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Clinical Trial of Automated Identification and Susceptibility Testing System

Clinical Trial of Automated Identification and Susceptibility Testing System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059336
Enrollment
Unknown
Registered
2022-04-28
Start date
2022-05-08
Completion date
Unknown
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial infection

Interventions

Gold Standard:The reference system is a similar product that has been registered in China and has a good market reputation: Merieux VITEK2 COMPACT, Thermo Fisher YeastOne, Bruker MALDI-TOF MS
Index test:Equipment information to be assessed: (1) Product name: automatic microbial identification drug susceptibility analyzer
(2) Model: AF-600
(3) Working temperature and relative humidity: ambient temperature 15 ? ~ 30 ?, relative humidity: 20 %~80%RH, no condensation
(4) Manufacturer: Hunan Mindray Medical Technology Co., Ltd.

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The samples tested in this test are clinical strains that have been identified and tested by the microbiology laboratory; 2. The collection and processing of samples must meet the requirements of the instructions, the samples and processing must meet the requirements of the instructions, and the relevant information of the samples is complete, including age, gender, sample collection date, clinical diagnosis, etc.

Exclusion criteria

Exclusion criteria: 1. Samples with human error in the test and quality problems in the reagents.

Design outcomes

Primary

MeasureTime frame
Identification accuracy and susceptibility accuracy;

Countries

China

Contacts

Public ContactXie Yi

West China Hospital, Sichuan University

Xie_yi_77@163.com+86 18980605782

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026