• Kapur, Shikha
• Maheetharan, Shanuja
• Kyriacou, Christopher
• Tan, Tricia
• Bourne, Tom
• Bobdiwala, Shabnam
• Barcroft, Jen F.
• Day, Andrea
• Ofili-Yebovi, Dede
• Parker, Nina
• Yang, Wei
• Gould, Deborah
• Pikovsky, Margaret
• Unsworth, Nick
• Sur, Shyamaly
• Wilkes, Edmund H.
• Stalder, Catriona

Abstract

<jats:title>Abstract</jats:title><jats:sec id="j_cclm-2023-0703_abs_001"><jats:title>Objectives</jats:title><jats:p>Quantitative human chorionic gonadotropin (hCG) measurements are used to manage women classified with a pregnancy of unknown location (PUL). Two point of care testing (POCT) devices that quantify hCG are commercially available. We verified the i-STAT 1 (Abbott) and the AQT 90 FLEX (Radiometer) prior to use in PUL triage.</jats:p></jats:sec><jats:sec id="j_cclm-2023-0703_abs_002"><jats:title>Methods</jats:title><jats:p>Tests for precision, external quality assurance (EQA), correlation, hook effect and recovery were undertaken alongside a POCT usability assessment during this prospective multi-center verification.</jats:p></jats:sec><jats:sec id="j_cclm-2023-0703_abs_003"><jats:title>Results</jats:title><jats:p>Coefficients of variation ranged between 4.0 and 5.1 % for the three i-STAT 1 internal quality control (IQC) solutions and between 6.8 and 7.3 % for the two AQT IQC solutions. Symmetric differences in POCT EQA results when compared with laboratory and EQA stock values ranged between 3.2 and 24.5 % for the i-STAT 1 and between 3.3 and 36.9 % for the AQT. Correlation coefficients (i-STAT 1: 0.96, AQT: 0.99) and goodness of fit curves (i-STAT 1: 0.92, AQT: 0.99) were excellent when using suitable whole blood samples. An hCG hook effect was noted with the i-STAT 1 between 572,194 and 799,089 IU/L, lower than the hook effect noted with the AQT, which was between 799,089 and 1,619,309 IU/L. When hematocrit concentration was considered in sample types validated for use with each device, hCG recovery was 108 % with the i-STAT 1 and 98 % with the AQT. The i-STAT 1 scored lower on usability overall (90/130) than the AQT (121/130, p&lt;0.001, Mann-Whitney).</jats:p></jats:sec><jats:sec id="j_cclm-2023-0703_abs_004"><jats:title>Conclusions</jats:title><jats:p>Both hCG POCT devices were verified for use in clinical practice. Practical factors must also be considered when choosing which device to use in each unit.</jats:p></jats:sec>

Topics

• size-exclusion chromatography