Finecare™ hs-CRP Control Set – Quality Controls for High-Sensitivity C-Reactive Protein Rapid Tests

The Finecare™ hs-CRP Control Set is a quality control material designed to support routine quality assurance, performance verification, and calibration monitoring of the Finecare™ hs-CRP Rapid Test used with the Finecare™ FIA immunofluorescence analyzer.

This control set typically includes two control levels that simulate expected target ranges for high-sensitivity C-Reactive Protein (hs-CRP) — helping laboratories and point-of-care testing programs ensure accurate, consistent, and reliable testing performance.

The control set is ideal for daily internal QC, lot verification when new reagent batches arrive, and confirmation of analyzer stability — meeting clinical lab quality standards.

Pack Size & Kit Contents

Pack Size: Typically 2 vials per set

Each Control Set Contains:

• Level 1 Control (Normal/Low) — baseline hs-CRP range

• Level 2 Control (High) — elevated hs-CRP range

• Instructions for Use (IFU)

• Target value & acceptable ranges per control level

⚠️ Actual presentation may vary by supplier — always check label and IFU.

 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

The IFU includes exact numeric target values and “acceptable ranges” for each control level.

 Usage Instructions 

1. Bring control vials to room temperature

2. Mix gently before use

3. Run each level like a patient sample

   • Apply to Finecare™ test strip / cartridge

   • Insert into Finecare™ FIA Reader

4. Compare results to target values and ranges in the IFU

5. Document in the QC log