TODA FFN DIAG

Overview

TODA fFN DIAG® is a cassette-based rapid test used for the early detection of threatened preterm labor (TPL) in pregnant women.

The test identifies Fetal Fibronectin (fFN), a protein found in cervico-vaginal secretions, using highly specific monoclonal antibodies. Detection of fFN provides valuable insight into the risk of premature birth and helps clinicians take timely preventive measures to protect both mother and child.

With a simple three-step process and results available in just 10 minutes, TODA fFN DIAG® offers an efficient and reliable solution for early pregnancy risk screening.

How It Works

Fetal Fibronectin (fFN) acts as a biological “glue” that helps maintain the attachment of the fetal sac to the uterine lining.
When this protein is detected in vaginal secretions during pregnancy, it may indicate that the body is preparing for early labor.

The TODA fFN DIAG® test uses an immunochromatographic method to detect fFN, providing a high negative predictive value (96–99% assurance that labor will not occur within 14 days*). This allows clinicians to avoid unnecessary hospital admissions and provide focused care where truly needed.

Key Features

• Quick results – interpretation in 10 minutes
• Easy to perform – just 3 simple steps
• High accuracy and reliability
  • Sensitivity: 99%
  • Specificity: 99.9%
• Excellent negative predictive value
• Convenient cassette format supplied in individual boxes
• Sample type: Cervico-vaginal secretions

Test Procedure

1. Collect sample: Take a vaginal swab and immerse it in the provided vial. Rotate rapidly for 10 seconds and remove the swab.
2. Prepare test: Open the foil pouch, place three drops of the extracted sample into the cassette well.
3. Read results: Wait 10 minutes for the final reading.
   • A positive line may appear as early as the first minute.
   • Ignore any line appearing after 15 minutes.

Interpretation of Results

• Negative: Only one colored line appears in the control zone (C).
• Positive: Two colored lines appear – one in the control zone (C) and one in the test zone.
• Invalid: No control line appears, or only the test line appears. Repeat the test with a new cassette.

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Kit Contents

Kit Reference: 1053-10 (10-Test Kit)

• 10 cassette-format tests
• 10 vials of diluent
• 10 flocked swabs
• Detailed usage instructions

Also available: Single-test format (Reference 1053-1)

Why Choose TODA fFN DIAG®

• Provides rapid, evidence-based insights into preterm labor risk
• Helps optimize patient management and reduce unnecessary hospitalization
• Designed for ease of use in clinical and maternity settings
• Ensures accurate and reproducible results with minimal training