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Multi-platform Performance Validation of NRM411-S7 CLIA Analyzer and Clinical Application for Whole Blood Specimens

Performance Verification of Multi-platform NRM411-S7 Fully Automated Chemiluminescence Immunoassay Analyzer and Its Clinical Application in Whole Blood Detection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128938
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-07-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

none

Interventions

Observation group:none

Sponsors

Yancheng First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with at least one prior test result of CRP, SAA, NT-proBNP, HBP, cTnI, ST2, MYO, CK-MB performed in our hospital. 2. Qualified retained EDTA-K2 anticoagulated whole blood specimens and matched serum specimens available. 3. Complete and retrievable patient clinical information and test records;

Exclusion criteria

Exclusion criteria: 1. Specimens show hemolysis, lipemia, icterus or other conditions interfering with test results. 2. Improper storage, expired retention (whole blood not tested on the collection day;frozen plasma stored over 3 months) or insufficient specimen volume for retesting. 3. Incomplete or missing patient clinical data and historical test records;

Design outcomes

Primary

MeasureTime frame
Test result correlation (Pearson r / R2);Kappa consistency coefficient;Positive and negative match rate;Sensitivity and specificity;Linear regression equation (Y = bX + a);

Secondary

MeasureTime frame
Accuracy;Precision (within-batch, overall CV);linear range;

Countries

China

Contacts

Public ContactShao keke

Yancheng First People's Hospital

shaokeke@ycsyy.com+86 515 6669 6923

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026