)-?

A

Umol/L

0-3,4

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23
Q

Reference intervals are sometimes erroneously referred to as “ _______.”

A

normal ranges

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24
Q

all normal ranges are reference intervals

T/F

A

T

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25
Q

all reference intervals are normal ranges.
T/F

A

F

26
Q

Reference intervals , reference ranges

the preferred term is ___________

Why?

A

reference interval

because range implies the absolute maximum and minimum values

27
Q

The clinical laboratory is required by good laboratory practice and accreditation agencies (i.e.,____________ checklist) to either _______ or _____ reference intervals for any new tests or significant changes in methodology.

A

College of American Pathologists [CAP]

verify or establish

28
Q

Establishing a reference interval

It is a costly and labor-intensive study that will involve laboratory resources at all levels and may require from ____ to as many as >___ study individuals.

A

120

700

29
Q

Verifying a reference interval

Verifying a reference interval (______): This is done to confirm the validity of an existing reference interval for an analyte using the same (identical) type of analytic system (method and/or instrument).
These can require as few as ___ study individuals

A

transference

20

30
Q

most common reference interval studies performed in the clinical laboratory is??

A

Verifying a reference interval

31
Q

Verifying a reference interval

The manufacturer’s reported 95% reference limits may be considered valid if no more than ___% of the tested subjects fall outside the original reported limits
If more than __% of the values fall outside of the proposed interval, an additional ____ or more specimens should be analyzed.

If the second attempt at verification fails, the laboratorian should re-examine the analytic procedure and identify any differences between the laboratory’s population and the population used by the manufacturer for their analysis.
If no differences are identified, the laboratory may need to establish the reference interval using at least ______ individuals.
Once a reference interval is determined, it needs to be communicated to the ____________
This is important given the slight variations in reference intervals seen even among testing facilities using similar methodologies.

A

10

10

20

120

physicians interpreting test results at the time the test results are reported.

32
Q

Use histogram or bar chart?

A

Histogram

33
Q

In the most basic sense, data may be either normally distributed (_____) or skewed (_____)

A

gaussian

nongaussian

34
Q

gaussian or _______ or _______ or ______

A

Normal distribution curve

Frequency distribution curve

Bell’s curve

35
Q

A parametric method defines the interval by the mean +/-___ SDs; this formula will include the central 95% of values as given in the example shown.

A

1.96

36
Q

In reality, most analytes display a normal (gaussian) distribution.

T/F

A

F

They do not

37
Q

Data that are not normally distributed (i.e., nongaussian) must be analyzed using _______ analyses.

A

nonparametric

38
Q

Nonparametric determination of the reference interval is analyzed using ______, which (do or do not?) depend on the distribution.

A

percentages

Do not

39
Q

For nonparametric

The reference interval is determined by using the central 95% of values; the reference range is therefore defined by the ____ to the ____ percentiles.

A

2.5th

97.5th

40
Q

Most reference interval analyses are determined using (parametric or nonparametric?) analysis.

This is because (parametric or nonparametric?) analysis can be used on (gaussian or skewed ?) distributed data and it is the ____-recommended method

A

nonparametric

nonparametric

gaussian

CLSI

41
Q

three most commonly used descriptions of the center are the ______,_____, and _____
The _____ is most commonly used and often referred to as the ______

The _____ is the “middle” point of the data and is often used with (Gaussian or skewed ?) data.

The ______ is rarely used as a measure of the data’s center but is more often used to describe data that seem to have _____

A

mean, the median, and the mode.

mean; average

median;skewed

mode; two centers (i.e., bimodal).

42
Q

In other words, given any gaussian distributed data:
Approximately ____% of the data fall between +/-1 SD from the mean;
Approximately ____% of the data fall between +/-2 SDs from the mean; and
Approximately ____% fall between +/- 3 SDs from the mean.

A

68

95

99

43
Q

When interpreting laboratory data, clinicians compare the measured test result from a patient with a _______

A

reference interval.

44
Q

The theory for the development of reference intervals was the work of _____ main expert committees.

A

two

45
Q

Reference intervals are usually established by the _________ or the ___________ and new methodologies.

A

scientific community

manufacturers of reagents

46
Q

_________________ is an example of an accreditation agency

A

College of American Pathologists [CAP] checklist

47
Q

Answer with pre-analytical or analytical considerations

Subject preparation
Stress

A

pre-analytical

pre-analytical

48
Q

Answer with pre-analytical or analytical

Collection time

A

pre-analytical

49
Q

Answer with pre-analytical or analytical

Prescription medications

A

Pre-analytical

50
Q

Answer with pre-analytical or analytical

Sample storage
Precision

A

Pre-analytical

Analytical

51
Q

Answer with pre-analytical or analytical

Food/beverage ingestion

A

pre-analytical

52
Q

Answer with pre-analytical or analytical

Accuracy

A

analytical

53
Q

Answer with pre-analytical or analytical

Linearity
Recovery

A

analytical

analytical

54
Q

Answer with pre-analytical or analytical

Interference

A

Analytical

55
Q

Answer with pre-analytical or analytical

Lot-to-lot reagents

A

Analytical

56
Q

The reference interval is calculated statistically using methods that depend on the __________

A

distribution of the data.

57
Q

Nonparametric determination of the reference interval is analyzed using _____

A

percentages

58
Q

Nonparametric curve depends on the distribution of data

T/F

A

F

It doesn’t

59
Q

There are three most commonly used descriptions of spread: (1) ____, (2) ______, and (3)___________.

A

range

Standard deviation(S.D)

coefficient of variation (CV)

60
Q

The total area under the gaussian curve is ___, or ___%.

A

1.0

100