Comparison of the performance of serum hCG (ELISA method) and Urinary pregnancy test (ICT method) in the early detection of pregnancy

DOI: https://doi.org/10.47648/zhswmcj.2026.v0802.01

Khan NZ1 , Ahmed SM2 , Sultana GS3 , Akter K4

Abstract

Background: Early identification of pregnancy enables timely antenatal care. Both serum β-hCG (ELISA) and urinary pregnancy tests (ICT) are commonly used, but their performance in early pregnancy varies. Objective: To compare the diagnostic performance of serum β-hCG (ELISA) and urinary pregnancy test (ICT) in the early detection of pregnancy, using ultrasonography (USG) as the reference standard. Methods: A cross-sectional study was conducted over six months among women aged 18–40 years who presented with suspicion of early pregnancy. A total of 100 participants were recruited through convenience sampling. Each participant underwent serum β-hCG (ELISA), an ICT test for urinary β-hCG, and USG for confirmation. The sensitivity, specificity, and overall accuracy of both tests were compared against USG findings. Results: Of 100 participants, 57 pregnancies and 43 non-pregnancies were confirmed by USG. Serum β-hCG was more sensitive (96.5% vs. 82.5%) and accurate (98% vs. 90%) than the urinary pregnancy test; both had 100% specificity. Quantitative β-hCG had limited discriminatory power (AUC = 0.601). Conclusion: Serum β-hCG performs better than urine ICT in early pregnancy detection. However, variability in hormone levels limits its diagnostic value alone. USG is the definitive standard. Combining β-hCG with USG improves the reliability of confirmation.

Keywords: Serum -hCG, ELISA, Urinary pregnancy test, Immunochromatographic technique, Early pregnancy detection, Diagnostic accuracy.


  1. Associate Professor, Department of Biochemistry

    BIRDEM General Hospital, Shahbag, Dhaka

  2. Consultant, Department of Orthopedic Surgery

    Bangabandhu Sheikh Mujib Medical University

  3. Professor and Head, Department of Laboratory Medicine

    BIRDEM General Hospital, Shahbag, Dhaka

  4. Assistant Professor, Department of Biochemistry

    BIRDEM General Hospital, Shahbag, Dhaka


Volume 8, Number 2, July 2026
Page: 4-10