Abstract
Vertical transmission of group B Streptococcus (GBS) is among the leading causes of neonatal illness and death. Colonization with GBS usually is screened weeks before delivery during pregnancy, on the basis of which preventive measures, such as antibiotic prophylaxis, were taken. However, the accuracy of such an antenatal screening strategy has been questionable because of the intermittent nature of GBS carriage. We developed a simple-to-use, rapid, CRISPR-based assay for GBS detection. We conducted studies in a prospective cohort of 412 pregnant women and a retrospective validation cohort to evaluate its diagnostic performance. We demonstrated that CRISPR-GBS is highly sensitive and offered shorter turnaround times and lower instrument demands than PCR-based assays. This novel GBS test exhibited an overall improved diagnostic performance over culture and PCR-based assays and represents a novel diagnostic for potential rapid, point-of-care GBS screening.
Highlights
Vertical transmission of group B Streptococcus (GBS) is among the leading causes of neonatal illness and death
To address the unmet clinical needs for GBS screening, we developed CRISPR-GBS, a novel CRISPR/Cas13-based in vitro diagnostic assay, and conducted a prospective cohort study and a validation study in >400 clinical cases to evaluate its diagnostic performance among different technology platforms, including culture and PCR-based methods
Our findings demonstrate that CRISPR-GBS is rapid and easy
Summary
Vertical transmission of group B Streptococcus (GBS) is among the leading causes of neonatal illness and death. Colonization with GBS usually is screened weeks before delivery during pregnancy, on the basis of which preventive measures, such as antibiotic prophylaxis, were taken. We demonstrated that CRISPR-GBS is highly sensitive and offered shorter turnaround times and lower instrument demands than PCRbased assays. This novel GBS test exhibited an overall improved diagnostic performance over culture and PCRbased assays and represents a novel diagnostic for potential rapid, point-of-care GBS screening. Author affiliations: Zhujiang Hospital, Southern Medical University, Guangzhou, China As many studies have pointed out, the predictive value of GBS decreases as the interval time increases between screening and delivery [10,11] These studies underlie the needs for a more rapid and sensitive diagnostic for intrapartum GBS screening. The collateral, promiscuous cleavage activities of a unique group of Cas enzymes were discovered and harnessed for in vitro nucleic acid detection [15,16,17]
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