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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2022.7
- 수록면
- 169 - 174 (6page)
- DOI
- 10.47429/lmo.2022.12.3.169
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초록· 키워드
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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.
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