Journal of clinical laboratory analysis · 2020
Comparison and evaluation of Abbott chemiluminescent microparticle immunoassay and ChIVD light-initiated chemiluminescent assay in the detection of Treponema pallidum antibody.
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Chen Xiaohui, Yang Ruifeng, Liang Yongming, Yuan Teng, Zhou Jiansuo, Wang Tiancheng, Cui Liyan
Аннотация
BACKGROUND: Laboratory tests play an important role in the diagnosis of syphilis. This study aimed to compare and assess the performance of the Abbott chemiluminescent microparticle immunoassay (CMIA) and the ChIVD light-initiated chemiluminescent assay (LICA) in the detection of Treponema pallidum (TP) antibody.
METHODS: A total of 10 498 serum samples were detected with two assays, and the Treponema pallidum particle agglutination assay (TPPA) and recombinant immunoblot assay (RIBA) methods were used for confirmation. The sensitivity, specificity, positive predictive value, and negative predictive value of the Abbott CMIA and ChIVD LICA were calculated. The coincidence rate between two assays was also evaluated. The causes of false positive and false negative of two assays were studied.
RESULTS: For the Abbott CMIA and ChIVD LICA, the sensitivity was 94.44% and 98.15%, the specificity was 99.89% and 99.81%, the positive predictive value was 93.29% and 88.83%, and the negative predictive value was 99.91% and 99.97%, respectively. The coincidence rate between Abbott CMIA and ChIVD LICA was 99.26%, and κ value was .790. The disease of infertility, hypertensive disease, liver disease, and cancer were the common causes of false positive in both assays, while infertility was also the main reason lead to false negative.
CONCLUSION: Our results demonstrated that the Abbott CMIA and ChIVD LICA generally had high sensitivity and specificity and therefore may be suitable for the detection of TP antibody and screening for syphilis.
METHODS: A total of 10 498 serum samples were detected with two assays, and the Treponema pallidum particle agglutination assay (TPPA) and recombinant immunoblot assay (RIBA) methods were used for confirmation. The sensitivity, specificity, positive predictive value, and negative predictive value of the Abbott CMIA and ChIVD LICA were calculated. The coincidence rate between two assays was also evaluated. The causes of false positive and false negative of two assays were studied.
RESULTS: For the Abbott CMIA and ChIVD LICA, the sensitivity was 94.44% and 98.15%, the specificity was 99.89% and 99.81%, the positive predictive value was 93.29% and 88.83%, and the negative predictive value was 99.91% and 99.97%, respectively. The coincidence rate between Abbott CMIA and ChIVD LICA was 99.26%, and κ value was .790. The disease of infertility, hypertensive disease, liver disease, and cancer were the common causes of false positive in both assays, while infertility was also the main reason lead to false negative.
CONCLUSION: Our results demonstrated that the Abbott CMIA and ChIVD LICA generally had high sensitivity and specificity and therefore may be suitable for the detection of TP antibody and screening for syphilis.