SPDS 09052014

Annex I: Controls

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This control is designed to demonstrate an appropriate test response. This positive control should be included at a low but easily detectable concentration, and should monitor the performance of the entire assay. The purpose of using a low concentration of positive control is to avoid contamination of the test sample and/or instrument. This control is designed to demonstrate that the assay itself does not produce a positive detection in the absence of target compounds. The

Success - Control detected at expected levels. Failure - Control not detected or at levels below expected.

Single use per sample (or sample set) Run

Positive Control

Success - No detections made.

Single use per sample (or sample set) run

Negative Control

purpose of this control is to rule-out contamination in the assay or test.

Failure - Detections made.

Success - Control detected at expected levels. Failure - Control not detected or at levels below expected.

This control is designed to specifically address the impact of a sample or sample matrix on the assay's ability to detect target compounds.

Interference Control

Single use per sample run

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