ArticleAdvances in laboratory medicine2025
Comparison of four different analyzers for prenatal trisomy 21 risk.
Article in Advances in laboratory medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objectives: Various analyzers are available for measuring first-trimester combined screening for trisomy 21 (T21) serum biomarkers (free-beta subunit of the human chorionic gonadotropin (β-hCG) and the pregnancy-associated plasma protein A (PAPP-A)). Our aim is to compare the analytical performance of four different analyzers and their false positive rates (FPR) for T21 risk. Methods: A 6-month study analyzed data from 1,136 pregnant women for first-trimester combined screening. Serum samples were processed using four analyzers (IMMULITE 2000, Centaur XP, Cobas e-411, KRYPTOR compact PLUS), each with its own risk calculation software. Comparative analyses of the biochemical markers and their multiples of the median (MoMs) were conducted using Passing-Bablok and Bland-Altman methods. Results: Significant variability was observed among the analyzers. For free β-hCG, only Centaur XP and KRYPTOR compact PLUS were interchangeable. For PAPP-A, only IMMULITE 2000 and Cobas e-411 were comparable. However, no analyzer pair was interchangeable for both markers simultaneously. Free β-hCG multiples of the median (MoMs) were highest in IMMULITE 2000 (1.85 MoM (IQR: 1.4-2.97)) and lowest in KRYPTOR compact PLUS (1.5 MoM (IQR: 1.23-2.21)). PAPP-A MoMs were lowest in IMMULITE 2000 (0.52 MoM (IQR: 0.38-0.82)) and highest in Cobas e-411 (0.58 MoM (IQR: 0.39-0.90)). In risk assessment, all analyzers detected true T21 cases but varied in their FPR, with Centaur XP (3.8 %), Cobas e-411 (2.5 %) and KRYPTOR compact PLUS (2.3 %) showing a FPR below 5 %. Conclusions: Measurement of serum biomarkers by the four analyzers is not interchangeable. KRYPTOR compact PLUS showed the lowest FPR for risk assessment.
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