About The Test
FIT Testing
Gastrointestinal conditions can cause occult (hidden) blood in the stool—often one of the earliest signs of disease. In their early stages, issues such as colorectal cancer, ulcers, polyps, colitis, diverticulitis, or fissures may not produce visible symptoms, making reliable screening essential.
The Topaz Insight FIT is a rapid, qualitative immunoassay designed to detect low levels of fecal occult blood. Using a double antibody sandwich method, it can selectively identify human hemoglobin at concentrations as low as 50 ng/mL (or 6 µg hemoglobin/g feces).
Unlike traditional guaiac-based tests, Insight FIT™ requires no dietary restrictions and offers greater sensitivity and specificity, making it a more accurate and convenient tool for early detection and routine screening.
This test is intended for in vitro diagnostic use only.
Results Interpretation
Positive: Two colored lines appear — one at C (Control) and one at T (Test), even if faint. This indicates occult blood is present.
Negative: Only one colored line appears at C (Control). No line appears at T (Test).
Invalid: No line appears at C (Control), regardless of whether a line appears at T (Test). The test is invalid and should be repeated with a new device.
Refer to diagram on left.
Specifications
Sample: Fecal Sample
Format: Cassette
Quantity: 2 kits
Cut-off level: 50ng/mL
Time to Result: 4 minutes
Storage Condition: 8-23°C
Test Principle: Lateral Flow Immunoassay
What’s inside the kit
- 1 Quick Guide
- 1 Insert
- 2 Test Cassettes (each sealed in a foil pouch)
- 2 Sample Collection Tubes
- 2 Collection Papers
How it works
The 3 C's Method: Easy steps for using the TopazFIT kit
1. Collect
Open your kit, review the short instruction card, and prepare the test device. Everything you need is included—no special setup required.
Use the collection wand to take a small stool sample, then apply it to the test device exactly as shown. The process takes just a few moments.
2. Check
Place the test on a flat surface and wait for the result window to develop. Your result appears directly on the device—no shipping, no lab, no delays.
3. Confidence
If your result is positive, we connect you with a live, real human patient navigator. at the Colorectal Cancer Alliance for guidance on next steps.