比较两种不同一步法联合检测试剂盒的检测性能，这两种试剂盒分别以荧光微球和彩色微球作为流感 A 型和 B 型病毒的示踪剂。
Comparison of the detection performance of two different one-step-combined test strips with fluorescent microspheres or colored microspheres as tracers for influenza A and B viruses.
机构信息
Institute of Nephrology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China.
Clinical Research Center, Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China.
出版信息
Virol J. 2019 Jul 19;16(1):91. doi: 10.1186/s12985-019-1190-0.
BACKGROUND
Influenza A and B viruses mainly cause respiratory infectious disease. Till now, few tests are able to simultaneously detect both, especially in primary medical establishments.
METHODS
This study was designed to compare the performance of two different one-step-combined test strips for the detection of influenza A and B: one strip with fluorescent microspheres for tracers (FMT); and the other strip with colored microspheres for tracers (CMT). To test the strips, cultures of influenza A, B, and other pathogenic viruses were used, in addition to 1085 clinical specimens from symptomatic patients with respiratory infections. Real-time RT-PCR was also considered as a reference method used to detect the different results of FMT and CTM.
RESULTS
Detection thresholds for influenza A and B cultures using serial dilutions revealed that the sensitivity of FMT was higher than that of CMT (both P < 0.05). With the culture mixtures of Coxsackie virus (A16), enteric cytopathic human orphan virus (ECHO type30), enterovirus (EV71), rotavirus (LLR strain), and enteric adenovirus (AdV 41), specificity assessment demonstrated that there was no cross reaction during the usage of the two test strips as shown by the results which were negative. In the detection of influenza A in 1085 clinical specimens, the total coincidence rate was 96.7%, the positive coincidence rate was 97.1%, and the negative coincidence rate was 96.7%. In the case of influenza B detection, the total coincidence rate was 99.1%, the positive coincidence rate was 92.6%, and the negative coincidence rate was 98.5%. In addition, with influenza A or B real-time RT-PCR detection method, the results showed that, for influenza A, 26 of the 33 specimens that negative with CMT but positive with FMT, showed positive results, and none of the 3 specimens that positive with CMT but negative with FMT showed a positive result; For influenza B, 12 of the 15 specimens that negative with CMT but positive with FMT, showed positive results, and none of the 5 specimens that positive with CMT but negative with FMT showed a positive result.
CONCLUSIONS
FMT performed better than CMT in the combined detection of influenza A and B viruses.
背景
甲型和乙型流感病毒主要引起呼吸道传染病。到目前为止，很少有检测方法能够同时检测到这两种病毒，特别是在基层医疗机构。
方法
本研究旨在比较两种不同的一步法联合检测试剂盒对甲型和乙型流感的检测性能：一种试剂盒使用荧光微球作为示踪剂（FMT）；另一种试剂盒使用彩色微球作为示踪剂（CMT）。为了测试这些试剂盒，我们使用流感 A、B 和其他致病病毒的培养物，以及 1085 份有呼吸道感染症状的患者的临床标本。实时 RT-PCR 也被认为是一种参考方法，用于检测 FMT 和 CMT 的不同结果。
结果
使用连续稀释法检测流感 A 和 B 培养物的检测阈值表明，FMT 的灵敏度高于 CMT（均 P<0.05）。用柯萨奇病毒（A16）、肠道细胞病变人孤儿病毒（ECHO 30 型）、肠道病毒（EV71）、轮状病毒（LLR 株）和肠道腺病毒（AdV 41）的混合培养物进行特异性评估表明，两种试剂盒在使用过程中没有交叉反应，结果均为阴性。在 1085 份临床标本中检测甲型流感时，总符合率为 96.7%，阳性符合率为 97.1%，阴性符合率为 96.7%。乙型流感检测时，总符合率为 99.1%，阳性符合率为 92.6%，阴性符合率为 98.5%。此外，用甲型或乙型流感实时 RT-PCR 检测方法，结果显示，对于甲型流感，33 份 CMT 阴性而 FMT 阳性的标本中，有 26 份为阳性，而 FMT 阳性而 CMT 阴性的 3 份标本均为阴性；对于乙型流感，15 份 CMT 阴性而 FMT 阳性的标本中，有 12 份为阳性，而 CMT 阳性而 FMT 阴性的 5 份标本均为阴性。
结论
FMT 在联合检测甲型和乙型流感病毒方面优于 CMT。
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