TODA AMNIODIAG 5 CASSETTE

Overview

TODA AMNIODIAG® 5 Cassette is a rapid immunochromatographic test designed for the detection of IGFBP-1 (Insulin-Like Growth Factor Binding Protein 1) in vaginal secretions — a key marker that indicates premature rupture of fetal membranes (PROM).

Accurate identification of PROM is crucial in protecting maternal and fetal health. This easy-to-use test delivers highly reliable results within 5 minutes, allowing clinicians to make timely and informed decisions that prevent complications and ensure safer outcomes.

How It Works

The fetal membranes act as a protective layer during pregnancy. When these membranes rupture prematurely, the fetus is exposed to infection risks and potential preterm delivery.

TODA AMNIODIAG® 5 Cassette detects IGFBP-1, a protein normally found in amniotic fluid, through an immunochromatographic method that uses highly specific monoclonal antibodies. Its visual readout provides clear confirmation or exclusion of PROM, supporting confident clinical decisions at the point of care.

This rapid diagnostic method enables healthcare professionals to:

• Confirm or rule out membrane rupture quickly
• Avoid unnecessary hospitalizations or treatments
• Identify risk of infection, including Group B Streptococcus
• Take early action to protect both mother and baby.

Key Features

• Fast results – interpretation in 5 minutes
• High accuracy – Sensitivity 99%, Specificity 99.9%
• Simple 3-step process 
• Minimal sample required – vaginal secretions only
• Barcode and reader compatible for traceability
• Clinically validated and widely trusted by obstetric professionals

Test Procedure

1. Collect sample: Take a vaginal swab, immerse it in the vial, and rotate rapidly for 10 seconds. Remove the swab.
2. Prepare test: Open the foil pouch, retrieve the cassette, and place three drops of the prepared sample into the test well.
3. Read results: Wait 5 minutes before interpretation.
   • Negative: One line appears at control zone (C)
   • Positive: Two lines appear – control (C) + test line
   • Invalid: No control line appears (repeat with a new cassette)

A positive line may appear as early as the first minute. Results should not be read after 15 minutes.

Learn more from the official source: Toda Pharma – TODA AMNIODIAG® 5 Cassette

Kit Details

Kit Reference: 1050-10 (10-Test Kit)
Includes:

• 10 cassette tests
• 10 vials of diluent
• 10 sterile swabs
• Detailed usage instructions

Also available: Single-test format (Reference 1050-1)

Summary

TODA AMNIODIAG® 5 Cassette provides a fast, accurate, and practical solution for diagnosing premature rupture of membranes. Designed for modern maternity care, it helps healthcare professionals make confident, on-the-spot decisions that promote safer pregnancies and healthier beginnings.