Evaluation of a Plasma hCG Method for Point of Care Testing with the Aim of Shortening Test-Turnaround-Times

Anna-Karin Wikström,Anders Larsson,Göran Ronquist,Magnus Hagmar

doi:10.4236/ojog.2015.56049

Abstract

Objective: To examine the correlation between plasma hCG results obtained with the new i-STAT&reg hCG point of care test with those concomitantly obtained from the central hospital laboratory utilizing the same patient samples. Methods: Prospective cross-sectional laboratory test evaluation. We compared plasma hCG results obtained with the i-STAT&reg hCG test (Abbott Point of Care, Princeton, NJ, USA) with Architect Ci8200 (Abbott Laboratories, Abbott Park, IL, USA). We also calculated the total coefficient of variation (CV) for the i-STAT&reg method. Results: The two methods showed a good linear correlation (R2 = 0.994; slope 1.03) and CV for the i-STAT&reg method was 2.1% - 5.2%. Conclusion: We suggest that the i-STAT&reg hCG blood assay could be used as a complement to urine hCG assays in clinical situations when rapid test results are needed and urine is not available.

Highlights

Pregnancy tests utilizing antibodies for detection of human chorionic gonadotropin in urine have been used for half a century
The i-Stat human chorionic gonadotropin (hCG) method was compared with the current central laboratory method
The samples used were from routine requests for plasma hCG at the Department of Clinical Chemistry and Pharmacology, Uppsala University Hospital, Uppsala

Summary

Introduction

Pregnancy tests utilizing antibodies for detection of human chorionic gonadotropin (hCG) in urine have been used for half a century. For the home pregnancy urine tests that are used around the world These tests are accurate and affordable and are used in large numbers. Since pregnancy is not compatible with risk-taking like certain clinical investigations, it is important to be able to rule out pregnancies in e.g. the X-ray department. In such situations it is not always possible for the women to quickly provide urine samples on request that certainly will cause a delay in the overall process. The aim of the current study was to evaluate the i-Stat hCG method as a complement to our urine based pregnancy tests. The i-Stat hCG method was compared with the current central laboratory method

Study Population

Plasma hCG Assays

Statistical Analyses