CRISPR-based diagnostics are attracting strong interest in molecular point-of-care testing because they combine sequence-specific recognition with simple signal readout. Cas12 and Cas13 systems are especially useful for nucleic acid detection. Cas12 is commonly associated with DNA target detection, while Cas13 is widely used for RNA target detection. When combined with lateral flow strips, these systems can create visually readable molecular tests for decentralized environments.
How CRISPR lateral flow detection works
A typical CRISPR lateral flow assay includes target amplification, CRISPR recognition, collateral cleavage of a labeled reporter, and strip-based signal generation. After the target sequence activates the Cas enzyme, the reporter is cleaved and produces a pattern on the lateral flow strip. This allows molecular recognition to be translated into a simple visual or reader-assisted result.
Because CRISPR detection is highly sequence-specific, it can be useful for infectious disease identification, mutation screening, antimicrobial resistance marker detection, veterinary pathogens, and food safety targets. The final strip format can be easier to deploy than complex fluorescence instruments in certain markets.
Cas12 versus Cas13 in assay design
Cas12-based assays are often selected for DNA targets or amplified DNA products. Cas13-based assays are useful when RNA recognition is required. The choice depends on the target organism, sample type, amplification method, desired workflow, and available guide RNA design strategy.
Developers should evaluate guide efficiency, off-target risk, reaction temperature, enzyme stability, reporter design, amplification compatibility, and strip signal intensity. A robust assay requires optimization of both the biochemical reaction and the physical lateral flow strip.
Key challenges for commercial products
CRISPR test strip development must address contamination control, reagent stability, workflow simplification, sensitivity, specificity, and result interpretation. Since many CRISPR assays use pre-amplification, closed-tube or well-controlled workflows are important to reduce carryover contamination. Lyophilized reagents or stabilized reaction mixes can help improve usability in field settings.
For IVD commercialization, manufacturers also need to generate validation data, define quality control materials, establish lot release criteria, and prepare regulatory documentation according to target market requirements.
Dedicated strips for CRISPR diagnostics
CRISPR lateral flow strips require consistent membrane performance, optimized conjugate systems, stable control lines, and reliable sample migration. A strip designed for ordinary antigen detection may not automatically perform well with CRISPR reporters. Dedicated CRISPR strip development helps improve sensitivity, reduce background, and support stable manufacturing.
DueBio supports partners with Cas12/Cas13 dedicated test strip development and OEM/ODM solutions for molecular POCT applications.