Simple, sensitive, specific self-sampling assay secures SARS-CoV-2 antibody signals in sero-prevalence and post-vaccine studies.
Simple, sensitive, specific self-sampling assay secures SARS-CoV-2 antibody signals in sero-prevalence and post-vaccine studies.
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DOI：
10.1038/s41598-022-05640-x
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发表时间：
2022-02-03
影响因子：
4.6
通讯作者：
Tedder RS
中科院分区：
文献类型：
--
作者：
Khan M;Rosadas C;Katsanovskaja K;Weber ID;Shute J;Ijaz S;Marchesin F;McClure E;Elias S;Flower B;Gao H;Quinlan R;Short C;Rosa A;Roustan C;Moshe M;Taylor GP;Elliott P;Cooke GS;Cherepanov P;Parker E;McClure MO;Tedder RS
家庭采样是大规模血清阳性率研究的关键。干血斑（DBS）自我采样消除了对医务人员进行样本采集的需要，但有助于将样本转介到适当认可的实验室进行准确的样本分析。建立一种高灵敏度和特异性的抗体检测方法，以便于流行率和疫苗反应研究的自我采样。通过捕获ELISA法测定了从439名血清阳性和382名血清阴性个体收集的配对血清和DBS洗脱液以及从34名疫苗接种者收集的DBS，以检测SARS-CoV-2的IgG和IgM抗体。与血清相比，DBS洗脱液上的IgG和IgM组合的诊断灵敏度为97.9%（95%CI 96.6至99.3），特异性为99.2%（95%CI 98.4至100），显示的检测限分别相当于23和10 WHO IU/ml。观察到血清和DBS反应性之间存在强相关性（r = 0.81）。故意使样品不充分（p = 0.234）以及样品意外损坏或“无效”时，反应性保持稳定。所有疫苗接种者均为血清阳性。该检测试剂盒提供了一种安全的DBS自采样方法，其灵敏度与血清相当。DBS检测在血清流行率研究和疫苗接种后应答监测中的可行性得到了证实，为人群水平的血清学监测提供了一种稳健可靠的工具。
At-home sampling is key to large scale seroprevalence studies. Dried blood spot (DBS) self-sampling removes the need for medical personnel for specimen collection but facilitates specimen referral to an appropriately accredited laboratory for accurate sample analysis. To establish a highly sensitive and specific antibody assay that would facilitate self-sampling for prevalence and vaccine-response studies. Paired sera and DBS eluates collected from 439 sero-positive, 382 sero-negative individuals and DBS from 34 vaccine recipients were assayed by capture ELISAs for IgG and IgM antibody to SARS-CoV-2. IgG and IgM combined on DBS eluates achieved a diagnostic sensitivity of 97.9% (95%CI 96.6 to 99.3) and a specificity of 99.2% (95% CI 98.4 to 100) compared to serum, displaying limits of detection equivalent to 23 and 10 WHO IU/ml, respectively. A strong correlation (r = 0.81) was observed between serum and DBS reactivities. Reactivity remained stable with samples deliberately rendered inadequate, (p = 0.234) and when samples were accidentally damaged or ‘invalid’. All vaccine recipients were sero-positive. This assay provides a secure method for self-sampling by DBS with a sensitivity comparable to serum. The feasibility of DBS testing in sero-prevalence studies and in monitoring post-vaccine responses was confirmed, offering a robust and reliable tool for serological monitoring at a population level.
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DOI：
10.1016/s0140-6736(20)32661-1
发表时间：
2021-01-09
期刊：
Lancet (London, England)
影响因子：
--
作者：
Voysey M;Clemens SAC;Madhi SA;Weckx LY;Folegatti PM;Aley PK;Angus B;Baillie VL;Barnabas SL;Bhorat QE;Bibi S;Briner C;Cicconi P;Collins AM;Colin-Jones R;Cutland CL;Darton TC;Dheda K;Duncan CJA;Emary KRW;Ewer KJ;Fairlie L;Faust SN;Feng S;Ferreira DM;Finn A;Goodman AL;Green CM;Green CA;Heath PT;Hill C;Hill H;Hirsch I;Hodgson SHC;Izu A;Jackson S;Jenkin D;Joe CCD;Kerridge S;Koen A;Kwatra G;Lazarus R;Lawrie AM;Lelliott A;Libri V;Lillie PJ;Mallory R;Mendes AVA;Milan EP;Minassian AM;McGregor A;Morrison H;Mujadidi YF;Nana A;O'Reilly PJ;Padayachee SD;Pittella A;Plested E;Pollock KM;Ramasamy MN;Rhead S;Schwarzbold AV;Singh N;Smith A;Song R;Snape MD;Sprinz E;Sutherland RK;Tarrant R;Thomson EC;Török ME;Toshner M;Turner DPJ;Vekemans J;Villafana TL;Watson MEE;Williams CJ;Douglas AD;Hill AVS;Lambe T;Gilbert SC;Pollard AJ;Oxford COVID Vaccine Trial Group
通讯作者：
Oxford COVID Vaccine Trial Group
BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
影响因子：
11.8
作者：
Morley GL;Taylor S;Jossi S;Perez-Toledo M;Faustini SE;Marcial-Juarez E;Shields AM;Goodall M;Allen JD;Watanabe Y;Newby ML;Crispin M;Drayson MT;Cunningham AF;Richter AG;O'Shea MK
通讯作者：
O'Shea MK
影响因子：
3.7
作者：
McDade, Thomas W.;McNally, Elizabeth M.;Demonbreun, Alexis R.
通讯作者：
Demonbreun, Alexis R.
影响因子：
5.2
作者：
Kumleben, N.;Bhopal, R.;Stigler, F. L.
通讯作者：
Stigler, F. L.