Clinical Microbiology Laboratory, "Attikon" University Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Front Public Health. 2022 Apr 25;10:840984. doi: 10.3389/fpubh.2022.840984. eCollection 2022.
As the COVID-19 pandemic resurges affecting large numbers of patients, rapid, and accurate diagnosis using point-of-care tests is very important.
To evaluate the NG-Test SARS-CoV-2 Ag (NG-Test) immunoassay for qualitative detection of SARS-CoV-2 antigen in nasopharyngeal (NP) and oropharyngeal (OP) samples compared with RT-PCR, in patients attending the Emergencies of an academic referral hospital.
All adult ambulatory patients presenting to the Emergencies of "Attikon" University hospital (Athens, Greece) within three consecutive hours per day between December 2020 and March 2021 and for whom SARS-CoV-2 PCR testing was requested were included. Two NP and one OP samples obtained from each participant were analyzed to determine the diagnostic performance [sensitivity, specificity, positive/negative predictive values (PPV/NPV)] of the NG-Test (NP/OP swabs) in comparison to the reference RT-PCR (NP swab).
Overall, 134/263 (51%) patients tested were RT-PCR positive, whereof 108 (overall sensitivity 81%, 95% CI 73-87%) were NP NG-Test positive (PPV 99%, NPV 83%) and 68 (overall sensitivity 51%, 95% CI 42-59%) were OP NG-Test positive (PPV 100%, NPV 66%). The test's specificity (95% CI) was 99% (95-100%) and 100% (96-100%) for NP and OP swabs, respectively. The assay's sensitivity (95% CI) for high viral load (C ≤25) was 99% (92-100%) and 71% (60-81%) for NP and OP swabs, respectively.
NG-Test using NP swabs detected almost all patients with high viral loads, showing satisfactory performance as a point-of-care test for NP samples obtained from patients with acute infection.
随着 COVID-19 大流行的反弹，大量患者需要快速、准确的诊断，床边即时检测（POCT）非常重要。
评估 NG-Test SARS-CoV-2 Ag（NG-Test）免疫测定法用于定性检测鼻咽（NP）和口咽（OP）样本中的 SARS-CoV-2 抗原，与 RT-PCR 相比，用于就诊于学术转诊医院急诊科的患者。
纳入 2020 年 12 月至 2021 年 3 月期间，每天连续 3 小时内每天到希腊雅典“Attikon”大学医院急诊科就诊的所有成年门诊患者，并且这些患者都需要进行 SARS-CoV-2 PCR 检测。对每位患者采集的两个 NP 和一个 OP 样本进行分析，以确定 NG-Test（NP/OP 拭子）的诊断性能[灵敏度、特异性、阳性/阴性预测值（PPV/NPV）]，与参考 RT-PCR（NP 拭子）相比。
共有 134/263（51%）患者的 RT-PCR 检测结果为阳性，其中 108 例（总体敏感性为 81%，95%CI 73-87%）为 NP NG-Test 阳性（PPV 为 99%，NPV 为 83%），68 例（总体敏感性为 51%，95%CI 42-59%）为 OP NG-Test 阳性（PPV 为 100%，NPV 为 66%）。该检测的特异性（95%CI）分别为 NP 和 OP 拭子的 99%（95-100%）和 100%（96-100%）。该检测对高病毒载量（C ≤25）的敏感性（95%CI）分别为 NP 和 OP 拭子的 99%（92-100%）和 71%（60-81%）。
使用 NP 拭子的 NG-Test 检测到几乎所有高病毒载量的患者，作为急性感染患者 NP 样本的 POCT，表现出令人满意的性能。
