KEY FEATURES:

• Fast Results: Obtain accurate cTnI levels in just 15 minutes, enabling rapid clinical decision-making.
• Easy to Use: Lateral flow format simplifies testing, requiring minimal training for healthcare personnel.
• Point-of-Care Testing: Perform testing conveniently in various healthcare settings without the need for bulky laboratory equipment.

RANGES:

• Working range: 0.1–50.00 ng/mL
• Quantitative, non-subjective results
• Increased sensitivity and broader detection range compared to rapid tests

PRECISION: 

• Intra-lot Precision: Intra-lot precision was determined by testing of cTnI reference materials using 10 test devices from the same lot. CV ≤ 15%.
• Inter-lot Precision: Inter-lot precision was determined by testing of cTnI reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.

ACCURACY:

• cTnI control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY:

• A serial concentration of cTnI reference materials at 0.1–50.00 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.

REAGENTS AND MATERIALS PROVIDED:

1. Individually sealed foil pouches containing:
   a. One test device
   b. One desiccant
2. Detection buffer tubes
3. SD card
4. Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED:

1. Clock or timer
2. Multi-channels FIA Immunofluorescence Analyzer