Effect of blood on ROM diagnosis accuracy of PAMG-1 and IGFBP-1 detecting rapid tests.
Vaginal bleeding may be present in up to 30% of patients presenting with signs and symptoms of a rupture of the fetal membranes (ROM). The presence of blood may lead to false positive results with biochemical markers. The data presented in this study came from a multi-centric prospective observational clinical study that, for the first time, systematically evaluated the performance of placental alpha microglobulin-1 (PAMG-1) and insulin-like growth factor binding protein-1 (IGFBP-1) detecting tests in 151 women with vaginal bleedings as well as signs and symptoms indicative of ROM. Our data showed better performance for the PAMG-1 compared with the IGFBP-1 detecting tests in all quality parameters evaluated. In detail, sensitivity (SN) was 97.8% (91.0%), specificity (SP) was 91.5% (75.0%), positive predictive value (PPV) was 94.6% (83.5%) and negative predictive value (NPV) was 96.4% (85.7%) for PAMG-1 tests (and IGFBP-1 tests, respectively). A major difference between both tests was related to the number of non-evaluable test results (e.g., hidden bands due to blood smear on the test strips). While 2% of all results were not evaluable for PAMG-1 tests, this artifact appeared in 11% of the results obtained with IGFBP-1 tests. This difference and also those in Specificity and PPV were statistically significant, demonstrating superiority of PAMG-1 over IGFBP-1 detecting tests. In conclusion, the PAMG-1 detecting test was significantly less susceptible to interference by blood than the IGFBP-1 detecting test.
Babett
B
Ramsauer
Wiebke
W
Duwe
Bettina
B
Schlehe
Regina
R
Pitts
Dirk
D
Wagner
Katja
K
Wutkewicz
Dmitry
D
Chuvashkin
Harald
H
Abele
Robert
R
Lachmann
D000293:Adolescent; D000328:Adult; D000510:Alpha-Globulins / Q000032:analysis* / Q000378:metabolism; D001769:Blood; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000175:diagnosis* / Q000378:metabolism; D006801:Humans; D018970:Insulin-Like Growth Factor Binding Protein 1 / Q000032:analysis*; D008875:Middle Aged; D010920:Placenta / Q000378:metabolism; D011247:Pregnancy; D011446:Prospective Studies; D014626:Vaginal Smears; D055815:Young Adult
D000510:Alpha-Globulins; C032231:IGFBP1 protein, human; D018970:Insulin-Like Growth Factor Binding Protein 1; C016001:alpha-1-microglobulin