Chapter 23 Pharmaceutical Analysis

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Comparison of Clinical Assay Methods

Basis for Comparison of Methods

Sample (Type and size)
Analysis Time
Sensitivity, Specificity
Accuracy, Precision
Ease of Use, Versatility
Cost of Equipment
Cost of Supplies

Table 23.10.1 Comparison of Assay Methods
HPLC GLC RIA EMIT FPIA

Separation Method Chromatography Chromatography Immunoassay Immunoassay Immunoassay

Quantitation Method Various including absorption, fluorescence, electrochemical, radioactivity, refractive index Various including flame ionization, thermal conductivity, electron capture, mass spectrometry Radioactivity Kinetic via Absorption Fluorescence

Sample Size (µl) 100 - 500 100 - 500 100 50 50

Sample Type^* P, S, U, Sa P, S, U, Sa P, S, U, Sa P, S, U P, S, U

Time (hr) 0.5 0.5 0.25 0.1 - 0.3 0.1 - 0.2

Sensitivity^** 1 1 2 3 2

Specificity^** 1 1 4 4 3

Accuracy^** 2 2 2 2 2

Precision^** 3 3 2 1 1

Training^** 5 5 3 3 2

Equipment Cost^** 4 4 5 3 4

Reagent Cost^** 3 2 2 3 2

Clinical Application^** 4 5 4 2 1

Research Application^** 1 2 3 3 3

Table 23.10.1 Comparison of Assay Methods
	HPLC	GLC	RIA	EMIT	FPIA
Separation Method	Chromatography	Chromatography	Immunoassay	Immunoassay	Immunoassay
Quantitation Method	Various including absorption, fluorescence, electrochemical, radioactivity, refractive index	Various including flame ionization, thermal conductivity, electron capture, mass spectrometry	Radioactivity	Kinetic via Absorption	Fluorescence
Sample Size (µl)	100 - 500	100 - 500	100	50	50
Sample Type^*	P, S, U, Sa	P, S, U, Sa	P, S, U, Sa	P, S, U	P, S, U
Time (hr)	0.5	0.5	0.25	0.1 - 0.3	0.1 - 0.2
Sensitivity^**	1	1	2	3	2
Specificity^**	1	1	4	4	3
Accuracy^**	2	2	2	2	2
Precision^**	3	3	2	1	1
Training^**	5	5	3	3	2
Equipment Cost^**	4	4	5	3	4
Reagent Cost^**	3	2	2	3	2
Clinical Application^**	4	5	4	2	1
Research Application^**	1	2	3	3	3

^* Plasma, Serum, Urine, Saliva
^** 1 excellent - 5 poor
Redrawn from: Pieper and Rutledge, Laboratory Techniques for Pharmacists, Upjohn 1989, page 47, table 3

Student Objectives for this Chapter

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