Diagnostic accuracy of rapid phIGFBP-I assay for predicting preterm labor in symptomatic patients

Objective:To estimate sensitivity, specificity, positive and negative predictive values (PPV, NPV) of insulin-like growth factor binding protein-1 (phIGFBP-1) test in predicting preterm delivery in women with symptoms of preterm labor. Secondary objectives were to compare test characteristics of the phIGFBP-1 and fetal fibronectin (fFN) tests.Study Design:Labor and delivery units in two Calgary hospitals. Subjects were 349 women with suspected labor between 24 and 35 weeks gestational age (GA). Women had cervical phIGFBP-1 test +/− and fFN testing. Sensitivity, specificity, PPV and NPV were estimated. Primary outcome was birth <37 weeks GA.Result:Sensitivity of phIGFBP-1 test for delivery <37 weeks was 0.39; specificity, 0.76; PPV, 0.24; NPV, 0.86. NPV of phIGFBP-1 did not differ greatly from that of fFN testing (0.88).Conclusion:NPV did not differ between phIGFBP-1 and fFN for delivery <37 weeks. Neither test improves on pretest probability of delivery <37 weeks, so clinicians must decide whether the use of either test is justified.