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Gynecological and maternal health

PartoSure Test

When a patient presents with signs and symptoms of preterm labor, you want accurate and reliable diagnostic tools to help guide next steps. Including PartoSure in your clinical assessment gives you strength in your decision.

Adding confidence to aid complex decisions

Accurately assessing the risk of preterm birth is a difficult diagnosis with significant implications for mother and baby. Clinical evaluation alone is limited in its ability to predict imminent delivery among patients with signs of threatened preterm labor (PTL).

Common biomarker tests have similarly shown poor positive predictive values (PPV) for imminent delivery (1). False positives, as indicated by lower PPV, can lead to unnecessary admissions and interventions - heightening concern and raising costs for vulnerable women and families (1).

PartoSure is a rapid, qualitative test to aid in the detection of preterm labor (2), featuring a higher PPV that offers more reliable clinical information to help guide decision making.

Threatened preterm illustration
Weighing the risk

Fortunately, most of the methods used to assess the risk of preterm labor, such as measuring uterine activity and cervical dilation, are relatively accurate at ruling it out. The more looming concern in the maternal medicine community is avoiding false positives - which can result in overtreatment. In fact, 85% of patients admitted for threatened preterm labor do not deliver within 7 days (3).

Unnecessary admissions cost over $20k on average and can place a heavy financial and emotional burden on expectant families (4).

A more accurate assessment is needed

The PartoSure Test is a rapid, qualitative test for detecting the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions in pregnant women with signs and symptoms of early preterm labor (6). The presence of PAMG-1 in these women has shown to be a strong indicator of PTL (2). Using a test with higher positive predictive value, such as PartoSure, may reduce costs by:

  • Decreasing unnecessary admissions and acute interventions
  • Reducing the length of stay of high-risk patients
  • Minimizing unnecessary patient transfers
Pregnant, ROM, women's health
Why PAMG-1?
PAMG-1 is a placental protein found in high concentrations in the amniotic cavity. Due to the low concentration of PAMG-1 in normal vaginal discharge, studies have demonstrated a strong correlation between a positive PAMG-1 test and imminent delivery in patients presenting with threatened PTL and intact membranes (5).
Read the literature

Confidence in your assessment

A prospective US multi-center trial conducted at 15 university and community hospitals compared PartoSure to conventional methods used to assess the risk of spontaneous preterm delivery within 7 days of testing (2).

As shown in the table, the study reported that for the prediction of spontaneous preterm delivery ≥ 7 days, PartoSure had the highest positive predictive value and comparable negative predictive value compared to other methods.

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Test method  PPV  NPV 
PartoSure  23.1  99.5 
Rapid fFN™  4.3  99.6 
Uterine activity (≥4 contractions/hr)  1.5  99.2 
Cervical dilation >1cm and <3cm  11.1  99.4 
Vaginal bleeding (any bleeding)  3.5  99.3 

Simple steps, rapid results

The PartoSure test is a rapid aid in the detection of PTL, completed bedside or in the lab using 4 simple steps.

 Positive: Two lines Negative: One control line   Invalid: No lines or test line only
Imminent delivery within ≤7 days or ≤14 days 
is highly likely		 Imminent delivery within ≤7 days or ≤14 days 
is highly unlikely		 Results not valid; retest
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References
  1. ACOG Committee on Practice Bulletins - Obstetrics. (2016) Management of Preterm Labor. Obstet Gynecol. 127, e29–38.
  2. Wing et al. (2017) Placental Alpha Microglobulin-1 compared with fetal fibronectin to predict preterm delivery in symptomatic women. Obstet Gynecol. 130, 1183–91.
  3. Alfirevic, Z., Allen-Coward, H., Vinuesa, F. (2007) Targeted therapy for threatened preterm labor based on sonographic measurement of the cervical length: a randomized controlled trial. Ultrasound Obstet Gynecol. 29,47–50.
  4. Lucovnik, M., Chambliss, L.R., Garfield, R.E. (2013) Costs of unnecessary admissions and treatments for “threatened preterm labor”. Am J Obstet Gynecol. 209, 271e1-e3.
  5. Lee et al. (2012) The clinical significance of a positive Amnisure test in women with preterm labor and intact membranes. J Matern Fetal Neonatal Med. 25, 1690–8.
  6. PartoSure Test Instructions for Use, QIAGEN, 1108422, Rev. 04, 09/2019. Available at www.qiagen.com.