Key Features & Benefits
✔ Designed specifically for Finecare™ hs-CRP assays
✔ Dual-level controls simulate low and high hs-CRP performance
✔ Ensures test precision and accuracy
✔ Detects analytical drift or errors in testing systems
✔ Supports laboratory quality assurance protocols
✔ Easy to use with Finecare™ FIA Reader
✔ For **in-vitro diagnostic (IVD) use only
Purpose of hs-CRP Controls
Quality controls are used to:
- Verify assay performance daily
- Confirm consistent responses across test lots
- Detect instrument or reagent issues
- Maintain accreditation standards
- Provide documented QC records for audits
Typical Control Levels
| Control Level | Typical Target Range | Clinical Context |
|---|---|---|
| Level 1 (Low) | Normal hs-CRP range | Confirms baseline performance |
| Level 2 (High) | Elevated hs-CRP range | Verifies detection of inflammation |
The IFU includes exact numeric target values and “acceptable ranges” for each control level.
Usage Instructions
- Bring control vials to room temperature
- Mix gently before use
- Run each level like a patient sample
- Apply to Finecare™ test strip / cartridge
- Insert into Finecare™ FIA Reader
- Compare results to target values and ranges in the IFU
- Document in the QC log
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