Sensibility and Specificity of the VitaPCR™ SARS-CoV-2 Assay for the Rapid Diagnosis of COVID-19 in Older Adults in the Emergency Department

Overview

Journal Viruses

Publisher MDPI

Specialty Microbiology

Date 2023 Jan 21

PMID 36680229

Authors

Francesco Piacenza

Antonio Cherubini

Roberta Galeazzi

Maurizio Cardelli

Robertina Giacconi

Elisa Pierpaoli

Francesca Marchegiani

Fiorella Marcheselli

Rina Recchioni

Tiziana Casoli

Elisabetta Farnocchia

Beatrice Bartozzi

Belinda Giorgetti

Pierpaolo Stripoli

Anna Rita Bonfigli

Massimiliano Fedecostante

Fabio Salvi

Adolfo Pansoni

Mauro Provinciali

Fabrizia Lattanzio

Affiliations

Soon will be listed here.

Abstract

(1) Background: During the COVID-19 pandemic, rapid and reliable diagnostic tools are needed for detecting SARS-CoV-2 infection in urgent cases at admission to the hospital. We aimed to assess the performances of the rapid molecular VitaPCR™ test (Menarini Diagnostics) in a sample of older adults admitted to the Emergency Department of two Italian hospitals (2) Methods: The comparison between the rapid VitaPCR™ and the RT-PCR was performed in 1695 samples. Two naso-pharyngeal swab samplings from each individual were obtained and processed using the VitaPCR™ and the RT-PCR for the detection of SARS-CoV-2 (3) Results: VitaPCR™ exhibited good precision (<3% CV) and an almost perfect overall agreement (Cohen’s K = 0.90) with the RT-PCR. The limit of detection of the VitaPCR™ was 4.1 copies/µL. Compared to the RT-PCR, the sensitivity, the specificity, and the positive and negative predictive values of VitaPCR™ were 83.4%, 99.9%, 99.2% and 98.3%, respectively (4) Conclusions: The VitaPCR™ showed similar sensitivity and specificity to other molecular-based rapid tests. This study suggests that the VitaPCR™ can allow the rapid management of patients within the Emergency Department. Nevertheless, it is advisable to obtain a negative result by a RT-PCR assay before admitting a patient to a regular ward.

References

Trombley Hall A, McKay Zovanyi A, Christensen D, Koehler J, Devins Minogue T . Evaluation of inhibitor-resistant real-time PCR methods for diagnostics in clinical and environmental samples. PLoS One. 2013; 8(9):e73845. PMC: 3767612. DOI: 10.1371/journal.pone.0073845. View

Wolters F, van de Bovenkamp J, van den Bosch B, van den Brink S, Broeders M, Chung N . Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic. J Clin Virol. 2020; 128:104426. PMC: 7211760. DOI: 10.1016/j.jcv.2020.104426. View

Lee S, Kim T, Lee E, Lee C, Kim H, Rhee H . Clinical Course and Molecular Viral Shedding Among Asymptomatic and Symptomatic Patients With SARS-CoV-2 Infection in a Community Treatment Center in the Republic of Korea. JAMA Intern Med. 2020; 180(11):1447-1452. PMC: 7411944. DOI: 10.1001/jamainternmed.2020.3862. View

Tu Y, Iqbal J, OLeary T . Sensitivity of ID NOW and RT-PCR for detection of SARS-CoV-2 in an ambulatory population. Elife. 2021; 10. PMC: 8081522. DOI: 10.7554/eLife.65726. View

Ricco M, Ferraro P, Gualerzi G, Ranzieri S, Henry B, Said Y . Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data. J Clin Med. 2020; 9(5). PMC: 7290955. DOI: 10.3390/jcm9051515. View

Drain P . Rapid Diagnostic Testing for SARS-CoV-2. N Engl J Med. 2022; 386(3):264-272. PMC: 8820190. DOI: 10.1056/NEJMcp2117115. View

Gan W, Lim J, Koh D . Preventing Intra-hospital Infection and Transmission of Coronavirus Disease 2019 in Health-care Workers. Saf Health Work. 2020; 11(2):241-243. PMC: 7102575. DOI: 10.1016/j.shaw.2020.03.001. View

Kinloch N, Ritchie G, Brumme C, Dong W, Dong W, Lawson T . Suboptimal Biological Sampling as a Probable Cause of False-Negative COVID-19 Diagnostic Test Results. J Infect Dis. 2020; 222(6):899-902. PMC: 7337811. DOI: 10.1093/infdis/jiaa370. View

Provenzano D, Sitzman B, Florentino S, Buterbaugh G . Clinical and economic strategies in outpatient medical care during the COVID-19 pandemic. Reg Anesth Pain Med. 2020; 45(8):579-585. PMC: 7402455. DOI: 10.1136/rapm-2020-101640. View

10.

Birkmeyer J, Barnato A, Birkmeyer N, Bessler R, Skinner J . The Impact Of The COVID-19 Pandemic On Hospital Admissions In The United States. Health Aff (Millwood). 2020; 39(11):2010-2017. PMC: 7769002. DOI: 10.1377/hlthaff.2020.00980. View

11.

Fournier P, Zandotti C, Ninove L, Prudent E, Colson P, Gazin C . Contribution of VitaPCR SARS-CoV-2 to the emergency diagnosis of COVID-19. J Clin Virol. 2020; 133:104682. PMC: 7598902. DOI: 10.1016/j.jcv.2020.104682. View

12.

Wee S, Sivalingam S, Yap E . Rapid Direct Nucleic Acid Amplification Test without RNA Extraction for SARS-CoV-2 Using a Portable PCR Thermocycler. Genes (Basel). 2020; 11(6). PMC: 7349311. DOI: 10.3390/genes11060664. View

13.

Lee J, Song J . Diagnostic accuracy of the Cepheid Xpert Xpress and the Abbott ID NOW assay for rapid detection of SARS-CoV-2: A systematic review and meta-analysis. J Med Virol. 2021; 93(7):4523-4531. PMC: 8207078. DOI: 10.1002/jmv.26994. View

14.

Pan Y, Long L, Zhang D, Yuan T, Cui S, Yang P . Potential False-Negative Nucleic Acid Testing Results for Severe Acute Respiratory Syndrome Coronavirus 2 from Thermal Inactivation of Samples with Low Viral Loads. Clin Chem. 2020; 66(6):794-801. PMC: 7184485. DOI: 10.1093/clinchem/hvaa091. View

15.

Hogan C, Sahoo M, Huang C, Garamani N, Stevens B, Zehnder J . Five-minute point-of-care testing for SARS-CoV-2: Not there yet. J Clin Virol. 2020; 128:104410. PMC: 7194071. DOI: 10.1016/j.jcv.2020.104410. View

16.

Wee L, Conceicao E, Sim X, Aung M, Tan K, Wong H . Minimizing intra-hospital transmission of COVID-19: the role of social distancing. J Hosp Infect. 2020; 105(2):113-115. PMC: 7152925. DOI: 10.1016/j.jhin.2020.04.016. View

17.

Fitoussi F, Dupont R, Tonen-Wolyec S, Belec L . Performances of the VitaPCR™ SARS-CoV-2 Assay during the second wave of the COVID-19 epidemic in France. J Med Virol. 2021; 93(7):4351-4357. PMC: 8250980. DOI: 10.1002/jmv.26950. View

18.

Black J, Bailey C, Przewrocka J, Dijkstra K, Swanton C . COVID-19: the case for health-care worker screening to prevent hospital transmission. Lancet. 2020; 395(10234):1418-1420. PMC: 7162624. DOI: 10.1016/S0140-6736(20)30917-X. View

19.

Jehi L, Ji X, Milinovich A, Erzurum S, Rubin B, Gordon S . Individualizing Risk Prediction for Positive Coronavirus Disease 2019 Testing: Results From 11,672 Patients. Chest. 2020; 158(4):1364-1375. PMC: 7286244. DOI: 10.1016/j.chest.2020.05.580. View

20.

Hogan C, Garamani N, Lee A, Tung J, Sahoo M, Huang C . Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens. J Clin Microbiol. 2020; 58(8). PMC: 7383558. DOI: 10.1128/JCM.01072-20. View