Validation of SARS-CoV-2 detection across multiple specimen types.

Validasi deteksi SARS-CoV-2 pada berbagai jenis spesimen.

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ID: 106810
2020
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Ranked #6 of 20 articles by views in journal of clinical virology : the official publication of the pan american society for clinical virology

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Abstract
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused considerable disruption across the world, resulting in more than 235,000 deaths since December 2019. SARS-CoV-2 has a wide tropism and detection of the virus has been described in multiple specimen types, including various respiratory secretions, cerebrospinal fluid, and stool.To evaluate the accuracy and sensitivity of a laboratory modified CDCbased SARS-CoV-2 N1 and N2 assay across a range of sample types. Study Design We compared the matrix effect on the analytical sensitivity of SARS-CoV-2 detection by qRT-PCR in nasal swabs collected in viral transport medium (VTM), bronchoalveolar lavage (BAL), sputum, plasma, cerebral spinal fluid (CSF), stool, VTM, phosphate buffered saline (PBS), and Hanks' Balanced Salt Solution (HBSS). Initial limits of detection (LoD) were subsequently narrowed to confirm an LoD for each specimen type and target gene.LoDs were established using a modified CDC-based laboratory developed test and ranged from a mean CT cut-off of 33.8-35.7 (10-20 copies/reaction) for the N1 gene target, and 34.0-36.2 (1-10 copies/reaction) for N2. Alternatives to VTM such as PBS and HBSS had comparable LoDs. The N2 gene target was found to be most sensitive in CSF.A modified CDC-based laboratory developed test is able to detect SARSCoV- 2 accurately with similar sensitivity across all sample types tested.
*Severe Acute Respiratory Syndrome Coronavirus 2* (SARS-CoV-2) telah menyebabkan disrupsi yang signifikan di seluruh dunia, mengakibatkan lebih dari 235.000 kematian sejak Desember 2019. SARS-CoV-2 memiliki tropisme yang luas dan deteksi virus ini telah dilaporkan pada berbagai jenis spesimen, termasuk berbagai sekresi pernapasan, cairan serebrospinal, dan feses. Untuk mengevaluasi akurasi dan sensitivitas uji SARS-CoV-2 N1 dan N2 berbasis CDC yang dimodifikasi di laboratorium pada berbagai jenis sampel. Desain Studi Kami membandingkan efek matriks terhadap sensitivitas analitis deteksi SARS-CoV-2 menggunakan qRT-PCR pada usap hidung yang dikumpulkan dalam *viral transport medium* (VTM), bilasan bronkoalveolar (*bronchoalveolar lavage*/BAL), sputum, plasma, cairan serebrospinal (*cerebrospinal fluid*/CSF), feses, VTM, *phosphate buffered saline* (PBS), dan *Hanks' Balanced Salt Solution* (HBSS). Batas deteksi awal (*limits of detection*/LoD) selanjutnya dipersempit untuk mengonfirmasi LoD bagi setiap jenis spesimen dan gen target. LoD ditetapkan menggunakan *laboratory developed test* berbasis CDC yang dimodifikasi dan berkisar dari ambang batas CT (*CT cut-off*) rata-rata 33,8–35,7 (10–20 kopi/reaksi) untuk gen target N1, dan 34,0–36,2 (1–10 kopi/reaksi) untuk N2. Alternatif pengganti VTM seperti PBS dan HBSS memiliki LoD yang sebanding. Gen target N2 ditemukan paling sensitif pada CSF. Suatu *laboratory developed test* berbasis CDC yang dimodifikasi mampu mendeteksi SARS-CoV-2 secara akurat dengan sensitivitas yang serupa di semua jenis sampel yang diuji.
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Authors Perchetti, Garrett A;Nalla, Arun K;Huang, Meei-Li;Zhu, Haiying;Wei, Yulun;Stensland, Larry;Loprieno, Michelle A;Jerome, Keith R;Greninger, Alexander L;
Journal journal of clinical virology : the official publication of the pan american society for clinical virology
Year 2020
DOI
S1386-6532(20)30180-3
URL
Keywords
coronavirus sensitivity csf sars-cov-2 bal specimen type

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