Babesia Nucleic Acid Amplification for Donated Blood Screening
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Solution Overview
Problem
There is no licensed test for screening Babesia species in donated blood, posing a significant risk of transfusion-transmitted babesiosis and necessitating a specific and sensitive assay for detecting Babesia nucleic acid in samples.
Innovation Solution
A method involving the use of specific oligomers for amplifying Babesia species nucleic acid, followed by an in vitro nucleic acid amplification reaction and detection of the amplification product to indicate the presence or absence of Babesia species in a sample.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If no licensed test is used for screening Babesia species in donated blood, then blood typing and compatibility testing can be performed, but transfusion-transmitted babesiosis risk increases and blood safety is compromised
Solution Approach 1:
The patent applies preliminary action by performing nucleic acid amplification and detection of Babesia species before blood transfusion. The method includes contacting the sample with amplification oligomers, performing in vitro nucleic acid amplification, and detecting amplification products to identify Babesia species presence prior to potential transfusion, thereby preventing transmission while maintaining blood safety protocols
2Reliability
If a specific and sensitive assay is developed for detecting Babesia nucleic acid, then transfusion-transmitted babesiosis can be prevented, but the complexity of the testing system increases
Solution Approach 1:
The patent replaces complex mechanical or manual detection methods with nucleic acid amplification technology. The method uses in vitro nucleic acid amplification reactions with specific amplification oligomers to detect Babesia species nucleic acid, substituting traditional mechanical or manual parasite detection with molecular biology-based amplification and detection systems
Solution Approach 2:
The patent applies parameter changes by optimizing amplification conditions including temperature, time, and reagent concentrations to achieve sensitive and specific detection. The method varies parameters such as amplification cycle number, oligomer concentration, and detection sensitivity to balance detection accuracy with system complexity
3Reliability
If screening all blood donations for Babesia species is implemented, then blood safety is enhanced, but the time required for blood typing and compatibility testing increases
Solution Approach 1:
The patent performs Babesia species nucleic acid detection as a preliminary screening step before completing full blood typing and compatibility testing. By conducting the nucleic acid amplification and detection of amplification products early in the testing workflow, the method identifies potential Babesia infections without delaying subsequent required blood safety tests
Solution Approach 2:
The patent integrates Babesia screening continuously into the existing blood testing workflow rather than adding it as a separate sequential step. The nucleic acid amplification and detection are performed alongside other blood safety tests, maintaining continuous useful action throughout the testing process to avoid time loss while enhancing blood safety
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
Provides a sensitive and specific method for detecting Babesia species nucleic acid, addressing the unmet need in blood screening and enhancing blood safety by identifying potential transfusion-transmitted infections.
Implementation Method 1
contacting a sample, said sample suspected of containing Babesia species nucleic acid, with at least two oligomers for amplifying a target region of a Babesia species target nucleic acid
Implementation Method 2
performing an in vitro nucleic acid amplification reaction, wherein any Babesia target nucleic acid present in said sample is used as a template for generating an amplification product
Data Source
AI summary
A combination of at least two oligomers is for determining the presence or absence of Babesia in a sample. The combination includes first and second amplification oligomers for amplifying a target region of Babesia target nucleic acid. The first amplification oligomer includes a first target-hybridizing sequence that is from about 15 to about 33 contiguous nucleotides in length, is contained in the sequence of SEQ ID NO:97 and includes SEQ ID NO: 101 or its analogue. The second amplification oligomer includes a second target-hybridizing sequence that is from about 15 to about 33 contiguous nucleotides in length. The second amplification oligomer can also be contained in SEQ ID NO:68 and include SEQ ID NO:85 or its analogue, or contained in SEQ ID NO:70 and include SEQ ID NO:48, or include SEQ ID NO:84.