fFN Rapid Test Device

Fetal fibronectin, commonly known as fFN, is a protein that acts like a biological adhesive during pregnancy. It helps support the attachment between the amniotic sac and the lining of the uterus. When fetal fibronectin is detected in vaginal fluid during certain pregnancy stages, it may indicate a higher risk of preterm labor. However, the fFN rapid test device should not be used as the only basis for diagnosis. The result must be interpreted together with clinical symptoms, gestational age, cervical assessment, medical history, ultrasound findings, and the healthcare provider’s judgment.

The fFN rapid test device (vaginal secretion) is intended for the detection of fetal fibronectin in vaginal secretion samples. It is mainly used as a professional screening aid in pregnancy-care evaluation.

Applications

• Obstetric assessment
• Fertility and maternity-care diagnostics
• Preterm labor risk evaluation support
• Hospital gynecology departments
• Maternity clinics
• Women’s health diagnostic laboratories
• Point-of-care screening environments

The fFN rapid test device uses the colloidal gold method, a proven immunochromatographic testing principle widely used in rapid diagnostic devices. In this method, colloidal gold-labeled antibodies react with the target analyte in the specimen. If fetal fibronectin is present at or above the device cut-off, a visible test line may appear according to the product’s instructions for use.

Benefits

• Simple testing procedure
• No complex laboratory equipment required
• Suitable for professional point-of-care settings
• Rapid visual result format
• Easy handling and storage
• Useful for decentralized healthcare environments

The correct specimen for this product should be vaginal secretion or cervicovaginal secretion. The test uses a vaginal fluid sample collected by swab and should be performed by trained healthcare professionals.

Guidance

• Use only the approved collection method mentioned in the product IFU
• Collect the vaginal secretion sample carefully using the recommended swab
• Avoid sample contamination
• Test should be performed by trained healthcare professionals
• Results should be read within the time window stated in the IFU
• Do not use urine unless the product’s validated IFU specifically states urine compatibility

Note

For accurate product labeling, LARKSOIS Pharma should list the specimen as Vaginal Secretion, not urine.

The provided product cut-off is 25 ng/ml. This means the fFN rapid test device is designed to detect fetal fibronectin at or above the stated threshold, based on the manufacturer’s validation and product instructions. LARKSOIS Pharma should clearly mention 25 ng/ml as the product-specific cut-off in the product insert, catalog, and website content.

Instructions

• Professional diagnostic format for women’s health screening
• Vaginal secretion specimen for clinically relevant sample testing
• Colloidal gold method for rapid immunochromatographic detection
• 25 ng/ml cut-off as per product specification
• Simple visual interpretation based on test and control lines
• Suitable for hospitals, clinics, laboratories, and maternity centers
• International product positioning for global diagnostic supply
• Quality-focused manufacturing support from LARKSOIS Pharma

Note

The fFN rapid test device is designed to support medical professionals with quick screening information. It is not a replacement for full clinical evaluation, but it can be a valuable part of a broader diagnostic approach.

• Preterm birth is a major concern in global maternity care. The fFN rapid test device can help healthcare professionals assess the presence of fetal fibronectin in vaginal secretion samples.
• A positive result may indicate increased risk and the need for further monitoring, while a negative result may support clinical reassurance when interpreted correctly.
• A positive fFN result does not guarantee early birth, but it allows providers to monitor the patient more closely and offer necessary treatment when appropriate.

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 swab
• Prepare the sample according to the product IFU
• Apply the prepared sample to the test device according to instructions
• Wait for the control and test lines to appear
• Read the result within the approved reading window

Note

The exact testing procedure must follow the official LARKSOIS Pharma product insert or IFU supplied with the fFN Rapid Test Device.

Positive

Indicates fetal fibronectin may be present in the vaginal secretion sample at or above the stated cut-off.

Negative

Indicates fetal fibronectin is not detected or is below the stated cut-off.

Invalid

If the control line does not appear, the result is invalid and the test should be repeated with a new device.

Instructions

• Store in a dry place
• Keep away from direct sunlight
• Do not freeze unless specifically allowed by the IFU
• Use before expiry date
• Keep sealed until use
• Do not use damaged pouches
• Follow temperature conditions printed on the pack

Note

Proper storage supports test reliability, especially for international distribution where products may pass through different climates and supply-chain conditions.

Instructions

• For professional diagnostic screening support only
• Use vaginal secretion or cervicovaginal secretion samples only
• Do not use urine unless specifically validated by the product IFU
• Do not reuse the device
• Do not use expired or damaged devices
• Do not use as the only basis for diagnosing preterm labor
• Results should be interpreted by trained healthcare professionals with clinical findings
• Follow local pregnancy-care and obstetric diagnostic guidelines

LARKSOIS Pharma focuses on delivering reliable pharmaceutical and diagnostic products for international healthcare markets. The fFN rapid test device reflects LARKSOIS Pharma’s commitment to women’s health, fertility diagnostics, pregnancy-care support, and global-quality medical solutions.

Advantages

• International market-focused product development
• Quality-driven diagnostic portfolio
• Support for hospitals, laboratories, and distributors
• Professional product documentation
• Focus on women’s health and fertility diagnostics
• Scalable supply for global markets