Internal Control (IC)

The internal control has been developed as part of a safety concept for the full sample preparation and analysis workflow.

Internal Control (IC)

The Internal control is monitoring the entire workflow from sample preparation to result reporting.

The IC Kit contains the inactivated virus, enabling multiple control functions. In the first step of sample preparation, a defined amount of IC virus is spiked into each sample, either automatically by the autoX-System or manually.

The specifications can only be evaluated along with the corresponding PCR kits.

For details please refer to the product information document.

IC Kit (Internal Control)
IC Kit (version 1.0)
GFE order number
packing unit = 30 kits
009-24-30
Kit components:
ir-SeV (IC)
Volume [µl]
2850
Label
IC

Intended Use

The IC Kit is a control kit for the Nucleic acid Amplification Technique (NAT) tests by GFE. It is designed as a non-competitive internal control (IC) for the overall process of virus detection in EDTA plasma samples collected from blood donations. The control function covers the whole process from virus enrichment (centrifugation) over nucleic acid extraction to the amplification of the target viruses and the result analysis, thereby evaluating the validity of the unknown samples tested negative. It is also a measure for the robustness of the whole process during the current run and over time. The IC Kit is used for monitoring sample pools containing 2 to 96 samples as well as individual and confirmatory samples.

The kit is not intended for diagnostic purposes.

The IC Kit is intended for use with the Applied BiosystemsTM 7500 Real-Time PCR System or the Roche LightCycler® 480 II Real-Time PCR System in conjunction with the GFE autoX-System and the respective GFE PCR and accessory kits.

The IC Kit is also intended for use with the Roche LightCycler® 480 II Real-Time PCR System in conjunction with the QIAamp® MinElute® Virus Spin Kit for nucleic acid extraction and the respective GFE PCR and control kits.

Doc. HO-4022

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