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Pre-term delivery is a serious complication of pregnancy, the Weqas Pre-term Labour Marker programme (PTLM) was launched as a pilot in February 2013, separate samples are distributed for Foetal Fibronectin and phosphorylated IGFBP-1, both markers are accredited to ISO 17043 (UKAS accredited testing laboratory no.4301)
Foetal Fibronectin (fFN)
Foetal Fibronectin (fFN) is not normally present in amniotic fluid between weeks 22-35 of gestation. A positive result indicates an increased risk of pre-term labour and is useful in aiding patient management. The negative predictive value (NPV) of the test at 10ng/ml is quoted as 100%, with a NPV at 50ng/ml of 99.2%. The manufacturers quote a cut-off of >50 ng/ml as a positive result; indicating the likelihood of a preterm birth within the following 14 days.
Two samples are distributed bi-monthly, the material is raw amniotic fluid tested negative for HIVAb, Hep B, Hep C and RPR. The amniotic fluid is prepared in an aqueous buffer for distribution, the qualitative range for fFN is 0 – 350ng/mL, results are interpreted both qualitative and quantitatively.
Phosphorylated IGFBP-1 increases significantly as the cervix matures, two separate samples for phIGFBP-1 are distributed along with the fFN samples.
Samples per set: 2 x 0.5mL fFN samples and 2 x 0.5mL phIGFBP-1 samples.
|Pre Term Labour Markers|
|Analyte||Approx. Range Covered|
|Foetal Fibronectin (fFN)||0 - 320||ng/ml|
|phIGFBP-1 (Actim Partus)||0 - 250||µg/L|
|*IGFBP-1 (Actim Prom)||0 - 250||µg/L|
fFN = Fetal Fibronectin (US)