Heger, Lukas Andreas, Elsen, Nils, Rieder, Marina, Gauchel, Nadine, Sommerwerck, Urte, Bode, Christoph, Duerschmied, Daniel, Oette, Mark and Ahrens, Ingo (2022). Clinical analysis on diagnostic accuracy of Bosch Vivalytic SARS-CoV-2 point-of-care test and evaluation of cycle threshold at admission for COVID-19 risk assessment. BMC Infect. Dis., 22 (1). LONDON: BMC. ISSN 1471-2334

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Abstract

Background Point-of-care (POC) polymerase chain reaction (PCR) tests have the ability to improve testing efficiency in the Coronavirus disease 2019 (COVID-19) pandemic. However, real-world data on POC tests is scarce. Objective To evaluate the efficiency of a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) POC test in a clinical setting and examine the prognostic value of cycle threshold (CT) on admission on the length of hospital stay (LOS) in COVID-19 patients. Methods Patients hospitalised between January and May 2021 were included in this prospective cohort study. Patients' nasopharyngeal swabs were tested for SARS-CoV-2 with Allplex (TM) 2019-nCoV (Seegene Inc.) real-time (RT) PCR assay as gold standard as well as a novel POC test (Bosch Vivalytic SARS-CoV-2 [Bosch]) and the SARS-CoV-2 Rapid Antigen Test (Roche) accordingly. Clinical sensitivity and specificity as well as inter- and intra-assay variability were analyzed. Results 120 patients met the inclusion criteria with 46 (38%) having a definite COVID-19 diagnosis by RT-PCR. Bosch Vivalytic SARS-CoV-2 POC had a sensitivity of 88% and specificity of 96%. The inter- and intra- assay variability was below 15%. The CT value at baseline was lower in patients with LOS >= 10 days when compared to patients with LOS < 10 days (27.82 (+/- 4.648) vs. 36.2 (25.9-39.18); p = 0.0191). There was a negative correlation of CT at admission and LOS (r[44](s) = - 0.31; p = 0.038) but only age was associated with the probability of an increased LOS in a multiple logistic regression analysis (OR 1.105 [95% CI, 1.03-1.19]; p = 0.006). Conclusion Our data indicate that POC testing with Bosch Vivalytic SARS-CoV-2 is a valid strategy to identify COVID-19 patients and decrease turnaround time to definite COVID-19 diagnosis. Also, our data suggest that age at admission possibly with CT value as a combined parameter could be a promising tool for risk assessment of increased length of hospital stay and severity of disease in COVID-19 patients.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Heger, Lukas AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Elsen, NilsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rieder, MarinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gauchel, NadineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sommerwerck, UrteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bode, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Duerschmied, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oette, MarkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ahrens, IngoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-669933
DOI: 10.1186/s12879-022-07447-7
Journal or Publication Title: BMC Infect. Dis.
Volume: 22
Number: 1
Date: 2022
Publisher: BMC
Place of Publication: LONDON
ISSN: 1471-2334
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
Infectious DiseasesMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/66993

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