Infectious Disease Screening Clinical Trial
Official title:
Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion
| Verified date | June 2020 |
| Source | The Third Xiangya Hospital of Central South University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 10000 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 1 Year to 100 Years |
| Eligibility |
Inclusion Criteria: - hosipital patients Exclusion Criteria: - No |
| Country | Name | City | State |
|---|---|---|---|
| China | the Third Xiangya Hospital of Central South University | Changsha | Hunan |
| Lead Sponsor | Collaborator |
|---|---|
| The Third Xiangya Hospital of Central South University | SANSURE BIOTECH INC. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hepatitis B Infection Analysis result | Nucleic acid examination and serological test | 20190601-20201231 | |
| Primary | Hepatitis C Infection Analysis result | Nucleic acid examination and serological test | 20190601-20201231 | |
| Primary | HIV Infection Analysis result | Nucleic acid examination and serological test | 20190601-20201231 |