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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