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Abstract：
As the COVID-19 pandemic moves towards endemic status, testing strategies are being de-escalated. A rapid and effective point of care test (POCT) assessment of SARS-CoV-2 immune responses can inform clinical decision-making and epidemiological monitoring of the disease. This cross-sectional seroprevalence study of anti-SARS-CoV-2 antibodies in Irish healthcare workers assessed how rapid anti-SARS-CoV-2 antibody testing can be compared to a standard laboratory assay, discusses its effectiveness in neutralisation assessment and its uses into the future of the pandemic.
A point of care lateral flow immunoassay (LFA) detecting anti-SARS-CoV-2 spike (S)-receptor binding domain (RBD) neutralising antibodies (Healgen SARS-CoV-2 neutralising Antibody Rapid Test Cassette) was compared to the Roche Elecsys/-S anti-SARS-CoV-2 antibody assays and an in vitro surrogate neutralisation assay. A correlation between anti-spike (S), anti-nucleocapsid (N) titres, and in vitro neutralisation was also assessed.
1,777 serology samples were tested using Roche Elecsys/-S anti-SARS-CoV-2 assays to detect total anti-N/S antibodies. 1,562 samples were tested using the POC LFA (including 50 negative controls), and 90 samples were tested using an in vitro ACE2-RBD binding inhibition surrogate neutralisation assay. The POCT demonstrated 97.7% sensitivity, 100% specificity, a positive predictive value (PPV) of 100%, and a negative predictive value (NPV) of 61% in comparison to the commercial assay. Anti-S antibody titres determined by the Roche assay stratified by the POC LFA result groups demonstrated statistically significant differences between the \"Positive\" and \"Negative\" LFA groups (p < 0.0001) and the \"Weak Positive\" and \"Positive\" LFA groups (p < 0.0001). No statistically significant difference in ACE2-RBD binding inhibition was demonstrated when stratified by the LFA POC results. A positive, statistically significant correlation was demonstrated between the in vitro pseudo-neutralisation assay results and anti-S antibody titres (rho 0.423, p < 0.001) and anti-N antibody titres (rho = 0.55, p < 0.0001).
High sensitivity, specificity, and PPV were demonstrated for the POC LFA for the detection of anti-S-RBD antibodies in comparison to the commercial assay. The LFA was not a reliable determinant of the neutralisation capacity of identified antibodies. POC LFA are useful tools in sero-epidemiology settings, pandemic preparedness and may act as supportive tools in treatment decisions through the rapid identification of anti-Spike antibodies.
A point of care lateral flow immunoassay (LFA) detecting anti-SARS-CoV-2 spike (S)-receptor binding domain (RBD) neutralising antibodies (Healgen SARS-CoV-2 neutralising Antibody Rapid Test Cassette) was compared to the Roche Elecsys/-S anti-SARS-CoV-2 antibody assays and an in vitro surrogate neutralisation assay. A correlation between anti-spike (S), anti-nucleocapsid (N) titres, and in vitro neutralisation was also assessed.
1,777 serology samples were tested using Roche Elecsys/-S anti-SARS-CoV-2 assays to detect total anti-N/S antibodies. 1,562 samples were tested using the POC LFA (including 50 negative controls), and 90 samples were tested using an in vitro ACE2-RBD binding inhibition surrogate neutralisation assay. The POCT demonstrated 97.7% sensitivity, 100% specificity, a positive predictive value (PPV) of 100%, and a negative predictive value (NPV) of 61% in comparison to the commercial assay. Anti-S antibody titres determined by the Roche assay stratified by the POC LFA result groups demonstrated statistically significant differences between the \"Positive\" and \"Negative\" LFA groups (p < 0.0001) and the \"Weak Positive\" and \"Positive\" LFA groups (p < 0.0001). No statistically significant difference in ACE2-RBD binding inhibition was demonstrated when stratified by the LFA POC results. A positive, statistically significant correlation was demonstrated between the in vitro pseudo-neutralisation assay results and anti-S antibody titres (rho 0.423, p < 0.001) and anti-N antibody titres (rho = 0.55, p < 0.0001).
High sensitivity, specificity, and PPV were demonstrated for the POC LFA for the detection of anti-S-RBD antibodies in comparison to the commercial assay. The LFA was not a reliable determinant of the neutralisation capacity of identified antibodies. POC LFA are useful tools in sero-epidemiology settings, pandemic preparedness and may act as supportive tools in treatment decisions through the rapid identification of anti-Spike antibodies.
摘要：
■随着COVID-19大流行走向地方性状态，测试策略正在降级。SARS-CoV-2免疫反应的快速有效的护理点测试（POCT）评估可以为临床决策和疾病的流行病学监测提供信息。这项针对爱尔兰医护人员的抗SARS-CoV-2抗体的横截面血清阳性率研究评估了如何将快速的抗SARS-CoV-2抗体检测与标准实验室检测进行比较，讨论其在中和评估中的有效性及其在大流行未来的用途。
■检测抗SARS-CoV-2尖峰（S）-受体结合域（RBD）中和抗体（HealgenSARS-CoV-2中和抗体快速测试盒）的护理侧流免疫测定（LFA）与RocheElecsys/-S抗SARS-CoV-2抗体测定和体外替代中和测定进行了比较。反尖峰(S)之间的相关性，抗核衣壳(N)滴度，和体外中和也进行了评估。
■使用RocheElecsys/-S抗SARS-CoV-2测定法测试了1,777个血清学样品以检测总抗N/S抗体。使用POCLFA测试了1,562个样品（包括50个阴性对照），使用体外ACE2-RBD结合抑制替代中和测定法测试90个样品。POCT显示97.7%的灵敏度，100%特异性,阳性预测值(PPV)为100%，与商业测定相比，阴性预测值（NPV）为61％。通过按POCLFA结果组分层的Roche测定确定的抗S抗体滴度表明，“阳性”和“阴性”LFA组（p<0.0001）与“弱阳性”和“阳性”LFA组（p<0.0001）之间存在统计学上的显着差异。当通过LFAPOC结果分层时,没有显示ACE2-RBD结合抑制的统计学显著差异。一个积极的,在体外假中和测定结果与抗S抗体滴度(rho0.423,p<0.001)和抗N抗体滴度(rho=0.55,p<0.0001)之间证明了统计学上显著的相关性。
■高灵敏度，特异性，与商业测定相比，POCLFA和PPV用于检测抗S-RBD抗体。LFA不是鉴定的抗体的中和能力的可靠决定因素。POCLFA是血清流行病学环境中的有用工具，大流行的准备，并可以作为支持工具，在治疗决策中通过快速鉴定抗-Spike抗体。
■检测抗SARS-CoV-2尖峰（S）-受体结合域（RBD）中和抗体（HealgenSARS-CoV-2中和抗体快速测试盒）的护理侧流免疫测定（LFA）与RocheElecsys/-S抗SARS-CoV-2抗体测定和体外替代中和测定进行了比较。反尖峰(S)之间的相关性，抗核衣壳(N)滴度，和体外中和也进行了评估。
■使用RocheElecsys/-S抗SARS-CoV-2测定法测试了1,777个血清学样品以检测总抗N/S抗体。使用POCLFA测试了1,562个样品（包括50个阴性对照），使用体外ACE2-RBD结合抑制替代中和测定法测试90个样品。POCT显示97.7%的灵敏度，100%特异性,阳性预测值(PPV)为100%，与商业测定相比，阴性预测值（NPV）为61％。通过按POCLFA结果组分层的Roche测定确定的抗S抗体滴度表明，“阳性”和“阴性”LFA组（p<0.0001）与“弱阳性”和“阳性”LFA组（p<0.0001）之间存在统计学上的显着差异。当通过LFAPOC结果分层时,没有显示ACE2-RBD结合抑制的统计学显著差异。一个积极的,在体外假中和测定结果与抗S抗体滴度(rho0.423,p<0.001)和抗N抗体滴度(rho=0.55,p<0.0001)之间证明了统计学上显著的相关性。
■高灵敏度，特异性，与商业测定相比，POCLFA和PPV用于检测抗S-RBD抗体。LFA不是鉴定的抗体的中和能力的可靠决定因素。POCLFA是血清流行病学环境中的有用工具，大流行的准备，并可以作为支持工具，在治疗决策中通过快速鉴定抗-Spike抗体。
