PCR Malaria Detection Oligonucleotide Primers

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

There is a need for a quick, reliable, specific, and sensitive method for detecting and quantifying the presence of Malaria parasites in biological samples, particularly for blood donations, as existing methods like microscopy, RDTs, and enzyme immunoassays are not sufficient for high-throughput and sensitive detection.

Innovation Solution

A polymerase chain reaction (PCR)-based assay using specific oligonucleotide primers and probes, such as those with sequences SEQ ID NOs: 1-15, for detecting and quantitating Malaria parasites like Plasmodium species in a single test tube, employing real-time PCR and fluorescent resonance energy transfer (FRET) for detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If microscopy or RDTs are used for Malaria detection, then the method is simple and inexpensive, but the sensitivity and throughput are insufficient

Engineering Contradiction:
Improvedetection sensitivityVSAvoiddetection method complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces mechanical microscopy methods with a molecular biology-based PCR system. The detection mechanism transitions from visual examination of stained blood smears to amplification and detection of parasite DNA using oligonucleotide primers and probes, achieving higher sensitivity through biochemical amplification rather than mechanical observation

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the detection parameter from visual/immunological detection to nucleic acid amplification detection. By targeting specific DNA sequences of Plasmodium species and using fluorescently labeled probes, the system achieves quantitative detection with much lower limits of detection compared to traditional methods

Inventive Principle:
Principle #35Parameter changes

2Reliability

If donor deferral policy is implemented, then blood supply safety is improved, but blood supply quantity decreases

Engineering Contradiction:
Improveblood supply safetyVSAvoidblood supply quantity
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent implements preliminary screening of blood donations using highly sensitive PCR-based Malaria detection before transfusion. By detecting Malaria parasites at very low levels in donated blood, the system identifies infected donations early, allowing for targeted deferral of only those specific donations rather than blanket deferral policies

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses nucleic acid amplification to create multiple copies of the parasite DNA present in the blood sample. This amplification process enables detection of extremely low levels of Malaria parasites that would otherwise be undetectable, allowing for more accurate identification of truly safe donations

Inventive Principle:
Principle #26Copying

3Quantity of substance

If selective testing is implemented, then impact on blood supply is reduced, but detection sensitivity must be maintained

Engineering Contradiction:
Improveblood supply quantityVSAvoiddetection sensitivity
Core Design Contradiction:
Quantity of substanceVSMeasurement precision

Solution Approach 1:

The patent replaces less sensitive immunological testing methods with molecular PCR-based detection. This substitution maintains high detection sensitivity while allowing selective testing of only those donations that require it, rather than universal deferral or testing policies

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

The PCR-based assay provides rapid, accurate, and sensitive detection and quantitation of Malaria parasites, ensuring the safety of blood supplies by identifying Plasmodium species with high specificity and sensitivity, even at low parasite levels.

Implementation Method 1

employing real-time PCR and fluorescent resonance energy transfer (FRET) for detection

Methodology Applied
Scientific EffectFluorescent resonance energy transfer (FRET):

Data Source

PatentEP4426865B1Compositions and methods for detection of malaria
Publication Date: 2026.04.01 F HOFFMANN LA ROCHE & CO AG
  • EP4426865B1 patent drawingFigure 1
  • EP4426865B1 patent drawingFigure 2A
  • EP4426865B1 patent drawingFigure 2B

AI summary

Methods for the rapid detection of the presence or absence of Malaria parasites (including Plasmodium) in a biological or non-biological sample are described. The methods can include performing an amplifying step, a hybridizing step, and a detecting step. Additionally, the assay can be a multiplex assay, to amplify and detect a plurality of Plasmodium targets simultaneously, which offers advantages over singleplex assays. Furthermore, primers and probes targeting Malaria parasites (including Plasmodium) and kits are provided that are designed for the detection of Plasmodium, including, but not limited to, the Plasmodium species of P. falciparum, P. vivax, P. ovale, P. knowlesi, and P. malariae. Also described are kits, reaction mixtures, and oligonucleotides (e.g., primer and probe) for the amplification and detection of Malaria parasites (including Plasmodium).