Control for diagnostic assay

US9822404B2 · kind B2 · utility

Assignee

• QIAGEN GmbH · DE

Inventors

• Gerd Grosshauser · Pulheim, DE
• Andy Wende · Hilden, DE
• Ralf Himmelreich · Langenfeld, DE

Key dates

• Filing date: Nov 7, 2013
• Grant date: Nov 21, 2017
• Expiry date: Jul 29, 2034

Classification

• Technology area (CPC C): Chemistry; Metallurgy
• CPC primary: C12Q1/6848
• WIPO field: Biotechnology
• WIPO sector: Chemistry

Abstract

A method for determining whether a lysate contains sufficient biological sample material for a nucleic acid amplification reaction that includes preparing the lysate in the presence of at least one compound that inhibits the amplification reaction if insufficient biological sample material was present during preparation of the lysate, but does not inhibit the amplification reaction if sufficient biological sample material was present during preparation of the lysate, subjecting the lysate to the amplification reaction, and analyzing a result of the amplification reaction. Due to the presence of the compound in the amplification reaction, no amplification signal is obtained if insufficient biological sample material was present during preparation of the lysate but an amplification signal is obtained if sufficient biological sample material was present during preparation of the lysate. The invention allows for reliable identification of false negatives that occur because insufficient sample material was subjected to the amplification assay.