PartoSure^®

Assess the Risk of Preterm Birth

Introduction
Instruction
How it works

The PartoSure^® Test is a qualitative immunochromatographic assay that allows clinicians to accurately identify whether preterm delivery will occur within 7 days or after 7 or 14 days. Unlike other tests currently on the market PartoSure^® offers the following combination:

Very high positive predictive value.
Excellent negative predictive value.
Reliable results within minutes.
Wide gestational age range.
With or without speculum exam.

The PartoSure^® TTD Test is a rapid bedside test that aids in the prediction of time to delivery. The test is indicated for patients presenting at 20 to 36 6/7 weeks gestational age with:

Signs, symptoms, or complaints suggestive preterm labour.
Clinically intact membranes.

The very high positive predictive value (PPV) of the PartoSure^® Test enables clinicians to more confidently assess the risk of delivery within 7 days, providing the opportunity for the appropriate administration of corticosteroids and/or tocolytics.

The excellent negative predictive value (NPV) of the PartoSure^® Test enables clinicians to more confidently rule out delivery within 7 or 14 days, thus avoiding unnecessary interventions or hospital admissions.

Instruction

When is the use of the PartoSure Test recommended ?

The test is for use by healthcare professionals to aid in identifying women at risk of delivery within 7 or 14 days that

present with signs, symptoms, or complaints suggestive of preterm labour with clinically intact membranes. The PartoSure TTD Test should be used by qualified personnel (physicians, nurses, and midwives) in settings where patients are evaluated for preterm labour.

1 Insert tip of sterile polyester swab into vagina, 5-7cm, for 30 seconds. No speculum exam required.

2 Place swab into vial and rotate in solvent for 30 seconds. Discard swab.

3 Insert white end of test into vial with solvent. Remove after the appearance of 2 lines or after 5 minutes. Do not read after 10 minutes from insertion into vial.

4 Observe and record results. A positive result exists if 2 lines occur. Specify faint or broken line. A negative result occurs if 1 line is present. If no lines appear the test is invalid.

Reading the Results

Positive result

Important Notice: Faint or broken line should always be read as positive.

Negative result

Invalid result

How it works

The PartoSure™ TTD Test detects placental alpha-microglobulin-1 (PAMG-1), a protein found in very high concentrations in amniotic fluid and in very low concentrations in normal vaginal discharge. Recent clinical studies have demonstrated a strong correlation between a positive PAMG-1 test and imminent delivery in those patients presenting with threatened preterm labour and clinically intact membranes.

Lee, Romero et al. postulated two possible explanations for the presence of PAMG-1 in cases of threatened preterm labour:

Transudation of PAMG-1 through chorioamniotic pores in fetal membranes during uterine contractions.
Degradation of extracellular matrix of fetal membranes due to inflammatory process of labour and/or infection.

Performance

In predicting preterm delivery in patients who present with suspected preterm labour, transvaginal ultrasound (TVU) assessment of endocervical length (CL) has been found to be superior to funneling and digital examination in predicting preterm delivery.7 However, TVU suffers from the subjective discernment of critical cervical length as well as a poor PPV. The PartoSureTTD Test demonstrates a consistently high NPV and PPV in patients presenting with threatened preterm delivery and clinically intact intact membranes.

PartoSure®