TY - JOUR
T1 - Abbott ARCHITECT Syphilis TP Chemiluminescent Immunoassay Accurately Diagnoses Past or Current Syphilis in Pregnancy
AU - Adhikari, Emily H.
AU - Frame, Ithiel J.
AU - Hill, Emilie
AU - Fatabhoy, Rizwana
AU - Strickland, Amanda L.
AU - Cavuoti, Dominick
AU - Mcintire, Donald D.
AU - Hollaway, Rita M.
PY - 2020
Y1 - 2020
N2 - Objective âWe evaluate diagnostic accuracy of the ARCHITECT chemiluminescent immunoassay (CIA) screening test in pregnancy, and evaluate pregnancy outcomes among screen-positive women. Study Design âSamples from routine prenatal rapid plasma reagin (RPR) tests were collected between June 22 and August 18, 2017 and frozen. Samples were batch-tested with the Abbott ARCHITECT syphilis TP immunoassay (CIA, index test). We calculated sensitivity, specificity, predictive value, and false positivity. We compared pregnancy and neonatal outcomes among screen-positive women. Results âOf 1,602 specimens, 35 (2.2%) were RPR +; of those, 24 (69%) were CIA +/Treponema pallidum particle agglutination assay (TPPA)+ and 11 (31%) were CIA-/TPPA-. Of 1,567 RPR-specimens, 14 (0.9%) were CIA +; of those, 13 (93%) were TPPA +, and one (7%) had a false positive CIA test. Sensitivity of the CIA (95% CI) was 100% (90.5-100%), specificity 99.9% (99.6-100%), positive predictive value 97.4% (86.2-99.9%), and false positive rate 0.06% (0.002-0.4%) for current or past syphilis. Among 37 CIA +/TPPA+ women, seven (19%) had RPR-negative status (Group 1), 11 (30%) had previously treated syphilis (Group 2), and 19 (51%) had active infection (Group 3). One stillbirth occurred in a woman with early, active syphilis identified at delivery; no adverse perinatal outcomes occurred among women in Groups 1 or 2. Conclusion âThe ARCHITECT syphilis TP immunoassay accurately diagnoses current or past syphilis in pregnancy. Clinical history and staging remain essential using a reverse algorithm.
AB - Objective âWe evaluate diagnostic accuracy of the ARCHITECT chemiluminescent immunoassay (CIA) screening test in pregnancy, and evaluate pregnancy outcomes among screen-positive women. Study Design âSamples from routine prenatal rapid plasma reagin (RPR) tests were collected between June 22 and August 18, 2017 and frozen. Samples were batch-tested with the Abbott ARCHITECT syphilis TP immunoassay (CIA, index test). We calculated sensitivity, specificity, predictive value, and false positivity. We compared pregnancy and neonatal outcomes among screen-positive women. Results âOf 1,602 specimens, 35 (2.2%) were RPR +; of those, 24 (69%) were CIA +/Treponema pallidum particle agglutination assay (TPPA)+ and 11 (31%) were CIA-/TPPA-. Of 1,567 RPR-specimens, 14 (0.9%) were CIA +; of those, 13 (93%) were TPPA +, and one (7%) had a false positive CIA test. Sensitivity of the CIA (95% CI) was 100% (90.5-100%), specificity 99.9% (99.6-100%), positive predictive value 97.4% (86.2-99.9%), and false positive rate 0.06% (0.002-0.4%) for current or past syphilis. Among 37 CIA +/TPPA+ women, seven (19%) had RPR-negative status (Group 1), 11 (30%) had previously treated syphilis (Group 2), and 19 (51%) had active infection (Group 3). One stillbirth occurred in a woman with early, active syphilis identified at delivery; no adverse perinatal outcomes occurred among women in Groups 1 or 2. Conclusion âThe ARCHITECT syphilis TP immunoassay accurately diagnoses current or past syphilis in pregnancy. Clinical history and staging remain essential using a reverse algorithm.
KW - Chemiluminescent
KW - Diagnostic accuracy
KW - Immunoassay
KW - Reverse algorithm
KW - Syphilis in pregnancy
KW - Syphilis screening
KW - Treponemal
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U2 - 10.1055/s-0039-3400994
DO - 10.1055/s-0039-3400994
M3 - Article
C2 - 31905408
AN - SCOPUS:85077567199
SN - 0735-1631
VL - 37
SP - 112
EP - 118
JO - American Journal of Perinatology
JF - American Journal of Perinatology
IS - 1
ER -