Department of Infectious Disease, Scholl of Medicine, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
Department of Genetic, Institute of Biology, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
Braz J Infect Dis. 2021 Sep-Oct;25(5):101630. doi: 10.1016/j.bjid.2021.101630. Epub 2021 Oct 12.
In the current standard of care (SoC) RT-PCR method for COVID-19, the patient's swab was extracted in viral transport media (VTM). For the Panbio™ COVID-19 Ag Rapid Test, the patient swab is flushed out in extraction buffer, of which a small fraction is used for testing, leaving more than half the sample unused. This study was designed to show that RT-PCR results from the residual sample of the Panbio™ COVID-19 Ag Rapid Test (called Novel RT-PCR) are not worse than the SoC RT-PCR result.
The study was performed using (1) dilution series of five patient samples, and (2) 413 patient samples comparing SOC versus Novel RT-PCR results.
For the dilution series samples, all tested positive by both methods. The bias between Ct values of Novel RT-PCR and SoC RT-PCR did not exceed 3.00 Ct using primers N1 and N2. A total of 413 COVID symptomatic patients seeking COVID testing were tested, of which 89 patients tested positive and 324 tested negative with SoC RT-PCR. In 324 patients who tested negative with SoC RT-PCR, 323 tested negative with Novel RT-PCR, and one (1) tested positive. Out of 89 who tested positive with SoC RT-PCR, 80 tested positive with the Novel RT-PCR, and nine patients showed a negative test result. The Overall Percent Agreement for the 413 valid patient sample pairs was 97.5 [95% CI 97 to 98].
The study demonstrated that the performance of the Novel RT-PCR method is acceptable compared to the SoC RT-PCR method and can be a useful tool to perform RT-PCR without the need for new swab collections.
在当前 COVID-19 的标准护理（SoC）实时荧光 RT-PCR 方法中，患者的拭子在病毒运输介质（VTM）中提取。对于 Panbio™ COVID-19 Ag 快速检测，患者的拭子在提取缓冲液中冲洗出来，其中一小部分用于检测，留下超过一半的样本未使用。本研究旨在证明 Panbio™ COVID-19 Ag 快速检测的剩余样本（称为新型 RT-PCR）的 RT-PCR 结果并不逊于 SoC RT-PCR 结果。
该研究使用（1）五个患者样本的稀释系列，和（2）413 个患者样本比较 SoC 与新型 RT-PCR 结果。
对于稀释系列样本，两种方法均检测为阳性。新型 RT-PCR 和 SoC RT-PCR 的 Ct 值之间的偏差不超过 3.00 使用引物 N1 和 N2。总共对 413 名寻求 COVID 检测的 COVID 症状患者进行了检测，其中 89 名患者用 SoC RT-PCR 检测为阳性，324 名患者检测为阴性。在用 SoC RT-PCR 检测为阴性的 324 名患者中，323 名用新型 RT-PCR 检测为阴性，1 名（1）检测为阳性。在 89 名用 SoC RT-PCR 检测为阳性的患者中，80 名用新型 RT-PCR 检测为阳性，9 名患者检测结果为阴性。413 对有效患者样本对的总一致性为 97.5%[95%置信区间 97 至 98]。
该研究表明，新型 RT-PCR 方法的性能可与 SoC RT-PCR 方法相媲美，并且可以作为一种无需新拭子采集即可进行 RT-PCR 的有用工具。
