Department of Respiratory Medicine, The Military General Hospital of Beijing PLA, Beijing, PR China.
Clin Chem Lab Med. 2011 Sep;49(9):1533-7. doi: 10.1515/CCLM.2011.235.
A low cost colloidal gold immunochromatographic assay (GICA) for rapid detection of influenza A virus was developed. The assay was evaluated in this study.
Six hundred and twenty-six patients were enrolled. All patients contributed two pharyngeal swabs, one used for colloidal gold immunochromatographic rapid assay for influenza A virus immediately after the collection of specimen and one used for real-time reverse transcriptase polymerase chain reaction (RT-PCR) test or virus culture at the Centers for Disease Control and Prevention (CDC) influenza network laboratory.
In reference to viral culture, GICA influenza A test demonstrated a sensitivity of 64%, a specificity of 95% and an overall accuracy of 93%. Consistency between the GICA test and virus culture assay is moderate, with Kappa being 0.46. In reference to RT-PCR, GICA test demonstrated considerable high sensitivity (74%) and specificity (86%), with Kappa value being 0.61 and overall accuracy of 81%. There was no significant difference between GICA test and virus culture/RT-PCR on the detected positive rates of influenza A cases.
GICA is a reliable, rapid, convenient and inexpensive test for the screening and diagnosis of influenza A disease. Given its lower cost than other rapid tests, the GICA test has the great potential in the management of influenza A disease in resource-poor countries.
开发了一种用于快速检测甲型流感病毒的低成本胶体金免疫层析检测法（GICA）。本研究对该检测方法进行了评估。
共纳入 626 例患者。所有患者均采集两份咽拭子，一份立即用于胶体金免疫层析快速检测甲型流感病毒，另一份用于疾病预防控制中心（CDC）流感网络实验室的实时逆转录聚合酶链反应（RT-PCR）检测或病毒培养。
以病毒培养为参照，GICA 甲型流感检测的灵敏度为 64%，特异性为 95%，总准确率为 93%。GICA 检测与病毒培养检测之间的一致性为中等，Kappa 值为 0.46。与 RT-PCR 相比，GICA 检测具有较高的灵敏度（74%）和特异性（86%），Kappa 值为 0.61，总准确率为 81%。GICA 检测与病毒培养/RT-PCR 在甲型流感病例的阳性检出率方面无显著差异。
GICA 是一种可靠、快速、方便、廉价的甲型流感疾病筛查和诊断方法。鉴于其比其他快速检测方法成本更低，GICA 检测在资源匮乏国家管理甲型流感疾病方面具有巨大潜力。
