PCR Positive Control Kit

The PCR Positive Control Kit contains a combination of extracted nucleic acids from HAV, HBV, HCV, HIV-1/2 and PB19 and is used in the PCR reactions.

PCR Positive Control Kit

The PCR Positive Control Kit contains a combination of extracted nucleic acids from human immunodeficiency virus‑1 and ‑2 (HIV‑1 and HIV‑2), hepatitis C virus (HCV), hepatitis B virus (HBV), hepatitis A virus (HAV) and parvovirus B19 (PB19) and is used in the PCR reaction instead of the purified nucleic acids of the samples. It monitors the validity of the PCR reaction.

For parvovirus B19 the concentration of the PCR positive control and hence the detection value is defined to correspond to a parvovirus B19 positive sample with a virus concentration of 105 IU/ml. Therefore, it is possible to make a semi-quantitative determination of the PB19 concentration of a sample by comparison of its detection value in relation to the detection value of the amplification curve of the PCR positive control. For all other viruses, the concentration of the PCR positive control is defined to reveal positive results with a probability of >95%.

The performance characteristics of the PCR Positive Control Kit can only be evaluated along with the corresponding GFE PCR kits. For details please refer to the user manual (product information) of the respective kit. Acceptance limits for manual processing can be found on the batch certificates of the respective PCR kits.

PCR Positive Control Kit
PCR Positive Control Kit (version 1.1)
GFE order number
packing unit = 30 kits
010-180-30
Kit components:
PCR positive control v2
Volume [µl]
350
Label
Pos

Intended Use

The PCR Positive Control Kit is a control kit for the Nucleic acid Amplification Technique (NAT) tests of GFE. It is designed as a positive control for Real-Time PCR virus detection in human EDTA plasma, which has been donated in the context of blood banking. The control function ranges from PCR setup to the amplification of viral nucleic acids and result evaluation. For parvovirus B19 the PCR Positive Control Kit gives also semi-quantitative information about the viral load in positive samples.

The PCR Positive Control 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 PCR Positive Control 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-4020

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