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Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion

Conditions
Infectious Disease Screening
Interventions
Diagnostic Test: infectious disease screening
Registration Number
NCT04471688
Lead Sponsor
The Third Xiangya Hospital of Central South University
Brief Summary

In the past ten years, nucleic acid detection technology has overcome the limitations of serological detection, reduced missed detections due to window period, occult infection, etc., and its application in the field of pathogen detection has developed rapidly. Since 2015, domestic blood collection and supply institutions have fully popularized nucleic acid testing. The safety screening of blood sources mostly adopts the method of combining two times of enzyme-free negative and one time of nucleic acid testing, which excludes the guarantee of blood safety to the greatest extent.

At present, the clinical pre-transfusion and pre-operative infectious disease screening in our country is still serological detection. The use of nucleic acid detection for infectious disease screening can better realize the significance of patients' pre-transfusion/pre-operative infectious disease screening. Therefore, this study will analyze the nucleic acid detection technology and clinical serological detection technology in order to solve three problems:

* Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening; ② Explore the confirmation process of the gray area results of infectious disease serological testing; ③ Better realize the significance of screening for patients' infectious diseases.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
10000
Inclusion Criteria
  • hosipital patients
Exclusion Criteria
  • No

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
patientsinfectious disease screeningPreoperative patients needing transfusions
Primary Outcome Measures
NameTimeMethod
Hepatitis C Infection Analysis result20190601-20201231

Nucleic acid examination and serological test

HIV Infection Analysis result20190601-20201231

Nucleic acid examination and serological test

Hepatitis B Infection Analysis result20190601-20201231

Nucleic acid examination and serological test

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

the Third Xiangya Hospital of Central South University

🇨🇳

Changsha, Hunan, China

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