임신 진단을 위한 현장검사용 AllCheck hCG Card 키트의 성능 평가 및 Alere hCG Cassette 키트와의 비교

Abstract

Background: Immunochromatographic point-of-care (POC) devices ae widely used by laboratories and lay users for urinary human chorionicgonadotropin (hCG) detection. Performance evaluation of pregnancy POC devices is rarely published. We performed an analytical and clinical vali dation of the newly introduced AllCheck hCG Card assay and compared it with the Alere hCG Cassette comparative assay. Methods: The analytical performance of the assay was evaluated using an international standard material for hCG, as per the protocol recom mended in the Clinical and Laboratory Standards Institute (CLSI) guideline. Clinical validation and comparison study with the comparative method were performed with remnant urine samples from pregnant and non-pregnant women. Results: Probit analysis showed an analytical sensitivity of 15.82 mIU/mL. The precision of the assay was validated at a threshold of 30%. Cross-reactivity with luteinizing hormone, follicle-stimulating hormone, and thyroid-stimulating hormone was not observed. Comparison with the comparative assay showed a negative percent agreement of 100.0% (95% confidence interval [CI]: 92.9%-100.0%) and a positive percent agreement of 96.4% (95% CI: 89.9%-98.8%). Cohen’s kappa value was 0.952 (95% CI: 0.899-1.000). Conclusions: Overall, we validated the performance of the urine hCG POC device and suggest that probit regression is suitable for qualitative tests other than molecular tests. The AllCheck hCG Card device satisfied the demanding standards suggested by the CLSI guideline and was suitable for clinical use.