NCT04535505

Pathogenic Bordetella Rapid Detection

Establishment a Nucleic Acid Rapid Detection Technology Platform for Detecting Pathogenic Bordetella and Its Drug Resistance Genes

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A CPA platform based on the CRISPR technology is going to established to achieve the goal of detecting pathogenic bordetella and drug resistance genes in one step. The accuracy of this platform will be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be set as a gold standard method.

Detailed description

Pertussis is an acute respiratory infectious disease caused by bordetella pertussis. Although it is a vaccine-preventable disease, outbreaks and epidemic cases of whooping cough worldwide have been reported from time to time. Bordella parapertussis, Bodella bronchiseptica, and bordetella hosei can cause pertussis-like diseases with symptoms similar to those of whooping cough. The clinical manifestations are difficult to distinguish, and they are easily reported as cases of whooping cough through the infectious disease network. The diagnosis of the infectious diseases caused by the four pathogenic bodella mainly relies on laboratory pathogenic testing. At present, the laboratory tests of bordetella that can be carried out in the clinical microbiology laboratory include culture, bordetella pertussis specific antibody (PT-IgG) serological detection, and bordetella pertussis nucleic acid PCR detection. However, none of them meet the requirements of early diagnosis. Cross primer constant temperature amplification (CPA) is nucleic acid constant temperature amplification technology with independent property rights. The fully automated nucleic acid detection platform equipped with CPA technology would make the detection of four pathogenic bordetella easy, quick and safe and accurate. As pathogenic bodella is difficult to cultivate and there is no standard for drug susceptibility test. Studies have shown that 57.4% of the isolated clinical isolates of bordetella pertussis have MIC value for erthomycin ≥256 μg/mL , and 23s rRNA 2047 site adenine (A) were mutated to guanine (G).CRISPR/Cas is an immune system in bacteria that can specifically recognize invading nucleic acids and shear them. The CRISPR technology developed based on the CRISPR/Cas principle can detect single point mutations in genes. The hypothesis that 4 pathogenic bordetella and their erythromycin resistance would be detected in one testing platform simultaneously. The accuracy, reliability, predictive value of this platform would be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be as the gold standard method.

Conditions

• Pertussis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology	This is an observational study and there are no interventions. The purpose of the study is to compare the accuracy （including sensitivity and specificity）of the new CPA platform based on CRISPR technology detection method and the gold standard in detecting pertussis patients.

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2020-09-02
• Last updated: 2022-09-14

Locations

1 site across 1 country: China