Plasmodium Nucleic Acid Detection Oligomers
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Solution Overview
Problem
Current methods for detecting Plasmodium species in blood donations are not effective in detecting low levels of parasitemia, leading to a risk of Transfused Transmitted Malaria (TTM) and result in unnecessary deferral of donors, as there are no approved nucleic acid tests available in the U.S. for screening blood donations.
Innovation Solution
A method involving the use of specific oligomers for amplifying and detecting Plasmodium species nucleic acid in a sample through in vitro nucleic acid amplification, utilizing oligomers with target-hybridizing sequences of varying lengths to generate amplification products, and subsequent detection to indicate the presence of Plasmodium species.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thick blood films or enzyme immunoassay are used for Plasmodium detection, then the testing process is simple and widely available, but the detection sensitivity is insufficient for low levels of parasitemia
Solution Approach 1:
The patent replaces traditional mechanical/optical detection methods (thick blood films, enzyme immunoassay) with a nucleic acid amplification system that uses specific oligomers to detect Plasmodium DNA. This substitution enables detection at the molecular level, achieving high sensitivity for low parasitemia while maintaining a relatively simple workflow through automated amplification and detection.
2Object-affected harmful factors
If no approved nucleic acid tests are available for blood donation screening, then the testing cost and complexity are reduced, but the risk of transfused transmitted malaria increases
Solution Approach 1:
The patent changes the detection parameter from protein-based (enzyme immunoassay) to nucleic acid-based (PCR amplification of Plasmodium DNA). This parameter change enables detection of asymptomatic infections and low-level parasitemia that would be missed by traditional methods, thereby reducing TTM risk while the standardized PCR protocol maintains ease of implementation in blood banking settings.
3Measurement precision
If traditional screening methods are used, then the number of deferred donors is reduced, but the detection accuracy for Plasmodium species is insufficient
Solution Approach 1:
The patent segments the detection process into distinct phases: DNA extraction from blood samples, specific oligomer amplification of Plasmodium genetic material, and detection of amplification products. This segmentation enables high-throughput processing of donor samples while achieving superior detection accuracy through molecular-specific targeting, resolving the contradiction between precision and productivity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method provides a specific and sensitive detection of Plasmodium species, reducing the risk of TTM and minimizing the number of deferred donors by accurately identifying the presence of Plasmodium nucleic acid in blood samples.
Implementation Method 1
performing an in vitro nucleic acid amplification reaction, where any Plasmodium target nucleic acid present in said sample is used as a template for generating an amplification product
Implementation Method 2
contacting a sample, the sample suspected of containing Plasmodium species nucleic acid, with at least two oligomers for amplifying a target region of a Plasmodium species target nucleic acid
Data Source
AI summary
Disclosed are nucleic acid oligomers, including amplification oligomers, detection probes, and capture probes, for detection of Plasmodium species nucleic acid in a sample. Also disclosed are methods of specific nucleic acid amplification and detection, including amplification and detection of target nucleic acid in real time, using the disclosed oligomers, as well as corresponding reaction mixtures and kits.