■\'急性COVID-19Ag(NPS)\'试剂盒(SGMedical,首尔,韩国)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),使用基于表面增强拉曼散射(SERS)的侧流免疫测定法(LFIA)。我们评估了其与标准QCOVID-19Ag(SD生物传感器,水原,Korea),以前批准的Ag-RDT。
■共收集了286个鼻咽拭子标本:SARS-CoV-2实时逆转录聚合酶链反应(rRT-PCR)中的104个阳性标本和182个阴性标本。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的临床表现与标准Q的临床表现进行比较。
■ACROSIS的敏感性明显高于标准Q(92.3%vs.85.6%,P=0.02),尤其是在25≤Ct<30的标本中(78.6%vs.42.9%)。RdRp/S基因的Ct值通过ACROSIS和STANDARDQ检测为95%,分别为25.8和23.0。
■这是第一项与标准Q相比评估ACROSIS表现的研究。ACROSIS的总体临床表现优于标准Q,尤其是在25≤Ct<30的标本中。即使在相对较低的病毒载量标本中,ACROSIS也可用于SARS-CoV-2Ag的检测。
UNASSIGNED: \'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.
UNASSIGNED: 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.
UNASSIGNED: ACROSIS showed significantly higher sensitivity than STANDARD Q (92.3% vs. 85.6%, P = 0.02), especially in specimens with 25 ≤ Ct < 30 (78.6% vs. 42.9%). The Ct values of RdRp/S genes for 95% detection rates by ACROSIS and STANDARD Q were 25.8 and 23.0, respectively.
UNASSIGNED: 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.