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一种新型即时检验试剂盒ABSOGEN PCT在全血降钙素原半定量检测中的评估。

Evaluation of a novel point-of-care test kit, ABSOGEN PCT, in semi-quantitative measurement of procalcitonin in whole blood.

作者信息

Kwon Hi Jeong, Lee Jehoon, Park Hae-Il, Han Kyungja

机构信息

Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.

The Seoul St. Mary's Hospital IVD Medical Devices Development Center, Seoul, Korea.

出版信息

J Clin Lab Anal. 2017 Nov;31(6). doi: 10.1002/jcla.22111. Epub 2016 Dec 13.

Abstract

BACKGROUND

In response to inflammation, procalcitonin plasma concentrations increase more rapidly than other acute-phase reactants and higher values are associated with severe disease. Procalcitonin measurements assist in determining whether antibiotic therapy should be used. point-of-care testing (POCT) is performed for early decision making about additional testing or therapy. The ABSOGEN PCT (Bumyoungbio, Inc., Suwon, Korea) is a rapid novel semi-quantitative immunochromatographic PCT assay that analyses whole blood samples. We compared the patient quantitative test results to ABSOGEN PCT test results.

METHODS

Whole blood was loaded onto an ABSOGEN PCT cartridge and incubated for 10 minutes. The color intensity of the band of the cartridge was measured using an accompanying device and with the naked eye. The results were graded as negative (<0.1 ng/mL), low (0.1 to <1.0 ng/mL), middle (1.0-2.0 ng/mL), and high (>2.0 ng/mL). A total of 158 specimens with procalcitonin levels measured from 0 to 18.96 ng/mL were used for comparison study.

RESULTS

The concordance rate between ABSOGEN PCT using the reader and quantitative assay, between ABSOGEN PCT using naked eyes and quantitative assay, and between ABSOGEN PCT using the reader and naked eyes for the same category was 83.5% (P=.040), 78.5% (P<.001), and 82.3% (P=.001), respectively. The concordance rates for the ±1 categories were all 100%.

CONCLUSION

ABSOGEN PCT is an accurate assay. It is easy to use, simple, fast, portable. The assay has potential value in clinical applications, especially in emergency care.

摘要

背景

作为对炎症的反应,降钙素原的血浆浓度比其他急性期反应物升高得更快,且较高的值与严重疾病相关。降钙素原检测有助于确定是否应使用抗生素治疗。即时检验(POCT)用于对进一步检测或治疗进行早期决策。ABSOGEN PCT(韩国水原市Bumyoungbio公司)是一种快速的新型半定量免疫层析降钙素原检测方法,可分析全血样本。我们将患者的定量检测结果与ABSOGEN PCT检测结果进行了比较。

方法

将全血加载到ABSOGEN PCT检测卡上并孵育10分钟。使用配套设备并通过肉眼测量检测卡条带的颜色强度。结果分为阴性(<0.1 ng/mL)、低(0.1至<1.0 ng/mL)、中(1.0 - 2.0 ng/mL)和高(>2.0 ng/mL)。总共158份降钙素原水平在0至18.96 ng/mL之间的标本用于比较研究。

结果

使用读数器的ABSOGEN PCT与定量检测之间、使用肉眼的ABSOGEN PCT与定量检测之间以及使用读数器和肉眼的ABSOGEN PCT在同一类别之间的一致性率分别为83.5%(P = 0.040)、78.5%(P < 0.001)和82.3%(P = 0.001)。±1类别的一致性率均为100%。

结论

ABSOGEN PCT是一种准确的检测方法。它易于使用,简单、快速且便于携带。该检测方法在临床应用中具有潜在价值,尤其是在急诊护理中。

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