Leung Wingman, Chan Cangel Puiyee, Rainer Timothy H, Ip Margaret, Cautherley George W H, Renneberg Reinhard
Department of Chemistry, Biosensors and Bioelectronics Laboratory, The Hong Kong University of Science and Technology, Clear Water Bay, Kowloon, Hong Kong, China.
J Immunol Methods. 2008 Jul 20;336(1):30-6. doi: 10.1016/j.jim.2008.03.009. Epub 2008 Apr 10.
In the present study, we describe an InfectCheck barcode-style lateral flow assay for semi-quantitative detection of CRP in distinguishing between bacterial and viral infections. The severity of bacterial infection can be assessed by simply counting the number of red lines developed at the CRP test zone of the test device. If only one visible line appeared at the CRP test zone, it represents a low or mild inflammation with CRP levels <10 mg/L. Two and three visible lines mean moderate (>or=10-25 mg/L) and severe (>or=25-50 mg/L) inflammations respectively while four visible lines stand for a very severe inflammation (>or=50-100 mg/L). If the visible lines become faint and the intensity of the first line is weaker than that of the control line and may even disappear, this outcome corresponds to the stage of having super severe inflammation (>or=100 mg/L). A total of 500 patients admitted to hospital through the Accident and Emergency Unit at the Prince of Wales Hospital were examined. The InfectCheck CRP barcode-style rapid test gave a high sensitivity of 88.7% and a high negative predictive value of 93.8%. This result indicates that the rapid test is reliable to exclude non-infected patients. The calculated intra- and inter-assay coefficient of variation for the five CRP concentration ranges was both within 20.0%. It is a one-step whole blood rapid test without any sample pre-treatment and the result is available within 20 min. This user friendly diagnostic tool can allow self-testing by interested individuals without any expensive reading device.
在本研究中，我们描述了一种用于半定量检测CRP以区分细菌和病毒感染的InfectCheck条形码式侧向流动分析方法。通过简单地计算测试装置CRP测试区出现的红线数量，可以评估细菌感染的严重程度。如果在CRP测试区仅出现一条可见线，则表示CRP水平<10mg/L的低炎症或轻度炎症。两条和三条可见线分别表示中度（≥10 - 25mg/L）和重度（≥25 - 50mg/L）炎症，而四条可见线代表非常严重的炎症（≥50 - 100mg/L）。如果可见线变模糊且第一条线的强度弱于对照线甚至可能消失，则此结果对应于超严重炎症阶段（≥100mg/L）。对通过威尔士亲王医院急症室入院的500名患者进行了检查。InfectCheck CRP条形码式快速检测的灵敏度高达88.7%，阴性预测值高达93.8%。这一结果表明该快速检测对于排除未感染患者是可靠的。在五个CRP浓度范围内计算的批内和批间变异系数均在20.0%以内。这是一种无需任何样品预处理的一步式全血快速检测，结果可在20分钟内获得。这种用户友好的诊断工具允许有兴趣的个人进行自我检测，无需任何昂贵的读取设备。
