Internationally standardized respiratory viral load testing with limited resources: A derivative-of-care calibration strategy for SARS-CoV-2.
Internationally standardized respiratory viral load testing with limited resources: A derivative-of-care calibration strategy for SARS-CoV-2.
复制标题
DOI：
10.1111/irv.13207
复制
发表时间：
2024-01
影响因子：
4.4
通讯作者：
Schmitz, Jonathan E.
中科院分区：
文献类型：
--
作者：
Tao, Lili;Chan, Allison;Maris, Alex;Schmitz, Jonathan E.
SARS-CoV-2已经证明，在有针对性的情况下，呼吸道标本中的病毒定量可以为患者管理和研究提供有价值的信息。尽管如此，大流行表明了获得高质量（和广泛可比）呼吸道病毒载量的挑战。这包括对标准化和校准的迫切需求，即使必要的资源可能并不总是可用于紧急病原体和非血流标本。为此，我们描述了一种新的策略，用于实施基于国际单位校准的定量SARS-CoV-2检测。在大流行的早期，当分析资源非常有限时，从我们的诊断实验室的常规护理中选择剩余的SARS-CoV-2阳性标本进行合并，以制定具有临床现实意义的高体积和分析物浓度的二级标准品，并与世界卫生组织的主要SARS-CoV-2标准品进行交叉校准。将所得校准品整合到SARS-CoV-2的原始CDC RT-qPCR检测试剂盒中，定义了其（现已扩展）性能特征，以生成适用于临床和研究用途的检测试剂盒。该检测允许将呼吸道标本中的病毒定量降至经验证的定量下限103.4 IU/ml。通过使用该衍生护理二级标准品自行配制校准品，我们成功验证了呼吸道病毒载量，而无需（当时）商业可用的定量测定或校准品。随着SARS-CoV-2大流行的持续下降-甚至超出了这种病原体-这一策略可能适用于实验室寻求实施非传统标本类型的病毒载量测试，尽管资源有限。
SARS‐CoV‐2 has demonstrated that, in targeted circumstances, viral quantification within respiratory specimens can valuably inform patient management, as well as research. Nevertheless, the pandemic has illustrated concomitant challenges for obtaining high‐quality (and broadly comparable) respiratory viral loads. This includes a critical need for standardization and calibration, even though the necessary resources may not always be available for emergent pathogens and non‐bloodstream specimens. To these ends, we describe a novel strategy for implementing quantitative SARS‐CoV‐2 testing with International Unit‐based calibration. Earlier in the course of the pandemic—when analytic resources were far more limited—select residual SARS‐CoV‐2 positive specimens from routine care in our diagnostic laboratory were pooled to formulate a clinically realistic secondary standard of high volume and analyte concentration, which was cross‐calibrated to the primary SARS‐CoV‐2 standard of the World Health Organization. The resultant calibrators were integrated into the original CDC RT‐qPCR assay for SARS‐CoV‐2, whose (now broadened) performance characteristics were defined to generate a test appropriate for both clinical and research use. This test allowed for the quantification of virus in respiratory specimens down to a validated lower limit of quantification of 103.4 IU/ml. By self‐formulating calibrators from this derivative‐of‐care secondary standard, we successfully validated respiratory viral loads without the commercial availability (at that time) of quantitative assays or calibrators. As the SARS‐CoV‐2 pandemic continues to decline—and even beyond this pathogen—this strategy may be applicable for laboratories seeking to implement viral load testing for nontraditional specimen types despite limited resources.
登录
查看更多内容
影响因子：
3.7
作者：
通讯作者：
--
影响因子：
4.4
作者：
Christensen, Bianca B.;Azar, Marwan M.;Turbett, Sarah E.
通讯作者：
Turbett, Sarah E.
DOI：
10.1007/s10096-020-03913-9
发表时间：
2020-04-27
影响因子：
4.5
作者：
La Scola, Bernard;Le Bideau, Marion;Raoult, Didier
通讯作者：
Raoult, Didier
DOI：
10.1016/s1473-3099(20)30985-3
发表时间：
2021-05
期刊：
The Lancet. Infectious diseases
影响因子：
--
作者：
Marks M;Millat-Martinez P;Ouchi D;Roberts CH;Alemany A;Corbacho-Monné M;Ubals M;Tobias A;Tebé C;Ballana E;Bassat Q;Baro B;Vall-Mayans M;G-Beiras C;Prat N;Ara J;Clotet B;Mitjà O
通讯作者：
Mitjà O
影响因子：
9.4
作者：
Binnicker MJ
通讯作者：
Binnicker MJ