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Laboratory Testing for the Assessment of Preterm Delivery AACC Guidance Document on Laboratory Testing for the Assessment of Preterm Delivery AUTHORS Christopher W. Farnsworth, PhD, FAACC Alison Woodworth, PhD, DABCC, FAACC E. Rebecca Pschirrer. MD, MPH Assistant Professor of Pathology & Immunology Professor, Pathology & Laboratory Medicine Associate Professor of Obstetrics Medical Director of Clinical Chemistry Director, Core Clinical Laboratory and Gynecology and Radiology and Point of Care Testing & Point of Care Testing The Geisel School of Medicine at Dartmouth Washington University School of Medicine University of Kentucky Medical Center Hanover, NH St. Louis, MO Lexington, KY Director, Prenatal Diagnosis Program Dartmouth-Hitchcock Medical Center Erin E. Schuler, PhD Joely A. Straseski, PhD, MT(ASCP), Lebanon, NH Assistant Professor DABCC, FAACC University of Kentucky Section Chief, Clinical Chemistry Rob Nerenz, PhD, DABCC (Chair) Lexington, KY Medical Director, Endocrinology and Assistant Professor of Pathology Automated Core Laboratories and Laboratory Medicine ARUP Laboratories The Geisel School of Medicine at Dartmouth Associate Professor, Department of Pathology Hanover, NH University of Utah School of Medicine Assistant Director of Clinical Chemistry Salt Lake City, UT Dartmouth-Hitchcock Medical Center Lebanon, NH TABLE OF CONTENTS Introduction . 2 What is the pre-test probability of preterm birth in the United States and what assay performance characteristics are required to demonstrate clinical benefit? . 3 What is Fetal Fibronectin (fFN)? . 3 What are the performance characteristics of fFN in women with symptoms of preterm labor? . 3 Does fFN impact clinical outcomes in symptomatic women? . 4 What are the performance characteristics of fFN in asymptomatic women? . 4 Do tiered cutoffs improve diagnostic performance? . .. 4 Are there any trends in the number of laboratories performing fFN testing? . 4 What is Il-6? . 5 What are the performance characteristics of Il-6 in the prediction of PTB? . 5 How does Il-6 compare to fFN?? . 5 CITATION Farnsworth CW, Schuler EE, Woodworth A, Straseski JA, Pschirrer ER, Nerenz R . AACC guidance document on laboratory testing for the assessment of preterm deliver . [Epub] J Appl Lab Med June 2, 2021, as doi:10 .1093/Jalm/Jfab039 . What is PAMG-1? . 6 What are the performance characteristics of PAMG-1 in the prediction of PTB in populations with rates of PTB <5% and how does it compare to fFN? . 6 What are the performance characteristics of PAMG-1 in the prediction of PTB when initial screening increases the rate of PTB in the population undergoing testing? . 7 Is there value in combining multiple biomarkers? . .. 7 Do other professional societies recommend the use of biomarkers in the evaluation of preterm labor? . 7 Conclusion . .. 7 References . .. 8 INTRODUCTION assisted reproductive technologies, a known risk factor for Spontaneous preterm birth (PTB) is a delivery of an infant prior to 37 weeks gestation as a result of preterm labor, preterm in preterm birth has also increased in recent years, indicating premature rupture of membranes (PPROM), and/or cervical otherPTB. However,causes for the the number increased of ratesingleton of PTB, pregnancies including increasing resulting contributors to perinatal mortality and morbidity, and it is the secondinsufficiency. most commonPrematurity cause and of infantits complications death in the Unitedare primary States maternal age (5, 6). Furthermore, there is a noticeable racial disparity in the prevalence of PTB in the USA, as approximately greater risk of low birth weight, respiratory distress syndrome, 14.1% of black infants, 11.3% of American Indian/Alaska Native, underdeveloped(1). Additionally, prematureorgans, neurodevelopmentalbirth places surviving disabilities, infants at differences9.7% of Hispanic, in socioeconomic and 9.1% of status white or infants maternal are bornbehavior preterm and cognitive impairment, visual and hearing impairments, several(5). Importantly, studies have these implicated differences certain cannot genetic be fully variants explained as risk by developmental coordination disorders, and behavioral and normal parturition are not fully elucidated, there are several life and emotional stress caused by these long-term health proposedfactors for etiologiesPTB (7, 8). leading While theto precisepremature mechanisms delivery, leadingincluding to emotional difficulties (2). In addition to decreased quality of complications, they also impose a significant financial burden. maternal or fetal stress, inflammation, decidual hemorrhage, A 2005 Institute of Medicine report estimated the overall cost toand/or allow pathological selective uterineinitiation distension of appropriate (9). therapy, while of PTB in the United States at $26 billion annually and this preventingIdentification unnecessary of women treatment who will of womendeliver whopreterm will deliveris critical at number remained essentially unchanged in 2018 (3, 4). This lifetimefigure included medical/special the cost ofeducation early intervention costs and lost and productivity delivery, direct for fetal lung maturation improves outcomes among infants who medical care of preterm infants up to 5 years of age, as well as areterm. born Administration preterm, while of antenatalantenatal corticosteroids magnesium sulfate to accelerate is often administered to improve neurologic outcome, and tocolytics are those with specific developmental disabilities associated with used to prolong the time to delivery when clinically appropriate PTB. The premature birth rate in the US rose to 10.0% in 2018, prematurely is inherently challenging, even in those with which was a modest increase relative to the 9.9% rate observed (10-12). However, identifying individuals at risk of delivering in 2017 (4). The rate of PTB had been declining until 2014 history of previous preterm delivery, which increases the risk of a (9.6%), but has risen steadily since that time, despite efforts by symptoms of preterm labor. The single best predictor is a personal the Marchrate of of PTB Dimes, have the been Healthy hindered People by 2020 a limited initiative, understanding and other risk factors related to maternal age, social behavior, medical ofprominent the underlying organizations. mechanisms, These aprograms lack of therapeuticaimed at reducing options history,subsequent and pretermsocioeconomic delivery status by 2.5-fold have been (13). described, A number but of othernone that directly target these pathways, and an inability to identify majority of the increased PTB rate has been due to late PTBs, of them reliably identifies individual women who will give birth which women will weeks, benefit while from the therapeutic rate of early intervention. PTB (less thanThe labor,prematurely including (14). uterine One of contractions, the challenges pelvic of assessing pressure, risk backache, for PTB 0/7 6/7 is the ubiquitous nature of signs associated with the onset of be34 due until in part36 to an increase in multi-fetal pregnancies from and are common among pregnant women who do not deliver 34weeks) has remained essentially unchanged (5). This may or increased vaginal discharge. These signs are nonspecific AACC GUIDANCE DOCUMENT on Laboratory Testing for the Assessment of Preterm Delivery Published in The Journal of Applied Laboratory Medicine, June 2, 2021 ∙ academic.oup.com/jalm 2 contractions, correctly identifying women in preterm labor who prematurely. Even in the presence of cervical change with uterine implantationbiomarkers for and predicting placental-uterine preterm birth attachment (PTB). fFNfor theis a duration440 kDa extracellular membrane glycoprotein that is thought to mediate will ultimately deliver prematurely is difficult. Thirty percent of women in preterm labor (PTL) will have spontaneous resolution, of pregnancy (24, 25). Using an antibody that targets an epitope and 50% of women who have been hospitalized for PTL will go unique to fFN, its presence has been demonstrated in amniotic hason to been deliver considerable at term (15). interest in identifying biomarkers to fluid, placental tissue, and cervicovaginal secretions (25-27). Given the nonspecific nature of clinical symptoms, there concentrationsCervicovaginal influid the (CVF)second fFN and concentrations third trimester, areand highestultimately in multiple etiologies, a number of different biomarkers have been increasingthe first trimester at term of following pregnancy fusion before of fallingmaternal to undetectablemembranes investigatedpredict which in women withwill deliversigns and preterm. symptoms Since of PTBpreterm has around 22 weeks gestation (27). fFN may be measured result,birth. While there isnumerous considerable studies variation have addressed in the incorporation the utility of these using commercially available assays in either qualitative or biomarkersbiomarkers, intonone clinical has demonstrated practice, as definitivewell as a clinicallack of value.consensus As a semiquantitative lateral flow assay formats weeks(26, 28).gestation The withqualitative signs deviceand symptoms is FDA cleared of pre-term 0/7for use labor,in6/7 CVF intact samples amniotic from guidance document describes the currently available biomarkers women who present between24 and 34 ofamong PTB, professional summarizes societies the literature regarding evaluating their utility their (16, diagnostic 17). This weeks gestation performance characteristics, and provides recommendations for membranes, and cervical dilation <30/7 cm. It is6/7 also approved for
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