CLINICAL PERFORMANCE CHARACTERISTICS OF ELECSYS® FREE-ΒHCG AND PAPP-A FOR FIRST TRIMESTER TRISOMY 21 RISK ASSESSMENT IN GESTATIONAL WEEKS 8+0 TO 14+0

Autor: Niels Tørring, Aulesa, C., Bernd Eiben, Luppa, P., Ortiz, J. U., Ferri, M., Sancken, U., Annie Vereecken, Wiedemann, U., Jürgen Zitzler, Nicolaides, K. H.
Jazyk: dánština
Rok vydání: 2014
Předmět:
Zdroj: Tørring, N, aulesa, C, Eiben, B, Luppa, P, Ortiz, J U, Ferri, M, Sancken, U, Vereecken, A, Wiedemann, U, Zitzler, J & Nicolaides, K H 2014, ' CLINICAL PERFORMANCE CHARACTERISTICS OF ELECSYS® FREE-ΒHCG AND PAPP-A FOR FIRST TRIMESTER TRISOMY 21 RISK ASSESSMENT IN GESTATIONAL WEEKS 8+0 TO 14+0 ' .
Aarhus University
Popis: Background Screening for fetal trisomy 21 (T21) in the first trimester includes analysis of the serological markers pregnancy-associated plasma protein A (PAPP-A) and free beta choriogonadotropin (free βhCG). With the launch of these assays on the cobas e and Elecsys platforms, we investigated their clinical and analytical performance. Patients and Methods We conducted a multicenter study in 5397 pregnancies including 108 cases with verified fetal T21 at 8 to 14 weeks of gestation. A technical validation of the Roche Elecsys® free βhCG and PAPP-A assays were performed, including method comparisons with the Brahms Kryptor®, PerkinElmer AutoDELFIA® and Siemens IMMULITE® assays. Furthermore a clinical validation including generation of assay specific medians from gestational age 8+0 to 14+0 weeks, and clinical test performance of risk assessment was performed. Results The imprecision of the Elecsys free βhCG and PAPP-A assays was between 1.0% and 2.8%. The assays showed correlation to Kryptor (free βhCG 0.981; PAPP-A 0.987), AutoDELFIA (free βhCG 0.995; PAPP-A 0.979) and IMMULITE assays (free βhCG 0.983; PAPP-A 0.983). With a cut off at 1:300 the overall sensitivity of the screening including nuchal translucency reached 94% for a 3% false positive rate. In gestational weeks 8 and 9 the sensitivity was 95% for a 2% false positive rate, and in gestational weeks 10 to 14 the sensitivity was 94% for a 3% false positive rate. Conclusions The technical and clinical validation of the Roche Elecsys free βhCG and PAPP-A assays for first trimester screening approve with the standards set by the Fetal Medicine Foundation.
Databáze: OpenAIRE
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