Article
Reference
Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2
RENZONI, Adriana Maria, et al.
Abstract
Extended community testing constitutes one of the main strategic pillars in controlling theCOVID-19 pandemic. Reverse transcription PCR (RT-PCR) targeting the SARS-CoV-2 genome onnasopharyngeal swab samples is currently the reference test. While displaying excellent analyticalsensitivity and specificity, this test is costly, often requires a substantial turnaround time, and, moreimportantly, is subject to reagent and other material shortages. To complement this technology,rapid antigen tests have been developed and made available worldwide, allowing cheap, quick, anddecentralized SARS-CoV-2 testing. The main drawback of these tests is the reduced sensitivity whenRT-PCR is the gold standard. In this study, we evaluate Visby an innovative, portable, easy-to-use RT-PCR point-of-care (POC) diagnostic device. Our retrospective analysis shows that overall, comparedto the Cobas 6800 RT-qPCR assay (Roche), this RT-PCR POC technology detects SARS-CoV-2 RNAwith 95% sensitivity (95%CI = 86.3–99%) and 100% specificity (95% CI = 80.5–100%). For sampleswith cycle-threshold values below 31, we observed 100% sensitivity (95% CI = [...]
RENZONI, Adriana Maria, et al . Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2. Diagnostics , 2021, vol. 11, no. 5, p. 813
DOI : 10.3390/diagnostics11050813 PMID : 33947153
Available at:
http://archive-ouverte.unige.ch/unige:151566
Disclaimer: layout of this document may differ from the published version.
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Device No.
Cobas CT E gene
VISBY Result
VISBY
Repetition Concordance Cobas Repetition
GeneXpert N / E gene
1 16 POS C
2 17 POS C
3 17 POS C
4 18 POS C
5 18 POS C
6 19 POS C
7 19 POS C
8 19 POS C
9 19 POS C
10 19 POS C
11 20 POS C
12 21 POS C
13 21 POS C
14 21 POS C
15 21 INV POS C
16 21 POS C
17 21 POS C
18 22 POS C
19 22 POS C
20 22 POS C
21 23 POS C
22 23 POS C
23 23 POS C
24 24 POS C
25 25 POS C
26 25 POS C
27 25 POS C
28 27 POS C
29 29 POS C
30 29 POS C
31 30 POS C
32 31 POS C 31
33 31 NEG NEG NC 31
34 33 POS C 35
39 27 POS C
40 17 POS C
41 16 POS C
42 19 POS C
43 26 POS C
44 17 POS C
45 17 POS C
46 32 POS C 33
47 22 POS C
48 18 POS C
49 25 POS C
50 17 POS C
51 26 POS C
52 23 POS C
53 25 POS C
54 21 POS C
55 20 POS C
56 21 POS C
57 26 POS C
58 34 POS C 34
59 32 POS C 34
60 34 NEG NC 34 37.8 / 34.5
61 0 NEG C
62 0 NEG C
63 0 NEG C
64 0 NEG C
65 0 NEG C
75 32 NEG NC 35.1 / 31.9
76 33 POS C
77 34 POS C
79 24 POS C
83 34 POS C
84 0 NEG C
85 0 NEG C
86 0 NEG C
87 0 NEG C
88 0 NEG C
89 0 NEG C
90 0 NEG C
91 0 NEG C
92 0 NEG C
93 0 NEG C
95 0 NEG C
96 0 NEG C
Supplemental Table 1. Positive and negative RT-qPCR Cobas samples tested on RT-PCR Visby diagnostic device. C = corncordant result; NC = Non-concordant results. INV= invalid result.
