CONTROL FOR DIAGNOSTIC ASSAY

摘要

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.

主权项

1: A method for determining whether a lysate contains sufficient biological sample material for a nucleic acid amplification reaction, the method comprising:
a) the lysate in the presence of a composition, wherein said composition comprises at least one compound (A) which comprises at least one anionic group, wherein compound (A) inhibits the nucleic acid amplification reaction if no sufficient biological sample material was present during preparation of the lysate but does not inhibit the nucleic acid amplification reaction if sufficient biological sample material was present during preparation of the lysate; b) optionally further processing the lysate; c) subjecting at least a portion of the lysate to the nucleic acid amplification reaction; and analyzing a result of the nucleic acid amplification reaction, wherein due to the presence of compound (A) in the nucleic acid amplification reaction, no amplification signal is obtained if no sufficient biological sample material was present during preparation of the lysate but wherein an amplification signal is obtained if sufficient biological sample material was present during preparation of the lysate.