Abstract
Introduction: Quickly identifying positive cases of SARS-CoV-2 is an effective method of reducing transmission.
The objective of the study was to determine the sensitivity of the respiratory panel of the Film Array to detect SARS-CoV-2 in a pediatric hospital population.
Material and Method: Study of diagnostic tests. The Film Array respiratory panel, a rapid PCR system (1 hour) was compared with the conventional RT-PCR (RocheDiagnostic Ltd, Forrenstrasse Swizerland), from the hospital laboratory as a gold standard. Patient from 0 to 18 years old with indication for nasopharyngeal swab for SARS-CoV-2 were included. In the laboratory the sample was divided into 2 aliquots, one for conventional RT- PCR and the other for the study with the Film Array and they were analyzed independently and blindly. The demographic variables, place and reason for sampling, presence of comorbidities and vulnerable family contact, were collected using the Google form and analyzed with SPSS, and the Alan Schwartz’s diagnostic test. The protocol was approved by the institutional ethics committee.
Results: 339 patients entered the study with a median age of 5 years (IQR 1-11),51% female,46% for respiratory symptoms, 41.6% for room protocol, 12.4% contact. 14% were positive by RT_ PCR and 18.5% by Film Array, concordance r = 0.8. Sensitivity was 98%, Specificity 95% PPV 75% and NPV 99% LR + 18 (95% CI 11-29) and LR – 0.02 (95% CI 00-0.15) Post-test probability 75% (95% CI 64- 83).
Conclusions: The respiratory panel of the Film Array presented a high sensitivity with a LR+ 18 and LR – 0,02 and a post-test probability of 75%.
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