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
- Resource Type
- Authors
- Nadine Gauchel; Daniel Duerschmied; Nils Elsen; Lukas Andreas Heger; Urte Sommerwerck; Christoph Bode; Ingo Ahrens; Marc Oette; Marina Rieder
- Source
- BMC Infectious Diseases. 22
- Subject
- medicine.medical_specialty
Cycle threshold
Coronavirus disease 2019 (COVID-19)
Clinical pathology
business.industry
SARS-CoV-2
Point-of-care testing
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
COVID-19
Diagnostic accuracy
Real-Time Polymerase Chain Reaction
Risk Assessment
Sensitivity and Specificity
COVID-19 Testing
Infectious Diseases
Point-of-Care Testing
Emergency medicine
medicine
Humans
Prospective Studies
Risk assessment
business
- Language
- ISSN
- 1471-2334
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™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 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.