Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product

Becton, Dickinson and Company394 enrolled

Overview

This study is a multi-center, randomized clinical validation. Subjects should be fully informed of this protocol and related risks, and can only be enrolled into this study after signing the informed consent form. Blood collection of the subjects at the same puncture point at a single site will be injected into the test vial and the control vial respectively, and the vials will be transferred to the BACTEC system for culture and the results will be observed. After the BACTEC system incubation completion, the vials will be subcultured. Strains grown on plates will be identified using appropriate methods and, if possible, at the species level.

Study Type

OBSERVATIONAL

Enrollment

394

Conditions

Sepsis

Interventions

test Aerobic/F Culture VialsDIAGNOSTIC_TEST

an additional blood sample will be collected compared to clinical routine of blood culture, inoculated into the test culture vial, and compared with the blood culture results of the control vial collected from the same site and the same puncture point

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is willing to provide written informed consent to sponsor. * Blood specimens * Patients with suspected blood infection that have one or more of the following characteristics : a) Body temperature \> 38°C or body temperature \<36°C; b) chills; c) increased peripheral blood leukocyte count (count \> 10.0×109/L, especially if there is a "left shift") or decrease (count \< 3.0×109/L); d) Respiratory rate \> 20 beats/min or arterial partial pressure of carbon dioxide (PaCO2) \<32mmHg; e) Heart rate\> 90 beats/min; f) mucocutaneous hemorrhage; g) coma; h) Multi-organ dysfunction; i) decreased blood pressure; j) Elevated inflammatory response parameters such as C-reactive protein or hypersensitive C-reactive protein, procalcitonin (PCT), 1,3-β-D-glucan (G test), etc. Exclusion Criteria: * Subjects have been enrolled in this study and samples have been collected * Patients with severe and very severe anemia (last hemoglobin \<60g/L within seven days) * Females with known pregnancy

Outcomes

Primary Outcomes

consistency rate

The consistency rate of the test vials and the control vials BACTEC™ system test results, including the overall consistency rate, positive consistency rate, and negative consistency rate

Time frame: 8 days