Page 20 - qp_17

APPENDIX 3

LINEARITY / REPORTABLE RANGE STUDY

ANALYTE :
METHOD :
ANALYZER :

LINEARITY/ REPORTABLE RANGE

• Analytical measurement range (AMR)

• Can use commercial linearity materials, PT or patient samples with known results,
standards or calibrators

Factors to consider

• It is convenient to use two pools – one near the zero level or close to the detection
limit and the other near or slightly above the expected upper limit of the reportable

range.

• Each sample should be prepared by direct dilution of the original high sample
• Serial dilutions SHOULD NOT BE USED because pipetting errors will be propagated

through subsequent samples.

• Diluent  Distilled water, normal saline (to maintain matrix of specimen)

PROCEDURE FOR PREPARING DILUTIONS

1. Prepare 5 pools of dilution

2. Label the low pool “Pool 1” and the high pool “Pool 5.”
3. No preparation is necessary for pool 1(use zero or very low sample) and pool 5 (use

sample with high concentration which is near top of desired range assay)

4. Prepare Mixture 2 (75/25) with 3 parts Pool 1 + 1 part Pool 5.
5. Prepare Mixture 3 (50/50) with 2 parts Pool 1 + 2 parts Pool 5.

6. Prepare Mixture 4 (25/75) with a part Pool 1 + 3 parts Pool 5.