IGFBP-1 Rapid Test Device

IGFBP-1 means insulin-like growth factor-binding protein 1. It is one of the binding proteins involved in the insulin-like growth factor system. In obstetric testing, IGFBP-1 is important because it is present in high levels in amniotic fluid and can be detected in vaginal secretions when membranes rupture. For this reason, the IGFBP-1 Rapid Test Device (Vaginal Secretion) is used as an aid in detecting ROM/PROM, especially when clinical symptoms are unclear.

The IGFBP-1 Rapid Test Device by LARKSOIS Pharma is intended for the qualitative detection of IGFBP-1 in vaginal secretion samples during pregnancy. It is used as a rapid screening aid for suspected rupture of fetal membranes.

Applications

• Suspected rupture of fetal membranes
• PROM and PPROM assessment support
• Obstetric emergency evaluation
• Maternity hospital testing
• Labor and delivery units
• Gynecology and pregnancy-care clinics
• Diagnostic laboratory support
• International maternal-care product supply

The IGFBP-1 Rapid Test Device uses the colloidal gold immunochromatographic method. In this method, labeled antibodies react with IGFBP-1 in the vaginal secretion sample. If IGFBP-1 is present at or above the test cut-off, a visible test line appears along with the control line.

Benefits

• Fast visual result
• Simple device format
• No complex instrument required
• Suitable for point-of-care obstetric testing
• Easy sample workflow
• Useful in emergency and maternity settings
• Practical for international healthcare distribution

The correct specimen for the IGFBP-1 Rapid Test Device is vaginal secretion or cervicovaginal secretion. Similar commercial IGFBP-1 rapid tests list vaginal discharge as the specimen and describe the test as intended for professional use in pregnant women.

Guidance

• Collect vaginal secretion using the recommended sterile swab
• Follow the official product insert carefully
• Avoid lubricants, antiseptics, or contaminated samples unless allowed by IFU
• Test should be performed by trained healthcare professionals
• Read results only within the approved time window
• Do not use urine unless the validated product insert specifically allows it

Note

For website and catalog accuracy, LARKSOIS Pharma should list this product as Vaginal Secretion, not urine.

The IGFBP-1 Rapid Test Device by LARKSOIS Pharma has a stated 25 ng/ml cut-off. This means the product is designed to detect IGFBP-1 at or above the validated detection threshold. The final product page, insert, and packaging should mention the cut-off exactly as confirmed by LARKSOIS Pharma’s technical file and regulatory documentation.

Steps

• Bring the test device and collected sample to the recommended testing condition
• Open the sealed pouch only when ready to test
• Collect vaginal secretion using the recommended sterile swab
• Prepare the sample according to the product IFU
• Apply the prepared sample to the test device according to instructions
• Wait for the colored lines to appear
• Read the result within the approved time window

Note

The exact procedure must follow the official LARKSOIS Pharma product insert or IFU supplied with the IGFBP-1 Rapid Test Device.

Positive

A positive result means IGFBP-1 has been detected in the vaginal secretion sample. This may suggest leakage of amniotic fluid and possible rupture of fetal membranes. The result should be reviewed by a healthcare professional.

Negative

A negative result means IGFBP-1 is not detected or is below the test cut-off. This may support intact membranes, but clinical judgment is still required if symptoms continue.

Invalid

If the control line does not appear, the result is invalid. The test should be repeated with a new device and fresh sample according to the IFU.

• PROM diagnosis is sometimes difficult because symptoms may look similar to normal vaginal discharge, urine leakage, or cervical mucus. This creates the need for objective testing in professional maternal-care settings.
• The IGFBP-1 Rapid Test Device can help healthcare professionals make faster decisions in suspected PROM cases. Early and accurate detection may support proper monitoring, infection prevention planning, fetal assessment, and appropriate obstetric care.
• The test is designed to support clinical evaluation and should always be interpreted together with patient history, gestational age, symptoms, physical examination, and professional medical judgment.

Instructions

• Store in a clean and dry place
• Keep away from direct sunlight
• Do not freeze unless stated on the label
• Keep the pouch sealed until use
• Do not use damaged or expired devices
• Use only within the recommended temperature range
• Dispose of used materials according to local medical waste rules

Instructions

• For professional diagnostic use only
• Use vaginal secretion or cervicovaginal secretion samples only
• Do not use urine unless specifically validated by the product IFU
• Do not reuse the test device
• Do not use expired or damaged devices
• Clinical decisions should not rely only on the test result
• Results should be interpreted by trained healthcare professionals with clinical findings
• Follow local pregnancy-care and obstetric diagnostic guidelines

LARKSOIS Pharma provides diagnostic products for international healthcare markets with a focus on quality, usability, and professional product positioning. The IGFBP-1 Rapid Test Device (Vaginal Secretion) is designed for maternal-care settings where fast and reliable screening support is required.

Advantages

• Vaginal secretion-based PROM assessment support
• Colloidal gold rapid test method
• 25 ng/ml cut-off
• Simple device format
• Rapid visual interpretation
• Suitable for maternity hospitals and obstetric clinics
• International diagnostic product positioning
• Professional healthcare use under LARKSOIS Pharma