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Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. However, the current diagnosis of infectious agents mainly depends on culture and molecular testing. Both of the methods either has long turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. However, there is currently no assessment of the diagnostic efficacy of mNGS in children infectious diseases. This study used the DNA extraction and library construction technology developed for children's low volume clinical samples to assess the sensitivity and specificity of mNGS in the diagnosis of infectious diseases, and the treatment outcome based on mNGS test results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mNGS diagnosis | Using mNGS to diagnosis infectious disease of this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | It's only observational study. No interventions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease | Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The sensitivity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods. | From the date of first samples enrolled until the last samples detected, up to 3 years |
| The specificity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease | Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The specificity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods. | From the date of first samples enrolled until the last samples detected, up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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This study mainly focus on the pediatric patients who is suspected of infectious disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhao Zhou, Doctor | Contact | (+86)021-64931003 | zwhchfu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenhao Zhou, Doctor | Children's Hospital of Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201102 | China |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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