TY - JOUR
T1 - Syphilis Immunoassay Signal Strength Correlates with Active Infection in Pregnant Women
AU - Zofkie, Amanda C.
AU - Seasely, Angela R.
AU - Rogers, Vanessa L.
AU - McIntire, Donald D.
AU - Roberts, Scott W.
AU - Adhikari, Emily H.
AU - Gaffney, Donna
N1 - Publisher Copyright:
© 2020 Georg Thieme Verlag. All rights reserved.
PY - 2020/6/1
Y1 - 2020/6/1
N2 - Objective â This study aimed to evaluate the association of ARCHITECT chemiluminescent immunoassay (CIA) signal strength (signal-To-cutoff [S/CO] ratio), with maternal syphilis stage, rapid plasma reagin (RPR) reactivity, and congenital syphilis. Study Design â A prospective observational study of reverse syphilis screening was conducted. Pregnant women were screened with CIA. Reactive CIA was reflexed to RPR; particle agglutination test (Treponema pallidum particle agglutination [TPPA]) was performed for CIA+/RPR-results. Clinical staging with history and physical was performed, and disease stage was determined. Prior treatment was confirmed. We compared S/CO ratio and neonatal outcomes among the following groups: Group 1: CIA+/RPR+/TPPA+ or CIA+/RPR-/TPPA+ with active syphilis; Group 2: CIA+/RPR-/TPPA+ or CIA+/serofast RPR/TPPA+, previously treated; Group 3: CIA+/RPR-/TPPA+, no history of treatment or active disease; Group 4: CIA+/RPR-/TPPA-, false-positive CIA. Results â A total of 144 women delivered with reactive CIA: 38 (26%) in Group 1, 69 (48%) in Group 2, 20 (14%) in Group 3, and 17 (12%) in Group 4. Mean (±standard deviation) S/CO ratio was 18.3 ± 5.4, 12.1 ± 5.3, 9.1 ± 4.6, and 1.9 ± 0.8, respectively (p < 0.001). Neonates with overt congenital syphilis occurred exclusively in Group 1. Conclusion â Women with active syphilis based on treatment history, clinical staging, and laboratory indices have higher CIA S/CO ratio and are more likely to deliver neonates with overt evidence of congenital syphilis.
AB - Objective â This study aimed to evaluate the association of ARCHITECT chemiluminescent immunoassay (CIA) signal strength (signal-To-cutoff [S/CO] ratio), with maternal syphilis stage, rapid plasma reagin (RPR) reactivity, and congenital syphilis. Study Design â A prospective observational study of reverse syphilis screening was conducted. Pregnant women were screened with CIA. Reactive CIA was reflexed to RPR; particle agglutination test (Treponema pallidum particle agglutination [TPPA]) was performed for CIA+/RPR-results. Clinical staging with history and physical was performed, and disease stage was determined. Prior treatment was confirmed. We compared S/CO ratio and neonatal outcomes among the following groups: Group 1: CIA+/RPR+/TPPA+ or CIA+/RPR-/TPPA+ with active syphilis; Group 2: CIA+/RPR-/TPPA+ or CIA+/serofast RPR/TPPA+, previously treated; Group 3: CIA+/RPR-/TPPA+, no history of treatment or active disease; Group 4: CIA+/RPR-/TPPA-, false-positive CIA. Results â A total of 144 women delivered with reactive CIA: 38 (26%) in Group 1, 69 (48%) in Group 2, 20 (14%) in Group 3, and 17 (12%) in Group 4. Mean (±standard deviation) S/CO ratio was 18.3 ± 5.4, 12.1 ± 5.3, 9.1 ± 4.6, and 1.9 ± 0.8, respectively (p < 0.001). Neonates with overt congenital syphilis occurred exclusively in Group 1. Conclusion â Women with active syphilis based on treatment history, clinical staging, and laboratory indices have higher CIA S/CO ratio and are more likely to deliver neonates with overt evidence of congenital syphilis.
KW - ARCHITECT Syphilis TP immunoassay
KW - congenital syphilis
KW - pregnancy
KW - reverse sequence screening algorithm
KW - signal strength
KW - signal-To-cutoff ratio
UR - https://www.scopus.com/pages/publications/85085233017
U2 - 10.1055/s-0039-3402748
DO - 10.1055/s-0039-3402748
M3 - Article
C2 - 31910464
AN - SCOPUS:85085233017
SN - 0735-1631
VL - 37
SP - 671
EP - 678
JO - American journal of perinatology
JF - American journal of perinatology
IS - 7
ER -