Quality control compositions and whole organism control materials for use in nucleic acid testing

A technology for quality control and composition, applied in the field of organisms or nucleic acid sequences of interest, and can solve problems such as unresolved control materials

Pending Publication Date: 2021-05-04
MICROBIX BIOSYSTEMS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] Furthermore, there are unresolved issues in the preparation of appropriate control materials
One such issue is how to prepare controls that are broadly useful in many different assays, whether those developed by commercial establishments of NAT (including diagnosing NAT) or those developed by individual research or clinical laboratories

Method used

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  • Quality control compositions and whole organism control materials for use in nucleic acid testing
  • Quality control compositions and whole organism control materials for use in nucleic acid testing
  • Quality control compositions and whole organism control materials for use in nucleic acid testing

Examples

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example 1

[0229] Example 1: Quality Control Compositions (Amplified Whole Organism Controls) that Can Be Used to Evaluate the Function of NATs Sensing MRSA

[0230] Staphylococcus aureus strains, including strains resistant to methicillin and many other antibiotics, are a major cause of nosocomial infections worldwide (DIEKEMA ET AL., CLIN INFECT DIS. 2001; 32:S114-32). Methicillin resistance is determined by the MECA gene encoding the low-affinity penicillin-binding protein PBP 2A (BECK ET AL., JBACTERIOL. 1986; 165(2):373-8). Single amplified molecule controls, including whole organism controls, were used in NAT to sense the presence of methicillin-resistant Staphylococcus aureus (MRSA).

[0231] For example, the whole organism control includes a S. aureus containing a nucleic acid (eg, the mecA gene) that provides a characteristic that does not occur naturally in a non-methicillin-resistant S. aureus strain. Staphylococcus aureus is genetically modified to contain the mecA gene or a...

example 2

[0237] Example 2: Quality Control Compositions (Amplified Multi-Organism Controls) that Can Be Used to Evaluate the Function of NATs Sensing MRSA

[0238] A multi-organism molecular control comprising a mixture of different organisms was used as a whole organism control for NAT to sense the presence of MRSA.

[0239] In one example, the whole organism control comprises a Staphylococcus aureus organism mixed with E. coli bacteria genetically modified to contain the mecA gene or a portion of the gene by using a plasmid or vehicle (in Which utilizes any one of the various recombinant plasmid construction methods well known to those skilled in the art to introduce the whole mecA gene or a part of the gene) for transfection ( image 3 ). Alternatively, by transduction with an appropriately engineered viral vector, such as a bacteriophage, into which the entire mecA gene or part of the gene), the entire mecA gene or a part of the gene can be introduced into E. coli. Other methods...

example 3

[0242] Example 3: Quality Control Compositions (Amplified Multi-Organism Controls) that Can Be Used to Evaluate the Function of NATs Sensing MRSA

[0243] A multi-organism molecular control comprising a mixture of different organisms (eg, from different species or origins) is used as a whole organism control material for NAT to sense the presence of MRSA.

[0244] In one example, the whole organism control comprises a Staphylococcus aureus organism mixed with human adenovirus type 5 genetically modified to contain the mecA gene or a portion of the gene by using a method in the art Any one of the various recombinant adenovirus construction methods well known to those skilled in the art is realized ( Figure 4A ). Genetic material can also be introduced into other viruses including, but not limited to, adeno-associated virus, human herpesvirus type 1, and human herpesvirus type 2 (also known as herpes simplex virus type 1 and type 2) by methods well known to those skilled in th...

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Abstract

The present disclosure relates in general, to quality control compositions and whole organism control materials for use in assessing the functionality of Nucleic Acid Tests (NAT) and to related methods, uses and kits. In some aspects the NAT is used to detect the presence of an organism and a target nucleic acid sequence in a test article, the quality control composition comprising: (i) a first protected nucleic acid sequence comprising a first nucleic acid sequence the presence of which is characteristic of the presence of the organism in the test article said first nucleic acid sequence being tested in the NAT; and (ii) a second protected nucleic acid sequence comprising a second nucleic acid sequence the presence of which is characteristic of the presence of the target nucleic acid sequence in the test article said second nucleic acid sequence being tested for in the NAT.

Description

[0001] cross reference [0002] This application claims priority to US Provisional Application US 62 / 673,480, entitled "Whole Organism Control Materials for Nucleic Acid Detection," filed May 18, 2018, the entire contents of which are incorporated herein by reference. The relevant PCT receiving Offices will be closed from May 18 to 20, 2019 (inclusive). technical field [0003] The present disclosure generally relates to whole organism control materials for nucleic acid detection (NAT), quality control compositions for evaluating the function of NAT, and for sensing biological substances of interest in tested samples (e.g., bioassay samples). body or nucleic acid sequence method. Background technique [0004] Nucleic acid detection and quality control [0005] Analytical and / or diagnostic detection of the presence of a biological organism or trait can be performed using methods of sensing the organism's nucleic acid or nucleic acid sequence, broadly referred to as nucle...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6844C12Q1/689
CPCC12Q1/6888C12Q1/689C12Q2600/106C12Q1/6844C12Q1/6813C12Q1/6827C12Q2537/143C12Q2545/113C12Q2525/161C12Q2545/101
Inventor 马克·拉斯彻肯尼斯·休斯帕弗尔·哲莱夫卡梅伦·格鲁米
Owner MICROBIX BIOSYSTEMS INC
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