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Clin Biochem . Comparison of serologic and molecular SARS-CoV 2 results in a large cohort in Southern Tuscany demonstrates a role for serologic test

tetano

Editor, Senior Moderator
Clin Biochem


. 2020 Jul 20;S0009-9120(20)30791-8.
doi: 10.1016/j.clinbiochem.2020.07.002. Online ahead of print.
Comparison of serologic and molecular SARS-CoV 2 results in a large cohort in Southern Tuscany demonstrates a role for serologic testing to increase diagnostic sensitivity


Alessandro Pancrazzi[SUP] 1 [/SUP], Pasqualino Magliocca[SUP] 2 [/SUP], Maria Lorubbio[SUP] 3 [/SUP], Guendalina Vaggelli[SUP] 4 [/SUP], Angelo Galano[SUP] 4 [/SUP], Manuela Mafucci[SUP] 2 [/SUP], Diletta Duranti[SUP] 5 [/SUP], Monica Cortesi[SUP] 2 [/SUP], Erica Mazzeschi[SUP] 2 [/SUP], Sara Fabbroni[SUP] 5 [/SUP], Gianluca Viti[SUP] 5 [/SUP], Alessandro Tartaglia Polcini[SUP] 4 [/SUP], Emanuela Tripodo[SUP] 6 [/SUP], Paola Sanchini[SUP] 6 [/SUP], Silvana Gervino[SUP] 7 [/SUP], Danilo Tacconi[SUP] 8 [/SUP], Simona Dei[SUP] 9 [/SUP], Monica Mazzierli[SUP] 2 [/SUP], Antonio D'Urso[SUP] 10 [/SUP], Agostino Ognibene[SUP] 5 [/SUP]



Affiliations

Abstract

Background: Since February 2019, Italian hospitals registered COVID-19 (COronaVIrus Disease 19) cases more often than the rest of the country. During this epidemic, health authorities requested swab tests, whileseeking new patient paths.
Methods: A dual laboratory approach was evaluated, consisting ofpatient care reports for viral RNA detection on swabs and rapid serological tests in 516 patients (192 symptomatic or paucisymptomatic and 324 asymptomatic).
Results: We found the molecular positive fraction equal to 12% (23/192) among symptomatic/paucisymptomatic (S/P) and 15.4% (50/324) in asymptomatic (As) sets. Among subsets, we observed serologically positive results, corresponding to 35% (8/23) for S/P and 38% (19/50) for As. Among molecular negative cases, we detected specific Immunoglobulin G or M (Ig G or Ig M) positivity in the S/P cohort equal to 6.6% (11/167) and 6% (15/246) in As cases. For indeterminate molecular results, we found S/P serological positivity equal to 100% (1/1) and 54% (13/24) in As patients. Wefound higher (p<0.05) seropositivity in older patients (n=8) among symptomatic and positives for viral RNA (n.23).
Conclusions: It has been observed that a dual approach of serological and molecular tests detects a higher absolute number of disease cases in a pandemic context,whichcould improve monitoring and health surveillance efficacy. The age-related seropositivity frequency in this study, if confirmed, could enhance the validity of serological tests, especially in older patients.In these subjects, molecular positivity accompanied by serological positivity (distinct for M and G immunoglobulins) should help determine disease status and support decisions related to patient management.

Keywords: COronaVIrus Disease 19; _serological tests; asymptomatic patients; swabs; symptomatic/paucisymptomaticpatients.
 
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