Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room.
RT-PCR
SARS-CoV-2
accuracy
diagnosis
serology
Journal
Diagnostics (Basel, Switzerland)
ISSN: 2075-4418
Titre abrégé: Diagnostics (Basel)
Pays: Switzerland
ID NLM: 101658402
Informations de publication
Date de publication:
03 Sep 2020
03 Sep 2020
Historique:
received:
17
08
2020
revised:
31
08
2020
accepted:
31
08
2020
entrez:
9
9
2020
pubmed:
10
9
2020
medline:
10
9
2020
Statut:
epublish
Résumé
We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection. A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-real time PCRs (RT-PCRs) including six different gene targets, five serologic rapid diagnostic tests (RDT) and one ELISA. The final classification of infected/non-infected patients was performed using Latent Class Analysis combined with clinical re-assessment of incongruous cases. Out of these, 24.6% of patients were classified as infected. The molecular test RQ-SARS-nCoV-2 showed the highest performance with 91.8% sensitivity, 100% specificity, 100.0% PPV and 97.4% NPV respectively. Considering the single gene targets, Molecular tests for SARS-CoV-2 infection showed excellent specificity, but significant differences in sensitivity. Serological tests have limited utility in a clinical context.
Sections du résumé
BACKGROUND
BACKGROUND
We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection.
METHODS
METHODS
A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-real time PCRs (RT-PCRs) including six different gene targets, five serologic rapid diagnostic tests (RDT) and one ELISA. The final classification of infected/non-infected patients was performed using Latent Class Analysis combined with clinical re-assessment of incongruous cases.
RESULTS
RESULTS
Out of these, 24.6% of patients were classified as infected. The molecular test RQ-SARS-nCoV-2 showed the highest performance with 91.8% sensitivity, 100% specificity, 100.0% PPV and 97.4% NPV respectively. Considering the single gene targets,
CONCLUSION
CONCLUSIONS
Molecular tests for SARS-CoV-2 infection showed excellent specificity, but significant differences in sensitivity. Serological tests have limited utility in a clinical context.
Identifiants
pubmed: 32899333
pii: diagnostics10090669
doi: 10.3390/diagnostics10090669
pmc: PMC7555224
pii:
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : italian ministry of health
ID : ricerca corrente L1P6
Références
J Clin Microbiol. 2020 Apr 23;58(5):
pubmed: 32102856
Heliyon. 2020 Sep 10;6(9):e04929
pubmed: 32984615
Euro Surveill. 2020 Jan;25(3):
pubmed: 31992387
Chin Med J (Engl). 2020 Dec 10;134(4):475-477
pubmed: 33323816
BMJ. 2020 May 12;369:m1808
pubmed: 32398230
J Med Virol. 2020 Oct;92(10):1724-1727
pubmed: 32227490
J Clin Microbiol. 2020 May 26;58(6):
pubmed: 32269100
BMJ. 2018 Jan 18;360:j5779
pubmed: 29348126
J Med Virol. 2020 Sep;92(9):1518-1524
pubmed: 32104917
Ann Intern Med. 2020 Aug 18;173(4):262-267
pubmed: 32422057
Virusdisease. 2020 Jun;31(2):97-105
pubmed: 32656306
Health Technol Assess. 2007 Dec;11(50):iii, ix-51
pubmed: 18021577
J Allergy Clin Immunol. 2020 Jul;146(1):18-22
pubmed: 32389590
Public Health. 2020 May;182:170-172
pubmed: 32334183
N Engl J Med. 2020 Aug 6;383(6):e38
pubmed: 32502334
Eur J Clin Microbiol Infect Dis. 2020 Dec;39(12):2271-2277
pubmed: 32681308
J Clin Epidemiol. 2009 Aug;62(8):797-806
pubmed: 19447581
Front Med (Lausanne). 2021 Apr 12;8:569266
pubmed: 33912572
Clin Microbiol Infect. 2020 Aug;26(8):1094.e7-1094.e10
pubmed: 32502646
Intensive Care Med. 2020 Aug;46(8):1590-1593
pubmed: 32504103
J Infect Dis. 2020 Jul 6;222(3):362-366
pubmed: 32473021
Stat Methods Med Res. 2000 Jun;9(3):231-48
pubmed: 11084706
Clin Exp Pediatr. 2020 Jul;63(7):239-250
pubmed: 32664709
BMJ. 2020 Jul 1;370:m2516
pubmed: 32611558
BMJ Open. 2016 Nov 14;6(11):e012799
pubmed: 28137831
J Clin Virol. 2020 Jul;128:104413
pubmed: 32403010
JAMA. 2020 Jun 9;323(22):2249-2251
pubmed: 32374370
BMJ. 2020 Apr 8;369:m1403
pubmed: 32269032
Infect Ecol Epidemiol. 2020 Apr 14;10(1):1754538
pubmed: 32363011
J Clin Microbiol. 2020 May 26;58(6):
pubmed: 32245835
J Infect. 2020 Jul;81(1):e28-e32
pubmed: 32283141
Emerg Microbes Infect. 2020 Dec;9(1):747-756
pubmed: 32196430
J Clin Pathol. 2020 Jul;73(7):370-377
pubmed: 32404473