Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration.

Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration.
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DOI:
10.1038/s41598-021-94055-1
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发表时间:
2021-07-16
期刊:
影响因子:
4.6
通讯作者:
Lam WA
Lam WA
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Frediani JK;Levy JM;Rao A;Bassit L;Figueroa J;Vos MB;Wood A;Jerris R;Van Leung-Pineda;Gonzalez MD;Rogers BB;Mavigner M;Schinazi RF;Schoof N;Waggoner JJ;Kempker RR;Rebolledo PA;O'Neal JW;Stone C;Chahroudi A;Morris CR;Suessmith A;Sullivan J;Farmer S;Foster A;Roback JD;Ramachandra T;Washington C;Le K;Cordero MC;Esper A;Nehl EJ;Wang YF;Tyburski EA;Martin GS;Lam WA

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尽管新型冠状病毒快速诊断技术的发展取得了重大进展,但随着疫情的发展,新的挑战出现了,包括这些技术是否能够可靠地检测出感染性更强的受关注变种,并作为“自我检测”在非临床环境中可行地部署。Abbott BinaxNOW COVID-19 Ag Card(BinaxNOW,一种广泛使用的快速抗原检测试剂)的多学科评价,包括检出限、变异检测、不同年龄组的检测性能以及自我/自我管理的可用性。虽然BinaxNOW检测到了高度传染性的变异体,B.1.1.7(Alpha)首先在英国发现,B.1.351(Beta)首先在南非发现,P.1(Gamma)首先在巴西发现,B.1.617.2(Delta)首先在印度发现,B.1.2是一种非VOC,但随着病毒载量的降低,检测灵敏度下降。此外,尽管在不同年龄组中自我/护理人员给药后的可用性评估普遍较高,但与经过培训的临床工作人员相比,由患者/护理人员自己使用器械时,BinaxNOW的灵敏度倾向于较低。总的来说,这些数据表明,虽然BinaxNOW准确地检测到了新的病毒变种,但随着快速COVID-19检测进入家庭,由于用户错误,它们与RT-PCR相比已经较低的灵敏度可能会下降更多。
While there has been significant progress in the development of rapid COVID-19 diagnostics, as the pandemic unfolds, new challenges have emerged, including whether these technologies can reliably detect the more infectious variants of concern and be viably deployed in non-clinical settings as “self-tests”. Multidisciplinary evaluation of the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW, a widely used rapid antigen test, included limit of detection, variant detection, test performance across different age-groups, and usability with self/caregiver-administration. While BinaxNOW detected the highly infectious variants, B.1.1.7 (Alpha) first identified in the UK, B.1.351 (Beta) first identified in South Africa, P.1 (Gamma) first identified in Brazil, B.1.617.2 (Delta) first identified in India and B.1.2, a non-VOC, test sensitivity decreased with decreasing viral loads. Moreover, BinaxNOW sensitivity trended lower when devices were performed by patients/caregivers themselves compared to trained clinical staff, despite universally high usability assessments following self/caregiver-administration among different age groups. Overall, these data indicate that while BinaxNOW accurately detects the new viral variants, as rapid COVID-19 tests enter the home, their already lower sensitivities compared to RT-PCR may decrease even more due to user error.
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