- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07921992
Clinical Application Research of the Fully Automatic Biochemical System
By applying the fully automatic biochemical analysis system, samples such as serum, plasma, urine or other body fluids are tested. The test results are compared with clinical diagnoses or those of other analytical instruments produced by established manufacturers to evaluate indicators such as the accuracy, precision and correlation of the analyzer. Additionally, the differences in the same-source samples are analyzed and studied.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
No restrictions on audience
Beskrivelse
Inclusion Criteria:
- During the research period, in accordance with the clinical application research plan of the fully automated sample processing system, the remaining clinical test samples that met the test results or corresponding clinical diagnoses were selected, including but not limited to serum, plasma, urine, etc. Approximately 2,900 samples that met the inclusion criteria for collection were provided, along with the test data and sample traceability information.
Exclusion Criteria:
- (1) Samples that do not meet the inclusion criteria; (2) Samples with unclear clinical diagnosis; (3) Test samples that are severely hemolyzed, deteriorated, contain chylous blood, or are significantly contaminated by microorganisms, etc., which do not meet the requirements.
Exclusion criteria
- Sample results of those that do not meet the inclusion criteria or those that meet the exclusion criteria but still underwent testing;
- Samples that did not complete the required tests for the complete trial or had missing data due to sample or instrument operation;
- When the test samples require re-testing due to human error, instrument failure, sample addition failure, etc., the re-tested results shall be taken as the standard, and the reasons for re-testing shall be recorded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
sensitivity
Tidsramme: 2026.11.01-2030.12.30
|
2026.11.01-2030.12.30
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NanjingFirst-LAB-03
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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