NICE has assessed 3 biomarker tests (Actim Partus, PartoSure and the Rapid fetal fibronectin 10Q Cassette Kit at thresholds other than 50 nanograms/millilitre [ng/ml]) to help the NHS decide whether to use these products.
NICE said that there is not enough evidence to recommend that these tests can be used routinely in the NHS. Further research is needed on their accuracy and how they affect treatment for the mother and baby.
Diagnosing preterm labour (starting before 37 weeks of pregnancy) in women with intact membranes may include measuring the length of the cervix by transvaginal ultrasound or checking the levels of a substance called a biomarker in cervical secretions. Actim Partus, PartoSure and the Rapid fetal fibronectin 10Q Cassette Kit (at thresholds other than 50 ng/ml) are biomarker tests that are used when transvaginal ultrasound isn’t available or acceptable. The results help healthcare professionals decide whether hospital treatment is needed to delay the birth.
Qualitative fetal fibronectin biomarker testing at a threshold of 50 ng/ml is already recommended in NICE’s guideline on preterm labour and birth and its use is not affected by this guidance.
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