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2020 ; 129
(ä): 104473
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gab.com Text
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Alltest rapid lateral flow immunoassays is reliable in diagnosing SARS-CoV-2
infection from 14 days after symptom onset: A prospective single-center study
#MMPMID32504945
Pérez-García F
; Pérez-Tanoira R
; Romanyk J
; Arroyo T
; Gómez-Herruz P
; Cuadros-González J
J Clin Virol
2020[Aug]; 129
(ä): 104473
PMID32504945
show ga
OBJECTIVES: SARS-CoV-2 infection diagnosis is challenging in patients from 2 to 3
weeks after the onset of symptoms, due to the low positivity rate of the PCR.
Serologic tests could be complementary to PCR in these situations. The aim of our
study was to analyze the diagnostic performance of one serologic rapid test in
COVID-19 patients. METHODS: We evaluated a lateral flow immunoassay (AllTest
COVID-19 IgG/IgM) which detects IgG and IgM antibodies. We validated the
serologic test using serum samples from 100 negative patients (group 1) and 90
patients with COVID-19 confirmed by PCR (group 2). Then, we prospectively
evaluated the test in 61 patients with clinical diagnosis of pneumonia of unknown
etiology that were negative for SARS-CoV-2 by PCR (group 3). RESULTS: All 100
patients from group 1 were negative for the serologic test (specificity = 100 %).
Regarding group 2 (PCR-positive), the median time from their symptom onset until
testing was 17 days. For these 90 group-2 patients, the test was positive for
either IgM or IgG in 58 (overall sensitivity = 64.4 %), and in patients tested 14
days or more after the onset of symptoms, the sensitivity was 88.0 %. Regarding
the 61 group-3 patients, median time after symptom onset was also 17 days, and
the test was positive in 54 (88.5 % positivity). CONCLUSIONS: Our study shows
that Alltest lateral flow immunoassay is reliable as a complement of PCR to
diagnose SARS-CoV-2 infection after 14 days from the onset of symptoms and in
patients with pneumonia and negative PCR for SARS-CoV-2.