Development and Clinical Evaluation of a CRISPR-Based Diagnostic for Rapid Group B Streptococcus Screening

Area of Science:

• Microbiology
• Molecular Diagnostics
• Maternal-Fetal Medicine

Background:

• Vertical transmission of Group B Streptococcus (GBS) is a major cause of neonatal morbidity and mortality.
• Current antenatal screening methods for GBS have limitations due to the intermittent nature of bacterial carriage.

Purpose of the Study:

• To develop and evaluate a rapid, simple-to-use CRISPR-based assay for detecting GBS colonization in pregnant women.
• To assess the diagnostic performance of the CRISPR-GBS assay compared to standard methods.

Main Methods:

• Development of a CRISPR-based diagnostic assay for GBS detection.
• Prospective cohort study of 412 pregnant women and a retrospective validation cohort.
• Comparison of CRISPR-GBS assay performance against culture and PCR-based methods.

Main Results:

• The CRISPR-GBS assay demonstrated high sensitivity for GBS detection.
• The assay offered significantly shorter turnaround times and required less complex instrumentation than PCR.
• Overall diagnostic performance of CRISPR-GBS surpassed that of culture and PCR.

Conclusions:

• The novel CRISPR-GBS assay is a highly sensitive and rapid diagnostic tool.
• This assay shows potential for improved point-of-care GBS screening during pregnancy.
• CRISPR-GBS offers a promising alternative to current GBS screening strategies, potentially reducing neonatal complications.