Clinical Application Research Plan for Fully Automated Sample Processing System
By utilizing the fully automated sample processing system from Xiamen U-Medical Instruments Co., Ltd. (compatible with the Wan200+/Wan600+ fully automatic chemiluminescent immunoassay systems and the Wan BC2800 fully automatic biochemical analyzer), serum, plasma, urine, or other bodily fluid samples are processed automatically throughout the entire workflow, covering pre-analytical, analytical, and post-analytical stages.
A systematic evaluation is conducted on the system's functional performance, user satisfaction, ease of operation, and stability during use.
Key performance indicators such as turnaround time (TAT) and sample throughput are assessed through node monitoring and recording across the entire sample processing workflow.
Statistical analysis is performed on the system's failure rate, maintenance requirements, and emergency response capabilities under continuous operation conditions.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
No restrictions on audience
Beskrivning
Inclusion Criteria:
- During the research period, according to the clinical application research plan of the fully automated sample processing system, the remaining clinical test samples that match the test results or corresponding clinical diagnoses were selected, including but not limited to serum, plasma, urine, etc.
Exclusion Criteria:
-
Exclusion Criteria
- Samples that do not meet the inclusion criteria;
- Samples with unclear clinical diagnosis;
- Test samples that are severely hemolyzed, deteriorated, contain chylous blood, or are significantly contaminated by microorganisms, etc., and do not meet the requirements.
Removal Criteria
- Sample results that do not meet the inclusion criteria or for which exclusion criteria were met but testing was still conducted;
- Samples that did not complete the required tests for the complete trial or had missing data due to sample or instrument operation;
- When 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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Evaluate the sample turnaround time
Tidsram: 202611.01-2030.12.31
|
202611.01-2030.12.31
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NanjingFirst-LAB-02
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