Abbott ARCHITECT Syphilis TP Chemiluminescent Immunoassay Accurately Diagnoses Past or Current Syphilis in Pregnancy

Emily H. Adhikari, Ithiel J. Frame, Emilie Hill, Rizwana Fatabhoy, Amanda L. Strickland, Dominick Cavuoti, Donald D. Mcintire, Rita M. Hollaway

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)112-118
Number of pages7
JournalAmerican Journal of Perinatology
Volume37
Issue number1
DOIs
StatePublished - 2020

Keywords

  • Chemiluminescent
  • Diagnostic accuracy
  • Immunoassay
  • Reverse algorithm
  • Syphilis in pregnancy
  • Syphilis screening
  • Treponemal

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology

Fingerprint Dive into the research topics of 'Abbott ARCHITECT Syphilis TP Chemiluminescent Immunoassay Accurately Diagnoses Past or Current Syphilis in Pregnancy'. Together they form a unique fingerprint.

Cite this