Yoon Sumi, Lim Yong Kwan, Kweon Oh Joo, Kim Tae-Hyoung, Lee Mi-Kyung
Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.
Department of Urology, Chung-Ang University College of Medicine, Seoul, South Korea.
Heliyon. 2023 Aug 29;9(9):e19492. doi: 10.1016/j.heliyon.2023.e19492. eCollection 2023 Sep.
'ACROSIS COVID-19 Ag (NPS)' kit (SG Medical, Seoul, Korea) is a newly developed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen-detection rapid diagnostic test (Ag-RDT) using surface-enhanced Raman scattering (SERS)-based lateral flow immunoassay (LFIA). We evaluated its clinical performance compared with STANDARD Q COVID-19 Ag (SD Biosensor, Suwon, Korea), a previously approved Ag-RDT.
A total of 286 nasopharyngeal swab specimens were collected: 104 positive and 182 negative specimens in SARS-CoV-2 real-time reverse-transcription polymerase-chain-reaction (rRT-PCR). SARS-CoV-2-positive specimens were divided according to the cycle threshold (Ct) value in rRT-PCR. The clinical performance of ACROSIS was compared with that of STANDARD Q.
ACROSIS showed significantly higher sensitivity than STANDARD Q (92.3% vs. 85.6%, = 0.02), especially in specimens with 25 ≤ Ct < 30 (78.6% vs. 42.9%). The Ct values of / genes for 95% detection rates by ACROSIS and STANDARD Q were 25.8 and 23.0, respectively.
This is the first study that evaluated the performance of ACROSIS compared with STANDARD Q. The overall clinical performance of ACROSIS was superior to that of STANDARD Q, especially in specimens with 25 ≤ Ct < 30. ACROSIS could be useful for SARS-CoV-2 Ag detection even in relatively low viral load specimens.
“ACROSIS COVID-19 Ag（鼻咽拭子）”试剂盒（SG Medical，韩国首尔）是一种新开发的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）抗原检测快速诊断测试（Ag-RDT），采用基于表面增强拉曼散射（SERS）的侧向流动免疫分析（LFIA）。我们将其与先前批准的Ag-RDT“STANDARD Q COVID-19 Ag”（SD Biosensor，韩国水原）的临床性能进行了评估。
共收集了286份鼻咽拭子标本：在SARS-CoV-2实时逆转录聚合酶链反应（rRT-PCR）中，104份阳性标本和182份阴性标本。SARS-CoV-2阳性标本根据rRT-PCR中的循环阈值（Ct）值进行划分。将ACROSIS的临床性能与STANDARD Q的临床性能进行比较。
ACROSIS显示出比STANDARD Q显著更高的灵敏度（92.3%对85.6%，P = 0.02），尤其是在25≤Ct<30的标本中（78.6%对42.9%）。ACROSIS和STANDARD Q检测率达到95%时的/基因Ct值分别为25.8和23.0。
这是第一项将ACROSIS与STANDARD Q的性能进行评估比较的研究。ACROSIS的总体临床性能优于STANDARD Q，尤其是在25≤Ct<30的标本中。即使在病毒载量相对较低的标本中，ACROSIS也可用于SARS-CoV-2抗原检测。
