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Analytical performance, sample preparation, and validation of CRISPR-Cas biosensors for point-of-care deployment
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DOI：10.1016/j.microc.2026.119289.png)
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Abstract
En 中文
• Cas12, Cas13, Cas14, and Cas3 are compared across key analytical figures of merit. • Amplification-coupled vs amplification-free assays: LOD, dynamic range, false-positive risk. • Sample preparation is characterized as a quantitative determinant of assay accuracy. • Four readout modalities are evaluated for quantitation, calibration, and precision. • Validation gaps are a major barrier to reliable point-of-care deployment.
Keywords:
Biosensors
CRISPR-Cas
Point-of-care diagnostics
Sample preparation
Validation
RT-qPCR
,
Reverse transcription quantitative polymerase chain reaction
NGS
,
Next-generation sequencing
CRISPR
,
Clustered regularly interspaced short palindromic repeats
WHO
,
World Health Organization
LOD
,
Limit of detection
crRNA
,
CRISPR RNA
PAM
,
Protospacer adjacent motif
SARS-CoV-2
,
Severe acute respiratory syndrome coronavirus 2
RPA
,
Recombinase polymerase amplification
PFS
,
Protospacer flanking site
LAMP
,
Loop-mediated isothermal amplification
NASBA
,
Nucleic acid sequence-based amplification
DETECTR
,
DNA endonuclease-targeted CRISPR trans reporter
SHERLOCK
,
Specific high-sensitivity enzymatic reporter unlocking
LFA
,
Lateral-flow assay
LOB
,
Limit of blank
LOQ
,
Limit of quantification
CV
,
Coefficient of variation
SNP
,
Single-nucleotide polymorphism
RAA
,
Recombinase-aided amplification
NIST
,
National Institute of Standards and Technology
FDA
,
U.S. Food and Drug Administration
CE-IVD
,
CE marking for in vitro diagnostics
IVDR
,
In Vitro Diagnostic Regulation
ISO
,
International Organization for Standardization
EUA
,
Emergency Use Authorization
CLIA
,
Clinical Laboratory Improvement Amendments
Journal
IF:
5.1
Papers:
1.8W
Citations:
3.7W
Organization
Cited Papers