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. 2017 Feb 2;55(2):139-143.
doi: 10.3760/cma.j.issn.0578-1310.2017.02.017.

[Clinical value of a rapid respiratory syncytial virus antigen detection in point-of-care testing]

[Article in Chinese]
Y X Ding  1 , R Tian, Y Qian, Y Sun, J Deng, F Wang, R N Zhu, L Q Zhao
Affiliations

[Clinical value of a rapid respiratory syncytial virus antigen detection in point-of-care testing]

[Article in Chinese]
Y X Ding et al. Zhonghua Er Ke Za Zhi. .

Abstract
in English, Chinese

Objective: To evaluate the clinical value of a rapid respiratory syncytial virus (RSV) antigen detection in point-of-care testing (POCT). Method: A total of 209 specimens, including 78 throat swabs (TS) and 131 nasopharyngeal aspirates (NPAs), were collected from inpatients who visited the Children's Hospital Affiliated to the Capital Institute of Pediatrics and were diagnosed as acute respiratory infection from 5 January to 7 February, 2015. These specimens were tested for RSV by a rapid antigen detection kit which was compared with reverse transcription polymerase chain reaction (RT-PCR) and direct immunofluorescence assay (DFA) for RSV detection. Result: Compared with DFA for NPAs, the sensitivity and specificity of rapid antigen detection were 83.9% and 97.3%, respectively, with Kappa value of 0.86; Compared with RT-PCR, the sensitivity (NPAs, 74.2%; TS, 77.8%) and specificity (NPAs, 100.0%; TS, 92.0%) of rapid antigen detection were high, too, with Kappa value of 0.74 in NPAs and 0.62 in TS. However, the RSV positive rate of rapid antigen detection in TS (21.7%) from pediatric patients with acute lower respiratory tract infection was lower than that in NPAs (78.3%), as well as that of RT-PCR (7.3% in TS verse 78% in NPAs). The RSV rapid antigen detection kit can be finished in about 10 minutes. Conclusion: With characteristics of high specificity, high sensitivity, being rapid, efficient and easy to operate in comparison with DFA and RT-PCR, RSV rapid antigen detection in this study is suitable for POCT. For pediatric patients with acute respiratory tract infection, NPA was better than TS for RSV detection.

目的： 探讨呼吸道合胞病毒(RSV)快速抗原检测方法的临床实用性，为临床选择床旁检测方法提供依据。 方法： 收集2015年1月5日至2月7日首都儿科研究所附属儿童医院临床疑为病毒感染的急性呼吸道感染(ARI)住院患儿呼吸道标本209份，其中包括咽拭子标本78份、鼻咽分泌物标本131份。应用免疫层析方法，对上述标本进行RSV快速抗原检测，应用转录(RT)-巢式PCR进行RSV核酸检测。对其中的鼻咽分泌物标本，同时应用直接免疫荧光进行RSV抗原检测。统计学分析快速抗原检测方法的灵敏度、特异度及与对照方法间的一致性。 结果： RSV快速抗原检测方法与直接免疫荧光相比较，在鼻咽分泌物检测中特异度为97.3%，灵敏度为83.9%，两种方法的一致性检验Kappa＝0.86；χ(2)＝73.956 1，P<0.01；与RT-巢式PCR相比较，特异度在鼻咽分泌物中为100.0%，咽拭子中为92.0%，灵敏度在鼻咽分泌物中为74.2%，咽拭子中为77.8%，两种方法的一致性检验在鼻咽分泌物中Kappa＝0.74，χ(2)＝73.956 1，P<0.01，在咽拭子中Kappa＝0.62，χ(2)＝25.247 8，P<0.01。采用RSV快速抗原和RT-巢式PCR检测，咽拭子标本的RSV阳性检出率(21.7%、7.3%)均明显低于鼻咽分泌物标本(78.3%、78.0%)。RSV快速抗原检测方法可床旁、手工操作，整体操作所需时间约为10 min。 结论： RSV快速抗原检测方法与直接免疫荧光及RT-巢式PCR方法相比较，有很好的灵敏度与特异度，RSV快速抗原检测为RSV阳性的标本可确定为阳性，但阴性结果需要进一步经直接免疫荧光及RT-巢式PCR方法确证；对临床诊断为急性呼吸道感染的儿童进行RSV检测时更适合用鼻咽分泌物标本；RSV快速抗原检测方法具有快速、高效、操作方便等特点，适合于床旁检测。.

Keywords: Antigen detection; Point-of-care testing; Respiratory syncytial virus.

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