OBJECTIVE: The purpose of this study was to determine whether quantification of cervicovaginal fluid fetal fibronectin (fFN) improves diagnostic accuracy of spontaneous preterm birth (sPTB) in symptomatic women. STUDY DESIGN: A prospective blinded predefined secondary analysis of a larger study of cervicovaginal fluid fFN concentration (nanograms per milliliter) in women symptomatic of preterm labor (n =300 women; 22-35 weeks' gestation) with a Hologic 10Q system (Hologic, Marlborough, MA). Clinicians were blinded to the result until after the delivery, but the qualitative Hologic TLI(IQ) fFN result was made available. RESULTS: The positive predictive value for sPTB (<34 weeks' gestation) increased from 19%, 32%, 61%, and 75% with increasing thresholds (10, 50, 200, and 500 ng/mL, respectively). Compared with <10 ng/mL fFN, the relative risk of delivery was 5.6 (95% confidence interval [CI], 1.05-29.57), 7.9 (95% CI, 1.38-45.0), 22.8 (95% CI, 3.84-135.5), and 51.3 (95% CI, 12.49-211.2; P < .01). CONCLUSION: Quantitative fFN provides thresholds (10 and 200 ng/mL) in addition to the qualitative method (50 ng/mL) to discriminate the risk of sPTB in symptomatic women.
OBJECTIVE: The purpose of this study was to determine whether quantification of cervicovaginal fluid fetal fibronectin (fFN) improves diagnostic accuracy of spontaneous preterm birth (sPTB) in symptomatic women. STUDY DESIGN: A prospective blinded predefined secondary analysis of a larger study of cervicovaginal fluid fFN concentration (nanograms per milliliter) in women symptomatic of preterm labor (n =300 women; 22-35 weeks' gestation) with a Hologic 10Q system (Hologic, Marlborough, MA). Clinicians were blinded to the result until after the delivery, but the qualitative Hologic TLI(IQ) fFN result was made available. RESULTS: The positive predictive value for sPTB (<34 weeks' gestation) increased from 19%, 32%, 61%, and 75% with increasing thresholds (10, 50, 200, and 500 ng/mL, respectively). Compared with <10 ng/mL fFN, the relative risk of delivery was 5.6 (95% confidence interval [CI], 1.05-29.57), 7.9 (95% CI, 1.38-45.0), 22.8 (95% CI, 3.84-135.5), and 51.3 (95% CI, 12.49-211.2; P < .01). CONCLUSION: Quantitative fFN provides thresholds (10 and 200 ng/mL) in addition to the qualitative method (50 ng/mL) to discriminate the risk of sPTB in symptomatic women.
Authors: Kenneth D Long; Elizabeth V Woodburn; Huy M Le; Utsav K Shah; Steven S Lumetta; Brian T Cunningham Journal: Lab Chip Date: 2017-09-26 Impact factor: 6.799
Authors: Gwen K Healey; William Alexander Macdonald; Stefan Grzybowski; Robert Nevin; Jude Kornelsen; William E Hogg Journal: Can Fam Physician Date: 2018-03 Impact factor: 3.275
Authors: Catherine E Majors; Chelsey A Smith; Mary E Natoli; Kathryn A Kundrod; Rebecca Richards-Kortum Journal: Lab Chip Date: 2017-10-11 Impact factor: 6.799