Assessing Sensitivity of hCG Pregnancy Rapid Test in Serum, Plasma, and Urine Samples for Early Pregnancy Diagnosis: A Multi-Center Clinical Study

In this study, the objective was to assess the diagnostic efficacy of the hCG Pregnancy Enhanced Sensitivity Rapid Test, which is a chromatographic immunoassay designed to qualitatively detect human chorionic gonadotropin (hCG) in urine, serum, or plasma, enabling the early detection of pregnancy. To selectively identify increased levels of hCG, the test utilizes a combination of monoclonal and polyclonal antibodies. A clinical evaluation, conducted across multiple centers, aimed to compare the hCG Pregnancy Enhanced Sensitivity Rapid Test with other commercially available rapid tests for the qualitative detection of hCG in urine, serum, or plasma. In the urine study, a total of 608 samples were examined, resulting in 377 negative and 231 positive outcomes. The serum or plasma study encompassed 308 samples, with 240 negative and 68 positive results. The findings revealed that the hCG Pregnancy Enhanced Sensitivity Rapid Test exhibited an overall accuracy exceeding 99% when compared to other rapid tests designed to detect hCG in urine, serum, or plasma. The test displayed no cross-reactivity interference with structurally related glycoprotein hormones hFSH, hLH, and hTSH even at high physiological levels, even when exposed to high physiological levels, at the claimed sensitivity threshold of 10 mIU/mL. These findings highlight the test's efficacy in accurately detecting hCG in urine, serum, or plasma. To conclude, the hCG Pregnancy Enhanced Sensitivity Rapid Test developed by Hangzhou AllTest Biotech Co., Ltd demonstrated excellent performance in detecting hCG in different sample types. The test exhibited high accuracy and reliability, rendering it suitable as an auxiliary tool for pregnancy determination in clinical settings. Additionally, its rapid and accurate results make it particularly valuable in facilitating prompt diagnosis and treatment, particularly in resource-limited settings.