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KMID : 1100820220120030169
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Laboratory Medicine Online
2022 Volume.12 No. 3 p.169 ~ p.174
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Performance Evaluation of the AllCheck hCG Card Point-of-Care Device and Method Comparison with the Alere hCG Cassette Assay for Pregnancy Test
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Lee Kwang-Seob
Kim Bo-Hee
Ahn Hyo-Jun
Kim Jung-Hee
Roh Kyoung-Ho
Yoo Jong-Ha
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Abstract
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Background: Immunochromatographic point-of-care (POC) devices ae widely used by laboratories and lay users for urinary human chorionic gonadotropin (hCG) detection. Performance evaluation of pregnancy POC devices is rarely published. We performed an analytical and clinical validation 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 recommended 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.
Keywords
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KEYWORD
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Analytical sensitivity, Probit regression, Pregnancy test, Human chorionic gonadotropin, Precision, Qualitative test
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