Lab Med Qual Assur.  2023 Sep;45(3):120-124. 10.15263/jlmqa.2023.45.3.120.

Comparison of Four Point-of-Care Devices for Pregnancy Test in Urine

• So H
• Kwon K
• Park J
• Kim K

• KMID: 2546625
• DOI: http://doi.org/10.15263/jlmqa.2023.45.3.120

Abstract

Point-of-care (POC) tests for human chorionic gonadotropin (hCG) are widely used in hospital laboratories. However, there is a lack of comparative studies focusing on pregnancy POC devices that test urine. In this study, we aimed to evaluate four commonly used pregnancy POC devices in Korea. From March to May 2023, remnant clinical urine samples were collected from 200 patients, consisting of 100 confirmed pregnant women and 100 nonpregnant women. The evaluated devices included the AllCheck hCG Card (Calth, Korea), Card ASAN Easy Test hCG (Asanpharm., Korea), Humasis hCG Card (Humasis, Korea), and careUS BEBE-CHECK (Wells bio, Korea). Among the four pregnancy POC devices, we observed a 99% negative percent agreement and 97% positive percent agreement. Only four samples showed discrepancies in results, which could be attributed to early pregnancy and abortion. Overall, the hCG POC devices assessed in this study demonstrated high concordance rates. However, we must be careful when interpreting urine pregnancy test results, particularly in cases involving early pregnancy or abortion.

Keyword

Human chorionic gonadotropin; Pregnancy tests; Point-of-care systems