期刊
JOURNAL OF CLINICAL MICROBIOLOGY
卷 59, 期 6, 页码 -出版社
AMER SOC MICROBIOLOGY
DOI: 10.1128/JCM.03271-20
关键词
diagnosis; LamPORE; nanopore sequencing; SARS-CoV-2
类别
资金
- National Institute for Health Research (NIHR) Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford
- Public Health England (PHE)
- NIHR Oxford Biomedical Research Centre
- Wellcome Trust [110110/Z/15/Z, 110058/Z/15/Z]
- Wellcome Trust [110058/Z/15/Z] Funding Source: Wellcome Trust
LamPORE is a novel diagnostic platform for detecting SARS-CoV-2 RNA with high sensitivity and specificity, making it suitable for high-throughput testing.
LamPORE is a novel diagnostic platform for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA combining loop-mediated isothermal amplification with nanopore sequencing, which could potentially be used to analyze thousands of samples per day on a single instrument. We evaluated the performance of LamPORE against reverse transcriptase PCR (RT-PCR) using RNA extracted from spiked respiratory samples and stored nose and throat swabs collected at two UK hospitals. The limit of detection of LamPORE was 10 genome copies/ ml of extracted RNA, which is above the limit achievable by RT-PCR, but was not associated with a significant reduction of sensitivity in clinical samples. Positive clinical specimens came mostly from patients with acute symptomatic infection, and among them, LamPORE had a diagnostic sensitivity of 99.1% (226/228; 95% confidence interval [CI], 96.9% to 99.9%). Among negative clinical specimens, including 153 with other respiratory pathogens detected, LamPORE had a diagnostic specificity of 99.6% (278/279; 98.0% to 100.0%). Overall, 1.4% (7/514; 0.5% to 2.9%) of samples produced an indeterminate result on first testing, and repeat LamPORE testing on the same RNA extract had a reproducibility of 96.8% (478/494; 94.8% to 98.1%). LamPORE has a similar performance as RT-PCR for the diagnosis of SARS-CoV-2 infection in symptomatic patients and offers a promising approach to high-throughput testing.
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