Schildgen Verena, Demuth Sabrina, Lüsebrink Jessica, Schildgen Oliver
Institut für Pathologie, Kliniken der Stadt Köln, 51109 Cologne, Germany.
Pathogens. 2021 Jan 5;10(1):38. doi: 10.3390/pathogens10010038.
Due to the steadily rising case numbers of SARS-CoV-2 infections worldwide, there is an increasing need for reliable rapid diagnostic devices in addition to existing gold standard PCR methods. Actually, public attention is focused on antigen assays including lateral flow tests (LFTs) as a diagnostic alternative. Therefore, different LFTs were analyzed regarding their performance in a clinical setting.
A pilot sample panel of 13 bronchoalveolar fluids (BALFs) and 60 throat washing (TW) samples with confirmed PCR results, as well as eight throat washes invalid by PCR, were tested with the BIOCREDIT test (RapiGEN), the Panbio assay (Abbott), and the SARS-CoV-2 rapid antigen test (Roche).
The analyzed antigen test showed an interassay correlation of 27.4%, with overall specificities ranging from 19.4% to 87.1%, while sensitivities of the respective tests ranged between 33.3% and 88.1%. Because these assays did not entirely meet all high expectations, their benefit has to be carefully evaluated for the respective test strategy and setting.
由于全球范围内严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染病例数持续上升，除了现有的金标准聚合酶链反应（PCR）方法外，对可靠的快速诊断设备的需求日益增加。实际上，公众的注意力集中在包括侧向流动测试（LFTs）在内的抗原检测上，将其作为一种诊断选择。因此，对不同的LFTs在临床环境中的性能进行了分析。
用BIOCREDIT测试（RapiGEN）、Panbio检测（雅培）和SARS-CoV-2快速抗原检测（罗氏）对一个试点样本组进行检测，该样本组包括13份支气管肺泡灌洗液（BALFs）和60份咽喉冲洗液（TW）样本，其PCR结果已得到确认，还有8份咽喉冲洗液样本经PCR检测无效。
所分析的抗原检测显示各检测方法之间的相关性为27.4%，总体特异性范围为19.4%至87.1%，而各检测方法的敏感性范围在33.3%至88.1%之间。由于这些检测方法并未完全满足所有的高期望，因此必须针对各自的检测策略和环境仔细评估其益处。
